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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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4. 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

6. 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

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

Published
2022
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7. 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

9. 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

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, Zoboli, A, 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 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. 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, 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, Zoboli, A, 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 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. 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., and Zoboli A.

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 (2·5 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 regist

Published
2018

12. Are adverse events (AEs) predictive of nivolumab activity? Data from the Italian expanded access program in metastatic renal cell carcinoma (mRCC)

Author

Verzoni, E., primary, Cartenì, G., additional, Cortesi, E., additional, Roila, F., additional, Vitale, M.G., additional, Buti, S., additional, Pignata, S., additional, Cognetti, F., additional, Giustini, L., additional, Damiani, A., additional, Turci, D., additional, Sternberg, C.N., additional, Porta, C., additional, Carrozza, F., additional, Tortora, G., additional, Tassinari, D., additional, Passalacqua, R., additional, Pazzola, A., additional, Surico, G., additional, and Procopio, G., additional

Published
2018
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13. Addition of Either Lonidamine or Granulocyte Colony-Stimulating Factor Does Not Improve Survival in Early Breast Cancer Patients Treated With High-Dose Epirubicin and Cyclophosphamide

Author

Papaldo, P., Lopez, M., Cortesi, Enrico, Cammilluzzi, E., Antimi, M., Terzoli, E., Lepidini, G., Vici, P., Barone, C., Ferretti, G., Di Cosimo, S., Nistico, C., Carlini, P., Conti, F., Di Lauro, L., Botti, C., Vitucci, C., Fabi, A., Giannarelli, D., Marolla, P., Di Maio, M., Perrone, F., Gallo, C., Iaffaioli, R. V., Manzione, L., Piantedosi, F. V., Cigolari, S., Illiano, A., Barbera, S., Robbiati, S. F., Piazza, E., Ianniello, G. P., Frontini, L., Veltri, E., Castiglione, F., Rosetti, F., De Maio, E., Maione, P., Gridelli, C., Rossi, A., Barletta, E., Barzelloni, M. L., 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., Sannicolo, M., Filipazzi, V., Esani, G., Gambaro, A., Ferrario, S., Tinessa, V., Caprio, M. G., 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, R. A., 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, M. R., Monfardini, S., Favaretto, A., Stefani, M., Corradini, G. M., Pavia, G., Scagliotti, G., Novello, S., Selvaggi, G., Tonato, M., Darwish, S., Michetti, G., Belometti, M. O., Labianca, R., Quadri, A., De Marinis, F., Migliorino, M. R., Martelli, O., Colucci, G., Galetta, D., Giotta, F., Isa, L., Candido, P., Rossi, N., Calandriello, A., Ferrau, F., Malaponte, E., Barni, S., Cazzaniga, M., Gebbia, N., Valerio, Mr, Belli, M., Colantuoni, G., Capuano, M. A., Angiolillo, M., Sollitto, F., Ardizzoia, A., Luporini, G., Locatelli, M. C., 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., Aschelter, A., and Foa, P.

Subjects
Adult, Cancer Research, medicine.medical_specialty, Indazoles, Filgrastim, Cyclophosphamide, medicine.medical_treatment, Breast Neoplasms, Gastroenterology, Disease-Free Survival, chemistry.chemical_compound, Internal medicine, Antineoplastic Combined Chemotherapy Protocols, Granulocyte Colony-Stimulating Factor, medicine, Humans, Survival rate, Aged, Epirubicin, Chemotherapy, business.industry, Lonidamine, Middle Aged, medicine.disease, Metastatic breast cancer, Recombinant Proteins, Granulocyte colony-stimulating factor, Surgery, Survival Rate, Oncology, chemistry, Female, business, Follow-Up Studies, medicine.drug
Abstract

Purpose: Lonidamine (LND) can enhance the activity of anthracyclines in patients with metastatic breast cancer. A multicenter, prospective, randomized trial was designed to determine whether the association of LND with high-dose epirubicin plus cyclophosphamide (EC) could improve disease-free survival (DFS) in patients with early breast cancer (BC) compared with EC alone. Granulocyte colony-stimulating factor (G-CSF) was added to maintain the EC dose-intensity. Patients and Methods: From October 1991 to April 1994, 506 patients with stage I/II BC were randomly assigned to four groups: (A) epirubicin 120 mg/m2 and cyclophosphamide 600 mg/m2 administered intravenously on day 1 every 21 days for four cycles (124 patients); (B) EC plus LND 450 mg/d administered orally (125 patients); (C) EC plus G-CSF administered subcutaneously (129 patients); (D) EC plus LND plus G-CSF (128 patients). Results: Median follow-up was 55 months. Five-year DFS rate was similar for LND (B+D groups; 69.6%) versus non-LND arms (A+C groups; 70.3%) and G-CSF (C+D groups; 67.2%) versus non–G-CSF arms (A+B groups; 72.9%). Five-year overall survival (OS) was comparable in LND (79.1%) versus non-LND arms (81.3%) and in G-CSF (80.6%) versus non–G-CSF arms (79.6%). DFS and OS distributions in LND and G-CSF arms did not change according to tumor size, node, receptor, and menopausal status. G-CSF dramatically reduced hematologic toxicity without having a significant impact on dose-intensity (98.1% v 95.5% for C+D and A+B groups, respectively). Conclusion: EC is active and well tolerated in patients with early breast cancer. The addition of LND or G-CSF does not improve DFS or OS.

