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Be-Positive: Beyond Progression After Tyrosine Kinase Inhibitor in Egfr-Positive Non-Small Cell Lung Cancer (Nsclc) Patients. Preliminary Results from a Multicenter Italian Observational Study
Annals of Oncology 25 (Supplement 4): iv426–iv470, 2014 doi:10.1093/annonc/mdu349.57
NSCLC, metastatic BE-POSITIVE: BEYOND PROGRESSION AFTER TYROSINE KINASE INHIBITOR IN EGFR-POSITIVE NON-SMALL CELL LUNG CANCER (NSCLC) PATIENTS. PRELIMINARY RESULTS FROM A MULTICENTER ITALIAN OBSERVATIONAL STUDY
T. Vavala1, A. Follador2, M. Tiseo3, D. Galetta4, A. Montanino5, O. Martelli6, O. Caffo7, P.L. Piovano8, D. Cortinovis9, N. Zilembo10, C. Casartelli11, G. Banna12, D. Colombo13, M.L. Barzelloni14, E. Rijavec15, F.L. Cecere16, E. Bria17, C. Lazzari18, A. Rossi19, S. Novello1 1 Department of Oncology, University of Turin AOU San Luigi, Orbassano (TO), ITALY 2 Oncologia, Azienda Ospedaliera Universitaria-UdineSta Maria della Misericordia, Udine, ITALY 3 Medical Oncology, Azienda Ospedaliera di Parma, Parma, ITALY 4 Oncologia Medica, Istituto Tumori Giovanni Paolo II, Bari, ITALY 5 Thoraco-pulmunary Department, Istituto Nazionale Tumori – Fondazione Pascale, Naples, ITALY 6 Oncology, A.O. S. Giovanni - Addolorata, Rome, ITALY 7 Oncology, S. Chiara Hospital, Trento, ITALY 8 Medical Oncology Unit, AO SS Antonio Biagio e Cesare Arrigo, Alessandria, ITALY 9 Dept. of Medical Oncology, Azienda Ospedaliera S. Gerardo U.O. Oncologia Medica, Monza, ITALY 10 Department of Oncology, IRCCS Fondazione Istituto Nazionale dei Tumori, Milan, ITALY 11 Medical Oncology Unit, Valduce Hospital, Como, ITALY 12 Divisione Di Oncologia Medica, Azienda Ospedaliera Cannizzaro, Catania, ITALY 13 Medical Oncology Unit, A.Manzoni Hospital, Lecco, ITALY 14 Department of Oncology, Azienda Ospedaliera UniversitariaS. Giovanni di Dio e Ruggi d’Aragona, Salerno, ITALY 15 Lung Cancer Unit, National Institute for Cancer Research, Genoa, ITALY 16 Medical Oncology Unit, Azienda Ospedaliero Universitaria Careggi, Florence,
Aim: Patients ( pts) with advanced lung adenocarcinoma harbouring EGFR mutations mainly experience tumour regressions when treated with EGFR Tyrosine Kinase inhibitors (TKis) but they always develop drug resistance causing progressive disease. Aim of this study is to evaluate therapeutic outcomes of first and second line treatment in different Italian centers. Methods: Caucasian EGFR-mutated pts with stage IV NSCLC, receiving 1st-line reversible EGFR TKi were evaluated from June 2009 until May 2013 in 23 Italian institutions. Primary end-points were objective response rate (ORR) to 1st- and 2nd-line treatment, together with: duration of treatment, progression-free survival (PFS), overall survival (OS) and safety for both therapies. Secondary end-point was the assessment of therapeutic approaches beyond EGFR TKis progression. Results: 299 pts (median age 65,6 years old; range: 32-87) were included. Most of them were females (196, 65,6%), never smokers (192, 64,2%), with adenocarcinoma histology (278, 93%) and received gefitinib (278, 93%). The most common mutations were EGFR exon 19 deletion and L858R, detected in 182 and 93 cases (60,9% and 31,1%, respectively). Pts who progressed after first line treatment at the time of data lock were 262: 261 evaluable for ORR and 260 for duration of treatment. The ORR was 48.7% (95% CI 42.6-54.7): 6 (2.3%, 95% CI 0.4-4.1) complete responses, 121 (46.4%, 95% CI 40.3-52.4) partial responses and 77 (29.5%, 95% CI 24.0-35.0) stable diseases (around 75% received the EGFR TKi for more than 6 months). Median duration of first line treatment was 42,9 weeks; 15 pts (5,7%) stopped early due to inacceptable toxicity and 156 pts (59,5%) received a second-line treatment (39% a platinum based doublet, 18% a monotherapy, in 13 cases a rechallenge with EGFR TKi was done). Conclusions: BE-Positive is the first multicenter observational study reporting outcomes of first-line EGFR TKi and second line approach in a large "real life population" of Caucasian patients. Disclosure: G. Banna: Partecipations on boards with Eli Lilly, Italfarmaco and Roche. All other authors have declared no conflicts of interest.
© European Society for Medical Oncology 2014. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: [email protected].
