Efficacy and safety of nivolumab in patients with advanced non-small-cell lung cancer and poor performance status

The study demonstrates that patients with NSCLC who had a performance status of 3 or 4 and were treated with nivolumab plus best supportive care (BSC) not only showed little survival benefit but also experienced increased frequency and severity of treatment-related adverse events when compared with patients who received BSC alone. In total, 50 patients with PS of 0–2 (good PS group) and 13 patients with PS of 3 or 4 (poor PS group) received nivolumab plus BSC; the remaining 36 patients received BSC alone in the PCU (PC group). Median overall survival was 28 days [95% confidence interval (CI), 17–39)] in the poor PS group and 31 days (95% CI, 25–37) in the PC group (hazard ratio, 1.235; 95% CI, 0.646–2.36; P = 0.516). The response rate was 0% (95% CI, 0–23) in the poor PS group and 20% (95% CI, 9–31) in the good PS group. Median progression free survival in the poor PS group was 14 days (95% CI, 7–21) and 98 days (95% CI, 48–147) in the good PS group (hazard ratio, 12.431; 95% CI, 5.096–30.322; P < 0.001). The frequency of severe pneumonitis and liver toxicity in the poor PS group was significantly higher than that in the good PS group (38% vs. 2%, P = 0.001 and 15% vs.0%, P = 0.040, respectively).