Dudnik Elizabeth, Moskovitz Mor, Rottenberg Yakir, Lobachov Anastasiya, Mandelboim Rinat, Shochat Tzippy, Urban Damien, Wollner Mira, Nechushtan Hovav, Rotem Ofer, Zer Alona, Daher Sameh, Bar Jair
Thoracic Cancer Service, Davidoff Cancer Center, Rabin Medical Center, Beilinson Campus, Petah Tikva, Israel.
Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.
Oncoimmunology. 2021 Jan 28;10(1):1865653. doi: 10.1080/2162402X.2020.1865653.
Both pembrolizumab (P) and combination of pembrolizumab with platinum-based chemotherapy (PCT) represent standard 1-line options for advanced non-small cell lung cancer (aNSCLC) with PD-L1 tumor proportion score (TPS) ≥50%. The two strategies have never been compared in a randomized trial. 256 consecutive patients with -wild-type PD-L1 TPS ≥50% aNSCLC receiving P (group P, n = 203) or PCT (group PCT, n = 53) as a 1-line treatment were identified in the electronic databases of 4 Israeli cancer centers. Time-to-treatment discontinuation (TTD) and overall survival (OS) were assessed. Baseline characteristics were well balanced, except for age and ECOG PS differences in favor of group PCT. Median (m)TTD was 4.9 months (mo) (95% CI, 3.1-7.6) 8.0mo (95% CI, 4.7-15.6) (-0.09), mOS was 12.5mo (95% CI, 9.8-16.4) 20.4mo (95% CI, 10.8-NR) (-0.08), with P and PCT, respectively. In the propensity score matching analysis (n = 106; 53 patients in each group matched for age, sex and ECOG PS), mTTD was 7.9mo (95% CI, 2.8-12.7) 8.0mo (95% CI, 4.7-15.6) (-0.41), and mOS was 13.3mo (95% CI, 6.8-20.3) 20.4mo (95% CI, 10.8-NR) (-0.18), with P and PCT, respectively. Among various subgroups of patients examined, only in females (n = 86) mOS differed significantly between treatments (10.2mo (95% CI, 6.8-17.2) with P NR (95% CI, 11.4-NR) with PCT; -0.02). In the real-world setting, no statistically significant differences in long-term outcomes with P PCT were observed; a prospective randomized trial addressing the comparative efficacy of P and PCT in different patient subgroups is highly anticipated.:
帕博利珠单抗(P)以及帕博利珠单抗与铂类化疗联合方案(PCT)均为程序性死亡受体-配体1(PD-L1)肿瘤比例分数(TPS)≥50%的晚期非小细胞肺癌(aNSCLC)的标准一线治疗方案。这两种策略从未在随机试验中进行过比较。在4家以色列癌症中心的电子数据库中,确定了256例连续的野生型PD-L1 TPS≥50%的aNSCLC患者,他们接受P(P组,n = 203)或PCT(PCT组,n = 53)作为一线治疗。评估了治疗中断时间(TTD)和总生存期(OS)。除年龄和东部肿瘤协作组(ECOG)体能状态存在有利于PCT组的差异外,基线特征保持良好平衡。P组和PCT组的中位(m)TTD分别为4.9个月(mo)(95%置信区间[CI],3.1 - 7.6)和8.0 mo(95% CI,4.7 - 15.6)(差异为-0.09),mOS分别为12.5 mo(95% CI,9.8 - 16.4)和20.4 mo(95% CI,10.8 - 未达到[NR])(差异为-0.08)。在倾向评分匹配分析中(n = 106;每组53例患者按年龄、性别和ECOG体能状态进行匹配),P组和PCT组的mTTD分别为7.9 mo(95% CI,2.8 - 12.7)和8.0 mo(95% CI,4.7 - 15.6)(差异为-0.41),mOS分别为13.3 mo(95% CI,6.8 - 20.3)和20.4 mo(95% CI,10.8 - NR)(差异为-0.18)。在检查的各亚组患者中,仅女性(n = 86)的治疗间mOS存在显著差异(P组为10.2 mo(95% CI,6.8 - 17.2),PCT组未达到(95% CI,11.4 - NR);差异为-0.02)。在现实世界中,未观察到P与PCT在长期结局方面的统计学显著差异;人们高度期待一项针对P和PCT在不同患者亚组中的比较疗效的前瞻性随机试验。