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73 results on '"Carrozza F."'

1. READY: REAl-world Data from an Italian compassionate use program of avelumab first-line maintenance for locallY advanced or metastatic urothelial carcinoma

Author: Antonuzzo, L., Maruzzo, M., De Giorgi, U., Santini, D., Tambaro, R., Buti, S., Carrozza, F., Calabrò, F., Di Lorenzo, G., Fornarini, G., Iacovelli, R., Cullurà, D., Messina, C., Cerbone, L., Fazzi, G., Venturini, F., Colasanto, R., Necchi, A., and Bracarda, S.
Published: 2024
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2. Fluorouracil and dose-dense adjuvant chemotherapy in patients with early-stage breast cancer (GIM2): end-of-study results from a randomised, phase 3 trial

Author: Venturini, M, Abate, A, Pastorino, S, Canavese, G, Vecchio, C, Guenzi, M, Lambertini, M, Levaggi, A, Giraudi, S, Accortanzo, V, Floris, C.A., Aitini, E, Fornari, G, Miraglia, S, Buonfanti, G, Cherchi, M.C., Petrelli, F, Vaccaro, A, Magnolfi, E, Contu, A, Labianca, R, Parisi, A, Basurto, C, Cappuzzo, F, Merlano, M, Russo, S, Mansutti, M, Poletto, E, Nardi, M, Grasso, D, Fontana, A, Isa, L, Comandè, M, Cavanna, L, Iacobelli, S, Milani, S, Mustacchi, G, Venturini, S, Scinto, A.F., Sarobba, M.G., Pugliese, P, Bernardo, A, Pavese, I, Coccaro, M, Massidda, B, Ionta, M.T., Nuzzo, A, Laudadio, L, Chiantera, V, Dottori, R, Barduagni, M, Castiglione, F, Ciardiello, F, Tinessa, V, Ficorella, A, Moscetti, L, Vallini, I, Giardina, G, Silva, R, Montedoro, M, Seles, E, Morano, F, Cruciani, G, Adamo, V, Pancotti, A, Palmisani, V, Ruggeri, A, Cammilluzzi, E, Carrozza, F, D'Aprile, M, Brunetti, M, Gallotti, P, Chiesa, E, Testore, F, D'Arco, A, Ferro, A, Jirillo, A, Pezzoli, M, Scambia, G, Iacono, C, Masullo, P, Tomasello, G, Gandini, G, Zoboli, A, Bottero, C, Cazzaniga, M, Genua, G, Palazzo, S, D'Amico, M, Perrone, D, Del Mastro, Lucia, Poggio, Francesca, Blondeaux, Eva, De Placido, Sabino, Giuliano, Mario, Forestieri, Valeria, De Laurentiis, Michelino, Gravina, Adriano, Bisagni, Giancarlo, Rimanti, Anita, Turletti, Anna, Nisticò, Cecilia, Vaccaro, Angela, Cognetti, Francesco, Fabi, Alessandra, Gasparro, Simona, Garrone, Ornella, Alicicco, Maria Grazia, Urracci, Ylenia, Mansutti, Mauro, Poletti, Paola, Correale, Pierpaolo, Bighin, Claudia, Puglisi, Fabio, Montemurro, Filippo, Colantuoni, Giuseppe, Lambertini, Matteo, and Boni, Luca
Published: 2022
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3. Association between asbestos exposure and pericardial and tunica vaginalis testis malignant mesothelioma: a case–control study and epidemiological remarks

Author: Marinaccio, A., Consonni, D., Mensi, C., Mirabelli, D., Migliore, E., Magnani, C., Di Marzio, D., Gennaro, V., Mazzoleni, G., Girardi, P., Negro, C., Romanelli, A., Chellini, E., Grappasonni, I., Madeo, G., Romeo, E., Ascoli, V., Carrozza, F., Angelillo, I. F., Cavone, D., Tumino, R., Melis, M., Curti, S., Brandi, G., Mattioli, S., Iavicoli, S., Dallari, B., Pesatori, A. C., Riboldi, L., Merletti, F., Gangemi, M., Stura, A., Brentisci, C., Gilardetti, M., Benfatto, L., Canessa, P. A., Malacarne, D., Mazzucco, G., Campi, M. G., Fedeli, U., Bressan, V., Gioffre, F., Ballarin, M. N., Chermaz, C., D'Agostin, F., De Michieli, P., Mangone, L., Storchi, C., Sala, O., Badiali, A. M., Cacciarini, V., Giovannetti, L., Martini, A., Calisti, R., Pascucci, C., Stracci, F., Masanotti, G., Davoli, M., Cavariani, F., Ancona, L., Annunziata, A., Menegozzo, S., Napolitano, F., Pelullo, C. P., Vimercati, L., Cascone, G., Frasca, G., Giurdanella, M. C., Martorana, C., Nicita, C., Rollo, C. P., Spata, E., Dardanoni, G., Scondotto, S., Nieddu, V., Pergola, M., Stecchi, S., Marinaccio, A., Consonni, D., Mensi, C., Mirabelli, D., Migliore, E., Magnani, C., Di Marzio, D., Gennaro, V., Mazzoleni, G., Girardi, P., Negro, C., Romanelli, A., Chellini, E., Grappasonni, I., Madeo, G., Romeo, E., Ascoli, V., Carrozza, F., Angelillo, I. F., Cavone, D., Tumino, R., Melis, M., Curti, S., Brandi, G., Mattioli, S., Iavicoli, S., Dallari, B., Pesatori, A. C., Riboldi, L., Merletti, F., Gangemi, M., Stura, A., Brentisci, C., Gilardetti, M., Benfatto, L., Canessa, P. A., Malacarne, D., Mazzucco, G., Campi, M. G., Fedeli, U., Bressan, V., Gioffre, F., Ballarin, M. N., Chermaz, C., D'Agostin, F., De Michieli, P., Mangone, L., Storchi, C., Sala, O., Badiali, A. M., Cacciarini, V., Giovannetti, L., Martini, A., Calisti, R., Pascucci, C., Stracci, F., Masanotti, G., Davoli, M., Cavariani, F., Ancona, L., Annunziata, A., Menegozzo, S., Napolitano, F., Pelullo, C. P., Vimercati, L., Cascone, G., Frasca, G., Giurdanella, M. C., Martorana, C., Nicita, C., Rollo, C. P., Spata, E., Dardanoni, G., Scondotto, S., Nieddu, V., Pergola, M., Stecchi, S., Marinaccio A., Consonni D., Mensi C., Mirabelli D., Migliore E., Magnani C., Di Marzio D., Gennaro V., Mazzoleni G., Girardi P., Negro C., Romanelli A., Chellini E., Grappasonni I., Madeo G., Romeo E., Ascoli V., Carrozza F., Angelillo I.F., Cavone D., Tumino R., Melis M., Curti S., Brandi G., Mattioli S., Iavicoli S., Dallari B., Pesatori A.C., Riboldi L., Merletti F., Gangemi M., Stura A., Brentisci C., Gilardetti M., Benfatto L., Canessa P.A., Malacarne D., Mazzucco G., Campi M.G., Fedeli U., Bressan V., Gioffre F., Ballarin M.N., Chermaz C., D'agostin F., De Michieli P., Mangone L., Storchi C., Sala O., Badiali A.M., Cacciarini V., Giovannetti L., Martini A., Calisti R., Pascucci C., Stracci F., Masanotti G., Davoli M., Cavariani F., Ancona L., Annunziata A., Menegozzo S., Napolitano F., Pelullo C.P., Vimercati L., Cascone G., Frasca G., Giurdanella M.C., Martorana C., Nicita C., Rollo C.P., Spata E., Dardanoni G., Scondotto S., Nieddu V., Pergola M., Stecchi S., Marinaccio, Alessandro, Consonni, Dario, Mensi, Carolina, Mirabelli, Dario, Migliore, Enrica, Magnani, Corrado, Di Marzio, Davide, Gennaro, Valerio, Mazzoleni, Guido, Girardi, Paolo, Negro, Corrado, Romanelli, Antonio, Chellini, Elisabetta, Grappasonni, Iolanda, Madeo, Gabriella, Romeo, Elisa, Ascoli, Valeria, Carrozza, Francesco, Angelillo, Italo Francesco, Cavone, Domenica, Tumino, Rosario, Melis, Massimo, Curti, Stefania, Brandi, Giovanni, Mattioli, Stefano, and Iavicoli, Sergio
Subjects: medicine.medical_specialty, pericardial and tunica vaginalis testis, Epidemiology, Population, rare disease, national registry, medicine.disease_cause, Epidemiology, Italy, National registry, Rare disease, Asbestos, epidemiology, Italy, national registry, rare disease, NO, 03 medical and health sciences, 0302 clinical medicine, italy, medicine, epidemiology, Italy, Mesothelioma, education, Gynecology, education.field_of_study, business.industry, Public Health, Environmental and Occupational Health, Tunica vaginalis testis, Case-control study, case–control study, Odds ratio, medicine.disease, asbestos, 030210 environmental & occupational health, National registry, exposure, mesothelioma, malignant mesothelioma, Original Article, Public aspects of medicine, RA1-1270, business, Rare disease
Abstract: Objectives: The purposes of this study are to describe the epidemiology of pericardial and tunica vaginalis testis mesothelioma and assess the role of asbestos exposure for these rare diseases. Methods: Based on incident pericardial and tunica vaginalis testis mesothelioma cases collected from the Italian national mesothelioma registry (ReNaM) in the period 1993–2015, incidence rates, survival median period and prognostic factors have been evaluated. A case–control study has been performed to analyze the association with asbestos exposure (occupational and non-occupational) for these diseases. Results: Between 1993 and 2015, 58 pericardial (20 women and 38 men) and 80 tunica vaginalis testis mesothelioma cases have been registered with a mean annual standardized (world standard population as reference) incidence rates of 0.049 (per million) in men and 0.023 in women for the pericardial site, and 0.095 for tunica vaginalis testis mesothelioma. Occupational exposure to asbestos was significantly associated with the risk of the diseases [odds ratio (OR) 3.68, 95% confidence interval (CI) 1.85–7.31 and OR 3.42, 95% CI 1.93–6.04 in pericardial and tunica vaginalis testis mesothelioma, respectively]. The median survival was 2.5 months for pericardial and 33.0 months for tunica vaginalis testis mesotheliomas. Age was the main predictive factor for survival for both anatomical sites. Conclusions: For the first time in an analytical study, asbestos exposure was associated with pericardial and tunica vaginalis testis mesothelioma risk, supporting the causal role of asbestos for all anatomical sites. The extreme rarity of the diseases, the poor survival and the prognostic role of age have been confirmed based on population and nationwide mesothelioma registry data.
Published: 2020

4. Authors’ response: Mezei et al's 'comments on a recent case-control study of malignant mesothelioma of the pericardium and the tunica vaginalis testis'

Author: Marinaccio A., Consonni D., Mensi C., Mirabelli D., Migliore E., Magnani C., Di Marzio D., Gennaro V., Mazzoleni G., Girardi P., Negro C., Romanelli A., Chellini E., Grappasonni I., Madeo G., Romeo E., Ascoli V., Carrozza F., Angelillo I. F., Cavone D., Tumino R., Melis M., Curti S., Brandi G., Mattioli S., Iavicoli S., Marinaccio, A., Consonni, D., Mensi, C., Mirabelli, D., Migliore, E., Magnani, C., Di Marzio, D., Gennaro, V., Mazzoleni, G., Girardi, P., Negro, C., Romanelli, A., Chellini, E., Grappasonni, I., Madeo, G., Romeo, E., Ascoli, V., Carrozza, F., Angelillo, I. F., Cavone, D., Tumino, R., Melis, M., Curti, S., Brandi, G., Mattioli, S., Iavicoli, S., Marinaccio A., Consonni D., Mensi C., Mirabelli D., Migliore E., Magnani C., Di Marzio D., Gennaro V., Mazzoleni G., Girardi P., Negro C., Romanelli A., Chellini E., Grappasonni I., Madeo G., Romeo E., Ascoli V., Carrozza F., Angelillo I.F., Cavone D., Tumino R., Melis M., Curti S., Brandi G., Mattioli S., and Iavicoli S.
Subjects: Mesothelioma, Tunica vaginalis testis, Economica, Letter, pericardial and tunica vaginalis testis (TVT), Socio-culturale, Ambientale, mesothelioma, ReNaM, Key terms: asbestos, Key terms: asbesto, Pericardium, Malignant mesothelioma
Abstract: Mezei et al's letter (1) is an opportunity to provide more details about our study on pericardial and tunica vaginalis testis (TVT) mesothelioma (2), which is based on the Italian national mesothelioma registry (ReNaM): a surveillance system on mesothelioma, with individual asbestos exposure assessment. Incidence of pericardial mesothelioma has been estimated around 0.5 and 0.2 cases per 10 million person-years in men and women, respectively, and around 1 case for TVT mesothelioma. ReNaM collected 138 cases thanks to its long period of observation (1993-2015) and national coverage. Conducting a population-based case-control study with incidence-density sampling of controls across Italy and over a 23 year time-span should have been planned in 1993 and would have been beyond feasibility and ReNaM scope. We rather exploited two existing series of controls (3). The resulting incomplete time- and spatial matching of cases and controls is a limitation of our study and has been acknowledged in our article. The analysis of case-control studies can nevertheless be accomplished in logistic models accounting for the variables of interest, in both individually and frequency matched studies (4). Furthermore, analyses restricted to (i) regions with enrolled controls, (ii) cases with definite diagnosis, (iii) incidence period 2000-2015, and (iv) subjects born before 1950 have been provided in the manuscript, confirming the strength of the association with asbestos exposure (supplemental material tables S4-7). Following Mezei et al's suggestion, we performed further sensitivity analyses by restriction to regions with controls and fitting conditional regression models using risk-sets made of combinations of age and year of birth categories (5-year classes for both). We confirmed positive associations with occupational exposure to asbestos of pericardial mesothelioma, with odds ratios (OR) (adjusted for region) of 9.16 among women [95% confidence interval (CI) 0.56-150] and 5.63 (95% CI 1.02-31.0) among men; for TVT mesothelioma the OR was 7.70 (95% CI 2.89-20.5). Using risk sets of age categories and introducing year of birth (5-year categories) as a covariate (dummy variables) the OR were similar: OR (adjusted for region) of 9.17 among women (95% CI 0.56-150) and 5.76 (95% CI 1.07-31.0) among men; for TVT the OR was 9.86 (95% CI 3.46-28.1). Possible bias from incomplete geographical overlap between cases and controls has been addressed in the paper (table S4) and above. In spatially restricted analyses, OR were larger than in those including cases from the whole country, indicating that bias was towards the null. Mezei et al further noted that "the regional distribution of controls is different from that of person-time observed". This objection is not relevant because the above analyses were adjusted by region. Our controls were provided by a population-based study on pleural mesothelioma (called MISEM) and a hospital-based study on cholangiocarcinoma (called CARA). In MISEM, the response rate was 48.4%, a low but not unexpected rate as participation among population controls is usually lower and has been declining over time (5). It is important to underline that ReNaM applied the same questionnaire that was used for interviews and carried out the same exposure assessment as both MISEM and CARA. As repeatedly stated in ReNaM papers (6-7), each regional operating center assesses asbestos exposure based on the individual questionnaire, other available information, and knowledge of local industries. Occupational exposure to asbestos is classified as definite, probable or possible. Occupational exposure is (i) definite when the subject`s work was reported or otherwise known to have involved the use of asbestos or asbestos-containing materials (MCA); (ii) probable when subjects worked in factories where asbestos or MCA were used, but their personal exposure could not be documented; and (iii) possible when they were employed in industrial activities known to entail the use of asbestos or MCA. Hence, the definite and probable categories are closer to one another and were combined in our analyses. In any case, restricting analyses to subjects with definite occupational exposure and using each set of controls separately, as suggested by Mezei et al, yielded elevated OR for TVT and pericardial mesothelioma among men using both the above described modelling strategies; the OR could not be calculated for women. There were 70 (25 pericardial and 45 TVT) occupationally exposed mesothelioma cases. In population-based studies, analyses by occupation are limited by the low prevalence of most specific jobs. As briefly reported in our paper, for purely descriptive purposes, the industrial activity of exposure (cases may have multiple exposures), were construction (22 exposures, 7 and 15 for pericardial and TVT mesotheliomas, respectively), steel mills and other metal working industries (4 and 11), textile industries (2 and 3), and agriculture (2 and 5); other sectors had lower exposure frequencies. The absence of industries like asbestos-cement production, shipbuilding and railway carriages production/repair should not be surprising and had already been observed (7). In the Italian multicenter cohort study of asbestos workers (8), given the person-years of observation accrued by workers employed in these industries and gender- and site-specific crude incidence rates, approximately 0.1 case of pericardial and 0.2 of TVT mesothelioma would have been expected from 1970 to 2010. Even increasing ten-fold such figures to account for higher occupational risks among these workers would not change much. Asbestos exposure in agriculture has been repeatedly discussed in ReNaM reports (9: pages 70, 73, 128, 164 and 205). Exposure opportunities included the presence of asbestos in wine production, reuse of hessian bags previously containing asbestos, or construction and maintenance of rural buildings. Similarly, mesothelioma cases and agricultural workers exposed to asbestos have been noted in France (10). In conclusion, the additional analyses we performed according to Mezei et al's suggestions confirm the association between asbestos exposure and pericardial and TVT mesothelioma, supporting the causal role of asbestos for all mesotheliomas. ReNaM`s continuing surveillance system with national coverage is a precious platform for launching analytical studies on pleural and extra pleural mesothelioma. References 1. Mezei G, Chang ET, Mowat FS, Moolgavkar SH. Comments on a recent case-control study of malignant mesothelioma of the pericardium and the tunica vaginalis testis Scand J Work Environ Health. 2021;47(1):85-86. https://doi.org/10.5271/3909 2. Marinaccio A, Consonni D, Mensi C, Mirabelli D, Migliore E, Magnani C et al.; ReNaM Working Group. Association between asbestos exposure and pericardial and tunica vaginalis testis malignant mesothelioma: a case-control study and epidemiological remarks. Scand J Work Environ Health. 2020;46(6):609-617. https://doi.org/10.5271/sjweh.3895. 3. Greenland S. Control-initiated case-control studies. Int J Epidemiol 1985 Mar;14(1):130-4. https://doi.org/10.1093/ije/14.1.130. 4. Pearce N. Analysis of matched case-control studies. BMJ 2016 Feb;352:i969. https://doi.org/10.1136/bmj.i969. 5. Bigert C, Gustavsson P, Straif K, Pesch B, Brüning T, Kendzia B et al. Lung cancer risk among cooks when accounting for tobacco smoking: a pooled analysis of case-control studies from Europe, Canada, New Zealand, and China. J Occup Environ Med 2015 Feb;57(2):202-9. https://doi.org/10.1097/JOM.0000000000000337. 6. Marinaccio A, Binazzi A, Marzio DD, Scarselli A, Verardo M, Mirabelli D et al.; ReNaM Working Group. Pleural malignant mesothelioma epidemic: incidence, modalities of asbestos exposure and occupations involved from the Italian National Register. Int J Cancer 2012 May;130(9):2146-54. https://doi.org/10.1002/ijc.26229. 7. Marinaccio A, Binazzi A, Di Marzio D, Scarselli A, Verardo M, Mirabelli D et al. Incidence of extrapleural malignant mesothelioma and asbestos exposure, from the Italian national register. Occup Environ Med 2010 Nov;67(11):760-5. https://doi.org/10.1136/oem.2009.051466. 8. Ferrante D, Chellini E, Merler E, Pavone V, Silvestri S, Miligi L et al.; the working group. Italian pool of asbestos workers cohorts: mortality trends of asbestos-related neoplasms after long time since first exposure. Occup Environ Med 2017 Dec;74(12):887-98. https://doi.org/10.1136/oemed-2016-104100. 9. ReNaM VI Report. Available from: https://www.inail.it/cs/internet/docs/alg-pubbl-registro-nazionale-mesoteliomi-6-rapporto.pdf. Italian 10. Marant Micallef C, Shield KD, Vignat J, Baldi I, Charbotel B, Fervers B et al. Cancers in France in 2015 attributable to occupational exposures. Int J Hyg Environ Health 2019 Jan;222(1):22-9. https://doi.org/10.1016/j.ijheh.2018.07.015.
Published: 2021

5. Epirubicin, taxotere and fluorouracil modulated by folinic acid in the treatment of advanced gastric cancer: A phase II study of the Gruppo Oncologico dell’ Italia Meridionale (GOIM)

Author: Giuliani, F., Romito, S., Maiello, E., Capobianco, A., Carrozza, F., Nugnes, I., Misino, A., Valerio, M.R., Manzione, L., and Colucci, G.
Published: 2008
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6. 885P - Are adverse events (AEs) predictive of nivolumab activity? Data from the Italian expanded access program in metastatic renal cell carcinoma (mRCC)

Author: Verzoni, E., Cartenì, G., Cortesi, E., Roila, F., Vitale, M.G., Buti, S., Pignata, S., Cognetti, F., Giustini, L., Damiani, A., Turci, D., Sternberg, C.N., Porta, C., Carrozza, F., Tortora, G., Tassinari, D., Passalacqua, R., Pazzola, A., Surico, G., and Procopio, G.
Published: 2018
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7. Pretreatment quality of life and functional status assessment significantly predict survival of elderly patients with advanced non-small-cell lung cancer receiving chemotherapy: a prognostic analysis of the multicenter Italian lung cancer in the elderly study

