帕博利珠单抗联合化疗对比帕博利珠单抗单药治疗晚期或复发性非小细胞肺癌的回顾性分析。
A retrospective analysis of pembrolizumab plus chemotherapy versus pembrolizumab monotherapy for advanced or recurrent non-small cell lung cancer.
机构信息
Department of Respiratory Medicine, Saitama Cardiovascular and Respiratory Center, Saitama, Japan.
出版信息
Thorac Cancer. 2021 May;12(9):1387-1397. doi: 10.1111/1759-7714.13915. Epub 2021 Mar 12.
BACKGROUND
Although clinical trials have investigated the addition of pembrolizumab to chemotherapy for non-small cell lung cancer, none have investigated the addition of chemotherapy to pembrolizumab.
METHODS
We conducted a retrospective study of 71 NSCLC patients including 33 treated with pembrolizumab plus chemotherapy (combination therapy group) and 38 treated with pembrolizumab monotherapy (monotherapy group) from 1 May 2016 to 31 August 2020.
RESULTS
Eleven of 33 (33.3%) patients in the combination therapy group and 37 of 38 (97.4%) patients in the monotherapy group had programmed cell death ligand-1 (PD-L1) tumor proportion score (TPS) ≥50%. Objective response rate (ORR) and median overall survival (OS) were not significantly different between the combination therapy group and monotherapy group (54.5% vs. 47.4, p = 0.637 and 16.6 vs. 27.0 months, p = 0.463). In patients with PD-L1 TPS ≥50%, ORR and median OS were not different between the combination therapy group and the monotherapy group (63.6% vs. 48.6%, p = 0.499 and not reached vs. 27.0 months, p = 0.976). Thirty-three (100%) patients experienced adverse events (AEs) in the combination therapy group and 32 (84.2%) in the monotherapy group. Treatment discontinuation at 1 year due to AEs occurred more frequently in the combination therapy group (45.2%) than in the monotherapy group (21.1%).
CONCLUSION
There was no significant difference in ORR and OS between the two groups, and treatment discontinuation was more frequent in the combination group. A randomized controlled trial is needed to evaluate the addition of chemotherapy to pembrolizumab for first-line treatment in patients with PD-L1 TPS ≥50%.
背景
尽管临床试验已经研究了将 pembrolizumab 与化疗联合用于非小细胞肺癌，但没有研究将化疗与 pembrolizumab 联合用于治疗。
方法
我们对 2016 年 5 月 1 日至 2020 年 8 月 31 日期间收治的 71 例 NSCLC 患者进行了回顾性研究，其中 33 例患者接受 pembrolizumab 联合化疗（联合治疗组），38 例患者接受 pembrolizumab 单药治疗（单药治疗组）。
结果
联合治疗组中有 11 例（33.3%）患者和单药治疗组中有 37 例（97.4%）患者的程序性死亡配体-1（PD-L1）肿瘤比例评分（TPS）≥50%。联合治疗组和单药治疗组的客观缓解率（ORR）和中位总生存期（OS）无显著差异（54.5% vs. 47.4%，p=0.637 和 16.6 vs. 27.0 个月，p=0.463）。在 PD-L1 TPS≥50%的患者中，联合治疗组和单药治疗组的 ORR 和中位 OS 也无差异（63.6% vs. 48.6%，p=0.499 和未达到 vs. 27.0 个月，p=0.976）。联合治疗组 33 例（100%）患者和单药治疗组 32 例（84.2%）患者均出现不良事件（AEs）。联合治疗组中有 14 例（42.4%）患者因 AEs 而在 1 年内停止治疗，而单药治疗组仅有 7 例（18.4%）患者。
结论
两组间 ORR 和 OS 无显著差异，联合组停药率更高。需要进行随机对照试验来评估在 PD-L1 TPS≥50%的患者中，将化疗与 pembrolizumab 联合用于一线治疗的效果。
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