Department of Pharmacy, Cancer Hospital of China Medical University, Liaoning Cancer Hospital & Institute, Shenyang, Liaoning Province, 110042, China.
School of Life Science and Biopharmaceutics, Shenyang Pharmaceutical University, Shenyang, China.
BMC Cancer. 2024 Jun 8;24(1):708. doi: 10.1186/s12885-024-12478-1.
Novel antibody-drug conjugates (ADCs) drugs present a promising anti-cancer treatment, although survival benefits for HER2-positive advanced breast cancer (BC) remain controversial. The aim of this meta-analysis was to evaluate the comparative effect of ADCs and other anti-HER2 therapy on progression-free survival (PFS) and overall survival (OS) for treatment of HER2-positive locally advanced or metastatic BC.
Relevant randomized controlled trials (RCTs) were retrieved from five databases. The risk of bias was assessed with the Cochrane Collaboration's tool for RCTs by RevMan5.4 software. The hazard ratio (HR) and 95% confidence intervals (CIs) were extracted to evaluate the benefit of ADCs on PFS and OS in HER2-positive advanced BC by meta-analysis.
Meta-analysis of six RCTs with 3870 patients revealed that ADCs significantly improved PFS (HR: 0.63, 95% CI: 0.49-0.80, P = 0.0002) and OS (HR: 0.79, 95% CI: 0.72-0.86, P < 0.0001) of patients with HER2-positive locally advanced or metastatic BC. Subgroup analysis showed that PFS and OS were obviously prolonged for patients who previously received HER2-targeted therapy. Sensitivity analysis and publication bias suggested that the results were stable and reliable.
Statistically significant benefits for PFS and OS were observed with ADCs in HER2-positive locally advanced or metastatic BC, especially for those who received prior anti-HER2 treatment.
新型抗体药物偶联物（ADC）为癌症治疗带来了新的希望，但针对人表皮生长因子受体 2（HER2）阳性晚期乳腺癌（BC）的生存获益仍存在争议。本荟萃分析旨在评估 ADC 与其他抗 HER2 治疗方案在 HER2 阳性局部晚期或转移性 BC 治疗中的无进展生存期（PFS）和总生存期（OS）的比较效果。
从五个数据库中检索相关的随机对照试验（RCT）。使用 RevMan5.4 软件的 Cochrane 协作工具评估偏倚风险。提取风险比（HR）和 95%置信区间（CI），以通过荟萃分析评估 ADC 对 HER2 阳性晚期 BC 的 PFS 和 OS 的获益。
对六项 RCT 共 3870 例患者的荟萃分析表明，ADC 显著改善了 HER2 阳性局部晚期或转移性 BC 患者的 PFS（HR：0.63，95%CI：0.49-0.80，P=0.0002）和 OS（HR：0.79，95%CI：0.72-0.86，P<0.0001）。亚组分析显示，对于先前接受过 HER2 靶向治疗的患者，PFS 和 OS 明显延长。敏感性分析和发表偏倚表明，结果是稳定可靠的。
ADC 对 HER2 阳性局部晚期或转移性 BC 患者的 PFS 和 OS 具有显著的获益，特别是对于那些接受过先前抗 HER2 治疗的患者。
