Published: April 16, 2024
Results from the phase III Keynote-024 clinical trial have established Pembrolizumab monotherapy as first-line standard of care for patients with metastatic NSCLC who PD-L1 expression ≥ 50%, EGFR and ALK wild-type. However, given differences between treated in routine practice within a trial, real-world data are needed to confirm treatment benefit practice. Given lack on large cohorts long follow-up, we designed retrospective observational study were Pembrolizumab, starting its reimbursement eligibility until December 2020. The primary endpoints assess PFS OS using Kaplan-Meier method, response safety. We followed 880 (median follow-up: 35.1 months) February 2022. Median 8.6 months (95% CI: 7.6-10.0) 25.5 21.8-31.6), respectively. also found that ECOG PS, smoking habit prognostic factors PFS, while age, sex, histology had an impact OS. Multivariable analysis confirms role both 39.9% reported adverse event, but only 6.3% discontinued therapy due toxicity. Our results suggest long-term setting well safety profile consistent Keynote-042. Many collected variables appear influence outcome, these exploratory unadjusted analyses should be interpreted caution.
Language: Английский