Published
2003
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14. Oral Anticancer Therapy Project: clinical utility of a specific home care nursing program

Author

Cirillo, M., primary, Carlucci, L., additional, Baldini, E., additional, Sacco, C., additional, Zagonel, V., additional, Leo, S., additional, Llimpe, F.L. Rojas, additional, Tonini, G., additional, Marialuisa, M., additional, Alfredo, T., additional, Farci, D., additional, Sava, T., additional, Zaninelli, M., additional, Valori, V.M., additional, Quaranta, A., additional, Carrozza, F., additional, Micheloni, B., additional, Marchetti, F., additional, Lunardi, G., additional, Zamboni, S., additional, Pinto, C., additional, and Gori, S., additional

Published
2016
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16. Impact of use of oral anticancer drugs on activity of Italian oncology practices: results of a survey conducted by the Italian Society of Medical Oncology (AIOM)

Author

Gori, S, DI MAIO, Massimo, Pinto, C, Alabiso, O, Baldini, E, Barbato, E, Beretta, Gd, Bravi, S, Caffo, O, Canobbio, L, Carrozza, F, Cinieri, S, Cruciani, G, Dinota, A, Gebbia, V, Giustini, L, Graiff, C, Molino, A, Muggiano, A, Pandoli, G, Puglisi, F, Tagliaferri, P, Tomao, S, Lunardi, G, Venturini, M, and AIOM Working Group 'Interaction with Regional Sections'

Subjects
Adult, Male, oral anticancer drugs, Administration, Oral, Antineoplastic Agents, Medical Oncology, Pharmacists, Drug Costs, Reimbursement Mechanisms, Physicians, Surveys and Questionnaires, drug dispensation, Humans, Molecular Targeted Therapy, Practice Patterns, Physicians', Societies, Medical, Aged, Oncology Nursing, Health Care Costs, Middle Aged, reimbursement, Italy, Health Care Surveys, Workforce, Female
Abstract

In recent years, the number of oral anticancer drugs used in clinical practice has rapidly increased. The Italian Society of Medical Oncology (AIOM) conducted a survey to describe the impact of the use of oral anticancer drugs on the daily activity of Italian oncology practices.A survey questionnaire was distributed to the coordinators of the regional sections of AIOM. A 6-month period was considered, from January 1, 2010 to June 30, 2010. The survey addressed (1) quantitative aspects of the use of oral anticancer drugs; (2) practical aspects in the management of patients treated with these drugs; (3) issues related to treatment costs and reimbursement procedures.Thirty-six questionnaires were received from institutions distributed throughout the Italian territory. Oral anticancer drugs (both chemotherapy and molecularly targeted agents) accounted for a significant proportion (17%) of prescribed treatments. Among the responding institutions, there were different dispensation procedures of oral drugs to patients: drugs were dispensed by the pharmacist (57%) or directly by the medical oncologist (23%) or nurse (20%). The medical oncologist played a major role in the communication with patients (73% alone and a further 24% in cooperation with other professional figures) and was the point of reference in the event of side effects in 97% of cases. In most cases, the reimbursement of drug costs was separated ("File F" procedure) from the flat fare received by the hospital for outpatient visits or day-hospital access.Optimal organization of oral anticancer treatment warrants the cooperation and integration of multiple professional figures. At least three figures are involved in patient management in the hospital: the medical oncologist, the nurse, and the hospital pharmacist. Oral anticancer treatments are associated with specific reimbursement issues: in the majority of cases, the cost of the drug is reimbursed separately from the cost of patient access.

Published
2013

18. The importance of network intervention for cancer patient welfare. the ccm 2012 project: the molise experience

Author

Di Lullo, L., primary, Viglione, M.A., additional, Spina, C., additional, Franchella, C., additional, Bellomo, M., additional, Antonecchia, P., additional, Manfredi Selvaggi, T., additional, Santella, P., additional, Marra, G., additional, Musacchio, M., additional, Antuzzi, G., additional, Silvestri, A., additional, Specchia, M., additional, Piano, S., additional, Giglio, G., additional, Fabrizio, G., additional, and Carrozza, F., additional

Published
2015
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19. Integrated support in neoplastic patient and family: experience of molise in ccm 2012 project

Author

Carrozza, F., primary, Spina, C., additional, Viglione, M.A., additional, Franchella, C., additional, Bellomo, M., additional, Antonecchia, P., additional, Manfredi Selvaggi, T., additional, Musacchio, M., additional, Antuzzi, G., additional, Specchia, M., additional, Piano, S., additional, Silvestri, A., additional, Giglio, G., additional, Fabrizio, G., additional, and Di Lullo, L., additional

Published
2015
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20. Pretreatment quality of life and functional status assessment significantly predict survival of elderly patients with advanced non-small-cell lung cancerreceiving chemotherapy: a prognostic analysis of the multicenter Italian lungcancer 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, 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, 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, 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, Borsellino, N, Testa, A, Malaponte, E, Capuano, Ma, Angiolillo, M, Sollitto, F, Tirelli, U, Spazzapan, S, Adamo, Vincenzo, Altavilla, Giuseppe, 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, E, D'Auria, G, 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, and Cazzaniga, M.

