CDK4/6抑制剂联合内分泌治疗与单纯内分泌治疗在高危浸润性HR+/HER2早期乳腺癌患者辅助治疗中的疗效和安全性对比：随机临床试验的全面更新荟萃分析

IF 5.7 2区医学 Q1 OBSTETRICS & GYNECOLOGY

Breast Pub Date : 2024-10-15 DOI:10.1016/j.breast.2024.103815

Merve Keskinkilic , Mehmet Emin Arayici , Yasemin Basbinar , Hulya Ellidokuz , Tugba Yavuzsen , Ilhan Oztop

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引用次数: 0

摘要

背景本文旨在通过荟萃分析评估将CDK 4/6抑制剂（CDK4/6i）纳入ET辅助治疗HR+HER2切除的早期乳腺癌（ESBC）患者的有效性。方法本文汇编了CDK4/6i用于高危浸润性HR阳性和HER2-ESBC患者辅助治疗的随机临床试验。结果我们确定了四项符合纳入标准的临床试验，这些试验发表于 2020 年至 2024 年之间。这些试验共涉及 17749 例乳腺癌患者。汇总分析得出的数据显示，与单用ET组相比，ET与CDK4/6i联合应用在无浸润性疾病生存期（iDFS）方面有显著的获益趋势（HR = 0.81，95 % CI：0.67-0.98，p = 0.03）。值得注意的是，CDK4/6 抑制剂对 2 级（HR = 0.69，95 % CI：0.59-0.81，p < 0.001）和 3 级（HR = 0.76，95 % CI：0.65-0.89，p < 0.001）患者均有显著疗效。接受abemaciclib和ribociclib治疗组的无远处复发生存期（dRFS）显著改善（HR = 0.65，95 % CI：0.56-0.76，p = 0.001；HR = 0.72，95 % CI：0.58-0.89，p = 0.003）。CDK4/6i在总生存期（OS）方面的差异无统计学意义（HR = 0.96，95 % CI：0.77-1.19，p = 0.69）。与单独使用ET相比，CDK4/6i与ET联合使用会增加不良事件风险，尤其是贫血和中性粒细胞减少症（OR = 9.12, 95 % CI = 5.04-16.48, p <0.001）。具体而言，阿贝昔单抗和利波昔单抗治疗的 dRFS 有明显改善。

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The efficacy and safety of CDK4/6 inhibitors combined with endocrine therapy versus endocrine therapy alone in the adjuvant treatment of patients with high-risk invasive HR+/HER2-early breast cancer: A comprehensive updated meta-analysis of randomized clinical trials

Background

This paper aimed to evaluate the effectiveness of incorporating CDK 4/6 inhibitors (CDK4/6i) into ET for the adjuvant treatment of HR + HER2-resected early-stage breast cancer (ESBC) patients, employing meta-analysis.

Methods

In this paper, we compiled randomized clinical trials focusing on CDK4/6i used in the adjuvant treatment of high-risk invasive HR-positive and HER2-ESBC patients. A meta-analysis was performed in line with the PRISMA guidelines.

Results

We identified four clinical trials that met our inclusion criteria and were published between 2020 and 2024. These trials involved a combined sample size of 17,749 patients diagnosed with breast cancer. The data obtained from the pooled analysis revealed a remarkable beneficial trend in terms of invasive disease-free survival (iDFS) for the use of ET in combination with CDK4/6i compared to the group receiving ET alone (HR = 0.81, 95 % CI: 0.67–0.98, p = 0.03). Of note, CDK4/6 inhibitors demonstrated a notably beneficial effect in both grade 2 (HR = 0.69, 95 % CI: 0.59–0.81, p < 0.001) and grade 3 (HR = 0.76, 95 % CI: 0.65–0.89, p < 0.001). Significant improvements were noted in terms of distant relapse-free survival (dRFS) in the groups treated with abemaciclib and ribociclib (HR = 0.65, 95 % CI: 0.56–0.76, p < 0.001; HR = 0.72, 95 % CI: 0.58–0.89, p = 0.003, respectively). CDK4/6i didn't yield a statistically significant difference in overall survival (OS) (HR = 0.96, 95 % CI: 0.77–1.19, p = 0.69). The use of CDK4/6i with ET was associated with an increased risk of adverse events, particularly anemia and neutropenia, compared with ET alone (OR = 9.12, 95 % CI = 5.04–16.48, p < 0.001).

Conclusion

The findings of this paper demonstrate a significant improvement in iDFS when ET is combined with CDK4/6i, compared to ET alone. Specifically, treatments with abemaciclib and ribociclib showed notable enhancements in dRFS.

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来源期刊

Breast 医学-妇产科学

CiteScore

8.70

自引率

2.60%

发文量

165

审稿时长

59 days

期刊介绍： The Breast is an international, multidisciplinary journal for researchers and clinicians, which focuses on translational and clinical research for the advancement of breast cancer prevention, diagnosis and treatment of all stages.