免疫治疗单药与免疫治疗联合化疗作为晚期非小细胞肺癌一线治疗的间接比较：系统评价。
Indirect comparison between immunotherapy alone and immunotherapy plus chemotherapy as first-line treatment for advanced non-small cell lung cancer: a systematic review.
机构信息
Department of Oncology, Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology, Wuhan, China.
Department of Oncology, Affiliated Hospital of Hebei University of Engineering, Handan, China.
出版信息
BMJ Open. 2020 Nov 20;10(11):e034010. doi: 10.1136/bmjopen-2019-034010.
OBJECTIVES
Use of immune checkpoint inhibitors as first-line treatment for advanced (stage IIIB/IV) non-small cell lung cancer (NSCLC) remains controversial. Clinical trials comparing single-drug immunotherapy (IO) with immunotherapy plus chemotherapy (IC) are lacking. We aimed to compare the efficacy of IO alone with that of IC as first-line treatment for advanced NSCLC.
DESIGN
Systematic review.
DATA SOURCES
PubMed, the Cochrane Library and Embase for related studies on NSCLC; ClinicalTrials.gov, American Society of Clinical Oncology Meeting Library and World Conference on Lung Cancer for relevant conference abstracts (to July 2019).
ELIGIBILITY CRITERIA
Articles meeting the following criteria were selected: (1) randomised controlled trials on NSCLC treatment, (2) all individuals in the studies had not received treatment previously and (3) research on IO monotherapy using programmed death-1/programmed death ligand-1 (PD-L1) inhibitors or IC.
DATA EXTRACTION AND SYNTHESIS
After reading the original literature, two reviewers independently extracted the relevant information. The primary outcomes were progression-free survival (PFS), overall survival (OS) and objective response rate (ORR). We also extracted data on treatment-related adverse events and immune-related adverse events (irAEs).
RESULTS
Overall, 10 randomised controlled clinical trials (n=5765) were included. As first-line treatment for advanced NSCLC, IC tended to yield better PFS, OS and ORR than did IO. Furthermore, IC yielded significantly better PFS than IO when tumour PD-L1 expression was at least 50% (HR: 1.81, 95% CI: 1.18 to 2.78) and yielded a better OS and PFS when tumour PD-L1 expression was at least 1%; IO resulted in fewer adverse events than did IC. However, the incidence of irAEs was higher for IO than for IC.
CONCLUSIONS
The findings of the indirect comparison indicate that IC as first-line treatment for advanced NSCLC is significantly more effective than IO in patients with PD-L1 expression in at least 50% of tumour cells.
TRIAL REGISTRATION NUMBER
CRD 42018116589.
目的
将免疫检查点抑制剂作为晚期（IIIb/IV 期）非小细胞肺癌（NSCLC）的一线治疗方法仍存在争议。缺乏比较单药免疫治疗（IO）与免疫联合化疗（IC）的临床试验。我们旨在比较 IO 单药治疗与 IC 作为晚期 NSCLC 一线治疗的疗效。
设计
系统评价。
数据来源
PubMed、Cochrane 图书馆和 Embase 用于 NSCLC 的相关研究；ClinicalTrials.gov、美国临床肿瘤学会会议图书馆和世界肺癌大会用于相关会议摘要（截至 2019 年 7 月）。
入选标准
符合以下标准的文章入选：（1）关于 NSCLC 治疗的随机对照试验，（2）所有研究个体均未接受过治疗，（3）使用程序性死亡-1/程序性死亡配体-1（PD-L1）抑制剂或 IC 的 IO 单药治疗研究。
数据提取和综合
阅读原始文献后，两名评审员独立提取相关信息。主要结局为无进展生存期（PFS）、总生存期（OS）和客观缓解率（ORR）。我们还提取了与治疗相关不良事件和免疫相关不良事件（irAEs）的数据。
结果
共有 10 项随机对照临床试验（n=5765）纳入研究。作为晚期 NSCLC 的一线治疗方法，IC 在 PFS、OS 和 ORR 方面的疗效优于 IO。此外，当肿瘤 PD-L1 表达至少为 50%时（HR：1.81，95%CI：1.18 至 2.78），IC 在 PFS 方面的疗效优于 IO，当肿瘤 PD-L1 表达至少为 1%时，OS 和 PFS 也更好；IO 引起的不良事件少于 IC。然而，IO 的 irAEs 发生率高于 IC。
结论
间接比较的结果表明，在至少 50%肿瘤细胞中 PD-L1 表达的患者中，IC 作为晚期 NSCLC 的一线治疗方法明显优于 IO。
试验注册
CRD 42018116589。
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