OBJECTIVES: Immunotherapy has recently evolved into a new standard of care for previously treated patients with advanced non–small-cell lung cancer (NSCLC). Nivolumab is the first PD-1 antibody-mediated inhibitor approved for second line treatment of NSCLC improving patient’s overall survival (OS). Outside clinical trials limited data are available regarding the efficacy and safety of nivolumab. In this context, the objective of the present study was to assess the efficacy and safety of nivolumab in a Greek real-world setting.

METHODS: All consecutive advanced NSCLC patients treated with nivolumab after failure of at least one prior therapy between 1/1/2016 and 31/12/2018 in the Oncology Unit of “Sotiria” Hospital, in Athens, Greece, were included (n=109). Demographic, clinical characteristics, treatment and outcomes for these patients were extracted from a hospital-based registry. Outcomes evaluated were the progression-free survival (PFS), OS and toxicities.

RESULTS: The baseline profile of patients was: mean (standard deviation) age of 65.9 (9.1) years; 86.1% of males; 54.1% of current smokers; and 82.3% with performance status 0-1. Half of patients were diagnosed with adenocarcinoma, 37.6% with squamous and the rest with other NSCLC types. Two third of patients (66.1%) were diagnosed with stage IV. 75.2% of patients received nivolumab as second line therapy and 21.1% as third line. 93.3% of patients had received platinum-based therapy as first line. The median PFS of nivolumab-treated patients was 3 (2, NR) months with a median treatment duration of 2.9 months. The median OS was not reached. 52 (47.4%) patients experienced one or more toxicity(s) during immunotherapy. The most frequent were pulmonary (13.9%) and gastrointestinal (13.9%) toxicities. No difference was detected in the PFS among patients with different histological type.

CONCLUSIONS: This study provides useful insights regarding the real-world experience with nivolumab in Greece and the results are consistent with those of other real-world studies and clinical trials.