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).

本研究证实，患有非小细胞肺癌（NSCLC）且病情评估为3或4级，并接受尼伏单抗联合最佳支持治疗（BSC）的患者，不仅未能获得显著的生存获益，而且与仅接受BSC治疗的患者相比，治疗相关不良事件的发生频率和严重程度均有所增加。总计，50名病情评估为0至2级（良好病情组）的患者和13名病情评估为3或4级（不良病情组）的患者接受了尼伏单抗联合BSC治疗；其余36名患者则在重症监护单元（PCU）中仅接受了BSC治疗。不良病情组的平均总生存期为28天[95%置信区间（CI）为17至39]，而PC组的平均总生存期为31天（95% CI，25至37）（风险比，1.235；95% CI，0.646至2.36；P = 0.516）。不良病情组的缓解率为0%（95% CI，0至23），而良好病情组的缓解率为20%（95% CI，9至31）。不良病情组的无进展生存期中位数为14天（95% CI，7至21），而良好病情组的无进展生存期中位数为98天（95% CI，48至147）（风险比，12.431；95% CI，5.096至30.322；P < 0.001）。不良病情组中严重肺炎和肝毒性的发生率显著高于良好病情组（38%对2%，P = 0.001和15%对0%，P = 0.040）。