Author: Maione, P, Perrone, F, Gallo, C, Manzione, L, Piantedosi, F, Barbera, S, Cigolari, S, Rosetti, F, Piazza, E, Robbiati, Sf, Bertetto, O, Novello, S, Migliorino, Mr, Favaretto, A, Spatafora, M, Ferraù, F, Frontini, L, Bearz, A, Repetto, L, Gridelli, C, Barletta, E, Barzelloni, Ml, Iaffaioli, Rv, DE MAIO, E, DI MAIO, M, DE FEO, G, Sigoriello, G, Chiodini, P, Cioffi, A, Guardasole, V, Angelini, V, Rossi, A, Bilancia, D, Germano, D, Lamberti, A, Pontillo, V, Brancaccio, L, Renda, F, Romano, F, Esani, G, Gambaro, A, Vinante, O, Azzarello, G, Clerici, M, Bollina, R, Belloni, P, Sannicolò, M, Ciuffreda, L, Parello, G, Cabiddu, M, Sacco, C, Sibau, A, Porcile, G, Castiglione, F, Ostellino, O, Monfardini, S, Stefani, M, Scagliotti, G, Selvaggi, G, DE MARINIS, F, Martelli, O, Gasparini, G, Morabito, A, Gattuso, D, Colucci, G, Galetta, D, Giotta, F, Gebbia, V, Borsellino, N, Testa, A, Malaponte, E, Capuano, Ma, Angiolillo, M, Sollitto, F, Tirelli, U, Spazzapan, S, Adamo, V, Altavilla, G, Scimone, A, Hopps, Mr, Tartamella, F, Ianniello, Gp, Tinessa, V, Failla, G, Bordonaro, R, Gebbia, N, Valerio, Mr, D'Aprile, M, Veltri, E, Tonato, M, Darwish, S, Romito, S, Carrozza, F, Barni, S, Ardizzoia, A, Corradini, Gm, Pavia, G, Belli, M, Colantuoni, G, Galligioni, E, Caffo, O, Labianca, R, Quadri, A, Cortesi, Enrico, D'Auria, Giuliana, Fava, S, Calcagno, A, Luporini, G, Locatelli, Mc, DI COSTANZO, F, Gasperoni, S, Isa, L, Candido, P, Gaion, F, Palazzolo, G, Nettis, G, Annamaria, A, Rinaldi, M, Lopez, M, Felletti, R, DI NEGRO GB, Rossi, N, Calandriello, A, Maiorino, L, Mattioli, R, Celano, A, Schiavon, S, Illiano, A, Raucci, Ca, Caruso, M, Foa, P, Tonini, G, Curcio, C, Cazzaniga, M., MAIONE P, PERRONE F, GALLO C, MANZIONE L, PIANTEDOSI F, BARBERA S, CIGOLARI, ROSETTI F, PIAZZA E, ROBBIATI SF, BERTETTO O, NOVELLO S, MIGLIORINO MR, FAVARETTO A, SPATAFORA M, FERRAU F, FRONTINI L, BEARZ A, REPETTO L, GRIDELLI C, BARLETTA E, BARZELLONI ML, IAFFAIOLI RV, DE MAIO E, DI MAIO M, DE FEO G, SIGORIELLO G, CHIODINI P, CIOFFI A, GUARDASOLE V, ANGELINI V, ROSSI A, BILANCIA, GERMANO D, LAMBERTI A, PONTILLO V, BRANCACCIO L, RENDA F, ROMANO F, ESANI G, GAMBARO A, VINANTE O, AZZARELLO G, CLERICI M, BOLLINA R, BELLONI P, SANNICOLO M, CIUFFREDA L, PARELLO G, CABIDDU M, SACCO C, SIBAU A, PORCILE G, CASTIGLIONE F, OSTELLINO O, MONFARDINI S, STEFANI M, SCAGLIOTTI G, SELVAGGI G, DE MARINIS F, MARTELLI O, GASPARINI G, MORABITO A, GATTUSO D, COLUCCI G, GALETTA D, GIOTTA F, GEBBIA V, ET AL, Maione, P, Perrone, F, Gallo, Ciro, Manzione, L, Piantedosi, F, Barbera, S, Cigolari, S, Rosetti, F, Piazza, E, Robbiati, Sf, Bertetto, O, Novello, S, Migliorino, Mr, Favaretto, A, Spatafora, M, Ferrau, F, Frontini, L, Bearz, A, Repetto, L, and Gridelli, C.
Subjects: Male, Cancer Research, medicine.medical_specialty, Lung Neoplasms, Activities of daily living, Health Status, carcinoma, Vinblastine, Vinorelbine, Deoxycytidine, older people, Quality of life, Instrumental activitie, Carcinoma, Non-Small-Cell Lung, Internal medicine, Activities of Daily Living, Antineoplastic Combined Chemotherapy Protocols, medicine, Humans, Lung cancer, Aged, Aged, 80 and over, validation, Proportional hazards model, business.industry, QLQ-C30, Age Factors, Cancer, clinical trial, Prognosis, medicine.disease, Gemcitabine, Comorbidity, humanities, comorbidity, Oncology, Quartile, Quality of Life, Physical therapy, impact, Geriatric oncology, Female, business, Randomized-trial, medicine.drug
Abstract: Purpose To study the prognostic value for overall survival of baseline assessment of functional status, comorbidity, and quality of life (QoL) in elderly patients with advanced non—small-cell lung cancer treated with chemotherapy. Patients and Methods Data from 566 patients enrolled onto the phase III randomized Multicenter Italian Lung Cancer in the Elderly Study (MILES) study were analyzed. Functional status was measured as activities of daily living (ADL) and instrumental ADL (IADL). The presence of comorbidity was assessed with a checklist of 33 items; items 29 and 30 of the European Organisation for Research and Treatment of Cancer (EORTC) core questionnaire QLQ-C30 (EORTC QLQ-C30) were used to estimate QoL. ADL was dichotomized as none versus one or more dependency. For IADL and QoL, three categories were defined using first and third quartiles as cut points. Comorbidity was summarized using the Charlson scale. Analysis was performed by Cox model, and stratified by treatment arm. Results Better values of baseline QoL (P = .0003) and IADL (P = .04) were significantly associated with better prognosis, whereas ADL (P = .44) and Charlson score (P = .66) had no prognostic value. Performance status 2 (P = .006) and a higher number of metastatic sites (P = .02) also predicted shorter overall survival. Conclusions Pretreatment global QoL and IADL scores, but not ADL and comorbidity, have significant prognostic value for survival of elderly patients with advanced non—small-cell lung cancer who were treated with chemotherapy. Using these scores in clinical practice might improve prognostic prediction for treatment planning.
Published: 2005

8. Supportive care in patients with advanced non-small-cell lung cancer

Author: DI MAIO, Massimo, Perrone, F, Gallo, C, Iaffaioli, Rv, Manzione, L, Piantedosi, Fv, Cigolari, S, Illiano, A, Barbera, S, Robbiati, Sf, Piazza, E, Ianniello, Gp, Frontini, L, Veltri, E, Castiglione, F, Rosetti, F, De Maio, E, Maione, P, Gridelli, C, Rossi, A, Barletta, E, Barzelloni, Ml, Signoriello, G, Bilancia, D, Dinota, A, Rosati, G, Germano, D, Lamberti, A, Pontillo, V, Brancacio, L, Crispino, C, Esposito, M, Battiloro, C, Tufano, G, Cioffi, A, Guardasole, V, Angelini, V, Guidetti, G, Renda, F, Romano, F, Volpintesta, A, Sannicolò, M, Filipazzi, V, Esani, G, Gambaro, A, Ferrario, S, Tinessa, V, Caprio, Mg, Zonato, S, Cabiddu, M, Raina, A, D'Aprile, M, Pistillucci, G, Porcile, G, Ostellino, O, Vinante, O, Azzarello, G, Gebbia, V, Borsellino, N, Testa, A, Gasparini, G, Morabito, A, Gattuso, D, Romito, S, Carrozza, F, Fava, S, Calcagno, A, Grimi, E, Bertetto, O, Ciuffreda, L, Parello, G, Maiorino, L, Santoro, A, Santoro, M, Failla, G, Aiello, Ra, Bearz, A, Sorio, R, Scalone, S, Clerici, M, Bollina, R, Belloni, P, Sacco, C, Sibau, A, Adamo, V, Altavilla, G, Scimone, A, Spatafora, M, Bellia, V, Hopps, Mr, Monfardini, S, Favaretto, A, Stefani, M, Corradini, Gm, Pavia, G, Scagliotti, Giorgio Vittorio, Novello, Silvia, Selvaggi, G, Tonato, M, Darwish, S, Michetti, G, Belometti, Mo, Labianca, R, Quadri, A, De Marinis, F, Migliorino, Mr, Martelli, O, Colucci, G, Galetta, D, Giotta, F, Isa, L, Candido, P, Rossi, N, Calandriello, A, Ferraù, F, Malaponte, E, Barni, S, Cazzaniga, M, Gebbia, N, Valerio, Mr, Belli, M, Colantuoni, G, Capuano, Ma, Angiolillo, M, Sollitto, F, Ardizzoia, A, Luporini, G, Locatelli, Mc, Pari, F, Aitini, E, Pedicini, T, Febbraro, A, Zollo, C, Di Costanzo, F, Bartolucci, R, Gasperoni, S, Gaion, F, Palazzolo, G, Galligioni, E, Caffo, O, Cortesi, E, D'Auria, G, Curcio, C, Vasta, M, Bumma, C, Celano, A, Bretti, S, Nettis, G, Anselmo, A, Mattioli, R, Nisticò, C, Aschelter, A, Foa, P., DI MAIO, M, Perrone, F, Gallo, Ciro, Iaffaioli, Rv, Manzione, L, Piantedosi, Fv, Cigolari, S, Illiano, A, Barbera, S, Robbiati, Sf, Piazza, E, Ianniello, Gp, Frontini, L, Veltri, E, Castiglione, F, Rosetti, F, DE MAIO, E, Maione, P, and Gridelli, C.
Subjects: Adult, Male, concomitant drugs, Cancer Research, medicine.medical_specialty, Aging, Palliative care, Lung Neoplasms, medicine.medical_treatment, Vinorelbine, Vinblastine, Deoxycytidine, Clinical, Quality of life, Internal medicine, Carcinoma, Non-Small-Cell Lung, Antineoplastic Combined Chemotherapy Protocols, polypharmacotherapy, medicine, Humans, Lung cancer, Survival rate, Aged, Randomized Controlled Trials as Topic, Aged, 80 and over, Chemotherapy, Performance status, business.industry, Palliative Care, Middle Aged, medicine.disease, Gemcitabine, Surgery, Survival Rate, supportive care, lung cancer, Oncology, Concomitant, Quality of Life, Antiemetics, Female, Cisplatin, business, medicine.drug
Abstract: The present study describes supportive care (SC) in patients with advanced non-small-cell lung cancer (NSCLC), evaluating whether it is affected by concomitant chemotherapy, patient's performance status (PS) and age. Data of patients enrolled in three randomised trials of first-line chemotherapy, conducted between 1996 and 2001, were pooled. The analysis was limited to the first three cycles of treatment. Supportive care data were available for 1185 out of 1312 (90%) enrolled patients. Gastrointestinal drugs (45.7%), corticosteroids (33.4%) and analgesics (23.8%) were the most frequently observed categories. The mean number of drugs per patient was 2.43; 538 patients (45.4%) assumed three or more supportive drugs. Vinorelbine does not produce substantial variations in the SC pattern, while cisplatin-based treatment requires an overall higher number of supportive drugs, with higher use of antiemetics (41 vs 27%) and antianaemics (10 vs 4%). Patients with worse PS are more exposed to corticosteroids (42 vs 30%). Elderly patients require drugs against concomitant diseases significantly more than adults (20 vs 7%) and are less frequently exposed to antiemetics (12 vs 27%). In conclusion, polypharmacotherapy is a relevant issue in patients with advanced NSCLC. Chemotherapy does not remarkably affect the pattern of SC, except for some drugs against side effects. Elderly patients assume more drugs for concomitant diseases and receive less antiemetics than adults.
Published: 2004

9. S02 - Oral Anticancer Therapy Project: clinical utility of a specific home care nursing program

Author: Cirillo, M., Carlucci, L., Baldini, E., Sacco, C., Zagonel, V., Leo, S., Llimpe, F.L. Rojas, Tonini, G., Marialuisa, M., Alfredo, T., Farci, D., Sava, T., Zaninelli, M., Valori, V.M., Quaranta, A., Carrozza, F., Micheloni, B., Marchetti, F., Lunardi, G., Zamboni, S., Pinto, C., and Gori, S.
Published: 2016
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10. 790P - Activity of Sequential New Drugs (Nds) Post-Docetaxel (Doc) Failure, in Metastatic Castration-Resistant Prostate Cancer (Mcrpc) Patients (Pts). Update from a Multicenter Italian Experience

Author: Caffo, O., De Giorgi, U., Fratino, L., Facchini, G., Basso, U., Alesini, D., Gasparro, D., Ortega, C., Tucci, M., Verderame, F., Campadelli, E., Re, G. Lo, Sabbatini, R., Donini, M., Procopio, G., Sartori, D., Zucali, P.A., Carrozza, F., D'Angelo, A., and Morelli, F.
Published: 2014
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11. Cisplatin plus gemcitabine or vinorelbine for elderly patients with advanced non small-cell lung cancer: the MILES-2P studies.

Author: Gridelli C, Maione P, Illiano A, Piantedosi FV, Favaretto A, Bearz A, Robbiati SF, Filipazzi V, Lorusso V, Carrozza F, Iaffaioli RV, Manzione L, Gallo C, Morabito A, and Perrone F
Published: 2007

12. Prevalence and management of pain in Italian patients with advanced non-small-cell lung cancer.

Author: Maio, M Di, Gridelli, C, Gallo, C, Manzione, L, Brancaccio, L, Barbera, S, Robbiati, Sf, Lanniello, Gp, Ferraù, F, Piazza, E, Frontini, L, Rosetti, F, Carrozza, F, Bean, A, Spatafora, M, Adamo, V, Isa, L, Iaffaioli, Rv, Salvo, E Di, and Perrone, F
Subjects: LUNG cancer patients, PAIN management, ANALGESICS, DRUG therapy, VINORELBINE
Abstract: Pain is a highly distressing symptom for patients with advanced cancer. WHO analgesic ladder is widely accepted as a guideline for its treatment. Our aim was to describe pain prevalence among patients diagnosed with advanced non-small-cell lung cancer (NSCLC), impact of pain on quality of life (QoL) and adequacy of pain management. Data of 1021 Italian patients enrolled in three randomised trials of chemotherapy for NSCLC were pooled. QoL was assessed by EORTC QLQ-C30 and LC-13. Analgesic consumption during the 3 weeks following QoL assessment was recorded. Adequacy of pain management was evaluated by the Pain Management Index (PMI). Some pain was reported by 74% of patients (42% mild, 24% moderate and 7% severe); 50% stated pain was affecting daily activities (30% a little, 16% quite a bit, 3% very much). Bone metastases strongly affected presence of pain. Mean global QoL linearly decreased from 64.9 to 36.4 from patients without pain to those with severe pain (P<0.001). According to PMI, 616 out of 752 patients reporting pain (82%) received inadequate analgesic treatment. Bone metastases were associated with improved adequacy and worst pain with reduced adequacy at multivariate analysis. In conclusion, pain is common in patients with advanced NSCLC, significantly affects QoL, and is frequently undertreated. We recommend that: (i) pain self-assessment should be part of oncological clinical practice; (ii) pain control should be a primary goal in clinical practice and in clinical trials; (iii) physicians should receive more training in pain management; (iv) analgesic treatment deserves greater attention in protocols of anticancer treatment.British Journal of Cancer (2004) 90, 2288-2296. doi:10.1038/sj.bjc.6601810 www.bjcancer.com Published online 25 May 2004 [ABSTRACT FROM AUTHOR]
Published: 2004
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13. First-line cisplatin (P) with docetaxel (TXT) or vinorelbine (VNR) in patients with advanced non-small-cell lung cancer: A phase II randomized trial of Gruppo Oncologico Italia Meridionale

Author: Gebbia, V., Lorusso, V., Galetta, D., Caruso, M., Maiello, E., Riccardi, F., Carrozza, F., Borsellino, N., Leo, S., Ferraù, F., Cinieri, S., and Colucci, G.
Published: 2008
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14. Adjuvant anastrozole versus exemestane versus letrozole, upfront or after 2 years of tamoxifen, in endocrine-sensitive breast cancer (FATA-GIM3): a randomised, phase 3 trial

