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免疫检查点抑制剂联合化疗与单纯化疗治疗三阴性乳腺癌患者的疗效比较:系统评价和荟萃分析。

Addition of immune checkpoint inhibitors to chemotherapy versus chemotherapy alone in patients with triple-negative breast cancer: A systematic review and meta-analysis.

机构信息

The First Affiliated Hospital of Zhejiang Chinese Medical University (Zhejiang Provincial Hospital of Chinese Medicine), Hangzhou, Zhejiang, China.

Anji Traditional Chinese Medical Hospital, Huzhou, Zhejiang, China.

出版信息

Cancer Med. 2023 Dec;12(24):21873-21884. doi: 10.1002/cam4.6760. Epub 2023 Dec 8.

Abstract

BACKGROUND

Triple-negative breast cancer (TNBC) is a relatively common malignant tumor with high mortality rates. There are limited treatment options and current therapy regimens often fall short of providing positive outcomes. The development of immune checkpoint inhibitors (ICIs) have provided a vital treatment option although efficacy has varied. Here, we review patient response to current TNBC treatment with and without the addition of ICIs.

METHODS

A systematic search of PubMed, Cochrane, and EMBASE library databases was done to search eligible studies published from their inception through April 3, 2022. The primary outcome indicators used were progression-free survival (PFS), overall survival (OS), pathological complete response rate (pCR) and objective remission rate (ORR), while adverse events (AEs) were also analyzed. Publication bias and sensitivity analyses and were performed to evaluate the quality of assessment.

RESULTS

Overall, the meta-analysis looked at seven randomized controlled trials (RCTs) that included 4631 patients with TNBC. Results showed an improvement in PFS for patients receiving ICI in addition to chemotherapy (CT) in both the intent-to-treat (ITT) population and PD-L1 positive patients. Increased pCR rates were observed in all patients irrespective of PD-L1 status as well as increased ORR in the ITT which was more notable in PD-L1 positive subjects. While significant improvement in OS was observed only in PD-L1 positive individuals, the use of ICIs plus CT resulted in severe adverse reactions, specifically immune-related.

CONCLUSIONS

This study supports the increased efficacy of ICIs in combination with CT compared to CT alone in patients with TNBC, with the most notable benefit observed in PD-L1 positive patients. However, combination therapy increases the risk of adverse reactions which warrants further investigation.

摘要

背景

三阴性乳腺癌(TNBC)是一种较为常见的恶性肿瘤,死亡率较高。目前治疗选择有限,当前的治疗方案往往无法提供积极的结果。免疫检查点抑制剂(ICIs)的开发为治疗提供了重要选择,尽管疗效存在差异。在这里,我们回顾了有和没有添加 ICI 的情况下当前 TNBC 治疗的患者反应。

方法

对 PubMed、Cochrane 和 EMBASE 图书馆数据库进行系统搜索,以搜索从成立到 2022 年 4 月 3 日发表的合格研究。主要的预后指标是无进展生存期(PFS)、总生存期(OS)、病理完全缓解率(pCR)和客观缓解率(ORR),同时也分析了不良事件(AEs)。进行了发表偏倚和敏感性分析,以评估评估的质量。

结果

总体而言,该荟萃分析共纳入了 7 项随机对照试验(RCT),共纳入了 4631 例 TNBC 患者。结果显示,在 ITT 人群和 PD-L1 阳性患者中,接受 ICI 加化疗(CT)的患者 PFS 得到改善。所有患者的 pCR 率均增加,无论 PD-L1 状态如何,以及 ITT 的 ORR 均增加,PD-L1 阳性患者更为显著。虽然仅在 PD-L1 阳性患者中观察到 OS 的显著改善,但 ICI 加 CT 的使用会导致严重的不良反应,特别是免疫相关的不良反应。

结论

这项研究支持在 TNBC 患者中,与单独使用 CT 相比,ICI 联合 CT 具有更高的疗效,在 PD-L1 阳性患者中观察到的益处最为显著。然而,联合治疗会增加不良反应的风险,这需要进一步研究。

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