解放军医学院学报2025，Vol.46Issue(5)：429-434,448,7.DOI:10.12435/j.issn.2095-5227.2025.25011201
CDK4/6抑制剂联合芳香化酶抑制剂对比联合氟维司群一线治疗HR+/HER2-晚期乳腺癌的疗效和安全性研究
Efficacy and safety of CDK4/6i combined with AI versus Fulvestrant as first-line therapy in patients with HR+/HER2-metastatic breast cancer
摘要
Abstract
Background In the first-line salvage treatment of advanced hormone receptor positive(HR+)/HER2 negative(HER2-)breast cancer,the optimal endocrine combination regimen for CDK4/6 inhibitors(CDK4/6i)remains unclear.Objective To compare the efficacy and safety of CDK4/6i combined with aromatase inhibitors(AI)or Fulvestrant as first-line salvage therapy in patients with HR+/HER2-advanced breast cancer.Methods Patients diagnosed with HR+/HER2-advanced breast cancer at the Fifth Medical Center of Chinese PLA General Hospital from October 2018 to June 2024 were enrolled.Based on the first-line salvage therapy regimen,patients were divided into AI combination group(CDK4/6i combined with AI)and Fulvestrant combination group(CDK4/6i combined with Fulvestrant).The primary endpoint was progression-free survival(PFS),and the secondary endpoints included objective response rate(ORR),clinical benefit rate(CBR),and safety.Results Totally 202 patients were enrolled,with 102 cases in the AI combination group and 100 cases in the Fulvestrant combination group.Disease progression in 70 cases in AI combination group and 80 cases in Fulvestrant combination,and there were no statistically significant differences in ORR(32.4%vs 28.0%,P=0.500),CBR(83.3%vs 81.0%,P=0.665)and the median PFS(18.0 months vs 13.0 months,HR=0.75,95%CI:0.54-1.03,P=0.067)between the two groups.In patients whose DFI≥24 months,the median PFS was 19 months in the AI combination group,which was superior to 13 months in the Fulvestrant combination group(HR=0.64,95%CI:0.44-0.94,P=0.019).The most common adverse events in the AI and Fulvestrant combination groups were neutropenia(72.5%vs 70.0%),leukopenia(70.6%vs 69.0%),and anemia(38.2%vs 29.0%).The most common grade 3/4 adverse events were neutropenia(35.3%vs 38.0%).There were 25 patients(12.4%)showing a dose reduction of CDK4/6i or endocrine drugs due to adverse events,and the dose reduction rate was 6.9%in the AI combination group and 18.0%in the Fulvestrant combination group,with statistically significant difference(P=0.016).Conclusion In first-line salvage therapy for HR+/HER2-advanced breast cancer,both AI and Fulvestrant are viable endocrine combination options with CDK4/6 inhibitors,exhibiting good safety profiles.For patients whose DFI≥24 months,the combination of CDK4/6i and AI may achieve better efficacy,and this combined regimen can maintain the targeted therapy dose of CDK4/6i.关键词
晚期乳腺癌/激素受体阳性/人表皮生长因子受体阴性/细胞周期蛋白依赖性激酶4/6抑制剂/内分泌治疗Key words
metastatic breast cancer/hormone receptor positive/human epidermal growth factor receptor negative/cyclin-dependent kinase 4/6 inhibitors/endocrine therapy分类
医药卫生引用本文复制引用
刘真,李健斌,刘滨,袁洋,边莉,王涛,张少华,江泽飞..CDK4/6抑制剂联合芳香化酶抑制剂对比联合氟维司群一线治疗HR+/HER2-晚期乳腺癌的疗效和安全性研究[J].解放军医学院学报,2025,46(5):429-434,448,7.基金项目
国家自然科学基金项目(82404074) （82404074）