Author: Sabino De Placido, Ciro Gallo, Michelino De Laurentiis, Giancarlo Bisagni, Grazia Arpino, Maria Giuseppa Sarobba, Ferdinando Riccardi, Antonio Russo, Lucia Del Mastro, Alessio Aligi Cogoni, Francesco Cognetti, Stefania Gori, Jennifer Foglietta, Antonio Frassoldati, Domenico Amoroso, Lucio Laudadio, Luca Moscetti, Filippo Montemurro, Claudio Verusio, Antonio Bernardo, Vito Lorusso, Adriano Gravina, Gabriella Moretti, Rossella Lauria, Antonella Lai, Carmela Mocerino, Sergio Rizzo, Francesco Nuzzo, Paolo Carlini, Francesco Perrone, Antonello Accurso, Biagio Agostara, Michele Aieta, Oscar Alabiso, Maria Grazia Alicicco, Dino Amadori, Laura Amaducci, Gianna Amiconi, Giustino Antuzzi, Mara Ardine, Antonio Ardizzoia, Caterina Aversa, Giuseppe Badalamenti, Sandro Barni, Carlo Basurto, Rossana Berardi, Cinzia Bergamasco, Paolo Bidoli, Claudia Bighin, Edoardo Biondi, Corrado Boni, Karen Borgonovo, Mario Botta, Stefano Bravi, Paolo Bruzzi, Giuseppe Buono, Alfredo Butera, Alessia Caldara, Giampiero Candeloro, Claudia Cappelletti, Cinzia Cardalesi, Elisabetta Carfora, Anna Cariello, Francesco Carrozza, Giacomo Cartenì, Michele Caruso, Virginia Casadei, Claudia Casanova, Luigi Castori, Luigi Cavanna, Giovanna Cavazzini, Marina Cazzaniga, Mario Chilelli, Paolo Chiodini, Silvia Chiorrini, Fortunato Ciardiello, Mariangela Ciccarese, Saverio Cinieri, Mario Clerico, Mariarosa Coccaro, Mario Comande, Claudia Corbo, Giuseppina Cortino, Stefania Cusenza, Gennaro Daniele, Alfonso Maria D'arco, Giuliana D'auria, Claudio Dazzi, Carmine De Angelis, Filippo de Braud, Gianfranco De Feo, Andrea De Matteis, Michele De Tursi, Anna Di Blasio, Giuseppe di Lucca, Liberato Di Lullo, Francesca Di Rella, Gianfranco Di Renzo, Pia Di Stefano, Aida Di Stefano, Anna Diana, Sara Donati, Agnese Fabbri, Alessandra Fabi, Marina Faedi, Gabriella Farina, Antonio Farris, Antonio Febbraro, Palma Fedele, Piera Federico, Francesco Ferraù, Gianluigi Ferretti, Antonella Ferro, Irene Floriani, Rosachiara Forcignanò, Samantha Forciniti, Valeria Forestieri, Gianni Fornari, Michela Frisinghelli, Vittorio Fusco, Giulia Gallizzi, Antonio Galvano, Antonio Gambardella, Angelo Gambi, Vittorio Gebbia, Erika Gervasi, Mara Ghilardi, Alice Giacobino, Giovanni Giardina, Francesco Giotta, Sara Giraudi, Mario Giuliano, Antonino Grassadonia, Donatella Grasso, Federica Grosso, Lorenzo Guizzaro, Pasquale Incoronato, Lorena Incorvaia, Giovanni Iodice, Nicla La Verde, Vincenzo Labonia, Gabriella Landi, Agnese Latorre, Vita Leonardi, Alessia Levaggi, Gennaro Limite, Linda Lina Bascialla, Lorenzo Livi, Evaristo Maiello, Daniela Mandelli, Ilaria Marcon, Daniela Menon, Michele Montedoro, Lucia Moraca, Anna Moretti, Maria Grazia Morritti, Patrizia Morselli, Antonella Mura, Silvia Mura, Michela Musacchio, Alberto Muzio, Donato Natale, Clara Natoli, Cinzia Nigro, Cecilia Nisticò, Antonio Nuzzo, Michele Orditura, Laura Orlando, Carmen Pacilio, Giuliano Palumbo, Raffaella Palumbo, Felice Pasini, Emanuela Paterno, Antonio Pazzola, Silvia Pelliccioni, Matilde Pensabene, Davide Perroni, Angela Pesenti Gritti, Fausto Petrelli, Maria Carmela Piccirillo, Graziella Pinotti, Claudia Pogliani, Davide Poli, Sonia Prader, Francesco Recchia, Daniele Rizzi, Carmen Romano, Rosalba Rossello, Chiara Rossini, Giuseppina Salvucci, Valeria Sanna, Alessandra Santini, Silvana Saracchini, Clementina Savastano, Giovanni Scambia, Francesco Schettini, Paola Schiavone, Alessio Schirone, Elena Seles, Simona Signoriello, Giuseppe Signoriello, Rosa Rita Silva, Antonia Silvestri, Vittorio Simeon, Ilaria Spagnoletti, Stefano Tamberi, Cristina Teragni, Verena Thalmann, Renato Thomas, Guglielmo Thomas, Amelia Tienghi, Nicola Tinari, Vincenza Tinessa, Federica Tomei, Giuseppe Tonini, Valter Torri, Divina Traficante, Marianna Tudini, Monica Turazza, Roberto Vignoli, Maria Giuseppa Vitale, Alessandra Zacchia, Pasquale Zagarese, Alda Zanni, Laura Zavallone, Maria Zavettieri, Alessandra Zoboli, De Placido, S., Gallo, C., De Laurentiis, M., Bisagni, G., Arpino, G., Sarobba, M. G., Riccardi, F., Russo, A., Del Mastro, L., Cogoni, A. A., Cognetti, F., Gori, S., Foglietta, J., Frassoldati, A., Amoroso, D., Laudadio, L., Moscetti, L., Montemurro, F., Verusio, C., Bernardo, A., Lorusso, V., Gravina, A., Moretti, G., Lauria, R., Lai, A., Mocerino, C., Rizzo, S., Nuzzo, F., Carlini, P., Perrone, F., Accurso, A., Agostara, B., Aieta, M., Alabiso, O., Alicicco, M. G., Amadori, D., Amaducci, L., Amiconi, G., Antuzzi, G., Ardine, M., Ardizzoia, A., Aversa, C., Badalamenti, G., Barni, S., Basurto, C., Berardi, R., Bergamasco, C., Bidoli, P., Bighin, C., Biondi, E., Boni, C., Borgonovo, K., Botta, M., Bravi, S., Bruzzi, P., Buono, G., Butera, A., Caldara, A., Candeloro, G., Cappelletti, C., Cardalesi, C., Carfora, E., Cariello, A., Carrozza, F., Carteni, G., Caruso, M., Casadei, V., Casanova, C., Castori, L., Cavanna, L., Cavazzini, G., Cazzaniga, M., Chilelli, M., Chiodini, P., Chiorrini, S., Ciardiello, F., Ciccarese, M., Cinieri, S., Clerico, M., Coccaro, M., Comande, M., Corbo, C., Cortino, G., Cusenza, S., Daniele, G., D'Arco, A. M., D'Auria, G., Dazzi, C., De Angelis, C., de Braud, F., De Feo, G., De Matteis, Ma., De Tursi, M., Di Blasio, A., di Lucca, G., Di Lullo, L., Di Rella, F., Di Renzo, G., Di Stefano, P., Di Stefano, A., Diana, A., Donati, S., Fabbri, A., Fabi, A., Faedi, M., Farina, G., Farris, A., Febbraro, A., Fedele, P., Federico, P., Ferrau, F., Ferretti, G., Ferro, A., Floriani, I., Forcignano, R., Forciniti, S., Forestieri, V., Fornari, G., Frisinghelli, M., Fusco, V., Gallizzi, G., Galvano, A., Gambardella, A., Gambi, A., Gebbia, V., Gervasi, E., Ghilardi, M., Giacobino, A., Giardina, G., Giotta, F., Giraudi, S., Giuliano, M., Grassadonia, A., Grasso, D., Grosso, F., Guizzaro, L., Incoronato, P., Incorvaia, L., Iodice, G., La Verde, N., Labonia, V., Landi, G., Latorre, A., Leonardi, V., Levaggi, A., Limite, G., Lina Bascialla, L., Livi, L., Maiello, E., Mandelli, D., Marcon, I., Menon, D., Montedoro, M., Moraca, L., Moretti, A., Morritti, M. G., Morselli, P., Mura, A., Mura, S., Musacchio, M., Muzio, A., Natale, D., Natoli, C., Nigro, C., Nistico, C., Nuzzo, A., Orditura, M., Orlando, L., Pacilio, C., Palumbo, G., Palumbo, R., Pasini, F., Paterno, E., Pazzola, A., Pelliccioni, S., Pensabene, M., Perroni, D., Pesenti Gritti, A., Petrelli, F., Piccirillo, M. C., Pinotti, G., Pogliani, C., Poli, D., Prader, S., Recchia, F., Rizzi, D., Romano, C., Rossello, R., Rossini, C., Salvucci, G., Sanna, V., Santini, A., Saracchini, S., Savastano, C., Scambia, G., Schettini, F., Schiavone, P., Schirone, A., Seles, E., Signoriello, S., Signoriello, G., Silva, R. R., Silvestri, A., Simeon, V., Spagnoletti, I., Tamberi, S., Teragni, C., Thalmann, V., Thomas, R., Thomas, G., Tienghi, A., Tinari, N., Tinessa, V., Tomei, F., Tonini, G., Torri, V., Traficante, D., Tudini, M., Turazza, M., Vignoli, R., Vitale, M. G., Zacchia, A., Zagarese, P., Zanni, A., Zavallone, L., Zavettieri, M., Zoboli, A., De Placido, Sabino, Gallo, Ciro, De Laurentiis, Michelino, Bisagni, Giancarlo, Arpino, Grazia, Sarobba, Maria Giuseppa, Riccardi, Ferdinando, Russo, Antonio, Del Mastro, Lucia, Cogoni, Alessio Aligi, Cognetti, Francesco, Gori, Stefania, Foglietta, Jennifer, Frassoldati, Antonio, Amoroso, Domenico, Laudadio, Lucio, Moscetti, Luca, Montemurro, Filippo, Verusio, Claudio, Bernardo, Antonio, Lorusso, Vito, Gravina, Adriano, Moretti, Gabriella, Lauria, Rossella, Lai, Antonella, Mocerino, Carmen, Rizzo, Sergio, Nuzzo, Francesco, Carlini, Paolo, Perrone, Francesco, Accurso, Antonello, Agostara, Biagio, Aieta, Michele, Alabiso, Oscar, Alicicco, Maria Grazia, Amadori, Dino, Amaducci, Laura, Amiconi, Gianna, Antuzzi, Giustino, Ardine, Mara, Ardizzoia, Antonio, Aversa, Caterina, Badalamenti, Giuseppe, Barni, Sandro, Basurto, Carlo, Berardi, Rossana, Bergamasco, Cinzia, Bidoli, Paolo, Bighin, Claudia, Biondi, Edoardo, Boni, Corrado, Borgonovo, Karen, Botta, Mario, Bravi, Stefano, Bruzzi, Paolo, Buono, Giuseppe, Butera, Alfredo, Caldara, Alessia, Candeloro, Giampiero, Cappelletti, Claudia, Cardalesi, Cinzia, Carfora, Elisabetta, Cariello, Anna, Carrozza, Francesco, Cartenì, Giacomo, Caruso, Michele, Casadei, Virginia, Casanova, Claudia, Castori, Luigi, Cavanna, Luigi, Cavazzini, Giovanna, Cazzaniga, Marina, Chilelli, Mario, Chiodini, Paolo, Chiorrini, Silvia, Ciardiello, Fortunato, Ciccarese, Mariangela, Cinieri, Saverio, Clerico, Mario, Coccaro, Mariarosa, Comande, Mario, Corbo, Claudia, Cortino, Giuseppina, Cusenza, Stefania, Daniele, Gennaro, D'arco, Alfonso Maria, D'auria, Giuliana, Dazzi, Claudio, De Angelis, Carmine, de Braud, Filippo, De Feo, Gianfranco, De Matteis, Andrea, De Tursi, Michele, Di Blasio, Anna, di Lucca, Giuseppe, Di Lullo, Liberato, Di Rella, Francesca, Di Renzo, Gianfranco, Di Stefano, Pia, Di Stefano, Aida, Diana, Anna, Donati, Sara, Fabbri, Agnese, Fabi, Alessandra, Faedi, Marina, Farina, Gabriella, Farris, Antonio, Febbraro, Antonio, Fedele, Palma, Federico, Piera, Ferraù, Francesco, Ferretti, Gianluigi, Ferro, Antonella, Floriani, Irene, Forcignanò, Rosachiara, Forciniti, Samantha, Forestieri, Valeria, Fornari, Gianni, Frisinghelli, Michela, Fusco, Vittorio, Gallizzi, Giulia, Galvano, Antonio, Gambardella, Antonio, Gambi, Angelo, Gebbia, Vittorio, Gervasi, Erika, Ghilardi, Mara, Giacobino, Alice, Giardina, Giovanni, Giotta, Francesco, Giraudi, Sara, Giuliano, Mario, Grassadonia, Antonino, Grasso, Donatella, Grosso, Federica, Guizzaro, Lorenzo, Incoronato, Pasquale, Incorvaia, Lorena, Iodice, Giovanni, La Verde, Nicla, Labonia, Vincenzo, Landi, Gabriella, Latorre, Agnese, Leonardi, Vita, Levaggi, Alessia, Limite, Gennaro, Lina Bascialla, Linda, Livi, Lorenzo, Maiello, Evaristo, Mandelli, Daniela, Marcon, Ilaria, Menon, Daniela, Montedoro, Michele, Moraca, Lucia, Moretti, Anna, Morritti, Maria Grazia, Morselli, Patrizia, Mura, Antonella, Mura, Silvia, Musacchio, Michela, Muzio, Alberto, Natale, Donato, Natoli, Clara, Nigro, Cinzia, Nisticò, Cecilia, Nuzzo, Antonio, Orditura, Michele, Orlando, Laura, Pacilio, Carmen, Palumbo, Giuliano, Palumbo, Raffaella, Pasini, Felice, Paterno, Emanuela, Pazzola, Antonio, Pelliccioni, Silvia, Pensabene, Matilde, Perroni, Davide, Pesenti Gritti, Angela, Petrelli, Fausto, Piccirillo, Maria Carmela, Pinotti, Graziella, Pogliani, Claudia, Poli, Davide, Prader, Sonia, Recchia, Francesco, Rizzi, Daniele, Romano, Carmen, Rossello, Rosalba, Rossini, Chiara, Salvucci, Giuseppina, Sanna, Valeria, Santini, Alessandra, Saracchini, Silvana, Savastano, Clementina, Scambia, Giovanni, Schettini, Francesco, Schiavone, Paola, Schirone, Alessio, Seles, Elena, Signoriello, Simona, Signoriello, Giuseppe, Silva, Rosa Rita, Silvestri, Antonia, Simeon, Vittorio, Spagnoletti, Ilaria, Tamberi, Stefano, Teragni, Cristina, Thalmann, Verena, Thomas, Renato, Thomas, Guglielmo, Tienghi, Amelia, Tinari, Nicola, Tinessa, Vincenza, Tomei, Federica, Tonini, Giuseppe, Torri, Valter, Traficante, Divina, Tudini, Marianna, Turazza, Monica, Vignoli, Roberto, Vitale, Maria Giuseppa, Zacchia, Alessandra, Zagarese, Pasquale, Zanni, Alda, Zavallone, Laura, Zavettieri, Maria, Zoboli, Alessandra, Mocerino, Carmela, D'Arco, Alfonso Maria, D'Auria, Giuliana, De Placido, S, Gallo, C, De Laurentiis, M, Bisagni, G, Arpino, G, Sarobba, M, Riccardi, F, Russo, A, Del Mastro, L, Cogoni, A, Cognetti, F, Gori, S, Foglietta, J, Frassoldati, A, Amoroso, D, Laudadio, L, Moscetti, L, Montemurro, F, Verusio, C, Bernardo, A, Lorusso, V, Gravina, A, Moretti, G, Lauria, R, Lai, A, Mocerino, C, Rizzo, S, Nuzzo, F, Carlini, P, Perrone, F, Accurso, A, Agostara, B, Aieta, M, Alabiso, O, Alicicco, M, Amadori, D, Amaducci, L, Amiconi, G, Antuzzi, G, Ardine, M, Ardizzoia, A, Aversa, C, Badalamenti, G, Barni, S, Basurto, C, Berardi, R, Bergamasco, C, Bidoli, P, Bighin, C, Biondi, E, Boni, C, Borgonovo, K, Botta, M, Bravi, S, Bruzzi, P, Buono, G, Butera, A, Caldara, A, Candeloro, G, Cappelletti, C, Cardalesi, C, Carfora, E, Cariello, A, Carrozza, F, Carteni, G, Caruso, M, Casadei, V, Casanova, C, Castori, L, Cavanna, L, Cavazzini, G, Cazzaniga, M, Chilelli, M, Chiodini, P, Chiorrini, S, Ciardiello, F, Ciccarese, M, Cinieri, S, Clerico, M, Coccaro, M, Comande, M, Corbo, C, Cortino, G, Cusenza, S, Daniele, G, D'Arco, A, D'Auria, G, Dazzi, C, De Angelis, C, de Braud, F, De Feo, G, De Matteis, A, De Tursi, M, Di Blasio, A, di Lucca, G, Di Lullo, L, Di Rella, F, Di Renzo, G, Di Stefano, P, Di Stefano, A, Diana, A, Donati, S, Fabbri, A, Fabi, A, Faedi, M, Farina, G, Farris, A, Febbraro, A, Fedele, P, Federico, P, Ferrau, F, Ferretti, G, Ferro, A, Floriani, I, Forcignano, R, Forciniti, S, Forestieri, V, Fornari, G, Frisinghelli, M, Fusco, V, Gallizzi, G, Galvano, A, Gambardella, A, Gambi, A, Gebbia, V, Gervasi, E, Ghilardi, M, Giacobino, A, Giardina, G, Giotta, F, Giraudi, S, Giuliano, M, Grassadonia, A, Grasso, D, Grosso, F, Guizzaro, L, Incoronato, P, Incorvaia, L, Iodice, G, La Verde, N, Labonia, V, Landi, G, Latorre, A, Leonardi, V, Levaggi, A, Limite, G, Lina Bascialla, L, Livi, L, Maiello, E, Mandelli, D, Marcon, I, Menon, D, Montedoro, M, Moraca, L, Moretti, A, Morritti, M, Morselli, P, Mura, A, Mura, S, Musacchio, M, Muzio, A, Natale, D, Natoli, C, Nigro, C, Nistico, C, Nuzzo, A, Orditura, M, Orlando, L, Pacilio, C, Palumbo, G, Palumbo, R, Pasini, F, Paterno, E, Pazzola, A, Pelliccioni, S, Pensabene, M, Perroni, D, Pesenti Gritti, A, Petrelli, F, Piccirillo, M, Pinotti, G, Pogliani, C, Poli, D, Prader, S, Recchia, F, Rizzi, D, Romano, C, Rossello, R, Rossini, C, Salvucci, G, Sanna, V, Santini, A, Saracchini, S, Savastano, C, Scambia, G, Schettini, F, Schiavone, P, Schirone, A, Seles, E, Signoriello, S, Signoriello, G, Silva, R, Silvestri, A, Simeon, V, Spagnoletti, I, Tamberi, S, Teragni, C, Thalmann, V, Thomas, R, Thomas, G, Tienghi, A, Tinari, N, Tinessa, V, Tomei, F, Tonini, G, Torri, V, Traficante, D, Tudini, M, Turazza, M, Vignoli, R, Vitale, M, Zacchia, A, Zagarese, P, Zanni, A, Zavallone, L, Zavettieri, M, and Zoboli, A
Subjects: Oncology, Receptor, ErbB-2, Settore MED/06 - Oncologia Medica, letrozole, law.invention, Adjuvant anastrozole, chemistry.chemical_compound, 0302 clinical medicine, Randomized controlled trial, Exemestane, law, exemestane, tamoxifen, breast cancer, Antineoplastic Combined Chemotherapy Protocols, 030212 general & internal medicine, Aromatase Inhibitors, Letrozole, Hazard ratio, Middle Aged, Receptors, Estrogen, Tolerability, Chemotherapy, Adjuvant, 030220 oncology & carcinogenesis, Female, Receptors, Progesterone, Breast Neoplasm, Human, medicine.drug, medicine.medical_specialty, Socio-culturale, Anastrozole, Breast Neoplasms, Disease-Free Survival, Drug Administration Schedule, 03 medical and health sciences, Breast cancer, Internal medicine, medicine, Aromatase Inhibitor, Humans, Aged, Antineoplastic Combined Chemotherapy Protocol, Androstadiene, business.industry, medicine.disease, Androstadienes, chemistry, business, Tamoxifen
Abstract: Background: Uncertainty exists about the optimal schedule of adjuvant treatment of breast cancer with aromatase inhibitors and, to our knowledge, no trial has directly compared the three aromatase inhibitors anastrozole, exemestane, and letrozole. We investigated the schedule and type of aromatase inhibitors to be used as adjuvant treatment for hormone receptor-positive early breast cancer. Methods: FATA-GIM3 is a multicentre, open-label, randomised, phase 3 trial of six different treatments in postmenopausal women with hormone receptor-positive early breast cancer. Eligible patients had histologically confirmed invasive hormone receptor-positive breast cancer that had been completely removed by surgery, any pathological tumour size, and axillary nodal status. Key exclusion criteria were hormone replacement therapy, recurrent or metastatic disease, previous treatment with tamoxifen, and another malignancy in the previous 10 years. Patients were randomly assigned in an equal ratio to one of six treatment groups: oral anastrozole (1 mg per day), exemestane (25 mg per day), or letrozole (2Â·5 mg per day) tablets upfront for 5 years (upfront strategy) or oral tamoxifen (20 mg per day) for 2 years followed by oral administration of one of the three aromatase inhibitors for 3 years (switch strategy). Randomisation was done by a computerised minimisation procedure stratified for oestrogen receptor, progesterone receptor, and HER2 status; previous chemotherapy; and pathological nodal status. Neither the patients nor the physicians were masked to treatment allocation. The primary endpoint was disease-free survival. The minimum cutoff to declare superiority of the upfront strategy over the switch strategy was assumed to be a 2% difference in disease-free survival at 5 years. Primary efficacy analyses were done by intention to treat; safety analyses included all patients for whom at least one safety case report form had been completed. Follow-up is ongoing. This trial is registered with the European Clinical Trials Database, number 2006-004018-42, and ClinicalTrials.gov, number NCT00541086. Findings: Between March 9, 2007, and July 31, 2012, 3697 patients were enrolled into the study. After a median follow-up of 60 months (IQR 46â72), 401 disease-free survival events were reported, including 211 (11%) of 1850 patients allocated to the switch strategy and 190 (10%) of 1847 patients allocated to upfront treatment. 5-year disease-free survival was 88Â·5% (95% CI 86Â·7â90Â·0) with the switch strategy and 89Â·8% (88Â·2â91Â·2) with upfront treatment (hazard ratio 0Â·89, 95% CI 0Â·73â1Â·08; p=0Â·23). 5-year disease-free survival was 90Â·0% (95% CI 87Â·9â91Â·7) with anastrozole (124 events), 88Â·0% (85Â·8â89Â·9) with exemestane (148 events), and 89Â·4% (87Â·3 to 91Â·1) with letrozole (129 events; p=0Â·24). No unexpected serious adverse reactions or treatment-related deaths occurred. Musculoskeletal side-effects were the most frequent grade 3â4 events, reported in 130 (7%) of 1761 patients who received the switch strategy and 128 (7%) of 1766 patients who received upfront treatment. Grade 1 musculoskeletal events were more frequent with the upfront schedule than with the switch schedule (924 [52%] of 1766 patients vs 745 [42%] of 1761 patients). All other grade 3â4 adverse events occurred in less than 2% of patients in either group. Interpretation: 5 years of treatment with aromatase inhibitors was not superior to 2 years of tamoxifen followed by 3 years of aromatase inhibitors. None of the three aromatase inhibitors was superior to the others in terms of efficacy. Therefore, patient preference, tolerability, and financial constraints should be considered when deciding the optimal treatment approach in this setting. Funding: Italian Drug Agency.
Published: 2018

15. Asbestos Exposure and Malignant Mesothelioma in Construction Workers—Epidemiological Remarks by the Italian National Mesothelioma Registry (ReNaM)

Author: Alessandra Binazzi, Davide Di Marzio, Marina Verardo, Enrica Migliore, Lucia Benfatto, Davide Malacarne, Carolina Mensi, Dario Consonni, Silvia Eccher, Guido Mazzoleni, Vera Comiati, Corrado Negro, Antonio Romanelli, Elisabetta Chellini, Alessia Angelini, Iolanda Grappasonni, Gabriella Madeo, Elisa Romeo, Annamaria Di Giammarco, Francesco Carrozza, Italo F. Angelillo, Domenica Cavone, Luigi Vimercati, Michele Labianca, Federico Tallarigo, Rosario Tumino, Massimo Melis, Michela Bonafede, Alberto Scarselli, Alessandro Marinaccio, on behalf of the ReNaM Working Group, Binazzi, A., Di Marzio, D., Verardo, M., Migliore, E., Benfatto, L., Malacarne, D., Mensi, C., Consonni, D., Eccher, S., Mazzoleni, G., Comiati, V., Negro, C., Romanelli, A., Chellini, E., Angelini, A., Grappasonni, I., Madeo, G., Romeo, E., Di Giammarco, A., Carrozza, F., Angelillo, I. F., Cavone, D., Vimercati, L., Labianca, M., Tallarigo, F., Tumino, R., Melis, M., Bonafede, M., Scarselli, A., and Marinaccio, A.
Subjects: Mesothelioma, Registrie, Malignant, national mesothelioma registry, Health, Toxicology and Mutagenesis, Mesothelioma, Malignant, mesothelioma, asbestos, construction workers, Italy, Construction Industry, Public Health, Environmental and Occupational Health, Asbesto, Asbestos, Construction workers, National mesothelioma registry, Humans, Registries, Occupational Exposure, Article, Medicine, Construction worker, Human
Abstract: Notwithstanding the ban in 1992, asbestos exposure for workers in the construction sector in Italy remains a concern. The purpose of this study is to describe the characteristics of malignant mesothelioma (MM) cases recorded by the Italian registry (ReNaM) among construction workers. Incident mesothelioma cases with a definite asbestos exposure have been analyzed. Characteristics of cases and territorial clusters of crude rates of MM in construction workers have been described, as well as the relation between asbestos use before the ban and the historical trend of workforce in the construction sector in Italy. ReNaM has collected 31,572 incident MM cases in the period from 1993 to 2018 and asbestos exposure has been assessed for 24,864 (78.2%) cases. An occupational exposure has been reported for 17,191 MM cases (69.1% of subjects with a definite asbestos exposure). Among them, 3574 had worked in the construction sector, with an increasing trend from 15.8% in the 1993–98 period to 23.9% in 2014–2018 and a ubiquitous territorial distribution. The large use of asbestos in construction sector before the ban makes probability of exposure for workers a real concern still today, particularly for those working in maintenance and removal of old buildings. There is a clear need to assess, inform, and prevent asbestos exposure in this sector.
Published: 2022