Published
2005

21. 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

22. 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

24. 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., primary, De Giorgi, U., additional, Fratino, L., additional, Facchini, G., additional, Basso, U., additional, Alesini, D., additional, Gasparro, D., additional, Ortega, C., additional, Tucci, M., additional, Verderame, F., additional, Campadelli, E., additional, Re, G. Lo, additional, Sabbatini, R., additional, Donini, M., additional, Procopio, G., additional, Sartori, D., additional, Zucali, P.A., additional, Carrozza, F., additional, D'Angelo, A., additional, and Morelli, F., additional

Published
2014
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25. Supportive care in patients with advanced non small cell lung cancer

Author

DI MAIO, M, 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, Sannicolo, 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, Vincenzo, Altavilla, Giuseppe, Scimone, A, Spatafora, M, Bellia, V, Hopps, Mr, Monfardini, S, Favaretto, A, Stefani, M, Corradini, Gm, Pavia, G, Scagliotti, G, Novello, S, 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, Ferrau, 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, Nistico, C, Aschelter, A, and Foa, P.

Published
2003

27. A phase I study of short-course accelerated whole brain radiation therapy for multiple brain metastases

Author

Caravatta, Luciana, Deodato, Francesco, Ferro, M, Macchia, Gabriella, Massaccesi, Mariangela, Cilla, Savino, Padula, Gda, Mignogna, Samantha, Tambaro, Rosa, Carrozza, F, Flocco, Mariano, Cantore, G, Scapati, A, Buwenge, M, Sticca, Giovanna, Valentini, Vincenzo, Cellini, Numa, Morganti, Alessio Giuseppe, Deodato, Francesco (ORCID:0000-0003-1276-5070), Valentini, Vincenzo (ORCID:0000-0003-4637-6487), Caravatta, Luciana, Deodato, Francesco, Ferro, M, Macchia, Gabriella, Massaccesi, Mariangela, Cilla, Savino, Padula, Gda, Mignogna, Samantha, Tambaro, Rosa, Carrozza, F, Flocco, Mariano, Cantore, G, Scapati, A, Buwenge, M, Sticca, Giovanna, Valentini, Vincenzo, Cellini, Numa, Morganti, Alessio Giuseppe, Deodato, Francesco (ORCID:0000-0003-1276-5070), and Valentini, Vincenzo (ORCID:0000-0003-4637-6487)

Abstract

To define the maximum tolerated dose (MTD) of a SHort-course Accelerated whole brain RadiatiON therapy (SHARON) in the treatment of patients with multiple brain metastases.

Published
2012

29. Effects of vinorelbine on quality of life and survival of elderly patients with advanced non-small-cell lung cancer

Author

Gridelli, C, Perrone, F, Gallo, C, Rossi, A, Scognamiglio, F, Monfardini, S, Ianniello, Gp, Tinessa, V, Caprio, Mg, Santoro, A, Maiorino, L, Santoro, M, Brancaccio, L, Crispino, C, Cigolari, S, DI LANNO, M, Angelini, V, Manzione, L, Bilancia, D, Dinota, A, Failla, G, Aiello, Ra, Tralongo, P, Figoli, F, Zuccarino, L, Pedicini, T, Febbraro, A, Zollo, C, Frontini, L, Zonato, S, Azzarello, G, Vinante, O, Castiglione, F, Porcile, G, Bearz, A, Sorio, R, Tonato, M, Darwish, S, Veltri, E, D'Aprile, M, Curcio, C, Vasta, M, Clerici, M, Luporini, G, Farris, A, Alicicco, Mg, Bretti, S, Bumma, C, Ionta, Mt, Massidda, B, Adamo, Vincenzo, Altavilla, Giuseppe, Stefani, M, Michetti, G, Iaffaioli, Rv, Marzano, N, Favaretto, A, Murtas, S, Nascimbene, C, Nistico, C, Robbiati, Sf, Strada, Mr, Belli, M, Loizzi, M, Bandera, M, Bochicchio, Am, Piazza, E, Foladore, S, Giura, R, Gualtieri, G, Barni, S, Cariello, A, Mattioli, R, Pazzola, A, Gioga, G, Puxeddu, G, Bartolucci, R, Graiff, C, DEL CONTE, G, Farriniello, Ga, Mauri, F, Corradini, Gm, Capuano, Ma, Carrozza, F, and Gianni, W.

