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

• Published in: Lung cancer (Amsterdam, Netherlands) Netherlands), 2020-02, Vol.140, p.71-79
• Main Authors: Reale, Maria Lucia, Chiari, Rita, Tiseo, Marcello, Vitiello, Fabiana, Barbieri, Fausto, Cortinovis, Diego, Ceresoli, Giovanni Luca, Finocchiaro, Giovanna, Romano, Gianpiero Diego, Piovano, Pier Luigi, Del Conte, Alessandro, Borra, Gloria, Verderame, Francesco, Scotti, Vieri, Nonnis, Daniela, Galetta, Domenico, Sergi, Concetta, Migliorino, Maria Rita, Tonini, Giuseppe, Cecere, Fabiana, Berardi, Rossana, Pino, Maria Simona, Martelli, Olga, Gelibter, Alain, Carta, Annamaria, Vattemi, Emanuela, Pagano, Maria, Zullo, Alessandro, Ferrari, Silvia, Rossi, Antonio, Novello, Silvia
• Format: Article
• Language: English
• Subjects: Adenocarcinoma of Lung - drug therapy; Adenocarcinoma of Lung - genetics; Adenocarcinoma of Lung - pathology; Aged; Biopsy; Carcinoma, Non-Small-Cell Lung - drug therapy; Carcinoma, Non-Small-Cell Lung - genetics; Carcinoma, Non-Small-Cell Lung - pathology; Carcinoma, Squamous Cell - drug therapy; Carcinoma, Squamous Cell - genetics; Carcinoma, Squamous Cell - pathology; Clinical practice; ErbB Receptors - antagonists & inhibitors; ErbB Receptors - genetics; Female; Follow-Up Studies; Humans; Italy; Lung Neoplasms - drug therapy; Lung Neoplasms - genetics; Lung Neoplasms - pathology; Male; Middle Aged; Molecular Targeted Therapy; Mutation; Neoplasm Metastasis; Prognosis; Prospective Studies; Protein Kinase Inhibitors - therapeutic use; Retrospective Studies; Second-line treatment; Survival Rate; T790M; Testing rate
• ISSN: 0169-5002; 1872-8332
• DOI: 10.1016/j.lungcan.2019.12.006

•Few data document the real-world strategies to manage advanced NSCLC after PD.•Be-TeaM provides the first snapshot of current practices in this setting in Italy.•Most patients were screened for T790M and had a post-PD therapy chosen.•However, testing in clinical practice is not always feasible.•This precludes many patients from receiving osimertinib after first-line TKI failure. 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. 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. 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+. 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.