Be-TeaM: An Italian real-world observational study on second-line therapy for EGFR-mutated NSCLC patients.

Maria Lucia Reale, Rita Chiari, Marcello Tiseo, Fabiana Vitiello, Fausto Barbieri, Diego Cortinovis, Giovanni Luca Ceresoli, Giovanna Finocchiaro, Gianpiero Diego Romano, Pier Luigi Piovano, Alessandro Del Conte, Gloria Borra, Francesco Verderame, Vieri Scotti, Daniela Nonnis, Domenico Galetta, Concetta Sergi, Maria Rita Migliorino, Giuseppe Tonini, Fabiana CecereRossana Berardi, Maria Simona Pino, Olga Martelli, Alain Gelibter, Annamaria Carta, Emanuela Vattemi, Maria Pagano, Alessandro Zullo, Silvia Ferrari, Antonio Rossi, Silvia Novello

Research output: Contribution to journalArticle

Abstract

Objectives: Molecular diagnostics and care of non-small cell lung cancer (NSCLC) are continuously evolving. Few data document the current strategies to manage advanced NSCLC patients beyond progression in clinical practice. Patients and methods: Be-TeaM is an Italian multi-center observational study conducted on consecutive EGFR-mutated stage IV NSCLC patients, progressed during/after a first-line EGFR-TKI. It consists of a retrospective phase, from first-line EGFR-TKI therapy start until study entry (i.e. beginning of the diagnostic process), and a prospective phase, until treatment choice or for 3 months if no therapy was prescribed. Primary objective was to describe the diagnostic and therapeutic approaches adopted after progression in a real-world setting. Results: Of 308 patients enrolled in 63 centers from July 2017 to June 2018, 289 were included in the analysis. In first line, 53.3 % received gefitinib, 32.5 % afatinib and 14.2 % erlotinib. The testing rate (i.e. rate of all patients undergone any biopsy -liquid and/or tissue- for the T790 M detection) was 90.7 %, with liquid biopsy being the most frequently executed. Of 262 biopsied patients, 64.5 % underwent only 1 liquid biopsy, 10.7 % only 1 tissue biopsy and 18.3 % >1 biopsy, both liquid and solid in 85.4 %. The T790M positivity rate was 45.3 %; of 166 patients undergone only a liquid biopsy and tested for the mutation, 39.8 % were T790M+ and 60.2 % T790M-/undetermined. By the observation end, 87.9 % patients had a post-progression treatment chosen, osimertinib being the most frequent among the T790M+. Conclusion: Be-TeaM provides the first snapshot of current practices for the management of NSCLC patients beyond progression in Italy; in clinical practice, assessing the T790M status is not always feasible.

Original languageEnglish
JournalLung Cancer
DOIs
Publication statusE-pub ahead of print - Dec 16 2019

Keywords

  • Biopsy
  • Clinical practice
  • Italy
  • Second-line treatment
  • T790M
  • Testing rate

ASJC Scopus subject areas

  • Oncology
  • Pulmonary and Respiratory Medicine
  • Cancer Research

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    Reale, M. L., Chiari, R., Tiseo, M., Vitiello, F., Barbieri, F., Cortinovis, D., Ceresoli, G. L., Finocchiaro, G., Romano, G. D., Piovano, P. L., Del Conte, A., Borra, G., Verderame, F., Scotti, V., Nonnis, D., Galetta, D., Sergi, C., Migliorino, M. R., Tonini, G., ... Novello, S. (2019). Be-TeaM: An Italian real-world observational study on second-line therapy for EGFR-mutated NSCLC patients. Lung Cancer. https://doi.org/10.1016/j.lungcan.2019.12.006