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1. 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

2. 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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3. 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

4. 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

5. 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

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

Author

Ciro Gallo, F. Perrone, Santi Barbera, F. Ferraù, E. Piazza, Luigi Manzione, M. Di Maio, G P Ianniello, Alessandra Bearz, Rosario Vincenz Iaffaioli, Cesare Gridelli, E. Di Salvo, Vincenzo Adamo, Mario Spatafora, L. Brancaccio, L. Isa, Sergio Federico Robbiati, Francesco Rosetti, Francesco Carrozza, Luciano Frontini, Di Maio, M, Gridelli, C, Gallo, C, Manzione, L, Brancaccio, L, Barbera, S, Robbiati, Sf, Ianniello, Gp, Ferraù, F, Piazza, E, Frontini, L, Rosetti, F, Carrozza, F, Bearz, A, Spatafora, M, Adamo, V, Isa, L, Iaffaioli, Rv, DI SALVO, Enrico, Perrone, F., DI MAIO, M, Gallo, Ciro, Ferra, F, DI SALVO, E, DI MAIO M, GRIDELLI C, GALLO C, MANZIONE L, BRANCACCIO L, BARBERA S, ROBBIATI SF, IANNIELLO GP, FERRA F, PIAZZA E, FRONTINI L, ROSETTI F, CARROZZA F, BEARZ A, SPATAFORA M, ADAMO V, ISA L, IAFFAIOIL V, DI SALVO E, and PERRONE F

Subjects
Adult, Male, cancer pain, Cancer Research, medicine.medical_specialty, Lung Neoplasms, Analgesic, Pain, Bone Neoplasms, Severity of Illness Index, law.invention, Clinical, Pain Management Index, Randomized controlled trial, Quality of life, law, Carcinoma, Non-Small-Cell Lung, Internal medicine, Epidemiology, Severity of illness, Prevalence, medicine, Humans, Pain Management, Aged, Pain Measurement, Randomized Controlled Trials as Topic, Aged, 80 and over, business.industry, Guideline, analgesic, Middle Aged, Clinical trial, lung cancer, Italy, Oncology, analgesics, Quality of Life, Physical therapy, Female, business, Cancer pain
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, 336 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. © 2004 Cancer Research UK.

Published
2004
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7. 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

8. 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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9. 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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10. 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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11. 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

12. 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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13. 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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14. 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

15. Prognostic impact of education level of patients with advanced non-small cell lung cancer enrolled in clinical trials

Author

E. Piazza, Cesare Gridelli, Vittorio Gebbia, Claudia Sandomenico, Ciro Gallo, Francovito Piantedosi, Alfonso Illiano, Anna Ceribelli, Bruno Daniele, Francesco Perrone, Gennaro Daniele, Pasqualina Giordano, Domenico Bilancia, Adolfo Favaretto, Raffaele Costanzo, Francesco Carrozza, Gaetano Rocco, Simona Signoriello, Antonio Rossi, Paolo Maione, Santi Barbera, Alessandro Morabito, Sergio Federico Robbiati, S. Cigolari, Maria Carmela Piccirillo, Massimo Di Maio, Di Maio, M, Signoriello, Simona, Morabito, A, Rossi, A, Maione, P, Piantedosi, F, Bilancia, D, Cigolari, S, Barbera, S, Gebbia, V, Daniele, B, Robbiati, Sf, Illiano, A, Ceribelli, A, Carrozza, F, Favaretto, A, Piazza, E, Piccirillo, Mc, Daniele, G, Giordano, P, Costanzo, R, Sandomenico, C, Rocco, G, Gallo, Ciro, Perrone, F, and Gridelli, C.