16. The epidemiological surveillance of malignant mesothelioma in Italy (1993-2015): methods, findings, and research perspectives

Author: Alessandro, Marinaccio, Marisa, Corfiati, Alessandra, Binazzi, Davide, Di Marzio, Michela, Bonafede, Marina, Verardo, Enrica, Migliore, Valerio, Gennaro, Carolina, Mensi, Gert, Schallemberg, Guido, Mazzoleni, Ugo, Fedeli, Corrado, Negro, Antonio, Romanelli, Elisabetta, Chellini, Iolanda, Grappasonni, Cristiana, Pascucci, Gabriella, Madeo, Elisa, Romeo, Luana, Trafficante, Francesco, Carrozza, Italo Francesco, Angelillo, Domenica, Cavone, Gabriella, Cauzillo, Federico, Tallarigo, Rosario, Tumino, Massimo, Melis, Sergio, Stecchi, Marinaccio, A., Corfiati, M., Binazzi, A., Di Marzio, D., Bonafede, M., Verardo, M., Migliore, E., Gennaro, V., Mensi, C., Schallemberg, G., Mazzoleni, G., Fedeli, U., Negro, C., Romanelli, A., Chellini, E., Grappasonni, I., Pascucci, C., Madeo, G., Romeo, E., Trafficante, L., Carrozza, F., Angelillo, I. F., Cavone, D., Cauzillo, G., Tallarigo, F., Tumino, R., and Melis, M.
Subjects: Mesothelioma, Adult, Male, Malignant, Incidence, Mesothelioma, Malignant, Asbestos, Asbesto, Middle Aged, Occupational Disease, Occupational Diseases, asbesto, Epidemiological surveillance system, Italy, Female, Humans, Occupational Exposure, Population Surveillance, Registries, epidemiological surveillance system, mesothelioma, Human
Abstract: BACKGROUND: As a legacy of the large asbestos consumption until the definitive ban in 1992, Italy had to tackle a real epidemic of asbestos related diseases. The Italian National Registry of Malignant Mesotheliomas (ReNaM) is a permanent surveillance system of mesothelioma incidence, with a regional structure. Aims, assignments and territorial network of ReNaM are described, as well as data collection, recording and coding procedures. OBJECTIVES: To describe the Italian epidemiological surveillance system of mesothelioma incidence, to provide updated data about occurrence of malignant mesothelioma in Italy, and to discuss goals, attainments, and expectations of registering occupational cancer. DESIGN: Analysis of data by malignant mesothelioma incident cases surveillance system. SETTING AND PARTICIPANTS: Italy, network of regional sur-veillance system, all Italian regions. MAIN OUTCOME MEASURES: A Regional Operating Centre (COR) is currently established in all the Italian regions, actively searching incident malignant mesothelioma cases from health care institutions. Occupational history, lifestyle habits, and residential history are obtained using a standardized questionnaire, administered to the subject or to the next of kin by a trained interviewer. The extent of dataset, epide-miological parameters, and occupations involved are reported updated at 31.12.2016, and standardized incidence rates are calculated. RESULTS: At December 2016, ReNaM has collected 27,356 malignant mesothelioma cases, referring to the period of incidence between 1993 and 2015. The modalities of exposure to asbestos have been investigated for 21,387 (78%) and an occupational exposure has been defined for around 70% of defined cases (14,818). CONCLUSIONS: The Italian experience shows that epidemiological systematic surveillance of asbestos related diseases incidence has a key importance for assessing and monitoring the public health impact of occupational and/or environmental hazards, programming preventive interventions, including remediation plans and information campaigns, and supporting the efficiency of insurance and welfare system. Monitor-ing the incidence of malignant mesothelioma through a specialized cancer registry is essential to follow-up the health effects of changing modalities and extent of occupational exposures over years and of environmental contamination. Such consolidated surveillance system is recommended also for occupational cancers with low aetiological fraction.
Published: 2020

17. Real-World Data on Cabozantinib in Previously Treated Patients with Metastatic Renal Cell Carcinoma: Focus on Sequences and Prognostic Factors

Author: Alessia Cimadamore, Camillo Porta, Giacomo Cartenì, Paolo Andrea Zucali, Cinzia Ortega, Roberto Iacovelli, Matteo Santoni, Daniele Santini, Alessandra Mosca, Erin Pierce, Marc R. Matrana, Elena Verzoni, Orazio Caffo, Michele Milella, Rodolfo Montironi, Sebastiano Buti, Jeffrey Graham, Sara Merler, Francesco Carrozza, Sergio Bracarda, Marina Scarpelli, Umberto Basso, Francesco Massari, Francesco Piva, Liang Cheng, Vittorio Paolucci, Angelo Martignetti, Franco Morelli, Cristina Masini, Fabio Calabrò, Giuseppe Fornarini, Sarah Scagliarini, Lorena Incorvaia, Nuno Vau, Mimma Rizzo, Francesco Atzori, Alain Gelibter, Riccardo Ricotta, Antonio Lopez-Beltran, Maria Giuseppa Vitale, Ugo De Giorgi, Simon J. Crabb, Giulia Sorgentoni, Pierangela Sepe, Luca Galli, Giuseppe Procopio, Daniel Y. Heng, Alessandro Conti, Nicola Battelli, Santoni M., Heng D.Y., Bracarda S., Procopio G., Milella M., Porta C., Matrana M.R., Carteni G., Crabb S.J., De Giorgi U., Basso U., Masini C., Calabro F., Vitale M.G., Santini D., Massari F., Galli L., Fornarini G., Ricotta R., Buti S., Zucali P., Caffo O., Morelli F., Carrozza F., Martignetti A., Gelibter A., Iacovelli R., Mosca A., Atzori F., Vau N., Incorvaia L., Ortega C., Scarpelli M., Lopez-Beltran A., Cheng L., Paolucci V., Graham J., Pierce E., Scagliarini S., Sepe P., Verzoni E., Merler S., Rizzo M., Sorgentoni G., Conti A., Piva F., Cimadamore A., Montironi R., and Battelli N.
Subjects: 0301 basic medicine, Oncology, Cancer Research, medicine.medical_specialty, renal cell carcinoma, Cabozantinib, Prognosi, Context (language use), urologic and male genital diseases, lcsh:RC254-282, Article, Pazopanib, 03 medical and health sciences, chemistry.chemical_compound, 0302 clinical medicine, Renal cell carcinoma, cabozantinib, Internal medicine, medicine, Progression-free survival, Nivolumab, Prognosis, Real-world data, Targeted therapy, nivolumab, real-world data, business.industry, Sunitinib, Retrospective cohort study, lcsh:Neoplasms. Tumors. Oncology. Including cancer and carcinogens, medicine.disease, targeted therapy, Axitinib, 030104 developmental biology, chemistry, 030220 oncology & carcinogenesis, prognosis, business, medicine.drug
Abstract: Cabozantinib is approved for the treatment of renal cell carcinoma (RCC). However, prognostic factors are still lacking in this context. The aim of this study was to evaluate prognostic factors in RCC patients treated with second- or third-line cabozantinib. A multicenter retrospective real-world study was conducted, involving 32 worldwide centers. A total of 237 patients with histologically confirmed clear-cell and non-clear-cell RCC who received cabozantinib as second- or third-line therapy for metastatic disease were included. We analyzed overall survival (OS), progression-free survival (PFS) and time-to-strategy failure (TTSF) using Kaplan&ndash, Meier curves. Cox proportional models were used at univariate and multivariate analyses.The median PFS and OS of cabozantinib were 7.76 months (95% CI 6.51&ndash, 10.88) and 11.57 months (95% CI 10.90&ndash, not reached (NR)) as second-line and 11.38 months (95% CI 5.79&ndash, NR) and NR (95% CI 11.51&ndash, NR) as third-line therapy. The median TTSF and OS were 11.57 and 15.52 months with the sequence of cabozantinib&ndash, nivolumab and 25.64 months and NR with nivolumab&ndash, cabozantinib, respectively. The difference between these two sequences was statistically significant only in good-risk patients. In the second-line setting, hemoglobin (Hb) levels (HR= 2.39, 95% CI 1.24&ndash, 4.60, p = 0.009) and IMDC (International Metastatic Renal Cell Carcinoma Database Consortium) group (HR = 1.72, 95% CI 1.04&ndash, 2.87, p = 0.037) were associated with PFS while ECOG-PS (HR = 2.33, 95%CI, 1.16&ndash, 4.69, p = 0.018) and Hb levels (HR = 3.12, 95%CI 1.18&ndash, 8.26, p = 0.023) correlated with OS at multivariate analysis, while in the third-line setting, only Hb levels (HR = 2.72, 95%CI 1.04&ndash, 7.09, p = 0.042) were associated with OS. Results are limited by the retrospective nature of the study.This real-world study provides evidence on the presence of prognostic factors in RCC patients receiving cabozantinib.
Published: 2019
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18. Cisplatin, fotemustine and whole-brain radiotherapy in non-small cell lung cancer patients with asymptomatic brain metastases: A multicenter phase II study of the Gruppo Oncologico Italia Meridionale (GOIM 2603)

Author: Galetta, D., Gebbia, V., Silvestris, N., Ferraù, F., Carrozza, F., Cigolari, S., Russo, P., Calista, F., Adamo, V., and Colucci, G.
Subjects: *CISPLATIN, *CANCER radiotherapy, *BRAIN cancer, *LUNG cancer diagnosis, *METASTASIS, *BLOOD-brain barrier, *ADENOCARCINOMA, *CANCER chemotherapy
Abstract: Abstract: Background: More than 50% of brain metastases (BMs) occur in advanced non-small cell lung cancer (NSCLC) patients. Untreated patients with BMs have a poor prognosis with a median survival of 2 months. In most cases BMs are multiple and their optimal therapy is whole-brain radiation therapy (WBRT). The role of systemic therapies for these patients is still a matter for investigation due to concerns about the ability of these drugs to cross the blood–brain barrier (BBB). Cisplatin (CDDP) remains the backbone for medical treatment of NSCLC and fotemustine (FTM) is a nitrosurea able to cross the BBB. Methods: Patients with advanced NSCLC, ECOG performance status (PS) 0–1 and multiple BMs not amenable to surgery or stereotactic radiotherapy were treated with 2 cycles of FTM 80mg/m2 days 1, 8 and CDDP 80mg/m2 day 1, every 3 weeks followed by WBRT 30Gy (3Gy daily in 10 fractions). Radiological restaging was performed before WBRT to assess the role of chemotherapy both for cranial and extracranial disease. Patients with disease control (DC: complete response plus partial response) received 4 more cycles. To assess the basic activities of daily living (ADL), the Barthel ADL Index was used to score patients’ performance every 2 cycles. The trial design provides a two-step evaluation according to the optimal two-stage design of Simon. In the first phase 29 patients were enrolled in order to verify if this schedule showed more than 25% response rate both for cranial and extracranial disease. If so, enrolment added up to a total of 81 patients. Results: After the first evaluation 4 out of 29 patients were excluded from the study (3 untreated/1 not included for administrative reasons). At the time of the planned interim analysis patient''s characteristics were the following: median age 61 years (range 44–70), M/F=16/9, adenocarcinoma 11, squamous 5, large cell 2, undefined NSCLC 7; PS 0/1 in 11/14 cases, median Barthel Index score was 20 . Three (12%) partial responses were observed, 9 subjects (36%) with stable disease and 13 (52%) showing disease progression. These data did not satisfy the pre-planned hypothesis and the study was stopped. At the time of the first evaluation before WBRT 12/25 (48%) patients had a systemic DC in contrast with 15/25 (60%) patients with BMs DC. Chemotherapy was relatively well tolerated with a prevalence of asthenia as the most relevant specific toxicity while the haematological toxicity was mild. Conclusion: CDDP and FTM combined with WBRT do not represent a therapeutic option for patients with NSCLC. Therefore further studies to evaluate the combination of systemic treatments with WBRT are warranted. [Copyright &y& Elsevier]
Published: 2011
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19. Prognostic impact of education level of patients with advanced non-small cell lung cancer enrolled in clinical trials

Author: E. Piazza, Cesare Gridelli, Vittorio Gebbia, Claudia Sandomenico, Ciro Gallo, Francovito Piantedosi, Alfonso Illiano, Anna Ceribelli, Bruno Daniele, Francesco Perrone, Gennaro Daniele, Pasqualina Giordano, Domenico Bilancia, Adolfo Favaretto, Raffaele Costanzo, Francesco Carrozza, Gaetano Rocco, Simona Signoriello, Antonio Rossi, Paolo Maione, Santi Barbera, Alessandro Morabito, Sergio Federico Robbiati, S. Cigolari, Maria Carmela Piccirillo, Massimo Di Maio, Di Maio, M, Signoriello, Simona, Morabito, A, Rossi, A, Maione, P, Piantedosi, F, Bilancia, D, Cigolari, S, Barbera, S, Gebbia, V, Daniele, B, Robbiati, Sf, Illiano, A, Ceribelli, A, Carrozza, F, Favaretto, A, Piazza, E, Piccirillo, Mc, Daniele, G, Giordano, P, Costanzo, R, Sandomenico, C, Rocco, G, Gallo, Ciro, Perrone, F, and Gridelli, C.
Subjects: Adult, Male, Pulmonary and Respiratory Medicine, Cancer Research, medicine.medical_specialty, Lung Neoplasms, ECOG Performance Status, law.invention, Randomized controlled trial, law, Carcinoma, Non-Small-Cell Lung, Internal medicine, medicine, Humans, Malignant pleural effusion, Lung cancer, Socioeconomic status, Aged, Neoplasm Staging, Randomized Controlled Trials as Topic, Aged, 80 and over, business.industry, Hazard ratio, Cancer, Middle Aged, Prognosis, medicine.disease, Surgery, Clinical trial, Oncology, Educational Status, Female, business
Abstract: Background Socioeconomic status can potentially affect prognosis of cancer patients. Our aim was to describe potential differences in demographic and clinical characteristics, treatment, and survival by education level in patients with advanced non-small cell lung cancer (NSCLC) enrolled in clinical trials of first-line treatment. Methods Individual data of Italian patients with advanced NSCLC (stage IV, or IIIB with supraclavicular nodes or malignant pleural effusion), ECOG performance status (PS) 0–2, enrolled in four phase III randomized trials conducted between 1996 and 2005 were pooled. Information about education was available for 1680 of 1709 patients (98.3%). Patients were divided in two groups according to education level: high (patients with at least high school diploma) or low (those with less than high school diploma). Survival analyses were stratified by treatment arm within trial. Results There were 312 (19%) and 1368 (81%) patients with high and low education, respectively. Education level was significantly different among birth cohorts, with a time-trend toward higher education level. Patients with high education were significantly younger (median age 65 vs. 70), were less frequently unfit at diagnosis (ECOG PS2 5% vs. 16%), and their tumor type was more frequently adenocarcinoma (47% vs. 37%). Number of treatment cycles received was not significantly different between education groups. Median survival was 9.4 and 7.6 months in high and low education, respectively (p = 0.012). At multivariable analysis, female sex, better PS and high education level (Hazard Ratio 0.85, 95%CI 0.73–0.99, p = 0.03) were independently associated with longer survival. Conclusions In Italian patients enrolled in four randomized trials of first-line chemotherapy for advanced NSCLC, high education was significantly more frequent among younger patients, and was associated with lower proportion of PS2 patients. Education level did not significantly affect number of chemotherapy cycles received. Overall survival was longer in patients with high education, after adjustment for PS and other prognostic factors. The exact underlying mechanisms of the independent prognostic role of education level are substantially unknown, but lead-time bias (anticipation in diagnosis and time to inclusion in the trial), differences in adherence to care outside the trial procedures, differences in comorbidities and life-style factors may all contribute.
Published: 2012

20. Cetuximab and gemcitabine in elderly or adult PS2 patients with advanced non-small-cell lung cancer: The cetuximab in advanced lung cancer (CALC1-E and CALC1-PS2) randomized phase II trials

Author: Cesare Gridelli, Vittorio Gebbia, Maria Grazia Viganò, G. Valmadre, Manlio Mencoboni, Alessandro Morabito, Massimo Di Maio, Ciro Gallo, Claudio Verusio, Maria Carmela Piccirillo, Maria Rosaria Valerio, Antonio Rossi, Roberto Bollina, Floriana Morgillo, Rodolfo Mattioli, Francesco Carrozza, Tina Cascone, Fortunato Ciardiello, Francesco Perrone, Paolo Maione, Gridelli, C, Morabito, A, Gebbia, V, Mencoboni, M, Carrozza, F, Viganò, Mg, Verusio, C, Bollina, R, Mattioli, R, Valerio, Mr, Valmadre, G, Maione, P, Rossi, A, Cascone, T, Morgillo, Floriana, DI MAIO, M, Piccirillo, Mc, Gallo, Ciro, Perrone, F, Ciardiello, Fortunato, Viganò, MG, Valerio, MR, Morgillo, F, Di Maio, M, Piccirillo, MC, Gallo, C, and Ciardiello, F
Subjects: Pulmonary and Respiratory Medicine, Oncology, Adult, Male, Cancer Research, medicine.medical_specialty, Lung Neoplasms, Adolescent, Settore MED/06 - Oncologia Medica, Cetuximab, NSCLC, Antibodies, Monoclonal, Humanized, Deoxycytidine, law.invention, Young Adult, Randomized controlled trial, law, Internal medicine, Carcinoma, Non-Small-Cell Lung, Antineoplastic Combined Chemotherapy Protocols, medicine, Humans, Lung cancer, PS2 patient, Survival analysis, Aged, business.industry, Cancer, Antibodies, Monoclonal, Middle Aged, medicine.disease, Gemcitabine, Surgery, Clinical trial, Treatment Outcome, Concomitant, Patient Compliance, Female, business, Elderly patient, medicine.drug
Abstract: Background:Two parallel randomized phase 2 trialswere performed to choose the optimal way of combining cetuximab with gemcitabine in the first-line treatment of elderly (CALC1-E) and adult PS2 (CALC1-PS2) patients with advanced NSCLC. Methods: Stage IV or IIIB NSCLC patients, aged ≥70 years with PS 0–2 for CALC1-E or aged
Published: 2010

21. Enfortumab Vedotin Following Platinum Chemotherapy and Avelumab Maintenance in Patients with Metastatic Urothelial Carcinoma: A Retrospective Data from the ARON-2 EV Study.

