在三阴性乳腺癌化疗中添加PD-1/PD-L1抑制剂：一项荟萃分析。
Addition of PD-1/PD-L1 inhibitors to chemotherapy for triple-negative breast cancer: a meta-analysis.
作者信息
Yang Juan, Liu Chen, Guo Yaru, Guo Wenwen, Wu Xiaojin
机构信息
Department of Radiation Oncology, The Affiliated Xuzhou Municipal Hospital of Xuzhou Medical University, Xuzhou, Jiangsu, China.
出版信息
Front Oncol. 2024 Feb 9;14:1309677. doi: 10.3389/fonc.2024.1309677. eCollection 2024.
BACKGROUND
In recent years, the addition of immune checkpoint inhibitors (ICI) to chemotherapy (CT) has become a research hotspot in the therapy of metastatic triple-negative breast cancer. Nevertheless, controversial results have been revealed among the published randomized controlled trials. Hence, a meta-analysis was performed to assess the therapeutic effect of this treatment regimen.
METHODS
Five English databases (PubMed, WOS, CENTRAL, Scopus, and Embase), and four Chinese databases (CBM, CNKI, VIP, and Wanfang), as well as oncological meetings, were systematically searched to identify eligible studies that assessed the addition of ICI to CT versus CT alone in metastatic triple-negative breast cancer. The pooled hazard ratios (HR) of progression-free survival (PFS) and overall survival (OS) were estimated using fixed- or random-effect model. Subgroup analyses were also performed in the intention-to-treat (ITT) and PD-L1-positive individuals.
RESULTS
All told there are five eligible randomized controlled trials involving 3,000 patients were enrolled in this meta-analysis. Compared with CT alone, the ICI plus CT regimen significantly increased PFS in the ITT (HR = 0.80, 95% CI: 0.73-0.88) and PD-L1-positive (HR = 0.70, 95% CI: 0.62-0.79) populations, as well as OS in the ITT (HR = 0.89, 95% CI: 0.81-0.97) and PD-L1-positive populations (HR = 0.80, 95% CI: 0.71-0.91). Moreover, the PFS of sufferers treated with the combination strategy of ICI with CT increased alongside PD-L1 enrichment. A clinical benefit in terms of objective response rate was also distinctly observed in both populations treated with ICI plus CT. In the subgroup analysis, patients in the no prior CT subgroup experienced a striking increase in PFS in both populations; however, a difference was not observed in other subgroups.
CONCLUSIONS
The combination strategy striking improves PFS and OS in both ITT and PD-L1-positive populations, and PFS is prolonged with PD-L1 enrichment. Patients who do not receive CT prior to this treatment are associated with longer PFS in both populations.
SYSTEMATIC REVIEW REGISTRATION
https://www.crd.york.ac.uk/PROSPERO/#recordDetails, identifier CRD42021289817.
背景
近年来，在转移性三阴性乳腺癌的治疗中，将免疫检查点抑制剂（ICI）添加到化疗（CT）中已成为一个研究热点。然而，已发表的随机对照试验结果存在争议。因此，进行了一项荟萃分析以评估该治疗方案的疗效。
方法
系统检索了五个英文数据库（PubMed、WOS、CENTRAL、Scopus和Embase）、四个中文数据库（CBM、CNKI、VIP和万方）以及肿瘤学会议，以确定评估在转移性三阴性乳腺癌中ICI联合CT与单纯CT治疗的合格研究。使用固定效应或随机效应模型估计无进展生存期（PFS）和总生存期（OS）的合并风险比（HR）。还在意向性治疗（ITT）人群和PD-L1阳性个体中进行了亚组分析。
结果
本荟萃分析共纳入五项合格的随机对照试验，涉及3000例患者。与单纯CT相比，ICI联合CT方案显著提高了ITT人群（HR = 0.80，95%CI：0.73 - 0.88）和PD-L1阳性人群（HR = 0.70，95%CI：0.62 - 0.79）的PFS，以及ITT人群（HR = 0.89，95%CI：0.81 - 0.97）和PD-L1阳性人群（HR = 0.80，95%CI：0.71 - 0.91）的OS。此外，ICI与CT联合治疗策略治疗的患者的PFS随着PD-L1富集而增加。在接受ICI联合CT治疗的两个群体中也明显观察到客观缓解率方面的临床获益。在亚组分析中，未接受过CT治疗的亚组患者在两个群体中的PFS均显著增加；然而，在其他亚组中未观察到差异。
结论
联合治疗策略显著改善了ITT人群和PD-L1阳性人群的PFS和OS，并且PFS随着PD-L1富集而延长。在该治疗前未接受CT治疗的患者在两个群体中均与更长的PFS相关。
系统评价注册
https://www.crd.york.ac.uk/PROSPERO/#recordDetails，标识符CRD42021289817。
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