BE-POSITIVE: Beyond progression after tyrosine kinase inhibitor in EGFR- positive non small cell lung cancer patients. Results from a multicenter Italian observational study.

Tiziana Vavalà, Alessandro Follador, Marcello Tiseo, Domenico Galetta, Alessandro Morabito, Massimo Di Maio, Olga Martelli, Orazio Caffo, Pier Luigi Piovano, D. L. Cortinovis, Nicoletta Zilembo, C. Casartelli, Giuseppe Luigi Banna, Antonio Ardizzoia, Maria Luisa Barzelloni, Alessandra Bearz, Giovenzio Genestreti, C. Mucciarini, Virginio Filipazzi, Jessica MenisElisa Rizzo, Fausto Barbieri, Erika Rijavec, F. Cecere, Emilio Bria, Gianluca Spitaleri, Antonio Rossi, Silvia Novello

Research output: Contribution to journalArticle

Abstract

Objectives: Non-small-cell-lung-cancer (NSCLC) patients harbouring epidermal growth factor receptor (EGFR) mutations develop drug resistance after 9-12 months of EGFR tyrosine kinase inhibitors (TKIs) therapy pointing out the issue of the second-line treatment choice. Materials and methods: From June 2009 until May 2013 patients affected by advanced NSCLC harbouring EGFR mutations receiving first-line TKI were collected mainly retrospectively in 24 Italian Centers. Primary objective was to describe the percentage of EGFR mutated patients receiving second-line therapy after progression to first-line EGFR-TKIs assessing the type, the activity in terms of objective response rate (ORR), efficacy in terms of progression free survival (PFS) and overall survival (OS), and safety of second-line treatment. Secondary objective was to describe the efficacy of first-line EGFR-TKIs. Results: 312 patients were included. Most of them were females (203, 65.1%), never smokers (200, 64.1%), with adenocarcinoma histology (290, 92.9%). The most common mutations were EGFR exon 19 deletion and L858R, detected in 186 and 97 cases (59.6% and 31.1%), respectively. At data cut-off, 274 patients (95.1%) received any second-line treatment (including best supportive care or local treatments only). A total of 163 patients received second-line systemic therapy with an ORR of 20.9% (95% CI:14.62-27.10), a median PFS and OS of 4.7 (95% CI:3.81-5.26) and 24.5 (95% CI:21.65-27.37) months, respectively. Grade 3-4 hematological and non-hematological toxicities were reported in 9% and 6.3% of 144 patients treated with chemotherapy while non-hematological toxicity was reported in 4 cases of the 17 patients receiving second-line target agents. Conclusions: BE-Positive is the first multicenter observational study reporting outcomes of therapies in a "real-life Caucasian EGFR-mutated population", highlighting the need of further researches about new treatment strategies in this setting.

Original languageEnglish
Pages (from-to)73-81
Number of pages9
JournalLung Cancer
Volume95
DOIs
Publication statusPublished - May 1 2016

Keywords

  • Acquired resistance
  • EGFR mutation
  • EGFR tyrosine kinase inhibitors
  • First line
  • Non small cell lung cancer
  • Second line

ASJC Scopus subject areas

  • Oncology
  • Pulmonary and Respiratory Medicine
  • Cancer Research

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    Vavalà, T., Follador, A., Tiseo, M., Galetta, D., Morabito, A., Di Maio, M., Martelli, O., Caffo, O., Piovano, P. L., Cortinovis, D. L., Zilembo, N., Casartelli, C., Banna, G. L., Ardizzoia, A., Barzelloni, M. L., Bearz, A., Genestreti, G., Mucciarini, C., Filipazzi, V., ... Novello, S. (2016). BE-POSITIVE: Beyond progression after tyrosine kinase inhibitor in EGFR- positive non small cell lung cancer patients. Results from a multicenter Italian observational study. Lung Cancer, 95, 73-81. https://doi.org/10.1016/j.lungcan.2016.02.011