Author: Fiala O, Massari F, Basso U, Giannatempo P, Grande E, Buti S, Myint ZW, De Giorgi U, Pichler R, Grillone F, Ürün Y, Calabrò F, Bourlon MT, Galli L, Kanesvaran R, Roviello G, Kucharz J, Rizzo M, Park SH, Cerbone L, Seront E, Messina C, Molina-Cerrillo J, Santini D, Yano A, Incorvaia L, Catalano M, Pinto A, Formisano L, Soares A, Facchini G, Fornarini G, Poprach A, Rebuzzi SE, Nasso C, Spinelli GP, Angel M, Stellato M, Tural D, Aurilio G, Epstein I, Carrozza F, Monteiro FSM, Benedetti G, Büchler T, Ortega C, Zakopoulou R, Battelli N, Porta C, Bellmunt J, Gupta S, and Santoni M
Subjects: Humans, Retrospective Studies, Male, Female, Aged, Middle Aged, Aged, 80 and over, Urologic Neoplasms drug therapy, Carcinoma, Transitional Cell drug therapy, Neoplasm Metastasis, Adult, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Antineoplastic Combined Chemotherapy Protocols pharmacology, Antibodies, Monoclonal, Humanized therapeutic use, Antibodies, Monoclonal, Humanized pharmacology, Antibodies, Monoclonal therapeutic use, Antibodies, Monoclonal pharmacology
Abstract: Background: Enfortumab vedotin (EV) has been approved for the treatment of patients with locally advanced/metastatic urothelial carcinoma (la/mUC) who previously received platinum-based chemotherapy followed by immune checkpoint inhibitors. However, the pivotal clinical trials did not include patients previously treated with avelumab maintenance therapy., Objective: The aim of the present retrospective analysis was to assess the effectiveness of EV following avelumab in patients with mUC enrolled in the ARON-2 EV study., Patients and Methods: The study included 182 patients with mUC treated with EV following avelumab maintenance. The primary objective was to assess clinical outcomes, including progression-free survival (PFS), overall survival (OS), overall response rate (ORR), and duration of response (DoR). Statistical analysis involved Fisher exact test, Kaplan-Meier method, log-rank test, and univariate/multivariate Cox proportional hazard regression models., Results: Median OS and PFS were 12.7 (95% CI 10.2-14.1) and 7.9 (95% CI 6.4-9.9) months, respectively. Complete response (CR) was achieved in 5% and partial response (PR) in 34% of patients, with an ORR of 39%. The DoR in patients who achieved CR/PR was 10.9 months (95% CI 8.1-11.4). The incidence of grade ≥ 3 peripheral neuropathy and skin rash was 9%, followed by 8% of grade ≥ 3 diarrhea and 4% of grade ≥ 3 hyperglycemia., Conclusions: The results of our large international retrospective study confirm the effectiveness of EV and endorse its use in the population of patients with mUC treated with EV following the frontline platinum-based chemotherapy and subsequent maintenance treatment with avelumab., Competing Interests: Declarations Funding No external funding was used in the preparation of this manuscript. Conflicts of Interest Ondřej Fiala received honoraria from Roche, Janssen, GSK, and Pfizer for consultations and lectures unrelated to this project. Francesco Massari has received research support and/or honoraria from Advanced Accelerator Applications, Astellas, Astra Zeneca, Bayer, BMS, Janssen, Ipsen, MSD, and Pfizer outside the submitted work. Umberto Basso received honoraria for Bristol-Myers Squibb, Novartis, and Astra Zeneca; research funding from Ipsen; and travel grants from Bristol-Myers Squibb, Janssen Oncology, Astellas Pharma, MSD Oncology, Merck/Pfizer, and Bayer, all unrelated to this project. Sebastiano Buti received honoraria as speaker at scientific events and advisory role by BMS, Pfizer, MSD, Ipsen, Roche, Eli Lilly, AstraZeneca, Pierre-Fabre, Novartis, Merck, Gentili, and Astellas, all unrelated to the present paper. Yüksel Ürün has served on advisory board for Abdi-İbrahim, Astellas, AstraZeneca, Bristol Myers-Squibb, Deva, Eczacıbaşı, Gen ilaç, Gilead, GSK, Janssen, Merck, MSD, Novartis, Pfizer, and Roche and received travel grants, honoraria, or consultation fees from Abdi-İbrahim, Astellas, Bristol Myers-Squibb, Deva, Eczacıbaşı, Gen İlaç, Gilead, GSK, Janssen, Merck, Novartis, Pfizer, and Roche, all unrelated to the present paper. Maria T. Bourlon is a consultant of Bristol Myers Squibb, Merck, MSD, Gilead, Astellas, and Asofarma and a speaker for Janssen Pharmaceuticasl, MSD, Merck, and Astellas, all unrelated to the present paper. Mimma Rizzo has received honoraria as a speaker/consultant by MSD, Merck Serono, Astrazeneca, Bristol Myers Squibb, Eisai, and Gilead, all unrelated to the present paper. Linda Cerbone has received honoraria for advisory boards, speaker engagements, and scientific consultancy for educational purposes from AstraZeneca, EISAI, MSD, Ipsen, BMS, and A.A.A.; and is a past MSD employee in Medical Affairs. Javier Molina-Cerrillo reports research funding from Roche, Ipsen, Pfizer, and Janssen; travel support from Pfizer, Janssen, Ipsen, and BMS; and a consulting or advisory role with Ipsen, Roche, BMS, Pfizer, Sanofi, Janssen, Astellas, Eisai, Adium, and MSD, all unrelated to the present paper. Álvaro Pinto is a member of advisory boards of Pfizer, Novartis, Ipsen, BMS, Janssen, Astellas, Sanofi, Bayer, Clovis, Roche, MSD, Pierre Fabre, and Merck; has received research support from Pfizer and BMS; clinical trial payments from Pfizer, Bayer, Janssen, MSD, Clovis, Pharmacyclics, BMS, Sanofi, Astra Zeneca, Roche, Eisai, and Aveo; and travel arrangements from Janssen, Roche, Pfizer, BMS, and Ipsen, all unrelated to the present paper. Andrey Soares reports honoraria from Janssen, Pfizer, Bayer, AstraZeneca, Astellas Pharma, Merck Serono, Sanofi, Ipsen, and Adium; consulting or advisory role from Astellas Pharma, Janssen, Roche, Bayer, AstraZeneca, MSD, Bristol-Myers Squibb, Adium, Ipsen, Pfizer, and Novartis; research funding from Bristol-Myers Squibb (Inst), Astellas (Inst), and AstraZeneca (Inst); travel, accommodations, and expenses from Bayer, Janssen, Ipsen, Adium, MSD, and Merck Serono; and ownership in BIO, Brazilian Information Oncology; all unrelated to this study. Alexandr Poprach has received payment or honoraria for lectures, presentations, speakers’ bureaus, manuscript writing, or educational events from BMS, Ipsen, Roche, Astellas, Merck, Eisai, MSD, Novartis, and Pfizer, unrelated to this project. Gian Paolo Spinelli has received payment or honoraria for advidory boards from Novartis, Roche, and Bayer, unrelated to this project. Martin Angel received honoraria from Roche, Johnson & Johnson, Raffo, and Pfizer for consultations and lectures unrelated to this project. Fernando Sabino M. Monteiro reports research support provided by Merck Sharp Dome; honoraria from Janssen, Ipsen, Bristol Myers Squibb, and Merck Sharp Dome; and ownership in BIO, Brazilian Information Oncology, all unrelated to this study. Camillo Porta acted as a remunerated consultant and/or speaker for Angelini Pharma, AstraZeneca, BMC, Eisai, Exilixis, Genenta, Ipsen, Merck Serono, and MSD; as a protocol steering committee member for Eisai and MSD; and as an Independent Review Board member for Genenta. Shilpa Gupta is a consultant for Bristol Myers Squibb, Merck, Pfizer, Gilead, Bayer, and Seattle Genetics; is a speaker for Bristol Myers Squibb; and has institutional research funding from Seatte Genetics, Pfizer, Merck, Bristol Myers Squibb, Roche, Novartis, and Tyra Biosciences. Matteo Santoni has received research support and honoraria from Janssen, Bristol Myers Squibb, Ipsen, MSD, Astellas, and Bayer, all unrelated to the present paper. Patrizia Giannatempo, Enrique Grande, Zin W. Myint, Ugo De Giorgi, Renate Pichler, Francesco Grillone, Fabio Calabrò, Luca Galli, Ravindran Kanesvaran, Giandomenico Roviello, Jakub Kucharz, Se Hoon Park, Emmanuel Seront, Carlo Messina, Daniele Santini, Akihiro Yano, Lorena Incorvaia, Martina Catalano, Luigi Formisano, Gaetano Facchini, Giuseppe Fornarini, Sara Elena Rebuzzi, Cecilia Nasso, Marco Stellato, Deniz Tural, Gaetano Aurilio, Ilana Epstein, Francesco Carrozza, Giovanni Benedetti, Tomáš Büchler, Cinzia Ortega, Roubini Zakopoulou, Nicola Battelli, and Joaquin Bellmunt declare that they have no conflicts of interest that might be relevant to the contents of this manuscript. Tomáš Büchler and Camillo Porta are Editorial Board members of Targeted Oncology. Tomáš Büchler and Camillo Porta were not involved in the selection of peer reviewers for the manuscript nor any of the subsequent editorial decisions. Ethics Approval The study protocol was approved on 28 September 2023, by the Ethical Committee of the coordinating center (Marche Region – Italy – no. 2022 39/7875, Study Protocol “ARON 2 Study” NCT05290038) and by the Institutional Review Boards of participating centers. Consent to Participate Informed consent with subsequent analysis of the follow-up data was obtained from all participants. Consent for Publication Not applicable. Availability of Data and Material The datasets generated and/or analyzed during the current study are not publicly available due to patient data security but are available from the corresponding author on reasonable request. Code Availability Not applicable. Author Contributions Study concept and design: all authors; acquisition of data: all authors; analysis and interpretation of data: all authors; drafting of the manuscript: Fiala, Massari, Gupta, and Santoni; critical revision of the manuscript for important intellectual content: all authors; statistical analysis: Santoni; obtaining funding: none; administrative, technical, or material support: none; and supervision: Gupta and Santoni., (© 2024. The Author(s).)
Published: 2024
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22. Papillary Renal Cell Carcinoma: Outcomes for Patients Receiving First-line Immune-based Combinations or Tyrosine Kinase Inhibitors from the ARON-1 Study.

Author: Massari F, Mollica V, Fiala O, De Giorgi U, Kucharz J, Vitale MG, Molina-Cerrillo J, Facchini G, Seront E, Lenci E, Bourlon MT, Carrozza F, Pichler R, Lolli C, Myint ZW, Kanesvaran R, Torniai M, Rescigno P, Gomez de Liaño A, Zakopoulou R, Buti S, Porta C, Grande E, and Santoni M
Subjects: Humans, Male, Female, Retrospective Studies, Middle Aged, Aged, Treatment Outcome, Adult, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Aged, 80 and over, Tyrosine Kinase Inhibitors, Carcinoma, Renal Cell drug therapy, Carcinoma, Renal Cell mortality, Kidney Neoplasms drug therapy, Kidney Neoplasms mortality, Kidney Neoplasms pathology, Protein Kinase Inhibitors therapeutic use
Abstract: Background and Objective: Papillary renal cell carcinoma (pRCC) is the most frequent histological subtype of non-clear cell RCC (nccRCC). Owing to the heterogeneity of nccRCC, patients are often excluded from large phase 3 trials focused on clear cell RCC, so treatment options for nccRCC remain limited. Our aim was to investigate the efficacy of first-line treatment with tyrosine kinase inhibitors (TKIs) or immuno-oncology (IO)-based combinations in patients with pRCC., Methods: We performed a multicenter retrospective analysis of real-world data collected for patients with advanced pRCC treated in 40 centers in 12 countries as part of the ARON-1 project (NCT05287464). The primary endpoints were overall survival (OS), progression-free survival (PFS), the overall response rate (ORR), and time to second progression (PFS2). OS, PFS, and PFS2 were estimated using the Kaplan-Meier method and results were compared between the treatment groups using a log-rank test. Univariate and multivariable analyses were carried out using Cox proportional-hazard models., Key Findings and Limitations: We included 200 patients with metastatic pRCC, of whom 73 were treated with IO-based combinations and 127 with TKIs. Median OS was 22.5 mo in the TKI group 28.8 mo in the IO group (p = 0.081). Median PFS was 6.4 mo in the TKI group and 17.4 mo in the IO group (p < 0.001). The ORR was higher in the IO group than in the TKI group (41% vs 27%; p = 0.037)., Conclusions and Clinical Implications: Our results show that IO-based combinations have superior efficacy outcomes to TKIs for first-line treatment of metastatic pRCC., Patient Summary: The ARON-1 project collects clinical data for patients with kidney cancer treated in multiple centers worldwide to assess outcomes in the real-world setting. We analyzed data for patients with metastatic kidney cancer of a specific subtype to evaluate the efficacy of different first-line treatments. Patients treated with immune-based combinations had better outcomes than patients treated with tyrosine kinase inhibitors., (Copyright © 2024 European Association of Urology. Published by Elsevier B.V. All rights reserved.)
Published: 2024
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23. Pembrolizumab in Patients with Advanced Urothelial Carcinoma with ECOG Performance Status 2: A Real-World Study from the ARON-2 Project.

Author: Rizzo A, Monteiro FSM, Ürün Y, Massari F, Park SH, Bourlon MT, Poprach A, Rizzo M, Takeshita H, Giannatempo P, Soares A, Roviello G, Molina-Cerrillo J, Carrozza F, Abahssain H, Messina C, Kopp RM, Pichler R, Formisano L, Tural D, Atzori F, Calabrò F, Kanesvaran R, Buti S, and Santoni M
Subjects: Humans, Male, Female, Aged, Middle Aged, Antineoplastic Agents, Immunological therapeutic use, Antineoplastic Agents, Immunological pharmacology, Urologic Neoplasms drug therapy, Urologic Neoplasms pathology, Aged, 80 and over, Adult, Antibodies, Monoclonal, Humanized therapeutic use, Antibodies, Monoclonal, Humanized pharmacology
Abstract: Background: The benefit of immune checkpoint inhibitors (ICIs) for poor performance status patients with advanced urothelial carcinoma (UC) remains unknown., Objective: In the present sub-analysis of the ARON-2 study, we investigated the role of pembrolizumab for advanced UC patients with ECOG (Eastern Cooperative Oncology Group) performance status (ECOG-PS) 2., Patients and Methods: Patients aged ≥ 18 years with a cytologically and/or histologically confirmed diagnosis of advanced UC progressing or recurring after platinum-based therapy and treated with pembrolizumab between 1 January 2016 to 1 April 2024 were included. In this sub-analysis we focused on patients with ECOG-PS 2., Results: We included 1,040 patients from the ARON-2 dataset; of these, 167 patients (16%) presented an ECOG-PS 2. The median overall survival (OS) was 14.8 months (95% confidence interval (CI) 12.5-16.1) in the overall study population, 18.2 months (95% CI 15.8-22.2) in patients with ECOG-PS 0-1, and 3.7 months (95% CI 3.2-5.2) in subjects with ECOG-PS 2 (p < 0.001). The median progression-free survival (PFS) in the overall study population was 5.3 months (95% CI 4.3-97.1), 6.2 months (95% CI 5.5-97.1) in patients with ECOG-PS 0-1, and 2.8 months (95% CI 2.1-3.4) in patients with ECOG-PS 2. Among the latter, liver metastases and progressive disease during first-line therapy were significant predictors of OS at both univariate and multivariate analyses. For PFS, univariate and multivariate analyses showed a prognostic role for lung metastases, liver metastases, and progressive disease during first-line therapy., Conclusions: This large real-world evidence study suggests the effectiveness of second-line pembrolizumab for mUC patients with poor performance status. The presence of liver metastases and progressive disease during first-line therapy is associated with worse clinical outcomes and, thus, should be taken into account when making treatment decisions in clinical practice., (© 2024. The Author(s), under exclusive licence to Springer Nature Switzerland AG.)
Published: 2024
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24. Clinical features and response to immune combinations in patients with renal cell carcinoma and sarcomatoid de-differentiation (ARON-1 study).

Author: Ciccarese C, Büttner T, Cerbone L, Zampiva I, Monteiro FSM, Basso U, Pichler M, Vitale MG, Fiala O, Roviello G, Kopp RM, Carrozza F, Pichler R, Grillone F, Calabuig EP, Zeppellini A, Küronya Z, Galli L, Facchini G, Sunela K, Mosca A, Molina-Cerrillo J, Spinelli GP, Ansari J, Scala A, Mollica V, Grande E, Buti S, Kanesvaran R, Zakopoulou R, Bamias A, Rizzo M, Massari F, Iacovelli R, and Santoni M
Subjects: Humans, Male, Female, Middle Aged, Aged, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Immunotherapy methods, Adult, Protein Kinase Inhibitors therapeutic use, Prognosis, Aged, 80 and over, Carcinoma, Renal Cell pathology, Carcinoma, Renal Cell drug therapy, Carcinoma, Renal Cell immunology, Kidney Neoplasms pathology, Kidney Neoplasms drug therapy, Kidney Neoplasms immunology, Kidney Neoplasms mortality
Abstract: Metastatic renal cell carcinoma (mRCC) carrying sarcomatoid features (sRCC) has aggressive biology and poor prognosis. First-line immunotherapy (IO)-based combinations have improved the outcome of clear cell RCC patients, including that of sRCC. Real-world data confirming the adequate first-line management of sRCC is largely lacking. We investigated the clinical features and the outcome of sRCC patients treated with IO-based combinations within the ARON-1 study population (NCT05287464). The primary objective was to define the incidence and baseline clinical characteristics of sRCC compared with non-sRCC patients. The secondary objective was to describe the outcome of sRCC patients based on type of first-line treatment (IO + IO vs. IO + tyrosin kinase inhibitor [TKI]). We identified 1362 mRCC patients with IMDC intermediate or poor risk, 226 sRCC and 1136 non-sRCC. These two subgroups did not differ in terms of baseline characteristics. The median overall survival (OS) was 26.8 months (95%CI 21.6-44.2) in sRCC and 35.3 months (95%CI 30.2-40.4) in non-sRCC patients (p = .013). The median progression-free survival (PFS) was longer in non-sRCC patients compared to sRCC (14.5 vs. 12.3 months, p = .064). In patients treated with first-line IO + TKI the median OS was 34.4 months compared to 26.4 months of those who received IO + IO (p = .729). The median PFS was 12.4 months with IO + TKI and 12.3 months with IO + IO (p = .606). In conclusion, we confirm that sRCC are aggressive tumors with poor prognosis. IO-based combinations improve survival outcomes of sRCC patients, regardless from the type of strategy (IO + IO versus IO + TKI) adopted., (© 2024 The Author(s). International Journal of Cancer published by John Wiley & Sons Ltd on behalf of UICC.)
Published: 2024
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25. Radiotherapy plus pembrolizumab for advanced urothelial carcinoma: results from the ARON-2 real-world study.

Author: Rizzo M, Soares A, Grande E, Bamias A, Kopp RM, Lenci E, Buttner T, Salah S, Grillone F, de Carvalho IT, Tapia JC, Gucciardino C, Pinto A, Mennitto A, Abahssain H, Rescigno P, Myint Z, Takeshita H, Spinelli GP, Popovic L, Vitale MG, Fiala O, Giannatempo P, Zakopoulou R, Carrozza F, Massari F, Monteiro FSM, Pace MP, Giannini M, Roviello G, Porta C, Battelli N, Kanesvaran R, and Santoni M
Subjects: Humans, Male, Female, Aged, Middle Aged, Aged, 80 and over, Antineoplastic Agents, Immunological therapeutic use, Urologic Neoplasms pathology, Urologic Neoplasms mortality, Urologic Neoplasms therapy, Urologic Neoplasms drug therapy, Radiosurgery methods, Retrospective Studies, Urinary Bladder Neoplasms therapy, Urinary Bladder Neoplasms pathology, Urinary Bladder Neoplasms mortality, Urinary Bladder Neoplasms drug therapy, Adult, Carcinoma, Transitional Cell therapy, Carcinoma, Transitional Cell pathology, Carcinoma, Transitional Cell mortality, Carcinoma, Transitional Cell drug therapy, Treatment Outcome, Combined Modality Therapy, Progression-Free Survival, Antibodies, Monoclonal, Humanized therapeutic use, Antibodies, Monoclonal, Humanized administration & dosage
Abstract: The addition of metastasis-directed radiotherapy (MDRT) to immunotherapy in patients with advanced urothelial carcinoma (aUC) has shown promising results. We report the real-world data from the ARON-2 study (NCT05290038) on the impact of conventional (CRT) or stereotactic body radiotherapy (SBRT) on the outcome of aUC patients receiving pembrolizumab after platinum-based-chemotherapy. Medical records of 837 patients were reviewed from 60 institutions in 20 countries. Two hundred and sixty-two patients (31%) received radiotherapy (cohort A), of whom 193 (23%) received CRT and 69 (8%) received SBRT. Patients were assessed for overall survival (OS), progression-free survival (PFS), and overall response rate (ORR). Univariate and multivariate analyses were used to explore the association of variables of interest with OS and PFS. With a median follow-up of 22.7 months, the median OS was 10.2 months, 6.8 months and 16.0 months in no RT, CRT and SBRT subgroups (p = 0.005), with an 1y-OS rates of 47%, 34% and 61%, respectively (p < 0.001). The 1y-OS rate in the SBRT subgroup were significantly higher for both lower (63%) and upper tract UC (68%), for pure urothelial histology (63%) and variant histologies (58%), and for patients with bone (40%) and lymph-node metastases (61%). Median PFS was 4.8 months, 9.6 months and 5.8 months in the CRT, SBRT and no RT subgroups, respectively (p = 0.060). The 1y-PFS rate was significantly higher (48%) in the SBRT population and was confirmed in all patient subsets. The difference in terms of ORR was in favour of SBRT. Our real-world analysis showed that the use of SBRT/pembrolizumab combination may play a role in a subset of aUC patients to increase disease control and possibly overall survival., (© 2024. The Author(s).)
Published: 2024
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26. Incidence of mesothelioma in young people and causal exposure to asbestos in the Italian national mesothelioma registry (ReNaM).

