Xia Zhengzheng, Hong Juan, Yu Xiangyang, Ran Yuhua, Xie Huali, Zhou Ziyuan, Zuo Jing, Chen Tujia, Meng Jun, Yang Jun
Department of Pharmacy, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital & Shenzhen Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Shenzhen, China.
Department of Thoracic Surgery, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital & Shenzhen Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Shenzhen, China.
Front Oncol. 2024 Dec 5;14:1422039. doi: 10.3389/fonc.2024.1422039. eCollection 2024.
Programmed cell death protein 1 (PD-1) inhibitors are commonly used worldwide for the management of non-small cell lung cancer (NSCLC). However, it remains unclear whether pembrolizumab and sintilimab, two of the most widely used PD-1 inhibitors in China, have significantly different effects on patients with NSCLC. A multicenter retrospective cohort study was designed and implemented using propensity-score matching (PSM) analysis to compare the effectiveness and safety profiles of pembrolizumab and sintilimab in patients with advanced NSCLC undergoing comprehensive therapy.
A total of 225 patients who received comprehensive therapy including pembrolizumab (n = 127) or sintilimab (n = 98), from 1 January to 31 December 2020 and met the eligibility criteria were included. PSM analysis (1:1) was performed to balance potential baseline confounding factors. For both treatments, Kaplan-Meier analysis and Cox regression were used to compare 1-year progression-free survival (PFS), disease control rate (DCR), objective response rate (ORR), and rates of all adverse events (AEs).
PSM analysis resulted in 63 matched pairs of patients. After PSM, the median PFS was 8.68 months in the sintilimab group and 9.46 months in the pembrolizumab group. The 1-year PFS showed no significant difference between the pembrolizumab and sintilimab groups before and after PSM ( = 0.873 and = 0.574, respectively). Moreover, within the matched cohort, the pembrolizumab group had an ORR of 30.2% and a DCR of 84.1%, whereas the sintilimab group exhibited an ORR of 41.3% and a DCR of 88.9%. There were no significant differences in the ORR and DCR between the two groups ( = 0.248 and = 0.629, respectively). The incidence of grade 3 or 4 treatment-related AEs was significantly higher in the pembrolizumab group than that in the sintilimab group (42.9% vs. 33.3%, = 0.043). Multivariable Cox proportional hazards regression analysis indicated that the lines of treatment and regimens significantly influenced the PFS of patients (0.05).
This study demonstrated the similar effectiveness of sintilimab and pembrolizumab in the treatment of patients with advanced NSCLC, with sintilimab potentially displaying a superior clinical safety profile.
https://www.medicalresearch.org.cn/, identifier MR4423000113.
程序性细胞死亡蛋白1（PD-1）抑制剂在全球范围内普遍用于非小细胞肺癌（NSCLC）的治疗。然而，在中国广泛使用的两种PD-1抑制剂帕博利珠单抗和信迪利单抗对NSCLC患者的疗效是否存在显著差异仍不清楚。本研究设计并实施了一项多中心回顾性队列研究，采用倾向得分匹配（PSM）分析比较帕博利珠单抗和信迪利单抗在接受综合治疗的晚期NSCLC患者中的有效性和安全性。
纳入2020年1月1日至12月31日期间接受包括帕博利珠单抗（n = 127）或信迪利单抗（n = 98）在内的综合治疗且符合纳入标准的225例患者。进行PSM分析（1:1）以平衡潜在的基线混杂因素。对于两种治疗方法，采用Kaplan-Meier分析和Cox回归比较1年无进展生存期（PFS）、疾病控制率（DCR）、客观缓解率（ORR）以及所有不良事件（AE）的发生率。
PSM分析产生了63对匹配患者。PSM后，信迪利单抗组的中位PFS为8.68个月，帕博利珠单抗组为9.46个月。PSM前后，帕博利珠单抗组和信迪利单抗组的1年PFS无显著差异（分别为 = 0.873和 = 0.574）。此外，在匹配队列中，帕博利珠单抗组的ORR为30.2%，DCR为84.1%，而信迪利单抗组的ORR为41.3%，DCR为88.9%。两组的ORR和DCR无显著差异（分别为 = 0.248和 = 0.629）。帕博利珠单抗组3/4级治疗相关AE的发生率显著高于信迪利单抗组（42.9%对33.3%， = 0.043）。多变量Cox比例风险回归分析表明，治疗线数和治疗方案对患者的PFS有显著影响（0.05）。
本研究表明信迪利单抗和帕博利珠单抗在治疗晚期NSCLC患者方面疗效相似，信迪利单抗可能具有更优的临床安全性。
