Efficacy and safety of nivolumab in previously treated patients with non-small cell lung cancer: Real world experience in Argentina

Abstract Background Nivolumab was the first anti PD 1 approved in Argentina for non small cell lung cancer treatment in the second line setting. Methods This study was a multicenter, observational, retrospective study of patients who progressed to platinum/stage IV NSCLC patients (pts.) who received nivolumab monotherapy in a drug expanded access program in Argentina. Results 109 patients were assessed retrospectively for safety and clinical outcomes. Follow up was 8.83 m (IQR 3.4-12.67). 57.8% men, 29.4% were current smokers, 78.0% with non-squamous cell cancer diagnosis. Median chemotherapy lines number before nivolumab was 2 (r 1-4), and 59.6% received radiotherapy. 89% had received platinum-based chemotherapy. Drug related toxicity was 78.9%. Grade 2-3 28.4%. Corticoid use was 33.9%. Response was evaluated in1 04 pts who had as best response CR 2/104 (2%), PR 28/104 (27. %), SD 33/104 (32%) and PD 41/104(39%). Univariate analysis revealed that absence of corticoids use (p=0.034), toxicity grade 1-3(p=0.0025), PS≤1 (p=0.049), were associated with longer DFS; PS≤1 (p Conclusions The use of Nivolumab in the real world setting, in heavily pre-treated NSCLC patients was well tolerated and showed promising clinical efficacy. PS, the use of corticoids and immune-mediated toxicity seem to be conditions which could affect clinical outcomes.