中医药联合阿贝西利及内分泌药物治疗激素受体阳性人表皮生长因子受体2阴性晚期乳腺癌的安全性分析  

Analysis on safety of TCM combined with abemaciclib and endocrine therapy for the treatment of HR+/HER2- advanced breast cancer

作　　者：赵依庞 张润泽 力一凡 刘鑫 张书翰 张青[2] Yipang Zhao;Runze Zhang;Yifan Li;Xin Liu;Shuhan Zhang;Qing Zhang(School of Clinical Medicine,Beijing University of Chinese Medicine,Beijing 100029,China;Department of Oncology,Beijing Hospital of TCM Affiliated to Capital Medical University,Beijing 100010,China)

机构地区：[1]北京中医药大学临床医学院,北京100029 [2]首都医科大学附属北京中医医院肿瘤科,北京100010

出　　处：《国际中医中药杂志》2024年第7期839-845,共7页International Journal of Traditional Chinese Medicine

基　　金：恩施州科技计划研究与开发项目(JCY2019000040)。

摘　　要：目的观察中医药辨证论治联合阿贝西利及内分泌药物治疗激素受体(HR)阳性、人表皮生长因子受体2(HER2)阴性晚期乳腺癌的不良反应及在不良反应影响下服用阿贝西利剂量情况。方法选择2021年3月-2023年2月首都医科大学附属北京中医医院接受中医药联合阿贝西利及内分泌治疗的HR+/HER2-晚期乳腺癌患者, 并提取阿贝西利随机Ⅲ期临床研究MONARCH 2、MONARCH 3中的东亚人群相关数据, 进行回顾性队列研究。中医药暴露队列分为中医药+阿贝西利+氟维司群组(EXP 1)20例、中医药+阿贝西利+芳香化酶抑制剂(AI)组(EXP 2)22例;MONARCH 2、3中的东亚人群为非暴露队列, 分为阿贝西利+氟维司群组(NEXP 1)146例、阿贝西利+AI组(NEXP 2)102例。对2队列进行安全性分析, 并统计患者在不良反应影响下服用阿贝西利减量、终止的情况。结果① EXP 1组与NEXP 1组患者CTCAE等级任意级别、2级(χ^(2)值分别为8.11、4.59), 以及EXP 2组与NEXP 2组患者CTCAE等级任意级别(χ^(2)=18.57)患者腹泻发生情况比较, 差异有统计学意义(P<0.05或P<0.01);EXP 1组与NEXP 1组CTCAE等级≥2级患者腹泻发生情况比较, 差异有统计学意义(χ^(2)=5.56, P=0.02)。暴露队列CTCAE等级≥3级的患者, 中性粒细胞减少发生率[EXP 1组为5例(27.78%)、EXP 2组为2例(13.33%)]低于非暴露队列[NEXP 1组为65例(44.52%)、NEXP 2组为30例(29.41%)]。暴露队列患者GPT、GOT、SCr升高情况较非暴露队列减少。②暴露队列患者较非暴露队列, 腹泻、中性粒细胞减少的首次发生时间延长、持续时间缩短。③暴露队列患者受腹泻、中性粒细胞减少、肝功能受损、SCr升高所致服用阿贝西利减量、停药的情况较非暴露队列患者减少。结论中医辨证论治联合阿贝西利及内分泌药物治疗HR+/HER2-晚期乳腺癌安全性良好, 可有效预防与治疗阿贝西利引起的不良反应, 并减少不良反应导致的减量停药�Objective To observe the toxic and side effects of TCM syndrome differentiation and treatment combined with abemaciclib and endocrine drugs in the treatment of hormone receptor(HR)positive and human epidermal growth factor receptor 2(HER2)negative advanced breast cancer and the dose of abemaciclib under the influence of toxic and side effects.Methods Patients with HR+/HER2-advanced breast cancer who received TCM combined with abemaciclib and endocrine therapy in Beijing Hospital of Traditional Chinese Medicine,Capital Medical University from March 2021 to February 2023 were selected,and the relevant data of East Asian population in MONARCH 2 and MONARCH 3 of abemaciclib random phaseⅢclinical study were extracted for retrospective cohort study.The TCM exposure cohort was divided into 20 cases of TCM+abemaciclib+fulvestrant group(EXP 1)and 22 cases of TCM+abemaciclib+aromatase inhibitor(AI)group(EXP 2).The East Asian populations in MONARCH 2 and 3 were non-exposed cohorts,which were divided into NEXP 1 group(146 cases)and NEXP 2 group(102 cases).The safety analysis of the 2 cohorts was carried out,and the reduction and termination of abemaciclib taken by patients under the influence of toxic and side effects were counted.Results①There were significant differences in CTCAE any grade,grade 2(χ^(2) values were 8.11,4.59,respectively)between EXP 1 group and NEXP 1 group,as well as in CTCAE any grade(χ^(2)=18.57)between EXP 2 group and NEXP 2 group compare the incidence rate of diarrhoea(P<0.05 or P<0.01).There was significant differences in CTCAE≥grade 2 EXP 1 group compare the incidence rate of diarrhoea(χ^(2)=5.56,P=0.02).The incidence of grade≥3 neutropenia in EXP 1 was[5 cases(27.78%)]and in EXP 2 was[2 cases(13.33%)].There were 65 cases(44.52%)in NEXP 1 and 30 cases(29.41%)in NEXP 2,and the exposed cohort were lower than those in the non-exposed cohort.The increase of GPT,GOT and SCr in the exposed cohort were lower than those in the non-exposed cohort.②Compared with the non-exposed cohort,the first o

关 键 词：乳腺肿瘤 激素受体 人表皮生长因子受体2 阿贝西利 CDK4/6抑制剂 中医药疗法 安全性 

分 类 号：R737.9[医药卫生—肿瘤]