Author: Marinaccio A, Di Marzio D, Mensi C, Consonni D, Gioscia C, Migliore E, Genova C, Rossetto Giaccherino R, Eccher S, Murano S, Comiati V, Casotto V, Negro C, Mangone L, Miligi L, Piro S, Angelini A, Grappasonni I, Madeo G, Cozzi I, Ancona L, Staniscia T, Carrozza F, Cavone D, Vimercati L, Labianca M, Tallarigo F, Cascone G, Melis M, Bonafede M, Scarselli A, and Binazzi A
Subjects: Humans, Adolescent, Middle Aged, Incidence, Italy epidemiology, Registries, Mesothelioma, Malignant complications, Mesothelioma epidemiology, Mesothelioma etiology, Asbestos adverse effects, Occupational Exposure adverse effects, Pleural Neoplasms epidemiology, Pleural Neoplasms etiology
Abstract: Introduction: The epidemiological surveillance of mesothelioma incidence is a crucial key for investigating the occupational and environmental sources of asbestos exposure. The median age at diagnosis is generally high, according to the long latency of the disease. The purposes of this study are to analyse the incidence of mesothelioma in young people and to evaluate the modalities of asbestos exposure., Methods: Incident malignant mesothelioma (MM) cases in the period 1993-2018 were retrieved from Italian national mesothelioma registry and analysed for gender, incidence period, morphology and exposure. Age-standardised rates have been calculated and the multiple correspondence analysis has been performed. The association between age and asbestos exposure has been tested by χ 2 test., Results: From 1993 to 2018, 30 828 incident MM cases have been collected and 1278 (4.1%) presented diagnosis at early age (≤50 years). There is a substantial association between age at diagnosis and the type of asbestos exposure and a significantly lower frequency of cases with occupational exposure to asbestos (497 cases vs 701 expected) in young people has been documented. Paraoccupational and environmental exposure to asbestos have been found more frequent in young MM cases (85 and 93 observed cases vs 52 and 44 expected cases, respectively)., Conclusions: Mesothelioma incidence surveillance at population level and the anamnestic individual research of asbestos exposure is a fundamental tool for monitoring asbestos exposure health effects, supporting the exposure risks prevention policies. Clusters of mesothelioma incident cases in young people are a significant signal of a potential non-occupational exposure to asbestos., Competing Interests: Competing interests: CM and DCo reported that they have served as expert witnesses in court trials on asbestos-related diseases., (© Author(s) (or their employer(s)) 2023. No commercial re-use. See rights and permissions. Published by BMJ.)
Published: 2023
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27. Mesothelioma Risk Among Maritime Workers According to Job Title: Data From the Italian Mesothelioma Register (ReNaM).

Author: Vimercati L, Cavone D, Negrisolo O, Pentimone F, De Maria L, Caputi A, Sponselli S, Delvecchio G, Cafaro F, Chellini E, Binazzi A, Di Marzio D, Mensi C, Consonni D, Migliore E, Brentisci C, Martini A, Negro C, D'Agostin F, Grappasonni I, Pascucci C, Benfatto L, Malacarne D, Casotto V, Comiati V, Storchi C, Mangone L, Murano S, Rossin L, Tallarigo F, Vitale F, Verardo M, Eccher S, Madeo G, Staniscia T, Carrozza F, Cozzi I, Romeo E, Pelullo P, Labianca M, Melis M, Cascone G, Ferri GM, and Serio G
Subjects: Male, Humans, Italy epidemiology, Mesothelioma, Malignant, Mesothelioma epidemiology, Mesothelioma etiology, Military Personnel, Asbestos adverse effects
Abstract: The study describes the 466 cases of malignant mesotheliomas (MM) collected by the National Mesothelioma Register (ReNaM) in Italy in the period 1993-2018 relating to subjects with exclusive asbestos exposure in merchant or military navy. The cases among maritime workers represent 1.8% of the total cases with defined exposure registred in the ReNaM, of which 212 cases (45.4%) among merchant maritime workers and 254 cases (54.5%) among navy. The distribution by site of mesothelioma showed 453 (97.2%) MM cases of the pleura, 11 (2.3%) of the peritoneum and 2 (0.4%) of the tunica vaginalis of the testis. With regard to occupational exposure, it was classified as certain in 318 (68.2%) cases, probable in 69 (14.8%) cases and possible in 79 (16.9%) cases. Among the 23 classified jobs, the highest percentages of certain exposures are among naval engineers, motor mechanics, machine captains and sailors. Machine crew accounted for 49.3% of the cases, deck crew for 27.6%. All cases began exposure on board between 1926 and 1988. Seamen were exposed to asbestos while at sea by virtue of living onboard ships and from continual release of asbestos fibers due to the motion of a vessel. Epidemiological surveillance through the ReNaM has allowed us to verify among cases in the maritime, navy and merchant marine sectors, that in the past, subjects were exposed regardless of the ship's department where have provided service therefore all these cases must be considered as occupational diseases.
Published: 2023

28. Pleural mesothelioma risk in the construction industry: a case-control study in Italy, 2000-2018.

Author: Stella S, Consonni D, Migliore E, Stura A, Cavone D, Vimercati L, Miligi L, Piro S, Landi MT, Caporaso NE, Curti S, Mattioli S, Brandi G, Gioscia C, Eccher S, Murano S, Casotto V, Comiati V, Negro C, D'Agostin F, Genova C, Benfatto L, Romanelli A, Grappasonni I, Madeo G, Cozzi I, Romeo E, Tommaso S, Carrozza F, Labianca M, Tallarigo F, Cascone G, Melis M, Marinaccio A, Binazzi A, and Mensi C
Subjects: Humans, Male, Case-Control Studies, Logistic Models, Italy epidemiology, Construction Industry, Occupational Exposure adverse effects, Occupational Diseases epidemiology, Mesothelioma epidemiology, Mesothelioma etiology, Mesothelioma, Malignant, Asbestos adverse effects, Pleural Neoplasms epidemiology, Pleural Neoplasms etiology
Abstract: Objectives: Workers in the construction industry have been exposed to asbestos in various occupations. In Italy, a National Mesothelioma Registry has been implemented more than 20 years ago. Using cases selected from this registry and exploiting existing control data sets, we estimated relative risks for pleural mesothelioma (PM) among construction workers., Design: Case-control study., Setting: Cases from the National Mesothelioma Registry (2000-2018), controls from three previous case-control studies., Methods: We selected male PM incident cases diagnosed in 2000-2018. Population controls were taken from three studies performed in six Italian regions within two periods (2002-2004 and 2012-2016). Age-adjusted and period-adjusted unconditional logistic regression models were fitted to estimate odds ratios (OR) for occupations in the construction industry. We followed two approaches, one (primary) excluding and the other (secondary) including subjects employed in other non-construction blue collar occupations for >5 years. For both approaches, we performed an overall analysis including all cases and, given the incomplete temporal and geographic overlap of cases and controls, three time or/and space restricted sensitivity analyses., Results: The whole data set included 15 592 cases and 2210 controls. With the primary approach (4797 cases and 1085 controls), OR was 3.64 (2181 cases) for subjects ever employed in construction. We found elevated risks for blue-collar occupations (1993 cases, OR 4.52), including bricklayers (988 cases, OR 7.05), general construction workers (320 cases, OR 4.66), plumbers and pipe fitters (305 cases, OR 9.13), painters (104 cases, OR 2.17) and several others. Sensitivity analyses yielded very similar findings. Using the secondary approach, we observed similar patterns, but ORs were remarkably lower., Conclusions: We found markedly increased PM risks for most occupations in the construction industry. These findings are relevant for compensation of subjects affected with mesothelioma in the construction industry., Competing Interests: Competing interests: DCo, SMa and CM served as consultants in trials concerning asbestos-related diseases., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
Published: 2023
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29. Mesothelioma Risk among Construction Workers According to Job Title: Data from the Italian Mesothelioma Register.

Author: Vimercati L, Cavone D, De Maria L, Caputi A, Pentimone F, Sponselli S, Delvecchio G, Chellini E, Binazzi A, Di Marzio D, Mensi C, Consonni D, Migliore E, Mirabelli D, Angelini A, Martini A, Negro C, D'Agostin F, Grappasonni I, Pascucci C, Benfatto L, Malacarne D, Casotto V, Comiati V, Storchi C, Mangone L, Murano S, Rossin L, Tallarigo F, Vitale F, Verardo M, Eccher S, Madeo G, Staniscia T, Carrozza F, Cozzi I, Romeo E, Pelullo P, Labianca M, Melis M, Cascone G, Marinaccio A, Ferri GM, and Serio G
Subjects: Humans, Registries, Construction Industry, Mesothelioma, Mesothelioma, Malignant, Occupational Health
Abstract: Background: An increased risk of mesothelioma has been reported in various countries for construction workers. The Italian National Mesothelioma Registry, from 1993 to 2018, reported exposure exclusively in the construction sector in 2310 cases. We describe the characteristics of these cases according to job title., Methods: We converted into 18 groups the original jobs (N=338) as reported by ISTAT codes ('ATECO 91'). The exposure level was attributed at certain, probable and possible in accordance with the qualitative classification of exposure as reported in the Registry guidelines. Descriptive analysis by jobs highlights the total number of subjects for each single job and certain exposure, in descending order, insulator, plumbing, carpenter, mechanic, bricklayer, electrician, machine operator, plasterer, building contractor, painter and labourer., Results: The cases grow for plumbing in the incidence periods 1993-2018, while, as expected, it decreases for insulator. Within each period considered the most numerous cases are always among bricklayers and labourers, these data confirm the prevalence of non-specialised "interchangeable" jobs in Italian construction sector in the past., Conclusions: Despite the 1992 ban, the construction sector still presents an occupational health prevention challenge, circumstances of exposure to asbestos may still occur due to incomplete compliance with prevention and protection measures.
Published: 2023
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30. A multicenter phase 2 single arm study of cabozantinib in patients with advanced or unresectable renal cell carcinoma pre-treated with one immune-checkpoint inhibitor: The BREAKPOINT trial (Meet-Uro trial 03).

Author: Procopio G, Claps M, Pircher C, Porcu L, Sepe P, Guadalupi V, De Giorgi U, Bimbatti D, Nolè F, Carrozza F, Buti S, Iacovelli R, Ciccarese C, Masini C, Baldessari C, Doni L, Cusmai A, Gernone A, Scagliarini S, Pignata S, de Braud F, and Verzoni E
Subjects: Humans, Immune Checkpoint Inhibitors therapeutic use, Protein Kinase Inhibitors adverse effects, Carcinoma, Renal Cell pathology, Kidney Neoplasms pathology
Abstract: Background: First-line therapies based on immune-checkpoint inhibitors (ICIs) significantly improved survival of metastatic renal cell carcinoma (mRCC) patients. Cabozantinib was shown to target kinases involved in immune-escape and to prolong survival in patients pre-treated with tyrosine-kinase-inhibitors (TKIs). The impact of ICIs combinations in first line on subsequent therapies is still unclear., Methods: This is an open label, multicenter, single arm, phase II study designed to assess activity, safety and efficacy of cabozantinib in mRCC patients progressed after an adjuvant or first line anti-Programmed Death (PD)-1/PD-Ligand (PD-L) 1-based therapy. Primary endpoint was progression free survival (PFS), secondary endpoints were overall survival (OS), objective response rate (ORR) and safety., Results: 31 patients were included in the analysis. After a median (m) follow-up of 11.9 months, mPFS was 8.3 months (90%CI 3.9-17.4) and mOS was 13.8 months (95%CI 7.7-29.0). ORR was 37.9% with an additional 13 patients achieving disease stability. Grade 3-4 adverse events occurred in 47% of patients, including more frequently creatine phosphokinase (CPK) serum level elevation, neutropenia, hyponatremia, diarrhea, hand-food syndrome, oral mucositis and hypertension., Conclusions: The BREAKPOINT trial met its primary endpoint showing that cabozantinib as second line therapy after ICIs was active in mRCC. Safety profile was manageable., Trial Registration Number: NCT03463681 - A Study of CaBozantinib in Patients With Advanced or Unresectable Renal cEll cArcinoma (BREAKPOINT) - https://clinicaltrials.gov/ct2/show/NCT03463681.
Published: 2023
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31. Concomitant Drugs Prognostic Score in Patients With Metastatic Renal Cell Carcinoma Receiving Ipilimumab and Nivolumab in the Compassionate Use Program in Italy: Brief Communication.

Author: Buti S, Basso U, Giannarelli D, De Giorgi U, Maruzzo M, Iacovelli R, Galli L, Porta C, Carrozza F, Procopio G, Fonarini G, Lo Re G, Santoni M, Sabbatini R, Cusmai A, Zucali PA, Aschele C, Baldini E, Zafarana E, Favaretto A, Leo S, Hamzaj A, Mirabelli R, Nole' F, Zai S, Chini C, Masini C, Fatigoni S, Rocchi A, Tamburini E, Cortellini A, and Bersanelli M
Subjects: Humans, Ipilimumab therapeutic use, Nivolumab therapeutic use, Compassionate Use Trials, Pharmaceutical Preparations, Prognosis, Prospective Studies, Communication, Carcinoma, Renal Cell diagnosis, Carcinoma, Renal Cell drug therapy, Kidney Neoplasms diagnosis, Kidney Neoplasms drug therapy
Abstract: A concomitant drug-based score was developed by our group and externally validated for prognostic and predictive purposes in patients with advanced cancer treated with immune checkpoint inhibitors (ICIs). The model considers the use of three classes of drugs within a month before initiating ICI, assigning score 1 for each between proton pump inhibitor and antibiotic administration until a month before immunotherapy initiation and score 2 in case of corticosteroid intake. In the present analysis, the drug score was validated in a prospective population of 305 patients with metastatic renal cell carcinoma treated with ipilimumab plus nivolumab in the first-line setting. The value of the model in predicting overall survival and progression-free survival was statistically significant and clinically meaningful, with an overall survival rate at 12 months of 73% vs. 44% (P<0.0001), and median progression-free survival of 11.6 (95% CI: 9.1-14.1) months versus 4.8 (95% CI: 2.7-7.0) months (P=0.002), respectively, for patients belonging to the favorable group (score 0-1) versus the unfavorable (score 2-4). Further development will be represented by the gut microbiome analysis according to the drug-based model classification and to the outcome of patients to ICI therapy to demonstrate the link between drug exposure and immune sensitivity., (Copyright © 2022 The Author(s). Published by Wolters Kluwer Health, Inc.)
Published: 2023
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32. Asbestos Exposure and Malignant Mesothelioma in Construction Workers-Epidemiological Remarks by the Italian National Mesothelioma Registry (ReNaM).

Author: Binazzi A, Di Marzio D, Verardo M, Migliore E, Benfatto L, Malacarne D, Mensi C, Consonni D, Eccher S, Mazzoleni G, Comiati V, Negro C, Romanelli A, Chellini E, Angelini A, Grappasonni I, Madeo G, Romeo E, Di Giammarco A, Carrozza F, Angelillo IF, Cavone D, Vimercati L, Labianca M, Tallarigo F, Tumino R, Melis M, Bonafede M, Scarselli A, Marinaccio A, and On Behalf Of The ReNaM Working Group
Subjects: Humans, Italy epidemiology, Registries, Asbestos, Construction Industry, Mesothelioma chemically induced, Mesothelioma epidemiology, Mesothelioma, Malignant, Occupational Exposure
Abstract: Notwithstanding the ban in 1992, asbestos exposure for workers in the construction sector in Italy remains a concern. The purpose of this study is to describe the characteristics of malignant mesothelioma (MM) cases recorded by the Italian registry (ReNaM) among construction workers. Incident mesothelioma cases with a definite asbestos exposure have been analyzed. Characteristics of cases and territorial clusters of crude rates of MM in construction workers have been described, as well as the relation between asbestos use before the ban and the historical trend of workforce in the construction sector in Italy. ReNaM has collected 31,572 incident MM cases in the period from 1993 to 2018 and asbestos exposure has been assessed for 24,864 (78.2%) cases. An occupational exposure has been reported for 17,191 MM cases (69.1% of subjects with a definite asbestos exposure). Among them, 3574 had worked in the construction sector, with an increasing trend from 15.8% in the 1993-98 period to 23.9% in 2014-2018 and a ubiquitous territorial distribution. The large use of asbestos in construction sector before the ban makes probability of exposure for workers a real concern still today, particularly for those working in maintenance and removal of old buildings. There is a clear need to assess, inform, and prevent asbestos exposure in this sector.
Published: 2021
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33. Cabozantinib in Pretreated Patients with Metastatic Renal Cell Carcinoma with Sarcomatoid Differentiation: A Real-World Study.

Author: Santoni M, Massari F, Grande E, Procopio G, Matrana MR, Rizzo M, De Giorgi U, Basso U, Milella M, Iacovelli R, Aurilio G, Incorvaia L, Buti S, Caffo O, Fornarini G, Carrozza F, Mollica V, Rizzo A, Farag F, Molina-Cerrillo J, and Battelli N
Subjects: Anilides, Cell Differentiation, Female, Humans, Male, Pyridines, Retrospective Studies, Carcinoma, Renal Cell drug therapy, Kidney Neoplasms drug therapy
Abstract: Background: Renal cell carcinoma with sarcomatoid differentiation is a highly aggressive form of kidney cancer., Objective: We aimed to analyze the outcomes of patients treated with cabozantinib for metastatic renal cell carcinoma with sarcomatoid features., Methods: We retrospectively collected data from 16 worldwide centers. Overall survival and progression-free survival were analyzed using Kaplan-Meier curves. Cox proportional models were used for univariate and multivariate analyses., Results: We collected data from 66 patients with metastatic sarcomatoid renal cell carcinoma receiving cabozantinib as second-line (51%) or third-line (49%) therapy. The median progression-free survival from the start of cabozantinib was 7.59 months (95% confidence interval [CI] 5.75-17.49) and was longer in male patients (8.81 vs 5.95 months, p = 0.042) and in patients without bone metastases (7.59 vs 5.11 months, p = 0.010); the median overall survival was 9.11 months (95% CI 7.13-23.80). At the multivariate analysis, female sex (hazard ratio = 1.81; 95% CI 1.02-3.37, p = 0.046), bone metastases (hazard ratio = 2.62; 95% CI 1.34-5.10, p = 0.005), and International Metastatic Renal Cell Carcinoma Database Consortium criteria (hazard ratio = 3.04; 95% CI 1.54-5.99, p = 0.001) were significant predictors of worse overall survival., Conclusions: Our data show that cabozantinib is active in pretreated patients with sarcomatoid renal cell carcinoma. Biomarkers are needed in this field to select patients for multi-kinase inhibitors or other options., (© 2021. The Author(s), under exclusive licence to Springer Nature Switzerland AG.)
Published: 2021
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34. Docetaxel and prednisone with or without enzalutamide as first-line treatment in patients with metastatic castration-resistant prostate cancer: CHEIRON, a randomised phase II trial.

Author: Caffo O, Ortega C, Nolè F, Gasparro D, Mucciarini C, Aieta M, Zagonel V, Iacovelli R, De Giorgi U, Facchini G, Veccia A, Palesandro E, Verri E, Buti S, Razzini G, Bozza G, Maruzzo M, Ciccarese C, Schepisi G, Rossetti S, Maines F, Kinspergher S, Fratino L, Ermacora P, Nicodemo M, Giordano M, Sartori D, Scapoli D, Sabbatini R, Lo Re G, Morelli F, D'Angelo A, Vittimberga I, Lippe P, Carrozza F, Messina C, Galli L, Valcamonico F, Porta C, Pappagallo G, and Aglietta M
Subjects: Aged, Antineoplastic Combined Chemotherapy Protocols pharmacology, Docetaxel pharmacology, Humans, Male, Middle Aged, Prednisone pharmacology, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Benzamides therapeutic use, Docetaxel therapeutic use, Nitriles therapeutic use, Phenylthiohydantoin therapeutic use, Prednisone therapeutic use, Prostatic Neoplasms, Castration-Resistant drug therapy
Abstract: Background: Pre-clinical data suggest that docetaxel and enzalutamide interfere with androgen receptor translocation and signalling. The aim of this study is to assess the efficacy of their concurrent administration in the first-line treatment for metastatic castration-resistant prostate cancer (mCRPC)., Methods: In this open-label, randomised, phase II trial, previously untreated mCRPC patients were randomised 1:1 to receive eight 21-d courses of docetaxel 75 mg/m 2 , oral prednisone 5 mg twice daily and oral enzalutamide 160 mg/d (arm DE), or the same treatment without enzalutamide (arm D). The primary end-point was the percentage of patients without investigator-assessed disease progression 6 months after the first docetaxel administration., Results: The 246 eligible patients were randomly assigned to receive docetaxel, prednisone and enzalutamide (n = 120) or docetaxel and prednisone (n = 126). The 6-month progression rate was 12.5% (95% confidence interval [CI] 8.1-20.6) in arm DE and 27.8% (95% CI 22.8-39.4) in arm D (chi-squared test 10.01; P = 0.002). The most frequent grade III-IV adverse events were fatigue (12.5% in arm DE versus 5.6% in arm D), febrile neutropenia (9.3% versus 4.0%) and neutropenia (7.6% versus 5.6%)., Conclusions: The combination of enzalutamide and docetaxel appears to be more clinically beneficial than docetaxel alone in previously untreated mCRPC patients, although serious adverse events were more frequent. Our findings suggest that first-line treatment with this combination could lead to an additional clinical benefit when prompt and prolonged disease control is simultaneously required. Clearly, these results should be considered cautiously because of the study's phase II design and the absence of an overall survival benefit., Trial Registration Numbers: EudraCT 2014-000175-43 - NCT02453009., Competing Interests: Conflict of interest statement The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Orazio Caffo is an advisor to Janssen, MSD and Bayer, and a speaker for Astellas, AstraZeneca, Bayer, Janssen, MSD, Pfizer and Sanofi. Cinzia Ortega is an advisor to Janssen, Astellas, Pfizer, Novartis and MSD, and a speaker for MSD, BMS and Sanofi. Donatello Gasparro is a speaker for and an advisor to Sanofi and Astellas. Vittorina Zagonel is an advisor to Bristol-Myers Squibb, MSD, Eisai and Italfarmaco, and a speaker for Roche, Bristol-Myers Squibb, Astellas Pharma, Servier, AstraZeneca, MSD, Janssen and Ipsen. Roberto Iacovelli is an advisor to Pfizer, Ipsen, Janssen, Astellas, MSD and BMS. Ugo De Giorgi is a consultant of Astellas Pharma, Bayer, BMS, Ipsen, Janssen, MSD, Novartis, Pfizer, Roche and Sanofi. Elena Verri is an advisor to Astellas, Bayer, Janssen and Sanofi. Sebastiano Buti is a speaker for and advisor to BMS, Pfizer, Pierre-Fabre, MSD, Ipsen, Roche, Eli-Lilly, AstraZeneca and Novartis. Marco Maruzzo is an advisor to Pfizer, BMS, Janssen, MSD, Merck Serono and Ipsen. Giovanni Pappagallo is a counsellor and trainer for Astellas, AstraZeneca, Daiichi-Sankyo, Ipsen, Janssen, MSD, Pierre Fabre, Pfizer, Roche, Servier and Teva. Massimo Aglietta is an advisor to Bayer, BMS, Merck and Novartis, and has received travel support from BMS, Merck and Tesaro. Maurizio Nicodemo is a speaker for and an advisor to Bristol-Myers Squibb, Ipsen, Molteni and Janssen. Roberto Sabbatini is an advisor to Janssen, and a speaker for Astellas, Janssen and Sanofi. Franco Morelli is a speaker for MSD and Pfizer. Francesco Carrozza is a speaker for Janssen. Camillo Porta is a consultant of and speaker for Angelini, AstraZeneca, Bristol-Myers Squibb, Eisai, EUSA, General Electric, Ipsen, Merck, MSD, Novartis and Pfizer; an expert witness for EUSA and Pfizer; a member of the Protocol Steering Committee of Bristol-Myers Squibb, Eisai and EUSA and has received travel support from Roche. The remaining authors have no conflict of interest to be declared, (Copyright © 2021 Elsevier Ltd. All rights reserved.)
Published: 2021
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35. Authors' response: Mezei et al's "Comments on a recent case-control study of malignant mesothelioma of the pericardium and the tunica vaginalis testis".