Published
1999

30. 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., primary, Gebbia, V., additional, Silvestris, N., additional, Ferraù, F., additional, Carrozza, F., additional, Cigolari, S., additional, Russo, P., additional, Calista, F., additional, Adamo, V., additional, and Colucci, G., additional

Published
2011
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32. Activity and tolerability of cisplatin (CDDP) and fotemustine (FTM) in non-small cell lung cancer (NSCLC) patients (PTS) with brain metastases (BM): A multicentric phase II study of the Gruppo Oncologico dell’Italia Meridionale (GOIM)

Author

Galetta, D., primary, Gebbia, V., additional, Ferraù, F., additional, Carrozza, F., additional, Cigolari, S., additional, Russo, P., additional, Calista, F., additional, Adamo, V., additional, and Colucci, G., additional

Published
2009
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33. 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., primary, Lorusso, V., additional, Galetta, D., additional, Caruso, M., additional, Maiello, E., additional, Riccardi, F., additional, Carrozza, F., additional, Borsellino, N., additional, Leo, S., additional, Ferraù, F., additional, Cinieri, S., additional, and Colucci, G., additional

Published
2008
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35. A factorial phase III randomized trial of rofecoxib and prolonged constant infusion of gemcitabine at 10mg/m2/min (PCI-G) in first-line treatment of adult patients (pts) with advanced non-small cell lung cancer (NSCLC): The GECO study

Author

Gridelli, C., primary, Ceribelli, A., additional, Gebbia, V., additional, Gamucci, T., additional, Ciardiello, F., additional, Carrozza, F., additional, Favaretto, A., additional, Daniele, B., additional, Galetta, D., additional, and Morabito, A., additional

Published
2006
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36. Prevalence and management of pain in Italian patients with advanced non-small-cell lung cancer

Author

Di Maio, M, primary, Gridelli, C, additional, Gallo, C, additional, Manzione, L, additional, Brancaccio, L, additional, Barbera, S, additional, Robbiati, S F, additional, Ianniello, G P, additional, Ferraù, F, additional, Piazza, E, additional, Frontini, L, additional, Rosetti, F, additional, Carrozza, F, additional, Bearz, A, additional, Spatafora, M, additional, Adamo, V, additional, Isa, L, additional, Iaffaioli, R V, additional, Di Salvo, E, additional, and Perrone, F, additional

Published
2004
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37. 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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39. 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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40. Disparity in the 'time to patient access' to new anti-cancer drugs in Italian regions. Results of a survey conducted by the Italian Society of Medical Oncology (AIOM)

Author

Gori, S, DI MAIO, Massimo, Pinto, C, Alabiso, O, Baldini, E, Barbato, E, Beretta, Gd, Bravi, S, Caffo, O, Canobbio, L, Carrozza, F, Cinieri, S, Cruciani, G, Dinota, A, Gebbia, V, Giustini, L, Graiff, C, Molino, A, Muggiano, A, Pandoli, G, Puglisi, F, Tagliaferri, P, Tomao, S, Venturini, M, and AIOM Working Group Interactions with Regional Sections

Subjects
Cancer Research, Time Factors, Italy, Oncology, Health Care Surveys, Humans, Antineoplastic Agents, General Medicine, disparity, time to patient access, anticancer drugs, Medical Oncology, Health Services Accessibility, Societies, Medical
Abstract

Aims and background In 2009, the Italian Society of Medical Oncology (AIOM) conducted a survey to describe the impact of regional pharmaceutical formularies on the disparity of access to eight new drugs among cancer patients treated in Italian regions. The survey documented some regional restrictions for some anti-cancer drugs. In the study, we analyzed the “time to patient access” to new anti-cancer drugs in Italian regions. Methods In March 2010, we analyzed the availability of 17 new anti-cancer drugs at a regional level, specifically the coherence of regional authorizations compared with national authorizations approved by the Italian Medicines Agency (AIFA). In the regions with pharmaceutical formularies, we analyzed the characteristics of technical-scientific committees for the evaluation of inclusion of hospital drugs in these formularies. We also analyzed the time from EMA (CMPH) authorization to AIFA marketing authorization, the time from AIFA marketing authorization to patient availability, and the total time from EMA (CMPH) authorization to patient availability of the drugs in all Italian regions, for 11 of these drugs. Results Some drugs were included in all the regional pharmaceutical formularies, without restrictions, whereas other drugs were not included in one and others were not included in more than one formulary. Median time from EMA to AIFA was 11.2 months (range, 2.9–17.1). Median time from AIFA to patient availability was 1.4 months (range, 0.0–50.5) in regions with drug formularies versus 0.0 months in regions without drugs formularies. Median total time from EMA to patient availability was longer in regions with formularies (13.3 months; range, 2.9–65.3) than in regions without formularies (11.2 months; range, 2.9–24.0), where drugs are immediately available after AIFA marketing authorization. Moreover, the interval was very long (range, 2.9–65.3) for some drugs in regions with formularies. Conclusions The analysis confirmed that the presence of multiple hierarchical levels of drug evaluation can create disparity in drug availability for Italian citizens.

41. 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 (2·5 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 46–72), 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 88·5% (95% CI 86·7–90·0) with the switch strategy and 89·8% (88·2–91·2) with upfront treatment (hazard ratio 0·89, 95% CI 0·73–1·08; p=0·23). 5-year disease-free survival was 90·0% (95% CI 87·9–91·7) with anastrozole (124 events), 88·0% (85·8–89·9) with exemestane (148 events), and 89·4% (87·3 to 91·1) with letrozole (129 events; p=0·24). No unexpected serious adverse reactions or treatment-related deaths occurred. Musculoskeletal side-effects were the most frequent grade 3–4 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 3–4 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

42. 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

43. Cabozantinib in Pretreated Patients with Metastatic Renal Cell Carcinoma with Sarcomatoid Differentiation: A Real-World Study