Downloaded from https://academic.oup.com/annonc/article-abstract/25/suppl_4/iv450/2241995 by guest on 24 October 2019
abstracts
1278P
ITALY Medical Oncology, Azienda Ospedaliera Universitaria Integrata Verona-"Borgo Roma", Verona, ITALY 18 Oncologia, IRCCS San Raffaele, Milan, ITALY 19 Medical Oncology, Azienda Ospedaliera S. Giuseppe Moscati, Avellino, ITALY 17
NSCLC, metastatic BE-POSITIVE: BEYOND PROGRESSION AFTER TYROSINE KINASE INHIBITOR IN EGFR-POSITIVE NON-SMALL CELL LUNG CANCER (NSCLC) PATIENTS. PRELIMINARY RESULTS FROM A MULTICENTER ITALIAN OBSERVATIONAL STUDY
T. Vavala1, A. Follador2, M. Tiseo3, D. Galetta4, A. Montanino5, O. Martelli6, O. Caffo7, P.L. Piovano8, D. Cortinovis9, N. Zilembo10, C. Casartelli11, G. Banna12, D. Colombo13, M.L. Barzelloni14, E. Rijavec15, F.L. Cecere16, E. Bria17, C. Lazzari18, A. Rossi19, S. Novello1 1 Department of Oncology, University of Turin AOU San Luigi, Orbassano (TO), ITALY 2 Oncologia, Azienda Ospedaliera Universitaria-UdineSta Maria della Misericordia, Udine, ITALY 3 Medical Oncology, Azienda Ospedaliera di Parma, Parma, ITALY 4 Oncologia Medica, Istituto Tumori Giovanni Paolo II, Bari, ITALY 5 Thoraco-pulmunary Department, Istituto Nazionale Tumori – Fondazione Pascale, Naples, ITALY 6 Oncology, A.O. S. Giovanni - Addolorata, Rome, ITALY 7 Oncology, S. Chiara Hospital, Trento, ITALY 8 Medical Oncology Unit, AO SS Antonio Biagio e Cesare Arrigo, Alessandria, ITALY 9 Dept. of Medical Oncology, Azienda Ospedaliera S. Gerardo U.O. Oncologia Medica, Monza, ITALY 10 Department of Oncology, IRCCS Fondazione Istituto Nazionale dei Tumori, Milan, ITALY 11 Medical Oncology Unit, Valduce Hospital, Como, ITALY 12 Divisione Di Oncologia Medica, Azienda Ospedaliera Cannizzaro, Catania, ITALY 13 Medical Oncology Unit, A.Manzoni Hospital, Lecco, ITALY 14 Department of Oncology, Azienda Ospedaliera UniversitariaS. Giovanni di Dio e Ruggi d’Aragona, Salerno, ITALY 15 Lung Cancer Unit, National Institute for Cancer Research, Genoa, ITALY 16 Medical Oncology Unit, Azienda Ospedaliero Universitaria Careggi, Florence,
Aim: Patients ( pts) with advanced lung adenocarcinoma harbouring EGFR mutations mainly experience tumour regressions when treated with EGFR Tyrosine Kinase inhibitors (TKis) but they always develop drug resistance causing progressive disease. Aim of this study is to evaluate therapeutic outcomes of first and second line treatment in different Italian centers. Methods: Caucasian EGFR-mutated pts with stage IV NSCLC, receiving 1st-line reversible EGFR TKi were evaluated from June 2009 until May 2013 in 23 Italian institutions. Primary end-points were objective response rate (ORR) to 1st- and 2nd-line treatment, together with: duration of treatment, progression-free survival (PFS), overall survival (OS) and safety for both therapies. Secondary end-point was the assessment of therapeutic approaches beyond EGFR TKis progression. Results: 299 pts (median age 65,6 years old; range: 32-87) were included. Most of them were females (196, 65,6%), never smokers (192, 64,2%), with adenocarcinoma histology (278, 93%) and received gefitinib (278, 93%). The most common mutations were EGFR exon 19 deletion and L858R, detected in 182 and 93 cases (60,9% and 31,1%, respectively). Pts who progressed after first line treatment at the time of data lock were 262: 261 evaluable for ORR and 260 for duration of treatment. The ORR was 48.7% (95% CI 42.6-54.7): 6 (2.3%, 95% CI 0.4-4.1) complete responses, 121 (46.4%, 95% CI 40.3-52.4) partial responses and 77 (29.5%, 95% CI 24.0-35.0) stable diseases (around 75% received the EGFR TKi for more than 6 months). Median duration of first line treatment was 42,9 weeks; 15 pts (5,7%) stopped early due to inacceptable toxicity and 156 pts (59,5%) received a second-line treatment (39% a platinum based doublet, 18% a monotherapy, in 13 cases a rechallenge with EGFR TKi was done). Conclusions: BE-Positive is the first multicenter observational study reporting outcomes of first-line EGFR TKi and second line approach in a large "real life population" of Caucasian patients. Disclosure: G. Banna: Partecipations on boards with Eli Lilly, Italfarmaco and Roche. All other authors have declared no conflicts of interest.
© European Society for Medical Oncology 2014. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: [email protected].
Downloaded from https://academic.oup.com/annonc/article-abstract/25/suppl_4/iv450/2241995 by guest on 24 October 2019
abstracts
1278P
ITALY Medical Oncology, Azienda Ospedaliera Universitaria Integrata Verona-"Borgo Roma", Verona, ITALY 18 Oncologia, IRCCS San Raffaele, Milan, ITALY 19 Medical Oncology, Azienda Ospedaliera S. Giuseppe Moscati, Avellino, ITALY 17