Qureshi Zaheer, Jamil Abdur, Fatima Eeshal, Altaf Faryal, Siddique Rimsha
The Frank H. Netter M.D. School of Medicine at Quinnipiac University, Bridgeport, CT.
Department of Medicine, Samaritan Medical Centre Watertown, NY.
Am J Clin Oncol. 2025 Jan 1;48(1):6-15. doi: 10.1097/COC.0000000000001143. Epub 2024 Sep 9.
Breast cancer, particularly the hormone receptor-positive (HR+) and human epidermal growth factor receptor 2-negative (HER2-) subtype, remains a major global health concern. Abemaciclib, a CDK4/6 inhibitor, has shown promising results in treating advanced cases. This study comprehensively assesses the efficacy and safety of abemaciclib in combination with endocrine therapy for HR+/HER2- advanced or metastatic breast cancer.
Following PRISMA guidelines, a systematic review and meta-analysis was conducted. A thorough literature search was conducted on PubMed, EMBASE, Cochrane Library, and ClinicalTrials.gov til December 2023. Inclusion criteria encompassed randomized controlled trials and retrospective cohort studies reporting on abemaciclib in approved doses, either as monotherapy or in combination. Outcome assessments included progression-free survival (PFS), overall response rate (ORR), side effects/adverse effects (SE/AE), and overall survival (OS). Quality assessment utilized Cochrane's revised risk of bias tool and Newcastle-Ottawa scale.
Pooled results of 22 studies involving 14,010 patients revealed that abemaciclib significantly improved PFS (hazard ratio=0.53; 95% CI: 0.48-0.59; P =0.00; I 2 =0%), ORR (risk ratio=2.31; 95% CI: 1.93-2.75; P =0.00; I 2 =0%), and OS (risk ratio=0.76 (95% CI: 0.65-0.87; P =0.001; I 2 =0%). However, abemaciclib increased the risk of adverse events in the fulvestrant and nonsteroidal aromatase inhibitor (NSAI) combinations, respectively.
Abemaciclib, particularly in combination with fulvestrant, emerges as an effective therapeutic option for HR+/HER2- advanced or metastatic breast cancer, improving PFS and OS. The higher toxicity profile warrants cautious use, especially in treatment-naive patients.
乳腺癌，尤其是激素受体阳性（HR+）和人表皮生长因子受体2阴性（HER2-）亚型，仍然是全球主要的健康问题。阿贝西利，一种CDK4/6抑制剂，在治疗晚期病例方面已显示出有前景的结果。本研究全面评估了阿贝西利联合内分泌治疗HR+/HER2-晚期或转移性乳腺癌的疗效和安全性。
遵循PRISMA指南，进行了系统评价和荟萃分析。截至2023年12月，在PubMed、EMBASE、Cochrane图书馆和ClinicalTrials.gov上进行了全面的文献检索。纳入标准包括报告阿贝西利批准剂量的随机对照试验和回顾性队列研究，无论是单药治疗还是联合治疗。结局评估包括无进展生存期（PFS）、总缓解率（ORR）、副作用/不良反应（SE/AE）和总生存期（OS）。质量评估采用Cochrane修订的偏倚风险工具和纽卡斯尔-渥太华量表。
涉及14010名患者的22项研究的汇总结果显示，阿贝西利显著改善了PFS（风险比=0.53；95%CI：0.48-0.59；P =0.00；I2 =0%）、ORR（风险比=2.31；95%CI：1.93-2.75；P =0.00；I2 =0%）和OS（风险比=0.76（95%CI：0.65-0.87；P =0.001；I2 =0%）。然而，阿贝西利分别增加了氟维司群和非甾体芳香化酶抑制剂（NSAI）联合用药时不良事件的风险。
阿贝西利，特别是与氟维司群联合使用时，成为HR+/HER2-晚期或转移性乳腺癌的一种有效治疗选择，可改善PFS和OS。较高的毒性特征需要谨慎使用，尤其是在未接受过治疗的患者中。