Author

Michele Milella, Orazio Caffo, Giuseppe Procopio, Francesco Carrozza, Nicola Battelli, Sebastiano Buti, Marc R. Matrana, Francesco Massari, Javier Molina-Cerrillo, Lorena Incorvaia, Veronica Mollica, Giuseppe Fornarini, Umberto Basso, Matteo Santoni, Gaetano Aurilio, Fady Farag, Enrique Grande, Mimma Rizzo, Ugo De Giorgi, Roberto Iacovelli, Alessandro Rizzo, Santoni M., Massari F., Grande E., Procopio G., Matrana M.R., 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
Male, Oncology, Cancer Research, medicine.medical_specialty, Multivariate analysis, Cabozantinib, Pyridines, chemistry.chemical_compound, Renal cell carcinoma, Internal medicine, medicine, Humans, Anilides, Pharmacology (medical), Carcinoma, Renal Cell, Sarcomatoid Differentiation, Retrospective Studies, business.industry, Hazard ratio, Cell Differentiation, medicine.disease, Kidney Neoplasms, Confidence interval, chemistry, Male patient, Female, business, Kidney cancer
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.

Published
2021
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44. Predictors of filing claims and receiving compensation in malignant mesothelioma patients

Author

Domenica Cavone, Gert Schallemberg, Elisa Romeo, Francesco Carrozza, Ugo Fedeli, Italo F. Angelillo, Gabriella Cauzillo, Valerio Gennaro, Corrado Negro, Federico Tallarigo, Enrica Migliore, Luana Trafficante, Alessandro Marinaccio, Claudio Gariazzo, Antonio Romanelli, Iolanda Grappasonni, Gabriella Madeo, Carolina Mensi, Davide Di Marzio, Elisabetta Chellini, Guido Mazzoleni, Sergio Iavicoli, Rosario Tumino, Marina Verardo, Massimo Melis, Marinaccio, A., Gariazzo, C., Di Marzio, D., Iavicoli, S., Verardo, M., Migliore, E., Gennaro, V., Mensi, C., Mazzoleni, G., Schallemberg, G., Fedeli, U., Negro, C., Romanelli, A., Chellini, E., Grappasonni, I., Madeo, G., Romeo, E., Trafficante, L., Carrozza, F., Angelillo, I. F., Cavone, D., Cauzillo, G., Tallarigo, F., Tumino, R., and Melis, M.

Subjects
Mesothelioma, medicine.medical_specialty, media_common.quotation_subject, Asbesto, Logistic regression, medicine.disease_cause, Occupational safety and health, Asbestos, 03 medical and health sciences, 0302 clinical medicine, Occupational Exposure, medicine, Humans, 030212 general & internal medicine, media_common, National Insurance, Insurance system, business.industry, 030503 health policy & services, Health Policy, Public health, Filing, Mesothelioma, Malignant, medicine.disease, Italy, Occupational diseases, Relative risk, Family medicine, 0305 other medical science, business, Welfare
Abstract

Although the predominant occupation origin of mesothelioma is well known, determinant factors involved in filing compensation are scarcely investigated. A linkage between incident mesothelioma cases collected by Italian mesothelioma register (ReNaM) and compensation claims and assignment by Italian national insurance Institute (INAIL) has been conducted for cases diagnosed in the period 2010-2015 and occupational exposure to asbestos. Logistic regression models and decision tree models have been used to identify demographic, diagnostic and anamnestic factors significant for filing and receiving compensation. We have included in the analyses 5019 mesothelioma cases, and among them, 3321 (66.2 %) were found in INAIL archives as mesothelioma cases who fil claims for compensation. The modalities of asbestos exposure, sector of working activities and job type are crucial factors. Furthermore, gender, age at diagnosis, area of residence have been found to be significant predictors of probability to fil claims. Relative risks to fil claims were obtained for the above determinants and conditions to maximize the probability to obtain compensation identified. Our findings demonstrate that there is a need to enforce policies for improving awareness of the occupational origin for mesothelioma cases. Stakeholders, occupational health and safety institutions can play an important role for improving the sensitization regarding the rights of compensation benefits, ensuring the equity and the effectiveness of insurance, welfare and public health systems.

Published
2020
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45. 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

46. 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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47. The epidemiology of malignant mesothelioma in women: gender differences and modalities of asbestos exposure