Author: Marinaccio A, Consonni D, Mensi C, Mirabelli D, Migliore E, Magnani C, Di Marzio D, Gennaro V, Mazzoleni G, Girardi P, Negro C, Romanelli A, Chellini E, Grappasonni I, Madeo G, Romeo E, Ascoli V, Carrozza F, Angelillo IF, Cavone D, Tumino R, Melis M, Curti S, Brandi G, Mattioli S, and Iavicoli S
Subjects: Case-Control Studies, Cohort Studies, Female, Humans, Italy epidemiology, Male, Pericardium, Testis, Asbestos adverse effects, Mesothelioma epidemiology, Mesothelioma, Malignant, Occupational Exposure
Abstract: Mezei et al's letter (1) is an opportunity to provide more details about our study on pericardial and tunica vaginalis testis (TVT) mesothelioma (2), which is based on the Italian national mesothelioma registry (ReNaM): a surveillance system on mesothelioma, with individual asbestos exposure assessment. Incidence of pericardial mesothelioma has been estimated around 0.5 and 0.2 cases per 10 million person-years in men and women, respectively, and around 1 case for TVT mesothelioma. ReNaM collected 138 cases thanks to its long period of observation (1993-2015) and national coverage. Conducting a population-based case-control study with incidence-density sampling of controls across Italy and over a 23 year time-span should have been planned in 1993 and would have been beyond feasibility and ReNaM scope. We rather exploited two existing series of controls (3). The resulting incomplete time- and spatial matching of cases and controls is a limitation of our study and has been acknowledged in our article. The analysis of case-control studies can nevertheless be accomplished in logistic models accounting for the variables of interest, in both individually and frequency matched studies (4). Furthermore, analyses restricted to (i) regions with enrolled controls, (ii) cases with definite diagnosis, (iii) incidence period 2000-2015, and (iv) subjects born before 1950 have been provided in the manuscript, confirming the strength of the association with asbestos exposure (supplemental material tables S4-7). Following Mezei et al's suggestion, we performed further sensitivity analyses by restriction to regions with controls and fitting conditional regression models using risk-sets made of combinations of age and year of birth categories (5-year classes for both). We confirmed positive associations with occupational exposure to asbestos of pericardial mesothelioma, with odds ratios (OR) (adjusted for region) of 9.16 among women [95% confidence interval (CI) 0.56-150] and 5.63 (95% CI 1.02-31.0) among men; for TVT mesothelioma the OR was 7.70 (95% CI 2.89-20.5). Using risk sets of age categories and introducing year of birth (5-year categories) as a covariate (dummy variables) the OR were similar: OR (adjusted for region) of 9.17 among women (95% CI 0.56-150) and 5.76 (95% CI 1.07-31.0) among men; for TVT the OR was 9.86 (95% CI 3.46-28.1). Possible bias from incomplete geographical overlap between cases and controls has been addressed in the paper (table S4) and above. In spatially restricted analyses, OR were larger than in those including cases from the whole country, indicating that bias was towards the null. Mezei et al further noted that "the regional distribution of controls is different from that of person-time observed". This objection is not relevant because the above analyses were adjusted by region. Our controls were provided by a population-based study on pleural mesothelioma (called MISEM) and a hospital-based study on cholangiocarcinoma (called CARA). In MISEM, the response rate was 48.4%, a low but not unexpected rate as participation among population controls is usually lower and has been declining over time (5). It is important to underline that ReNaM applied the same questionnaire that was used for interviews and carried out the same exposure assessment as both MISEM and CARA. As repeatedly stated in ReNaM papers (6-7), each regional operating center assesses asbestos exposure based on the individual questionnaire, other available information, and knowledge of local industries. Occupational exposure to asbestos is classified as definite, probable or possible. Occupational exposure is (i) definite when the subject`s work was reported or otherwise known to have involved the use of asbestos or asbestos-containing materials (MCA); (ii) probable when subjects worked in factories where asbestos or MCA were used, but their personal exposure could not be documented; and (iii) possible when they were employed in industrial activities known to entail the use of asbestos or MCA. Hence, the definite and probable categories are closer to one another and were combined in our analyses. In any case, restricting analyses to subjects with definite occupational exposure and using each set of controls separately, as suggested by Mezei et al, yielded elevated OR for TVT and pericardial mesothelioma among men using both the above described modelling strategies; the OR could not be calculated for women. There were 70 (25 pericardial and 45 TVT) occupationally exposed mesothelioma cases. In population-based studies, analyses by occupation are limited by the low prevalence of most specific jobs. As briefly reported in our paper, for purely descriptive purposes, the industrial activity of exposure (cases may have multiple exposures), were construction (22 exposures, 7 and 15 for pericardial and TVT mesotheliomas, respectively), steel mills and other metal working industries (4 and 11), textile industries (2 and 3), and agriculture (2 and 5); other sectors had lower exposure frequencies. The absence of industries like asbestos-cement production, shipbuilding and railway carriages production/repair should not be surprising and had already been observed (7). In the Italian multicenter cohort study of asbestos workers (8), given the person-years of observation accrued by workers employed in these industries and gender- and site-specific crude incidence rates, approximately 0.1 case of pericardial and 0.2 of TVT mesothelioma would have been expected from 1970 to 2010. Even increasing ten-fold such figures to account for higher occupational risks among these workers would not change much. Asbestos exposure in agriculture has been repeatedly discussed in ReNaM reports (9: pages 70, 73, 128, 164 and 205). Exposure opportunities included the presence of asbestos in wine production, reuse of hessian bags previously containing asbestos, or construction and maintenance of rural buildings. Similarly, mesothelioma cases and agricultural workers exposed to asbestos have been noted in France (10). In conclusion, the additional analyses we performed according to Mezei et al's suggestions confirm the association between asbestos exposure and pericardial and TVT mesothelioma, supporting the causal role of asbestos for all mesotheliomas. ReNaM`s continuing surveillance system with national coverage is a precious platform for launching analytical studies on pleural and extra pleural mesothelioma. References 1. Mezei G, Chang ET, Mowat FS, Moolgavkar SH. Comments on a recent case-control study of malignant mesothelioma of the pericardium and the tunica vaginalis testis Scand J Work Environ Health. 2021;47(1):85-86. https://doi.org/10.5271/3909 2. Marinaccio A, Consonni D, Mensi C, Mirabelli D, Migliore E, Magnani C et al.; ReNaM Working Group. Association between asbestos exposure and pericardial and tunica vaginalis testis malignant mesothelioma: a case-control study and epidemiological remarks. Scand J Work Environ Health. 2020;46(6):609-617. https://doi.org/10.5271/sjweh.3895. 3. Greenland S. Control-initiated case-control studies. Int J Epidemiol 1985 Mar;14(1):130-4. https://doi.org/10.1093/ije/14.1.130. 4. Pearce N. Analysis of matched case-control studies. BMJ 2016 Feb;352:i969. https://doi.org/10.1136/bmj.i969. 5. Bigert C, Gustavsson P, Straif K, Pesch B, Brüning T, Kendzia B et al. Lung cancer risk among cooks when accounting for tobacco smoking: a pooled analysis of case-control studies from Europe, Canada, New Zealand, and China. J Occup Environ Med 2015 Feb;57(2):202-9. https://doi.org/10.1097/JOM.0000000000000337. 6. Marinaccio A, Binazzi A, Marzio DD, Scarselli A, Verardo M, Mirabelli D et al.; ReNaM Working Group. Pleural malignant mesothelioma epidemic: incidence, modalities of asbestos exposure and occupations involved from the Italian National Register. Int J Cancer 2012 May;130(9):2146-54. https://doi.org/10.1002/ijc.26229. 7. Marinaccio A, Binazzi A, Di Marzio D, Scarselli A, Verardo M, Mirabelli D et al. Incidence of extrapleural malignant mesothelioma and asbestos exposure, from the Italian national register. Occup Environ Med 2010 Nov;67(11):760-5. https://doi.org/10.1136/oem.2009.051466. 8. Ferrante D, Chellini E, Merler E, Pavone V, Silvestri S, Miligi L et al.; the working group. Italian pool of asbestos workers cohorts: mortality trends of asbestos-related neoplasms after long time since first exposure. Occup Environ Med 2017 Dec;74(12):887-98. https://doi.org/10.1136/oemed-2016-104100. 9. ReNaM VI Report. Available from: https://www.inail.it/cs/internet/docs/alg-pubbl-registro-nazionale-mesoteliomi-6-rapporto.pdf. Italian 10. Marant Micallef C, Shield KD, Vignat J, Baldi I, Charbotel B, Fervers B et al. Cancers in France in 2015 attributable to occupational exposures. Int J Hyg Environ Health 2019 Jan;222(1):22-9. https://doi.org/10.1016/j.ijheh.2018.07.015.
Published: 2021
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36. Correlation Between Immune-related Adverse Event (IRAE) Occurrence and Clinical Outcome in Patients With Metastatic Renal Cell Carcinoma (mRCC) Treated With Nivolumab: IRAENE Trial, an Italian Multi-institutional Retrospective Study.

Author: Vitale MG, Pipitone S, Venturelli M, Baldessari C, Porta C, Iannuzzi F, Basso U, Scagliarini S, Zucali PA, Galli L, Rossetti S, Caserta C, Bracarda S, Iacovelli R, Masini C, Cortellini A, Di Girolamo S, Buti S, Fornarini G, Carrozza F, Santoni M, Caputo F, Giaquinta S, Balduzzi S, D'Amico R, Vitale G, Mighali P, and Sabbatini R
Subjects: Humans, Italy epidemiology, Nivolumab adverse effects, Retrospective Studies, Antineoplastic Agents, Immunological adverse effects, Carcinoma, Renal Cell drug therapy, Kidney Neoplasms drug therapy
Abstract: Background: Immunotherapy has brought clinical benefits to patients with metastatic renal cell cancer (mRCC). Most patients tolerate immunotherapy but serious immune-related adverse events (irAEs) have been reported. Some studies indicate a correlation between irAEs and clinical response in other cancer types (eg, lung cancer and melanoma). For patients with mRCC, the impact of irAE on clinical outcome is unknown., Patients and Methods: A retrospective review of 167 patients with mRCC treated with nivolumab as standard of care between March 2017 and January 2018 in 16 Italian centers was performed. irAEs were assessed using Common Terminology Criteria for Adverse Events (CTCAE) v.4.0., Results: Any grade and grade 3/4 irAEs occurred in 46% and 8.9% of patients, respectively. The median time to appearance of irAEs was 10 weeks; 38.8% of patients required steroid treatment. The most common irAEs were cutaneous (33.7%) and gastrointestinal (23.3%). The median overall survival and progression-free survival were 20.13 and 7.86 months, respectively. Patients with irAEs showed a greater overall survival (hazard ratio, 0.38; 95% confidence interval [CI], 0.23-0.63) and progression-free survival (hazard ratio, 0.44; 95% CI, 0.29-0.66) benefit as well as better overall response rate (27.3% vs. 13.7%; odds ratio, 2.36; 95% CI, 1.03-5.44) and disease control rate (68.8% vs. 48%; odds ratio, 2.4; 95% CI, 1.23-4.67) if compared with those without irAEs. No correlation was found between steroid use and clinical outcomes., Conclusions: Our analysis revealed that the appearance of irAEs was associated with better outcomes in patients treated with nivolumab. This data may be limited by sample size and the retrospective nature of the study., (Copyright © 2020 Elsevier Inc. All rights reserved.)
Published: 2020
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37. Symptomatic COVID-19 in advanced-cancer patients treated with immune-checkpoint inhibitors: prospective analysis from a multicentre observational trial by FICOG.

Author: Bersanelli M, Giannarelli D, De Giorgi U, Pignata S, Di Maio M, Verzoni E, Clemente A, Guadalupi V, Signorelli D, Tiseo M, Giusti R, Filetti M, Di Napoli M, Calvetti L, Cappetta A, Ermacora P, Zara D, Barbieri F, Baldessari C, Scotti V, Mazzoni F, Veccia A, Guglielmini PF, Maruzzo M, Rossi E, Grossi F, Casadei C, Cortellini A, Verderame F, Montesarchio V, Rizzo M, Mencoboni M, Zustovich F, Fratino L, Cinieri S, Negrini G, Banzi M, Sorarù M, Zucali PA, Lacidogna G, Russo A, Battelli N, Fornarini G, Mucciarini C, Bracarda S, Bonetti A, Pezzuolo D, Longo L, Sartori D, Iannopollo M, Cavanna L, Meriggi F, Tassinari D, Corbo C, Gernone A, Prati V, Carnio S, Giordano P, Dicorato AM, Verusio C, Atzori F, Carrozza F, Gori S, Castro A, Pilotto S, Vaccaro V, Garzoli E, Di Costanzo F, Maiello E, Labianca R, Pinto C, Tognetto M, and Buti S
Abstract: Background: This prospective, multicentre, observational INVIDIa-2 study is investigating the clinical efficacy of influenza vaccination in advanced-cancer patients receiving immune-checkpoint inhibitors (ICIs), enrolled in 82 Italian centres, from October 2019 to January 2020. The primary endpoint was the incidence of influenza-like illness (ILI) until 30 April 2020. All the ILI episodes, laboratory tests, complications, hospitalizations and pneumonitis were recorded. Therefore, the study prospectively recorded all the COVID-19 ILI events., Patients and Methods: Patients were included in this non-prespecified COVID-19 analysis, if alive on 31 January 2020, when the Italian government declared the national emergency. The prevalence of confirmed COVID-19 cases was detected as ILI episode with laboratory confirmation of SARS-CoV-2. Cases with clinical-radiological diagnosis of COVID-19 (COVID-like ILIs), were also reported., Results: Out of 1257 enrolled patients, 955 matched the inclusion criteria for this unplanned analysis. From 31 January to 30 April 2020, 66 patients had ILI: 9 of 955 cases were confirmed COVID-19 ILIs, with prevalence of 0.9% [95% confidence interval (CI): 0.3-2.4], a hospitalization rate of 100% and a mortality rate of 77.8%. Including 5 COVID-like ILIs, the overall COVID-19 prevalence was 1.5% (95% CI: 0.5-3.1), with 100% hospitalization and 64% mortality. The presence of elderly, males and comorbidities was significantly higher among patients vaccinated against influenza versus unvaccinated ( p = 0.009, p < 0.0001, p < 0.0001). Overall COVID-19 prevalence was 1.2% for vaccinated (six of 482 cases, all confirmed) and 1.7% for unvaccinated (8 of 473, 3 confirmed COVID-19 and 5 COVID-like), p = 0.52. The difference remained non-significant, considering confirmed COVID-19 only ( p = 0.33)., Conclusion: COVID-19 has a meaningful clinical impact on the cancer-patient population receiving ICIs, with high prevalence, hospitalization and an alarming mortality rate among symptomatic cases. Influenza vaccination does not protect from SARS-CoV-2 infection., Competing Interests: Conflict of interest statement: The Federation of Italian Cooperative Oncology Groups (FICOG) received funding for the present study by Seqirus and Roche S.p.A.; the Federation also received funding during the conduct of the present study by Astra Zeneca, Bristol Myers Squibb (BMS), Sanofi. Melissa Bersanelli received funding for the present study by Seqirus and Roche S.p.A. (FICOG as Institution, no personal fees). She also received, outside the present work, research funding from Pfizer and Novartis (Institution), honoraria as speaker at scientific events (personal fees) by Astra Zeneca, Bristol Myers Squibb (BMS), Novartis and Pfizer; as consultant for advisory role (personal fees) by Novartis, BMS and Pfizer. Ugo De Giorgi received honoraria from AstraZeneca, Roche, MSD, Pfizer, GSK, Clovis, Incyte and research funding from Roche, AstraZeneca, MSD, Pfizer. Dr Di Maio reports personal fees from Bristol Myers Squibb, personal fees from Merck Sharp & Dohme, personal fees from AstraZeneca, personal fees from Janssen, personal fees from Astellas, personal fees from Pfizer, personal fees from Eisai, personal fees from Takeda, grants from Tesaro GSK, outside the submitted work. Sebastiano Buti received honoraria as speaker at scientific events and advisory role by BMS, Pfizer; MSD, Ipsen, Roche S.p.A., Eli Lilly, AstraZeneca and Novartis; he also received research funding from Novartis. Marcello Tiseo received honoraria (personal fees) by MSD, BMS, Boehringer (BI), Takeda, AstraZeneca, and research funding by AstraZeneca (Institution). Vieri Scotti participated, with personal fees, to advisory boards and speaker’s bureaus for Roche S.p.A. Dr Cortellini reports grants from AstraZeneca, grants from MSD, grants from BMS, grants from Roche, during the conduct of the study; grants from AstraZeneca, grants from MSD, grants from BMS, grants from Roche, grants from Novartis, outside the submitted work. Saverio Cinieri declared international board for Eli Lilly international. Paolo Andrea Zucali acts in a consultant or advisory role for Sanofi, BMS, Pfizer, MSD, Astellas, Janssen, Ipsen, Novartis, all outside the scope of work. Sergio Bracarda declares to have acted as advisory board member (uncompensated) for: Janssen, Astellas, Pfizer, MSD, BMS, Merck, AstraZeneca, AAA, Ipsen, Bayer, Roche/Genentech. Francesco Carozza declared personal fees from Janssen. Sara Pilotto reports personal fees from AstraZeneca, Eli Lilly, Boehringer Ingelheim, Merk & Co, Roche, outside the submitted work. All remaining authors have declared no conflicts of interest., (© The Author(s), 2020.)
Published: 2020
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38. Post-Traumatic Ostial Avulsion of a Polar Inferior Renal Artery Treated by Endovascular Covered Aortic Stenting.

Author: Carrozza F and Deprez FC
Abstract: Renovascular traumas are rare in abdominal blunt traumas, especially those involving complete avulsion of a renal artery. Their management poses a dilemma between blood flow preservation and the risks of bleeding. We present the case of a rare variant of renovascular injury, with a post traumatic ostial avulsion of a polar inferior renal artery, successfully treated percutaneously by endovascular aortic covered stenting under c-arm cone-beam computed tomography guiding., Competing Interests: The authors have no competing interests to declare., (Copyright: © 2020 The Author(s).)
Published: 2020
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39. Spontaneous Esophageal Rupture or Boerhaave's Syndrome.

Author: Carrozza F and Dragean C
Abstract: Teaching point: Boerhaave syndrome is a very rare life-threatening surgical emergency, often misdiagnosed at the patient's admittance., Competing Interests: The authors have no competing interests to declare., (Copyright: © 2020 The Author(s).)
Published: 2020
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40. Oral anticancer therapy project: Clinical utility of a specific home care nursing programme on behalf of Italian Association of Medical Oncology (AIOM).

