Efficacy and Safety of Nivolumab in Patients with Advanced Non-small-cell Lung Cancer and Poor Performance Status
Efficacy and Safety of Nivolumab in Patients with Advanced Non-small-cell Lung Cancer and Poor Performance Status
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DOI：
10.7150/jca.31217
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发表时间：
2019-01-01
影响因子：
3.9
通讯作者：
Mase, Hiroki
中科院分区：
文献类型：
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作者：
Katsura, Hideyuki;Suga, Yukio;Mase, Hiroki
背景：Nivolumab在非小细胞肺癌（NSCLC）和体能状态（PS）为2-4的患者中的疗效尚不清楚。我们旨在比较接受纳武单抗加最佳支持治疗（BSC）的PS较差的NSCLC患者与在姑息治疗室（PCU）中仅接受BSC的患者的生存率、治疗疗效和安全性。患者和方法：这项回顾性研究包括2015年12月至2018年3月期间接受纳武单抗加BSC或仅接受BSC的99例连续NSCLC患者。总共有43例PS为0-1的患者（PS良好组）和20例PS为2-4的患者（PS差组）接受纳武利尤单抗加BSC;其余36例患者在PCU中单独接受BSC（PC组）。PS较差组的中位总生存期为32天[95%置信区间（CI），21-43]，PC组为31天（95% CI，25-37）（风险比，0.653; 95% CI，0.368-1.158; P = 0.137）。此外，PS差组中PS为3或4的患者的中位总生存期并不显著长于PC组（HR，1.235; 95%CI，0.646-2.360; P = 0.516）。PS较差组中严重肺炎的发生率明显高于PS良好组（25% vs. 2%，P = 0.010）。结论：纳武利尤单抗对PS较差（尤其是3或4）的非小细胞肺癌患者的生存益处尚未得到证实。需要更多患者的进一步研究来证实我们的结果。
Background: Nivolumab efficacy in patients with non-small-cell lung cancer (NSCLC) and performance status (PS) of 2-4 is unclear. We aimed to compare survival, treatment efficacy, and safety in patients with NSCLC with poor PS who received nivolumab plus best supportive care (BSC) with those in patients who received BSC alone in a palliative care unit (PCU).Patients and methods: This retrospective study included 99 consecutive patients with NSCLC who received nivolumab plus BSC or BSC alone between December 2015 and March 2018.Results: In total, 43 patients with PS of 0-1 (good PS group) and 20 patients with PS of 2-4 (poor PS group) received nivolumab plus BSC; the remaining 36 patients received BSC alone in the PCU (PC group). Median overall survival was 32 days [95% confidence interval (CI), 21-43] in the poor PS group and 31 days (95% CI, 25-37) in the PC group (hazard ratio, 0.653; 95% CI, 0.368-1.158; P = 0.137). Moreover, median overall survival in patients with PS of 3 or 4 among the poor PS group was not significantly longer than that in the PC group (HR, 1.235; 95% CI, 0.646-2.360; P = 0.516). The frequency of severe pneumonitis in the poor PS group was significantly higher than that in the good PS group (25% vs. 2%, P = 0.010).Conclusion: Survival benefit of nivolumab in patients with NSCLC with poor PS, especially 3 or 4, was not confirmed. Further studies with larger numbers of patients are required to confirm our results.