Author

Marinaccio, Alessandro, Corfiati, Marisa, Binazzi, Alessandra, Di Marzio, Davide, Scarselli, Alberto, Ferrante, Pierpaolo, Bonafede, Michela, Verardo, Marina, Mirabelli, Dario, Gennaro, Valerio, Mensi, Carolina, Schallemberg, Gert, Mazzoleni, Guido, Merler, Enzo, Girardi, Paolo, Negro, Corrado, D'Agostin, Flavia, Romanelli, Antonio, Chellini, Elisabetta, Silvestri, Stefano, Pascucci, Cristiana, Calisti, Roberto, Stracci, Fabrizio, Romeo, Elisa, Ascoli, Valeria, Trafficante, Luana, Carrozza, Francesco, Angelillo, Italo Francesco, Cavone, Domenica, Cauzillo, Gabriella, Tallarigo, Federico, Tumino, Rosario, Melis, Massimo, Iavicoli, Sergio, Detragiache, E, Merletti, F, Gangemi, M, Stura, A, Brentisci, C, Diglio, Gc, Macerata, V, Gilardetti, M, Lazzarotto, A, Benfatto, L, Bianchelli, M, Mazzucco, G, Campi, M, Malacarne, D, Camposeragno, D, Giorgio, Fd, Canessa, P, Consonni, D, Pesatori, A, Riboldi, L, Bressan, V, Gioffrè, F, Ballarinl, M, Chermaz, C, Michieli, P, Mangone, L, Storchi, C, Sala, O, Badiali, A, Cacciarini, V, Giovannetti, L, Martini, A, Grappasonni, I, Masanotti, G, D'Alo', D, Petrucci, M, Davoli, M, Forastiere, F, Cavariani, F, Ancona, L, Giammarco, Ad, Menegozzo, S, Canfora, M, Santoro, M, Viscardi, F, Brangi, A, Cozza, V, Vimercati, L, Lio, S, Cascone, G, Frasca, G, Giurdanella, M, Martorana, C, Nicita, C, Rollo, P, Spata, E, Dardanoni, G, Scondotto, S, Nieddu, V, Pergola, M, Stecchi, S., 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, Iavicoli, S., Marinaccio, Alessandro, Corfiati, Marisa, Binazzi, Alessandra, Di Marzio, Davide, Scarselli, Alberto, Ferrante, Pierpaolo, Bonafede, Michela, Verardo, Marina, Mirabelli, Dario, Gennaro, Valerio, Mensi, Carolina, Schallemberg, Gert, Mazzoleni, Guido, Merler, Enzo, Girardi, Paolo, Negro, Corrado, D'Agostin, Flavia, Romanelli, Antonio, Chellini, Elisabetta, Silvestri, Stefano, Pascucci, Cristiana, Calisti, Roberto, Stracci, Fabrizio, Romeo, Elisa, Ascoli, Valeria, Trafficante, Luana, Carrozza, Francesco, Angelillo, Italo Francesco, Cavone, Domenica, Cauzillo, Gabriella, Tallarigo, Federico, Tumino, Rosario, Melis, Massimo, and Iavicoli, Sergio

Subjects
medicine.medical_specialty, asbestos, gender, mesothelioma, asbestos, gender, mesothelioma, medicine.disease_cause, Asbestos, asbesto, 03 medical and health sciences, 0302 clinical medicine, Epidemiology, Medicine, 030212 general & internal medicine, Mesothelioma, Workplace, Modalities, business.industry, Incidence (epidemiology), Mortality rate, Environmental and Occupational Health, Public Health, Environmental and Occupational Health, medicine.disease, 030220 oncology & carcinogenesis, Workforce, Etiology, Public Health, Settore SECS-S/01 - Statistica, business, Demography
Abstract

IntroductionThe 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.MethodsIncident 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.ResultsIn 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.ConclusionsThe 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.

Published
2018

48. Factorial phase III randomised trial of rofecoxib and prolonged constant infusion of gemcitabine in advanced non-small-cell lung cancer: the GEmcitabine-COxib in NSCLC (GECO) study

Author

Santi Barbera, Teresa Gamucci, Francesco Perrone, Domenico Galetta, Francesco Carozza, Massimo Di Maio, Anna Ceribelli, Cesare Gridelli, Adolfo Favaretto, Vittorio Gebbia, Bruno Daniele, Antonio Testa, Antonio Rossi, Francesco Rosetti, Alessandro Morabito, Paolo Maione, Fortunato Ciardiello, Ciro Gallo, Francesco Cognetti, Gridelli, C., Gallo, Ciro, Ceribelli, A., Gebbia, V., Gamucci, T., Ciardiello, Fortunato, Carrozza, F., Favaretto, A., Daniele, B., Galetta, D., Barbera, S., Rosetti, F., Rossi, A., Maione, P., Cognetti, F., Testa, Alfredo, DI MAIO, M., Morabito, A., and Perrone, F.

Subjects
Adult, Male, medicine.medical_specialty, Lung Neoplasms, Adenocarcinoma, rofecoxib, Deoxycytidine, Gastroenterology, Lactones, Carcinoma, Non-Small-Cell Lung, Internal medicine, Antineoplastic Combined Chemotherapy Protocols, medicine, Clinical endpoint, Humans, Prospective Studies, Sulfones, Infusions, Intravenous, Lung cancer, Survival rate, Rofecoxib, Aged, Performance status, business.industry, Hazard ratio, gemcitabine, Middle Aged, Prognosis, randomized clinical trial, medicine.disease, Gemcitabine, Survival Rate, non-small-cell lung cancer, Oncology, factorial design, Anesthesia, Conventional PCI, Carcinoma, Squamous Cell, Quality of Life, Carcinoma, Large Cell, Female, Cisplatin, business, medicine.drug
Abstract

