PD-1/PD-L1检查点抑制剂与抗PD-1/PD-L1联合其他疗法治疗肿瘤的疗效与安全性：一项系统评价
Efficacy and Safety of PD-1/PD-L1 Checkpoint Inhibitors versus Anti-PD-1/PD-L1 Combined with Other Therapies for Tumors: A Systematic Review.
作者信息
Zhang Yiru, Yao Qigu, Pan Yong, Fang Xinru, Xu Haoying, Zhao Tingxiao, Zhu Guangqi, Jiang Tianan, Li Shibo, Cao Hongcui
机构信息
State Key Laboratory for the Diagnosis and Treatment of Infectious Diseases, The First Affiliated Hospital, Zhejiang University School of Medicine, 79 Qingchun Rd., Hangzhou 310003, China.
Department of Infectious Disease, Zhoushan Hospital, Wenzhou Medical University, 739 Dingshen Rd., Zhoushan 316021, China.
出版信息
Cancers (Basel). 2023 Jan 22;15(3):682. doi: 10.3390/cancers15030682.
OBJECTIVE
In recent years, the anti-programmed cell death protein-1 and its ligand (PD-1/PD-L1) or combination therapies have been recommended as an alternative emerging choice of treatment for oncology patients. However, the efficacy and adverse events of different combination strategies for the treatment of tumors remain controversial.
METHODS
PubMed, Embase, Cochrane Library, the American Society of Clinical Oncology (ASCO), and the European Society of Medicine Oncology (ESMO) were searched from database inception until 16 February 2022. The endpoints of objective response rate (ORR), disease control rate (DCR), overall survival (OS), progression-free survival (PFS), and adverse events (AEs) were analyzed from different treatment schemes and tumor types. The protocol was registered in PROSPERO (CRD42022328927).
RESULTS
This meta-analysis included forty-eight eligible studies. Combination therapy has improved ORR (RR = 1.40, < 0.001), DCR (RR = 1.22, < 0.001), and PFS (the median survival ratio (MSR) was estimated to be 1.475 < 0.001) compared to anti-PD-1/PD-L1 but had no significant benefit on OS (MSR was estimated to be 1.086 = 0.117). Besides, combination treatment strategies are more toxic in any grade AEs (RR = 1.13, < 0.001) and grade 3-5 AEs (RR = 1.81, < 0.001).
CONCLUSIONS
Treatment with PD-1/PD-L1 inhibitors in combination with other antitumor therapies improve patients' ORR, DCR, and PFS compared to anti-PD-1/PD-L1. However, it is regrettable that there is no benefit to OS and an increased risk of AEs in combinatorial therapies.
目的
近年来，抗程序性细胞死亡蛋白1及其配体（PD-1/PD-L1）疗法或联合疗法已被推荐为肿瘤患者新兴的替代治疗选择。然而，不同联合策略治疗肿瘤的疗效和不良事件仍存在争议。
方法
检索了PubMed、Embase、Cochrane图书馆、美国临床肿瘤学会（ASCO）和欧洲医学肿瘤学会（ESMO），检索时间从数据库建立至2022年2月16日。分析了不同治疗方案和肿瘤类型的客观缓解率（ORR）、疾病控制率（DCR）、总生存期（OS）、无进展生存期（PFS）和不良事件（AE）等终点指标。该方案已在国际前瞻性系统评价注册库（PROSPERO）注册（注册号：CRD42022328927）。
结果
该荟萃分析纳入了48项符合条件的研究。与抗PD-1/PD-L1单药治疗相比，联合治疗提高了ORR（风险比[RR]=1.40，P<0.001）、DCR（RR=1.22，P<0.001）和PFS（中位生存比[MSR]估计为(1.475)，P<0.001），但对OS无显著益处（MSR估计为(1.086)，P=0.117）。此外，联合治疗策略在任何级别的AE（RR=1.13，P<0.001）和3-5级AE（RR=1.81，P<0.001）方面毒性更大。
结论
与抗PD-1/PD-L1单药治疗相比，PD-1/PD-L1抑制剂联合其他抗肿瘤疗法可提高患者的ORR、DCR和PFS。然而，遗憾的是，联合疗法对OS无益处，且不良事件风险增加。
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