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).

本研究显示，体力状态评分（performance status, PS）为3或4分的非小细胞肺癌（NSCLC）患者，接受纳武利尤单抗（nivolumab）联合最佳支持治疗（best supportive care, BSC）时，不仅生存获益微乎其微，且相较于仅接受BSC的患者，其治疗相关不良事件的发生频率与严重程度均显著升高。总计有50例PS评分为0~2分的患者（良好体力状态组）与13例PS评分为3或4分的患者（较差体力状态组）接受了纳武利尤单抗联合BSC治疗；剩余36例患者仅接受BSC治疗，纳入姑息治疗单元对照组（PC组）。较差体力状态组的中位总生存期为28天[95%置信区间（confidence interval, CI）：17~39]，PC组为31天（95%CI：25~37）；风险比为1.235，95%CI为0.646~2.36，P=0.516。较差体力状态组的缓解率为0%（95%CI：0~23），良好体力状态组为20%（95%CI：9~31）。较差体力状态组的中位无进展生存期为14天（95%CI：7~21），良好体力状态组为98天（95%CI：48~147）；风险比为12.431，95%CI为5.096~30.322，P<0.001。较差体力状态组的重度肺炎与肝毒性发生率显著高于良好体力状态组（分别为38% vs 2%，P=0.001；15% vs 0%，P=0.040）。