2022 年第 6 期 第 17 卷

细胞周期蛋白依赖性激酶4/6抑制剂治疗激素受体阳性人表皮生长因子受体2阴性晚期乳腺癌的临床效果及安全性

Clinical effect and safety of cyclin-dependent kinase 4/6 inhibitors on the treatment of hormone receptor positive and human epidermal growth factor receptor-2 negative advanced breast cancer

作者：顾媛媛1张晓静1杨磊2关印1

英文作者：Gu Yuanyuan1 Zhang Xiaojing1 Yang Lei2 Guan Yin1

单位：1首都医科大学附属北京朝阳医院肿瘤科，北京100020；2首都医科大学附属北京朝阳医院医学研究中心，北京100020

英文单位：1Department of Oncology Beijing Chao-yang Hospital Capital Medical University Beijing 100020 China; 2Medical Research Center Beijing Chao-yang Hospital Capital Medical University Beijing 100020 China

关键词：乳腺癌；细胞周期蛋白依赖性激酶4/6抑制剂；不良反应

英文关键词：Breastcancer;Cyclin-dependentkinase4/6inhibitors;Adversereaction

• 摘要：

• 目的 探讨细胞周期蛋白依赖性激酶4/6（CDK4/6）抑制剂治疗激素受体阳性（HR+）/人表皮生长因子受体2（HER-2）阴性晚期乳腺癌的临床效果及安全性。方法 回顾性收集2018年12月至2021年6月于首都医科大学附属北京朝阳医院接受CDK4/6抑制剂（哌柏西利或阿贝西利）联合内分泌治疗的57例HR+/HER-2阴性晚期乳腺癌患者，采集患者临床病理及治疗信息，分析客观缓解率（ORR）、疾病控制率（DCR）、无进展生存期（PFS）和不良反应。结果 纳入研究的57例患者接受CDK4/6抑制剂联合内分泌治疗后，疗效达完全缓解0例、部分缓解19例、稳定33例、进展5例，ORR为33.3%（19/57），DCR为91.2%（52/57），中位PFS为15.2个月。治疗中患者的不良反应以血液系统毒性中白细胞减少［26.3%（15/57）］、中性粒细胞减少［26.3%（15/57）］最为常见。其他不良反应包括恶心、呕吐、腹痛、腹泻、肝功能异常、乏力、脱发、口腔炎等。结论 晚期HR+/HER-2阴性乳腺癌患者应用CDK4/6抑制剂联合内分泌治疗临床效果较好，不良反应可控，耐受性良好。

• Objective To evaluate the clinical effect and safety of cyclin-dependent kinase 4/6(CDK4/6) inhibitors on the treatment of hormone receptor positive(HR+)/human epidermal growth factor receptor-2(HER-2) negative advanced breast cancer. Methods The clinicopathological and treatment information of 57 patients from December 2018 to June 2021, who received the treatment of CDK4/6 inhibitors(palbociclib or abemacicib) combined with endocrine therapy in Beijing Chao-yang Hospital, Capital Medical University were collected. The information was used to analyze the objective response rate(ORR), disease control rate(DCR), progression free survival(PFS) and adverse events of the treatment. Results   In the 57 patients, no complete remission was observed. The number of patients who reached the best efficacy of partial remission, stable, and progress were 19, 33 and 5, respectively. The ORR was 33.3%(19/57) and the DCR was 91.2%(52/57). The median PFS was 15.2 months. The most common adverse reactions were leucopenia［26.3%(15/57)］ and neutropenia［26.3%(15/57)］ in hematological toxicity. Other adverse reactions included nausea, vomiting, abdominal pain, diarrhea, abnormal liver function, fatigue, hair loss, stomatitis. Conclusion  In HR+/HER2- advanced breast cancer patients, CDK4/6 inhibitors combined with endocrine therapy has good clinical effect, controllable adverse reaction and good tolerance.