Summary Background The addition of cyclo-oxygenase-2 (COX-2) inhibitors and prolonged constant infusion (PCI) of gemcitabine to treatment for advanced non-small-cell lung cancer (NSCLC) might improve treatment efficacy. We aimed to assess whether the addition of rofecoxib or PCI gemcitabine could improve overall survival compared with first-line treatment with cisplatin plus gemcitabine given by standard infusion. Methods Patients with stage IV or IIIb (with supraclavicular nodes or pleural effusion) NSCLC who were under 70 years of age and who had performance status 0 or 1 were eligible for this multicentre, prospective, open-label, randomised phase III trial with 2×2 factorial design. Patients were randomly assigned to one of four treatment groups: group A, gemcitabine 1200 mg/m 2 in a 30-min intravenous infusion on days 1 and 8 and intravenous cisplatin 80 mg/m 2 on day 1, every 21 days for six cycles; group B, the same treatments as group A plus oral rofecoxib 50 mg/day until disease progression; group C, intravenous PCI gemcitabine 1200 mg/m 2 in a 120-min infusion on days 1 and 8 and intravenous cisplatin 80 mg/m 2 on day 1, every 21 days for six cycles; group D, the same drugs as group C plus oral rofecoxib 50 mg/day until disease progression. The primary endpoint was overall survival; secondary endpoints were progression-free survival, response rate, quality of life, and toxicity. Analyses were intention-to-treat. This trial is registered on the clinical trials site of the US National Institutes of Health website http://clinicaltrials.gov/ct/show/NCT00385606. Findings Between Jan 30, 2003, and May 3, 2005, 400 patients were enrolled. Median age was 60 years (range 29–71). PCI gemcitabine did not improve overall survival (median 47 weeks [95% CI 40–55] vs 44 [36–52], with standard gemcitabine infusion, hazard ratio (HR) of death 0·93 [0·74–1·17], p=0·41), progression-free survival, nor any other secondary endpoint. Vomiting and fatigue were significantly worse with PCI gemcitabine. The two rofecoxib groups were closed early (on Oct 1, 2004) due to withdrawal of the drug because of safety issues. With intention-to-treat statistical analyses limited to 240 patients (ie, those randomised before July 1, 2004) who had at least 3 months of treatment, rofecoxib did not prolong overall survival (median 44 weeks [CI 36–55] vs 44 [40–54] without rofecoxib, and HR of death 1·00 [0·75–1·34], p=0·85), or progression-free survival, but did improve response rate (41% vs 26%, p=0·02), global quality of life, physical, emotional and role functioning, fatigue, and sleeping. Rofecoxib significantly increased the incidence of diarrhoea and decreased constipation, fatigue, fever, weight loss, and pain, and analgesic consumption. Severe cardiac ischaemia was more frequent with rofecoxib than without; however, the difference was not statistically significant in the primary analysis (p=0·06) and became significant when patients who were randomised between July 1, 2004, and Sept 30, 2004, were included in the analysis (p=0·03). Interpretation Neither PCI gemcitabine nor rofecoxib prolonged survival in the patients in this study. Rofecoxib improved response rate and several quality-of-life items, including pain-related items and global quality of life. Further studies with less cardiotoxic COX-2 inhibitors are needed in NSCLC.

Published
2007
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49. Phase III Randomized Trial of FOLFIRI Versus FOLFOX4 in the Treatment of Advanced Colorectal Cancer: A Multicenter Study of the Gruppo Oncologico Dell’Italia Meridionale

Author

Giuseppe, Colucci, Vittorio, Gebbia, Giancarlo, Paoletti, Francesco, Giuliani, Michele, Caruso, Nicola, Gebbia, Giacomo, Cartenì, Biagio, Agostara, Giuseppe, Pezzella, Luigi, Manzione, Nicola, Borsellino, Andrea, Misino, Sante, Romito, Ernesto, Durini, Stefano, Cordio, Marisa, Di Seri, Massimo, Lopez, Evaristo, Maiello, Severino, Montemurro, Antonio, Cramarossa, Vito, Lorusso, Maurizio, Di Bisceglie, Maurizio, Chiarenza, Maria Rosaria, Valerio, Teresa, Guida, Vita, Leonardi, Salvatore, Pisconti, Gerardo, Rosati, Francesco, Carrozza, Giuseppe, Nettis, Matteo, Valdesi, Gianfranco, Filippelli, Santo, Fortunato, Sergio, Mancarella, Cosimo, Brunetti, COLUCCI G, GEBBIA V, PAOLETTI G, GIULIANI F, CARUSO M, GEBBIA N, CARTENI G, AGOSTARA B, PEZZELLA G, MANZIONE L, BORSELLINO N, MISINO A, ROMITO S, DURINI E, CORDIO S, DI SERI M, LOPEZ M, MAIELLO E, MONTEMURRO S, CRAMAROSSA A, LORUSSO V, DI BISCEGLIE M, CHIARENZA M, VALERIO MR, GUIDA T, LEONARDI V, PISCONTI S, ROSATI, CARROZZA F, NETTIS G, VALDESI M, FILIPPELLI G, FORTUNATO S, MANCARELLA S, and BRUNETTI C

Subjects
Adult, Male, Cancer Research, medicine.medical_specialty, Randomization, Organoplatinum Compounds, Colorectal cancer, folinic acid, atropine, platinum complex, Leucovorin, Gastroenterology, law.invention, Randomized controlled trial, Folfox protocol, law, Internal medicine, Antineoplastic Combined Chemotherapy Protocols, medicine, Humans, Infusions, Intravenous, irinotecan, antineoplastic agent, Aged, business.industry, oxaliplatin, Middle Aged, medicine.disease, Survival Analysis, Oxaliplatin, Surgery, Irinotecan, Regimen, Treatment Outcome, Oncology, Fluorouracil, drug derivative, Disease Progression, FOLFIRI, Camptothecin, Female, IFL protocol, Colorectal Neoplasms, business, medicine.drug
Abstract

