RESUMEN
OBJECTIVES: To compare real life effectiveness and safety of nivolumab in patients with non-small cell lung cancer (NSCLC), according to age and Eastern Cooperative Group performance status (ECOG-PS). METHODS: We performed a retrospective analysis of patients treated with nivolumab for NSCLC within a Belgian compassionate use program from July 2015 until December 2016. Safety and effectiveness were compared between patients aged ≥70â¯years andâ¯<â¯70â¯years and between ECOG-PS 0/1 andâ¯≥â¯2. RESULTS: A total of 324 patients with NSCLC were included. There was no significant difference between older (≥70) and younger (<70â¯years) patients with regards to progression free survival (PFS) (4â¯months (95%CI 2.6;4.8) versus 3.7â¯months (95%CI 1;7), pâ¯=â¯0.483) and overall survival (OS) (9.3â¯months (95% CI 5.5;13.1â¯months) versus 8.4â¯months (95%CI 6.3; 10.5), pâ¯=â¯0,638). Patients with an ECOG-PS ≥2 had a significant lower median PFS and OS compared to patients with an ECOG-PS 0-1 (2.2 (95%CI 1.4; 2.9) versus 5.6â¯months (95%CI 4.1; 7.1), pâ¯=â¯0.001 and 3.4 (95%CI 2.3; 4.5) versus 11.1â¯months (95%CI 8.9; 13.2), pâ¯<â¯0.001 respectively). No significant difference in all grades or grade 3/4 adverse events (AEs) were observed between the different age groups (pâ¯=â¯0.526 and pâ¯=â¯0.603 respectively). Patients with an ECOG-PS 0/1 had significantly more all grades AEs (pâ¯=â¯0.009) but no difference in grade 3/4 AEs was observed (pâ¯=â¯0.406) compared to ECOG-PS ≥2. CONCLUSION: This real life retrospective study confirms that safety and effectiveness of nivolumab is similar between different age groups, but that effectiveness is driven by performance status.