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).
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•Nivolumab efficacy in NSCLC patients with performance status (PS) 3/4 is unknown. •We included 99 NSCLC patients who received nivolumab or best supportive care (BSC). •Patients with poor PS who received nivolumab or BSC alone showed similar survival. •No tumor response was observed in patients with poor PS treated with nivolumab. •Poor PS patients often had nivolumab-related adverse events including pneumonitis.