Objective:

To evaluate the effectiveness and safety profile of nivolumab used in second line for the treatment of nonsmall cell lung cancer in real clinical practice.

Material and methods:

Retrospective observational study was carried off in patients with non-small cell lung cancer treated with nivolumab in the second line between December 2015 and November 2019. The response was evaluated using RECIST v1.1 criteria. Main survival variables: objective response rate (ORR) and overall survival (OS); secondary variables: progression-free survival (PFS). The possible predictive response factors (age, sex, histology and ECOG-PS) were analyzed using a Cox proportional hazard model for survival, and odds ratio for the objective response rate. The safety was evaluated through the occurrence of adverse events (AD) and their degree according to CTCEA v5.

Results:

48 patients were included, medianage of 65.5 years (range 46-83), mostly men (85.5%), ECOG-PS 0-1 (85%). Regarding effectiveness, ORR=27% (95% CI 14.04-40.12), median SG 13.01 months (95% CI 7.67-18.36) and SLP 5.29 months (95% CI 3.53-7.05). Sex was identified as a predictor of better response in terms of ORR. EA G3-G4 appeared in 10% of patients.

Conclusions:

Nivolumab had a slightly higher effectiveness than demonstrated in clinical trials. The safety of the treatment was acceptable, positioning nivolumab as a valid alternative in the treatment of non-small cell lung cancer in second line.

        · abstract in Spanish     · text in Spanish     · Spanish ( pdf )