Author: Cirillo M, Carlucci L, Legramandi L, Baldini E, Sacco C, Zagonel V, Leo S, Di Fabio F, Tonini G, Meacci ML, Tartarone A, Farci D, Tortora G, Zaninelli M, Valori VM, Cinieri S, Carrozza F, Barbato E, Fabbroni V, Cretella E, Gamucci T, Lunardi G, Zamboni S, Micallo G, Cascinu S, Pinto C, and Gori S
Subjects: Administration, Oral, Female, Humans, Italy, Male, Medical Oncology organization & administration, Middle Aged, Therapeutics, Antineoplastic Agents administration & dosage, Home Care Services organization & administration, Neoplasms drug therapy, Neoplasms nursing, Oncology Nursing organization & administration
Abstract: Aims and Objectives: To assess the effectiveness of a specific home care nursing programme in addition to standard care in patients (pts) receiving oral anticancer treatments., Background: Oral anticancer therapy present challenges for pts since treatment is a home-based therapy. This study evaluates the potentiality of a home care nursing programme in decreasing hospital accesses for not severe toxicity., Methods: This is an open-label, multicentre, randomised trial including pts who were receiving an anticancer oral drug. The study complies with the CONSORT checklist published in 2010. Concomitant use of radiation therapy, intravenous or metronomic therapies, or the intake of previous oral drugs was not allowed. Pts were randomly assigned to home care nursing programme (A) or standard care (B). In arm A, dedicated nurses provided information to pts, a daily record on which pts would take note of drugs and dosages and a telephone monitoring during the first two cycles of therapy. The primary outcome was the reduction in improper hospital accesses for grade 1-2 toxicity according to CTCAE v4.0., Results: Out of 432 randomised pts, 378 were analysed (184 pts in arm A and 194 in arm B). Hospital accesses were observed in 41 pts in arm A and in 42 pts in arm B (22.3% vs. 21.6%, respectively). No difference was detected in proportion of improper accesses between arm A and arm B (29.3% vs. 23.8%, respectively)., Conclusions: Our experience failed to support the role of a specific home care nursing programme for pts taking oral chemotherapy. An improved attention to specific educational practice and information offered to pts can explain these results., Relevance to Clinical Practice: Our results underline the role of nurse educational practice and information offered to patients. A careful nurse information of patients about drugs is essential to reduce toxicities avoiding the opportunity of a specific home monitoring., (© 2019 John Wiley & Sons Ltd.)
Published: 2020
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41. The epidemiological surveillance of malignant mesothelioma in Italy (1993-2015): methods, findings, and research perspectives.

Author: Marinaccio A, Corfiati M, Binazzi A, Di Marzio D, Bonafede M, Verardo M, Migliore E, Gennaro V, Mensi C, Schallemberg G, Mazzoleni G, Fedeli U, Negro C, Romanelli A, Chellini E, Grappasonni I, Pascucci C, Madeo G, Romeo E, Trafficante L, Carrozza F, Angelillo IF, Cavone D, Cauzillo G, Tallarigo F, Tumino R, and Melis M
Subjects: Adult, Female, Humans, Incidence, Italy epidemiology, Male, Middle Aged, Occupational Diseases epidemiology, Occupational Exposure statistics & numerical data, Population Surveillance, Registries, Mesothelioma, Malignant epidemiology
Abstract: Background: as a legacy of the large asbestos consumption until the definitive ban in 1992, Italy had to tackle a real epidemic of asbestos related diseases. The Italian National Registry of Malignant Mesotheliomas (ReNaM) is a permanent surveillance system of mesothelioma incidence, with a regional structure. Aims, assignments and territorial network of ReNaM are described, as well as data collection, recording and coding procedures., Objectives: to describe the Italian epidemiological surveillance system of mesothelioma incidence, to provide updated data about occurrence of malignant mesothelioma in Italy, and to discuss goals, attainments, and expectations of registering occupational cancer., Design: analysis of data by malignant mesothelioma incident cases surveillance system., Setting and Participants: Italy, network of regional surveillance system, all Italian regions., Main Outcome Measures: a Regional Operating Centre (COR) is currently established in all the Italian regions, actively searching incident malignant mesothelioma cases from health care institutions. Occupational history, lifestyle habits, and residential history are obtained using a standardized questionnaire, administered to the subject or to the next of kin by a trained interviewer. The extent of dataset, epidemiological parameters, and occupations involved are reported updated at 31.12.2016, and standardized incidence rates are calculated., Results: at December 2016, ReNaM has collected 27,356 malignant mesothelioma cases, referring to the period of incidence between 1993 and 2015. The modalities of exposure to asbestos have been investigated for 21,387 (78%) and an occupational exposure has been defined for around 70% of defined cases (14,818)., Conclusions: the Italian experience shows that epidemiological systematic surveillance of asbestos related diseases incidence has a key importance for assessing and monitoring the public health impact of occupational and/or environmental hazards, programming preventive interventions, including remediation plans and information campaigns, and supporting the efficiency of insurance and welfare system. Monitoring the incidence of malignant mesothelioma through a specialized cancer registry is essential to follow-up the health effects of changing modalities and extent of occupational exposures over years and of environmental contamination. Such consolidated surveillance system is recommended also for occupational cancers with low aetiological fraction.
Published: 2020
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42. Real-World Data on Cabozantinib in Previously Treated Patients with Metastatic Renal Cell Carcinoma: Focus on Sequences and Prognostic Factors.

Author: Santoni M, Heng DY, Bracarda S, Procopio G, Milella M, Porta C, Matrana MR, Cartenì G, Crabb SJ, De Giorgi U, Basso U, Masini C, Calabrò F, Vitale MG, Santini D, Massari F, Galli L, Fornarini G, Ricotta R, Buti S, Zucali P, Caffo O, Morelli F, Carrozza F, Martignetti A, Gelibter A, Iacovelli R, Mosca A, Atzori F, Vau N, Incorvaia L, Ortega C, Scarpelli M, Lopez-Beltran A, Cheng L, Paolucci V, Graham J, Pierce E, Scagliarini S, Sepe P, Verzoni E, Merler S, Rizzo M, Sorgentoni G, Conti A, Piva F, Cimadamore A, Montironi R, and Battelli N
Abstract: Cabozantinib is approved for the treatment of renal cell carcinoma (RCC). However, prognostic factors are still lacking in this context. The aim of this study was to evaluate prognostic factors in RCC patients treated with second- or third-line cabozantinib. A multicenter retrospective real-world study was conducted, involving 32 worldwide centers. A total of 237 patients with histologically confirmed clear-cell and non-clear-cell RCC who received cabozantinib as second- or third-line therapy for metastatic disease were included. We analyzed overall survival (OS), progression-free survival (PFS) and time-to-strategy failure (TTSF) using Kaplan-Meier curves. Cox proportional models were used at univariate and multivariate analyses.The median PFS and OS of cabozantinib were 7.76 months (95% CI 6.51-10.88) and 11.57 months (95% CI 10.90-not reached (NR)) as second-line and 11.38 months (95% CI 5.79-NR) and NR (95% CI 11.51-NR) as third-line therapy. The median TTSF and OS were 11.57 and 15.52 months with the sequence of cabozantinib-nivolumab and 25.64 months and NR with nivolumab-cabozantinib, respectively. The difference between these two sequences was statistically significant only in good-risk patients. In the second-line setting, hemoglobin (Hb) levels (HR= 2.39; 95% CI 1.24-4.60, p = 0.009) and IMDC (International Metastatic Renal Cell Carcinoma Database Consortium) group (HR = 1.72, 95% CI 1.04-2.87, p = 0.037) were associated with PFS while ECOG-PS (HR = 2.33; 95%CI, 1.16-4.69, p = 0.018) and Hb levels (HR = 3.12; 95%CI 1.18-8.26, p = 0.023) correlated with OS at multivariate analysis, while in the third-line setting, only Hb levels (HR = 2.72; 95%CI 1.04-7.09, p = 0.042) were associated with OS. Results are limited by the retrospective nature of the study.This real-world study provides evidence on the presence of prognostic factors in RCC patients receiving cabozantinib.
Published: 2019
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43. Toward a genome-based treatment landscape for renal cell carcinoma.

Author: Massari F, Di Nunno V, Santoni M, Gatto L, Caserta C, Morelli F, Zafarana E, Carrozza F, Mosca A, Mollica V, Iacovelli R, Sabbatini R, Porta C, and Bracarda S
Subjects: Animals, Carcinoma, Renal Cell genetics, Genomics, Humans, Kidney Neoplasms genetics, Carcinoma, Renal Cell therapy, Kidney Neoplasms therapy, Mutation, Precision Medicine
Abstract: Knowledge about molecular mechanisms driving development and progression of renal cell carcinoma has been elucidated by different studies. In few years we discovered a large difference between genomic landscapes of clear cell and non-clear cell carcinoma. Moreover, tumor heterogeneity and different acquisition of gene mutations during tumor progression are issues of particular interest. In this review we focalized our attention on principal genomic alterations identified among RCC subtypes. Acquired gene mutations may be an adaptive response to several external pressure including metabolic, treatment, genomic and immune-related external pressure. Thus we correlated and discussed principal genomic alterations adopted by tumor to escape from each external pressures. The aim of the present work is to summarize current knowledge about genomic alterations in RCC with special interest of treatment strategies tailored on the basis of disease mutations assessment., (Copyright © 2019 Elsevier B.V. All rights reserved.)
Published: 2019
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44. Letter concerning: 'Response to: 'The epidemiology of malignant mesothelioma in women: gender differences and modalities of asbestos exposure' by Marinaccio et al '.

Author: Marinaccio A, Corfiati M, Binazzi A, Di Marzio D, Scarselli A, Ferrante P, Bonafede M, Verardo M, Mirabelli D, Gennaro V, Mensi C, Schallemberg G, Mazzoleni G, Merler E, Girardi P, Negro C, D'Agostin F, Romanelli A, Chellini E, Silvestri S, Pascucci C, Calisti R, Stracci F, Romeo E, Ascoli V, Trafficante L, Carrozza F, Angelillo I, Cavone D, Cauzillo G, Tallarigo F, Tumino R, Melis M, and Iavicoli S
Subjects: Female, Humans, Asbestos, Lung Neoplasms, Mesothelioma
Abstract: Competing Interests: Competing interests: None declared.
Published: 2018
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45. Emerging immunotherapeutic strategies targeting telomerases in genitourinary tumors.

Author: Carrozza F, Santoni M, Piva F, Cheng L, Lopez-Beltran A, Scarpelli M, Montironi R, Battelli N, and Tamberi S
Subjects: Animals, Humans, Telomerase immunology, Urogenital Neoplasms immunology, Antibodies, Monoclonal therapeutic use, Antineoplastic Agents therapeutic use, Immunotherapy, Telomerase antagonists & inhibitors, Urogenital Neoplasms therapy
Abstract: Telomerase activity and telomere length are essential for the pathogenesis of several human diseases, including genitourinary tumors. Telomerase constitutes a complex system that includes human telomerase reverse transcriptase (hTERT), human telomerase RNA component (hTR) and telomerase associated protein 1 (TEP1), which are overexpressed in tumor cells compared to normal cells and are involved in the carcinogenesis and progression of renal cell carcinoma (RCC), bladder (BC) and prostate cancer (PCa). In addition, telomerase degraded peptide fragments expressed on the surface of tumor cells lead to their recognition by immune cells. On this scenario, in vitro and in vivo studies have shown effective anti-tumor activity of hTERT-tailored strategies in genitourinary tumors, including active immunotherapy with hTERT-peptide vaccines and passive immunotherapy with hTERT-transduced T cell infusion. This review emphasizes the role of telomerase in the carcinogenesis and progression of genitourinary tumors, thus underlying the potential of emerging telomerase-tailored immunotherapies in these patients., (Copyright © 2018. Published by Elsevier B.V.)
Published: 2018
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46. Exploring Small Extracellular Vesicles for Precision Medicine in Prostate Cancer.

Author: Giulietti M, Santoni M, Cimadamore A, Carrozza F, Piva F, Cheng L, Lopez-Beltran A, Scarpelli M, Battelli N, and Montironi R
Abstract: Tumor microenvironment constitutes a complex network in which tumor cells communicate among them and with stromal and immune cells. It has been shown that cancer cells are able to exchange genetic materials through small extracellular vesicles (EVs), a heterogeneous group of vesicles with different size and shape, cargo content, and function. The importance to investigate populations of circulating EVs would be of great importance as prostate cancer (PCa) biomarkers. In several neoplasms as well as in PCa, nanometer-sized EVs of endosomal origin are implicated in supporting tumor growth and metastatic spread by both altering local stroma cells and creating a protumor environment that favors the formation of pre-metastatic niches. Several techniques are applicable for the isolation and analysis of PCa-derived small EVs and are illustrated in this article. Due to the high sensitivity and specificity of these techniques, small EVs have become ideal candidates for early diagnosis. Moreover, we discuss the role of small EVs during PCa carcinogenesis, as well as in modulating the development of drug resistance to hormonal therapy and chemotherapy, thus underlining the potential of EV-tailored strategies in PCa patients.
Published: 2018
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47. Tivozanib for the treatment of renal cell carcinoma.

Author: Santoni M, Massari F, Piva F, Carrozza F, Di Nunno V, Cimadamore A, Martignetti A, Montironi R, and Battelli N
Subjects: Carcinoma, Renal Cell pathology, Clinical Trials as Topic, Half-Life, Humans, Kidney Neoplasms pathology, Phenylurea Compounds chemistry, Phenylurea Compounds pharmacokinetics, Protein Kinase Inhibitors chemistry, Protein Kinase Inhibitors pharmacokinetics, Quinolines chemistry, Quinolines pharmacokinetics, Receptors, Vascular Endothelial Growth Factor antagonists & inhibitors, Receptors, Vascular Endothelial Growth Factor metabolism, TOR Serine-Threonine Kinases antagonists & inhibitors, TOR Serine-Threonine Kinases metabolism, Treatment Outcome, Carcinoma, Renal Cell drug therapy, Kidney Neoplasms drug therapy, Phenylurea Compounds therapeutic use, Protein Kinase Inhibitors therapeutic use, Quinolines therapeutic use
Abstract: Introduction: Renal cell carcinoma (RCC) represents a heterogeneous group of cancers with distinct histological features, molecular alterations, prognosis, and response to therapy. Target agents directed against vascular endothelial growth factor and its receptor and mammalian target of rapamycin (mTOR) inhibitors have completely changed the landscape of RCC. However, the rate of complete response is still low, thus supporting the research of novel therapeutic agents. Area covered: The authors describe the chemical features of tivozanib, its pharmacodynamic and pharmacokinetic properties, and the results obtained in human phase I-III clinical trials. Tivozanib received its first global approval in EU, Iceland, and Norway on 28 August 2017 for the first-line treatment of adult patients with advanced RCC and for adult patients who are VEGFR and mTOR inhibitor-naive following disease progression after one prior treatment with cytokines. Expert opinion: The US Food and Drug Administration did not approve tivozanib due to the lack of a significant advantage in terms of survival compared to sorafenib. To date, the role of tivozanib in the pharmaceutical landscape of mRCC appears to be very limited. However, ongoing trials on the association between tivozanib and immunotherapy may represent a promising strategy to be assessed in future clinical trials.
Published: 2018
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48. The epidemiology of malignant mesothelioma in women: gender differences and modalities of asbestos exposure.

Author: Marinaccio A, Corfiati M, Binazzi A, Di Marzio D, Scarselli A, Ferrante P, Bonafede M, Verardo M, Mirabelli D, Gennaro V, Mensi C, Schallemberg G, Mazzoleni G, Merler E, Girardi P, Negro C, D'Agostin F, Romanelli A, Chellini E, Silvestri S, Pascucci C, Calisti R, Stracci F, Romeo E, Ascoli V, Trafficante L, Carrozza F, Angelillo IF, Cavone D, Cauzillo G, Tallarigo F, Tumino R, Melis M, and Iavicoli S
Subjects: Adult, Aged, Aged, 80 and over, Female, Humans, Italy epidemiology, Lung Neoplasms chemically induced, Male, Mesothelioma chemically induced, Mesothelioma, Malignant, Middle Aged, Occupational Exposure statistics & numerical data, Registries, Risk Factors, Sex Factors, Asbestos adverse effects, Lung Neoplasms epidemiology, Mesothelioma epidemiology, Occupational Exposure adverse effects
Abstract: Introduction: The epidemiology of gender differences for mesothelioma incidence has been rarely discussed in national case lists. In Italy an epidemiological surveillance system (ReNaM) is working by the means of a national register., Methods: Incident malignant mesothelioma (MM) cases in the period 1993 to 2012 were retrieved from ReNaM. Gender ratio by age class, period of diagnosis, diagnostic certainty, morphology and modalities of asbestos exposure has been analysed using exact tests for proportion. Economic activity sectors, jobs and territorial distribution of mesothelioma cases in women have been described and discussed. To perform international comparative analyses, the gender ratio of mesothelioma deaths was calculated by country from the WHO database and the correlation with the mortality rates estimated., Results: In the period of study a case list of 21 463 MMs has been registered and the modalities of asbestos exposure have been investigated for 16 458 (76.7%) of them. The gender ratio (F/M) was 0.38 and 0.70 (0.14 and 0.30 for occupationally exposed subjects only) for pleural and peritoneal cases respectively. Occupational exposures for female MM cases occurred in the chemical and plastic industry, and mainly in the non-asbestos textile sector. Gender ratio proved to be inversely correlated with mortality rate among countries., Conclusions: The consistent proportion of mesothelioma cases in women in Italy is mainly due to the relevant role of non-occupational asbestos exposures and the historical presence of the female workforce in several industrial settings. Enhancing the awareness of mesothelioma aetiology in women could support the effectiveness of welfare system and prevention policies., Competing Interests: Competing interests: The following authors reported that they have served as expert witness for the public prosecutor in court trials on asbestos-related diseases: EM, DM, SS, VG, CM, RC., (© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.)
Published: 2018
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49. Asbestos Exposures, Mesothelioma Incidence and Mortality, and Awareness by General Practitioners in the Molise Region, Central Italy.

Author: Ripabelli G, Tamburro M, Di Tella D, Carrozza F, and Sammarco ML
Subjects: Adult, Age Factors, Aged, Asbestosis diagnosis, Asbestosis epidemiology, Clinical Competence, Female, Humans, Incidence, Italy epidemiology, Lung Neoplasms mortality, Male, Mesothelioma diagnosis, Mesothelioma mortality, Middle Aged, Pleural Neoplasms mortality, Registries, Environmental Exposure, General Practitioners, Health Knowledge, Attitudes, Practice, Lung Neoplasms epidemiology, Mesothelioma epidemiology, Pleural Neoplasms epidemiology
Abstract: Objective: The aim of this study was to evaluate environmental asbestos sources, mesothelioma incidence and mortality, and awareness on asbestos-related diseases (ARDs) by general practitioners (GPs) in Molise Region., Methods: The contaminated sites in three towns were identified by census; mesothelioma incidence (2000 to 2012) and mortality (2003 to 2013) was achieved from local registries; GPs were interviewed on practiced population's exposures and ARDs diagnosis., Results: About 54.3% of visited sites were contaminated (71.2% by friable asbestos) and 38.8% was extremely damaged. Over above time-periods, 32 mesothelioma cases (62.5% males, 25% in people aged 70 to 75 years) and 27 deaths (90% males, 69 ± 10 years, 70.4% pleural mesothelioma) have been reported. A total of 122 GPs were interviewed who had diagnosed 40 mesothelioma and 28 asbestosis cases., Conclusion: There is the need of remediation/removal interventions for contaminated sites and of strategies to increase GPs awareness on asbestos risks for better patients' management.
Published: 2018
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50. Long-term clinical impact of PSA surge in castration-resistant prostate cancer patients treated with abiraterone.

Author: Conteduca V, Caffo O, Lolli C, Aieta M, Scarpi E, Bianchi E, Maines F, Schepisi G, Salvi S, Massari F, Carrozza F, Veccia A, Chiuri VE, Campadelli E, Facchini G, and De Giorgi U
Subjects: Aged, Antineoplastic Agents administration & dosage, Disease-Free Survival, Drug Monitoring methods, Drug Monitoring statistics & numerical data, Humans, Italy epidemiology, Male, Medication Therapy Management, Retrospective Studies, Time, Androstenes administration & dosage, Prostate-Specific Antigen analysis, Prostatic Neoplasms, Castration-Resistant blood, Prostatic Neoplasms, Castration-Resistant drug therapy, Prostatic Neoplasms, Castration-Resistant epidemiology, Prostatic Neoplasms, Castration-Resistant pathology
Abstract: Background: Early changes in PSA have been evaluated in association to treatment outcome. The aim of this study was to assess PSA surge phenomenon in castration-resistant prostate cancer (CRPC) patients treated with abiraterone and to correlate those variations with long-term treatment outcome., Patients and Methods: We retrospectively evaluated 330 CRPC patients in 11 Italian hospitals, monitoring PSA levels at baseline and every 4 weeks. Other clinical, biochemical and molecular parameters were determined at baseline. We considered PSA surge as PSA increase within the first 8 weeks from starting abiraterone more than 1% from baseline followed by a PSA decline. The log-rank test was applied to compare survival between groups of patients according to PSA surge. The impact of PSA surge on survival was evaluated by Cox regression analyses., Results: A total of 330 patients with CRPC, median age 74 years (range, 45-90), received abiraterone (281 chemotherapy-treated and 49 chemotherapy-naïve). PSA surge was observed in 20 (7%) post-chemotherapy and 2 (4%) chemotherapy-naïve patients. For overall patients presenting PSA surge, timing of PSA peak from baseline was 5 ± 1.8 weeks and PSA rise from baseline was 21 ± 18.4%. The overall median follow-up was 23 months (range 1-62). No significant differences in progression-free survival and overall survival were observed between patients with and without PSA surge (P = 0.16 and =0.86, respectively). In addition, uni- and multivariate analyses showed no baseline factors related to PSA surge., Conclusion: PSA surge occurs in both chemotherapy-treated and chemotherapy-naïve patients treated with abiraterone resulting, however, in no long-term impact on outcome. Physicians and patients should be aware of PSA surge challenge to prevent a premature discontinuation of potentially effective therapy with abiraterone. Further larger and prospective studies are warranted to investigate this not infrequent phenomenon., (© 2017 Wiley Periodicals, Inc.)
Published: 2017
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