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

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 T790 M 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 T790 M status is not always feasible.