1278P - BE-POSITIVE: Beyond progression after tyrosine kinase inhibitor in EGFR-Positive non-small cell lung cancer (NSCLC) patients. Preliminary results f...

Date 27 September 2014
Event ESMO 2014
Session Poster Display session
Topics Anticancer Agents
Non-Small Cell Lung Cancer
Biological Therapy
Presenter Tiziana Vavala
Citation Annals of Oncology (2014) 25 (suppl_4): iv426-iv470. 10.1093/annonc/mdu349
Authors 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
  • 1Department Of Oncology, University of Turin AOU San Luigi, 10043 - Orbassano (TO)/IT
  • 2Oncologia, Azienda Ospedaliera Universitaria-UdineSta Maria della Misericordia, IT-33100 - Udine/IT
  • 3Medical Oncology, Azienda Ospedaliera di Parma, IT-43100 - Parma/IT
  • 4Oncologia Medica, Istituto Tumori Giovanni Paolo II, IT-70124 - Bari/IT
  • 5Thoraco-pulmunary Department, Istituto Nazionale Tumori – Fondazione Pascale, 80131 - Napoli/IT
  • 6Oncology, A.O. S. Giovanni - Addolorata, Rome/IT
  • 7Oncology, S. CHIARA HOSPITAL, 38122 - TRENTO/IT
  • 8Medical Oncology Unit, AO SS Antonio Biagio e Cesare Arrigo, Alessandria/IT
  • 9Dept. Of Medical Oncology, Azienda Ospedaliera S. GerardoU.O. Oncologia Medica, IT-20052 - Monza/IT
  • 10Department Of Oncology, IRCCS Fondazione Istituto Nazionale dei Tumori, Milan/IT
  • 11Medical Oncology Unit, Valduce Hospital, Como/IT
  • 12Divisione Di Oncologia Medica, Azienda Ospedaliera Cannizzaro, Catania/IT
  • 13Medical Oncology Unit, A.Manzoni Hospital, Lecco/IT
  • 14Department Of Oncology, Azienda Ospedaliera UniversitariaS. Giovanni di Dio e Ruggi d'Aragona, IT-84126 - Salerno/IT
  • 15Lung Cancer Unit, National Institute for Cancer Research, Genoa/IT
  • 16Medical Oncology Unit, Azienda Ospedaliero Universitaria Careggi, 50134 - Firenze/IT
  • 17Medical Oncology, Azienda Ospedaliera Universitaria Integrata Verona-"Borgo Roma", 37134 - Verona/IT
  • 18Oncologia, IRCCS San Raffaele, IT-20132 - Milano/IT
  • 19Medical Oncology, Azienda Ospedaliera S. Giuseppe Moscati, Avellino/IT



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.


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.


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).


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.


G. Banna: Partecipations on boards with Eli Lilly, Italfarmaco and Roche. All other authors have declared no conflicts of interest.