Purpose We performed this phase III study to compare the irinotecan, leucovorin (LV), and fluorouracil (FU) regimen (FOLFIRI) versus the oxaliplatin, LV, and FU regimen (FOLFOX4) in previously untreated patients with advanced colorectal cancer. Patients and Methods A total of 360 chemotherapy-naive patients were randomly assigned to receive, every 2 weeks, either arm A (FOLFIRI: irinotecan 180 mg/m2 on day 1 with LV 100 mg/m2 administered as a 2-hour infusion before FU 400 mg/m2 administered as an intravenous bolus injection, and FU 600 mg/m2 as a 22-hour infusion immediately after FU bolus injection on days 1 and 2 [LV5FU2]) or arm B (FOLFOX4: oxaliplatin 85 mg/m2 on day 1 with LV5FU2 regimen). Results One hundred sixty-four and 172 patients were assessable in arm A and B, respectively. Overall response rates (ORR) were 31% in arm A (95% CI, 24.6% to 38.3%) and 34% in arm B (95% CI, 27.2% to 41.5%; P = .60). In both arms A and B, median time to progression (TTP; 7 v 7 months, respectively), duration of response (9 v 10 months, respectively), and overall survival (OS; 14 v 15 months, respectively) were similar, without any statistically significant difference. Toxicity was mild in both groups: alopecia and gastrointestinal disturbances were the most common toxicities in arm A; thrombocytopenia and neurosensorial were the most common toxicities in arm B. Grade 3 to 4 toxicities were uncommon in both arms, and no statistical significant difference was observed. Conclusion There is no difference in ORR, TTP, and OS for patients treated with the FOLFIRI or FOLFOX4 regimen. Both therapies seemed effective as first-line treatment in these patients. The difference between these two combination therapies is mainly in the toxicity profile.

Published
2005
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50. A phase I study of short-course accelerated whole brain radiation therapy for multiple brain metastases

Author

Luciana Caravatta, Gabriella Macchia, Andrea Scapati, Mariangela Massaccesi, Marica Ferro, Francesco Deodato, Numa Cellini, M. Buwenge, Alessio G. Morganti, Mariano Flocco, Francesco Carrozza, Savino Cilla, Vincenzo Valentini, Gilbert D.A. Padula, Rosa Tambaro, S. Mignogna, Giovanna Sticca, Giampaolo Cantore, Caravatta L, Deodato F, Ferro M, Macchia G, Massaccesi M, Cilla S, Padula GDA, Mignogna S, Tambaro R, Carrozza F, Flocco M, Cantore G, Scapati A, Buwenge M, Sticca G, Valentini V, Cellini N, and Morganti AG

Subjects
Adult, Male, Cancer Research, Maximum Tolerated Dose, Recursive partitioning analysi, Whole brain radiation therapies, medicine.medical_treatment, Radiotherapy Planning, ECOG Performance Status, Phases of clinical research, Severity of Illness Index, Cohort Studies, Young Adult, Radiation therapy oncology group, Computer-Assisted, Severity of illness, 80 and over, Medicine, Humans, Radiology, Nuclear Medicine and imaging, Dose limiting toxicity, Radiation Injuries, Dose Fractionation, Settore MED/36 - DIAGNOSTICA PER IMMAGINI E RADIOTERAPIA, Aged, Skin, Aged, 80 and over, Radiation, Performance status, business.industry, Brain Neoplasms, Radiotherapy Planning, Computer-Assisted, Dose fractionation, Brain, Middle Aged, Multiple brain metastasi, Radiation therapy, Eastern Cooperative Oncology Group, Oncology, Twice-daily fraction, Toxicity, Multivariate Analysis, Quality of Life, Female, Dose Fractionation, Radiation, Accelerated Radiation Therapy, Nuclear medicine, business
Abstract

Purpose: To define the maximum tolerated dose (MTD) of a SHort-course Accelerated whole brain RadiatiON therapy (SHARON) in the treatment of patients with multiple brain metastases. Methods and Materials: A phase 1 trial in 4 dose-escalation steps was designed: 12 Gy (3 Gy per fraction), 14 Gy (3.5 Gy per fraction), 16 Gy (4 Gy per fraction), and 18 Gy (4.5 Gy per fraction). Eligibility criteria included patients with unfavorable recursive partitioning analysis (RPA) class > or Z2 with at least 3 brain metastases or metastatic disease in more than 3 organ systems, and Eastern Cooperative Oncology Group (ECOG) performance status ≤3. Treatment was delivered in 2 days with twice-daily fractionation. Patients were treated in cohorts of 6-12 to define the MTD. The dose-limiting toxicity (DLT) was defined as any acute toxicity ≥grade 3, according to the Radiation Therapy Oncology Group scale. Information on the status of the main neurologic symptoms and quality of life were recorded. Results: Characteristics of the 49 enrolled patients were as follows: male/female, 30/19; median age, 66 years (range, 23-83 years). ECOG performance status was

Published
2012

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