CDK4/6抑制剂的功效和安全性与内分泌疗法相对于内分泌治疗的功效和安全性在辅助治疗高风险侵入性HR+/HER2-过早乳腺癌的辅助治疗中：一项全面的更新的随机荟萃分析
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
影响因子:7.90000
分区:医学2区 / 妇产科学2区 肿瘤学2区
发表日期:2024 Dec
作者:
Merve Keskinkilic, Mehmet Emin Arayici, Yasemin Basbinar, Hulya Ellidokuz, Tugba Yavuzsen, Ilhan Oztop
摘要
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.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.根据PRISMA指南进行了一致的荟萃分析。我们确定了四项符合我们的纳入标准的临床试验，并在2020年至2024年之间发表。这些试验涉及诊断为乳腺癌的17,749名患者的合并样本量。从汇总分析中获得的数据显示，与单独接收ET相比，与CDK4/6i相比，与CDK4/6i结合使用ET的侵入性生存率（IDF）具有显着的有益趋势（HR = 0.81，95％CI：0.67-0.98，p = 0.03）。值得注意的是，CDK4/6抑制剂在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）中都表现出显着有益的作用。在用Abemaciclib和Ribociclib治疗的组中，在无遥远的无复发生存（DRF）方面注意到了显着改善（HR = 0.65，95％CI：0.56-0.76，p <0.001; hr = 0.72，95％CI：0.58-0.89，p = 0.003，相应地）。 CDK4/6i在总生存期（OS）（HR = 0.96，95％CI：0.77-1.19，p = 0.69）上没有产生统计学上的显着差异。与单独使用ET相比，CDK4/6i与ET的使用与不良事件的风险增加有关（OR = 9.12，95％CI = 5.04-16.48，p <0.001）。本文的发现表明，当IDF与CDK4/6i/6i相比与Et相比，IDF的结果表现出显着改善。具体而言，用abemaciclib和ribociclib的处理在DRF中显示出显着的增强。
Abstract
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.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.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).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.