Subjects
Adult, Male, Pulmonary and Respiratory Medicine, Cancer Research, medicine.medical_specialty, Lung Neoplasms, ECOG Performance Status, law.invention, Randomized controlled trial, law, Carcinoma, Non-Small-Cell Lung, Internal medicine, medicine, Humans, Malignant pleural effusion, Lung cancer, Socioeconomic status, Aged, Neoplasm Staging, Randomized Controlled Trials as Topic, Aged, 80 and over, business.industry, Hazard ratio, Cancer, Middle Aged, Prognosis, medicine.disease, Surgery, Clinical trial, Oncology, Educational Status, Female, business
Abstract

Background Socioeconomic status can potentially affect prognosis of cancer patients. Our aim was to describe potential differences in demographic and clinical characteristics, treatment, and survival by education level in patients with advanced non-small cell lung cancer (NSCLC) enrolled in clinical trials of first-line treatment. Methods Individual data of Italian patients with advanced NSCLC (stage IV, or IIIB with supraclavicular nodes or malignant pleural effusion), ECOG performance status (PS) 0–2, enrolled in four phase III randomized trials conducted between 1996 and 2005 were pooled. Information about education was available for 1680 of 1709 patients (98.3%). Patients were divided in two groups according to education level: high (patients with at least high school diploma) or low (those with less than high school diploma). Survival analyses were stratified by treatment arm within trial. Results There were 312 (19%) and 1368 (81%) patients with high and low education, respectively. Education level was significantly different among birth cohorts, with a time-trend toward higher education level. Patients with high education were significantly younger (median age 65 vs. 70), were less frequently unfit at diagnosis (ECOG PS2 5% vs. 16%), and their tumor type was more frequently adenocarcinoma (47% vs. 37%). Number of treatment cycles received was not significantly different between education groups. Median survival was 9.4 and 7.6 months in high and low education, respectively (p = 0.012). At multivariable analysis, female sex, better PS and high education level (Hazard Ratio 0.85, 95%CI 0.73–0.99, p = 0.03) were independently associated with longer survival. Conclusions In Italian patients enrolled in four randomized trials of first-line chemotherapy for advanced NSCLC, high education was significantly more frequent among younger patients, and was associated with lower proportion of PS2 patients. Education level did not significantly affect number of chemotherapy cycles received. Overall survival was longer in patients with high education, after adjustment for PS and other prognostic factors. The exact underlying mechanisms of the independent prognostic role of education level are substantially unknown, but lead-time bias (anticipation in diagnosis and time to inclusion in the trial), differences in adherence to care outside the trial procedures, differences in comorbidities and life-style factors may all contribute.

Published
2012

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

Author

Cesare Gridelli, Vittorio Gebbia, Maria Grazia Viganò, G. Valmadre, Manlio Mencoboni, Alessandro Morabito, Massimo Di Maio, Ciro Gallo, Claudio Verusio, Maria Carmela Piccirillo, Maria Rosaria Valerio, Antonio Rossi, Roberto Bollina, Floriana Morgillo, Rodolfo Mattioli, Francesco Carrozza, Tina Cascone, Fortunato Ciardiello, Francesco Perrone, Paolo Maione, Gridelli, C, Morabito, A, Gebbia, V, Mencoboni, M, Carrozza, F, Viganò, Mg, Verusio, C, Bollina, R, Mattioli, R, Valerio, Mr, Valmadre, G, Maione, P, Rossi, A, Cascone, T, Morgillo, Floriana, DI MAIO, M, Piccirillo, Mc, Gallo, Ciro, Perrone, F, Ciardiello, Fortunato, Viganò, MG, Valerio, MR, Morgillo, F, Di Maio, M, Piccirillo, MC, Gallo, C, and Ciardiello, F

Subjects
Pulmonary and Respiratory Medicine, Oncology, Adult, Male, Cancer Research, medicine.medical_specialty, Lung Neoplasms, Adolescent, Settore MED/06 - Oncologia Medica, Cetuximab, NSCLC, Antibodies, Monoclonal, Humanized, Deoxycytidine, law.invention, Young Adult, Randomized controlled trial, law, Internal medicine, Carcinoma, Non-Small-Cell Lung, Antineoplastic Combined Chemotherapy Protocols, medicine, Humans, Lung cancer, PS2 patient, Survival analysis, Aged, business.industry, Cancer, Antibodies, Monoclonal, Middle Aged, medicine.disease, Gemcitabine, Surgery, Clinical trial, Treatment Outcome, Concomitant, Patient Compliance, Female, business, Elderly patient, medicine.drug
Abstract

