Background After the approval of nivolumab some time ago it is necessary to analyse if the results of the randomised clinical trials are correlated with usual clinical practice.
Purpose In this study we assessed median progression-free survival, overall survival and safety in patients diagnosed with advanced nonsquamous non-small cell lung cancer who received the second line of treatment with nivolumab monotherapy in our hospital, comparing it with the results of the pivotal trial.
Material and methods A retrospective and descriptive review of patients treated with nivolumab in our centre from January 2016 to September 2018 was done. The patients received 3 mg/kg every 14 days. The following variables were collected from the unified clinical history and the cytostatic management programme: nonsquamous non-small cell lung cancer diagnosis, sex and performance status. The progression-free survival and overall survival curve was constructed using the Kaplan–Meier method, from which the median was obtained and compared to the pivotal trial (CheckMate 057). The main adverse events were collected.
Results Twenty-five patients were treated in the second line with advanced nonsquamous non-small cell lung cancer with nivolumab of whom 80% was male. Performance status was 0, 1 or 2 in 28%, 68% and 4% patients respectively. Median progression-free survival reached was 5.5 months, which was 3.2 months higher than the trial (2.3 months). Median overall survival reached was 12 months which was 0.2 months lower than the trial (12.2 months). The most prevalent adverse events were asthaenia (44%), nausea (20%) and diarrhoea (12%). There were two patients with grade 3 asthaenia, one patient with alanine aminotransferase increased grade 3 and one patient with pneumonitis.
Conclusion The effectiveness obtained measured with median progression-free survival was higher than that of the pivotal trial, and analogous measured as overall survival, however we must take into account the limitations of a study with a low number of patients. A small percentage of patients present adverse events grade 3.
References and/or acknowledgements No conflict of interest.