Background and importance Many studies support pembrolizumab (a humanised monoclonal antibody directed towards programmed cell death protein-1 (PD-1)) as the firstline treatment of advanced non-small cell lung cancer (NSCLC) without EGFR/ALK alterations.
Aim and objectives The aim of this observational was to report clinical outcome in terms of overall survival (OS) analysis, as well as in stratified OS, in subgroups of patients.
Material and methods Between 1 July 2017 and 28 February 2020, 98 patients with NSCLC were eligible to be treated with pembrolizumab (200 mg q3w fixed dose). The last follow-up date was 24 August 2020. Clinical data, such as expression of PD-L1, performance status (ECOG-PS), treatment duration, toxicity (CTCAE V.5.0) and outcome were collected from the local electronic medical records. OS, defined as the time from the start of therapy to death or last follow-up, was compared in subgroups of patients using the log rank test (with R software); p<0.05 was considered statistically significant.
Results This investigation provided preliminary results for 98 patients (of whom 64% were male). Median age was 73 years (range 44–89). ECOG-PS was 0 or 1 in 91% of cases and 29.6% of patients had a PD-L1 >90%. Median duration of treatment was seven cycles. At a median follow-up of 14.6 months, the percentage of patients still alive was 51% and median OS was 13.3 months (95% CI 10.5 to 31.4). The analysis revealed that OS was not influenced by sex or PD-L1, but significantly associated with ECOG-PS (p<0.001). Immunorelated adverse events occurred in 75.5% of patients (29.6% cutaneous, 24.5% gastrointestinal and 19.4% endocrinological). Patients with toxicity showed a significantly higher median OS (29.6 months, 95% CI 12.2 to NA) compared with those without significant toxicity (6.5 months, 95% CI 1.3 to 13.1, p=0.002).
Conclusion and relevance These real life findings in the setting of advanced NSCLC patients with PD-L1 TPS ≥50% demonstrated the effectiveness of pembrolizumab. A median OS of 13.3 months was similar to that estimated in the real world Pembreizh study (15.3 months). The detection rate of AE of 75.5% was comparable with 73.4% in the KEYNOTE-024 study. However, pembrolizumab as mono-immunotherapy represents the standard of care as firstline treatment but results from trials evaluating combinations with chemotherapy (KEYNOTE189) could further change the therapeutic approaches.
Conflict of interest No conflict of interest
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