Background:Two parallel randomized phase 2 trialswere performed to choose the optimal way of combining cetuximab with gemcitabine in the first-line treatment of elderly (CALC1-E) and adult PS2 (CALC1-PS2) patients with advanced NSCLC. Methods: Stage IV or IIIB NSCLC patients, aged ≥70 years with PS 0–2 for CALC1-E or aged

Published
2010

17. Cisplatin plus gemcitabine or vinorelbine for elderly patients with advanced non small-cell lung cancer: the MILES-2P studies

Author

V. Filipazzi, Alessandro Morabito, Cesare Gridelli, Sergio Federico Robbiati, Francesco Perrone, Vito Lorusso, Paolo Maione, Franco Vito Piantedosi, Luigi Manzione, Adolfo Favaretto, Alfonso Illiano, Francesco Carrozza, Alessandra Bearz, Ciro Gallo, Rosario Vincenzo Iaffaioli, Gridelli, C, Maione, P, Illiano, A, Piantedosi, Fv, Favaretto, A, Bearz, A, Robbiati, Sf, Filipazzi, V, Lorusso, V, Carrozza, F, Iaffaioli, Rv, Manzione, L, Gallo, Ciro, Morabito, A, and Perrone, F.

Subjects
Male, Cancer Research, medicine.medical_specialty, Lung Neoplasms, medicine.drug_class, medicine.medical_treatment, Phases of clinical research, Vinorelbine, Vinblastine, Antimetabolite, Gastroenterology, Deoxycytidine, Disease-Free Survival, Internal medicine, Carcinoma, Non-Small-Cell Lung, Antineoplastic Combined Chemotherapy Protocols, Medicine, Humans, Lung cancer, Aged, Cisplatin, Aged, 80 and over, Chemotherapy, Performance status, business.industry, Middle Aged, medicine.disease, Gemcitabine, Surgery, Treatment Outcome, Oncology, Feasibility Studies, Female, business, medicine.drug
Abstract

Purpose Two phase I/II trials were done to evaluate the feasibility of cisplatin combined with gemcitabine or vinorelbine in elderly patients with advanced non–small-cell lung cancer (NSCLC). Patients and Methods Patients with advanced NSCLC who were older than 70 years of age and who had a performance status of 0 to 1 were eligible. Cisplatin was given on day 1 (a starting dose of 50 mg/m2 with increasing increments of 10 mg/m2 at each level) and gemcitabine (1,000 mg/m2) or vinorelbine (25 mg/m2) on days 1 and 8. Cycles were repeated every 21 days. A two-stage flexible optimal design was applied in the phase II study, and unacceptable toxicity was the primary end point. Results Overall, 159 patients were enrolled: 38 in phase I and 121 in phase II studies. Cisplatin was feasible at 60 mg/m2 with gemcitabine and at 40 mg/m2 with vinorelbine. With the former combination, 50 of 60 (83.3%) patients were treated without unacceptable toxicity; objective responses were reported in 26 of 60 patients (43.5%; 95% CI, 30.6 to 56.8); median progression-free and overall survivals were 25.3 and 43.6 weeks, respectively. With the latter combination, 50 (82.0%) of 61 patients were treated without unacceptable toxicity; objective responses were reported in 22 of 61 patients (36.1%; 95% CI, 24.2 to 49.4); median progression-free and overall survivals were 21.1 and 33.1 weeks, respectively. Conclusion Both cisplatin (60 mg/m2) plus gemcitabine and cisplatin (40 mg/m2) plus vinorelbine are feasible and active in the treatment of elderly patients with advanced NSCLC. The former combination, which provides a higher dose of cisplatin, deserves comparison versus single-agent chemotherapy in this setting of patients.

Published
2007

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