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一线CDK4/6抑制剂联合内分泌治疗与内分泌治疗用于HR+/HER2-转移性或晚期乳腺癌患者的比较长期结局：一项荟萃分析。

Comparative long-term outcomes of first-line CDK4/6 inhibitors plus endocrine therapy versus endocrine therapy in patients with HR+/HER2-metastatic or advanced breast cancer: a meta-analysis.

作者信息

Wang Xiaojian, Liang Xinyi, Li Chenchen, Qin Mengtian, Wu Jianyu, Qin Yuechen, Zou Yue, Zeng Haijian, Li Chunlan, Huang Xiaomeng, Tao Haiyun, Quan Jieru, Wang Xiao

机构信息

The First Affiliated Hospital of Guangxi University of Science and Technology, Guangxi University of Science and Technology, Liuzhou, Guangxi, China.

Department of Medical Oncology, The Sixth Affiliated Hospital, Sun Yat-sen University, Guangzhou, Guangdong, China.

出版信息

Front Pharmacol. 2025 Jul 25;16:1600892. doi: 10.3389/fphar.2025.1600892. eCollection 2025.

DOI:10.3389/fphar.2025.1600892
PMID:40786051
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12331727/
Abstract

INTRODUCTION: This meta-analysis was designed to compare the long-term outcomes of first-line cyclin-dependent kinase 4/6 (CDK4/6) inhibitors plus endocrine therapy (ET) versus ET in patients with HR+/HER2-metastatic or advanced breast cancer (BC). MATERIALS AND METHODS: Four databases (Medline, Embase, Web of Science, and CENTRAL) were searched for literature comparing First-line CDK4/6 inhibitors plus ET to ET in patients with HR+/HER2-metastatic or advanced breast cancer. The search was conducted from the database's establishment to April 3, 2025. Progression-free survival (PFS), overall survival (OS), objective response rate (ORR), disease control rate (DCR), and severe treatment-related adverse events (SAEs) were subjected to meta-analyses. RESULTS: Twelve Randomized controlled trials (RCTs) were included in the meta-analysis. The meta-analysis included a group of 4,957 patients diagnosed with HR+/HER2-metastatic or advanced breast cancer. Within this cohort, 2,877 patients were administered First-line CDK4/6 inhibitors together with ET, while 2080 patients received first-line ET alone. Compared with ET, First-line CDK4/6 inhibitors plus ET yielded superior ORR (RR = 1.39, 95% CI, 1.28 to 1.51, P < 0.01), DCR (RR = 1.09, 95% CI, 1.05 to 1.14, P < 0.01), PFS (HR: 0.57, 95%CI 0.53 to 0.62, P < 0.01) and OS (HR: 0.81, 95%CI 0.73 to 0.89, P < 0.01). Reconstruction of Kaplan-Meier curves for OS and PFS using the IPDformKM program provided a clear and comprehensible representation of oncological outcomes. First-line CDK4/6 inhibitors plus ET was more effective than ET in terms of PFS (median survival time: 27.0 months versus 14.4 months, HR: 0.55, 95%CI 0.51 to 0.59, P < 0.01) and OS (median survival time: 59.6 months versus 50.0 months, HR: 0.79, 95%CI 0.72 to 0.87, P < 0.01). With regards to safety, First-line CDK4/6 inhibitors plus ET exhibited a greater likelihood of encountering SAEs (RR = 1.54, 95% CI: 1.30 to 1.82, P < 0.01) in comparison to ET. CONCLUSION: The present meta-analysis reported comparative long-term outcomes of CDK4/6 inhibitors plus ET versus ET as first-line therapy for HR+/HER2-metastatic or advanced breast cancer. Compared with ET alone, CDK4/6 inhibitors plus ET as first-line therapy provided improved ORR, DCR, PFS, and OS. Furthermore, the heightened efficacy of CDK4/6 inhibitors plus ET was accompanied by a rise in SAEs. SYSTEMATIC REVIEW REGISTRATION: https://www.crd.york.ac.uk/PROSPERO/view/CRD42024590572, Identifier CRD42024590572.

摘要

引言：本荟萃分析旨在比较一线细胞周期蛋白依赖性激酶4/6（CDK4/6）抑制剂联合内分泌治疗（ET）与ET用于激素受体阳性/人表皮生长因子受体2阴性（HR+/HER2-）转移性或晚期乳腺癌（BC）患者的长期疗效。 材料与方法：检索了四个数据库（Medline、Embase、Web of Science和CENTRAL），以查找比较一线CDK4/6抑制剂联合ET与ET用于HR+/HER2-转移性或晚期乳腺癌患者的文献。检索时间从数据库建立至2025年4月3日。对无进展生存期（PFS）、总生存期（OS）、客观缓解率（ORR）、疾病控制率（DCR）和严重治疗相关不良事件（SAE）进行荟萃分析。 结果：荟萃分析纳入了12项随机对照试验（RCT）。该荟萃分析纳入了一组4957例被诊断为HR+/HER2-转移性或晚期乳腺癌的患者。在该队列中，2877例患者接受一线CDK4/6抑制剂联合ET治疗，而2080例患者仅接受一线ET治疗。与ET相比，一线CDK4/6抑制剂联合ET的ORR更高（RR = 1.39，95%CI，1.28至1.51，P < 0.01）、DCR更高（RR = 1.09，95%CI，1.05至1.14，P < 0.01）、PFS更长（HR：0.57，95%CI 0.53至0.62，P < 0.01）以及OS更长（HR：0.81，95%CI 0.73至0.89，P < 0.01）。使用IPDformKM程序重建OS和PFS的Kaplan-Meier曲线，清晰且直观地展示了肿瘤学结局。一线CDK4/6抑制剂联合ET在PFS（中位生存时间：27.0个月对14.4个月，HR：0.55，95%CI 0.51至0.59，P < 0.01）和OS（中位生存时间：59.6个月对50.0个月，HR：0.79，95%CI 0.72至0.87，P < 0.01）方面比ET更有效。在安全性方面，与ET相比，一线CDK4/6抑制剂联合ET发生SAE的可能性更大（RR = 1.54，95%CI：1.30至1.82，P < 0.01）。 结论：本荟萃分析报告了CDK4/6抑制剂联合ET与ET作为HR+/HER2-转移性或晚期乳腺癌一线治疗的比较长期疗效。与单独使用ET相比，CDK4/6抑制剂联合ET作为一线治疗可提高ORR、DCR、PFS和OS。此外，CDK4/6抑制剂联合ET疗效增强的同时SAE也有所增加。 系统评价注册：https://www.crd.york.ac.uk/PROSPERO/view/CRD42024590572，标识符CRD42024590572。

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