Combined chemo-endocrine therapy as a potential new option for HR+/HER2−advanced breast cancer:a prospective study of fulvestrant plus oral vinorelbine  

作　　者：Xue Wang Jian Yue Yikun Kang Zhong Dai Jie Ju Jiayu Wang Pin Zhang Fei Ma Binghe Xu Peng Yuan 

机构地区：[1]Department of VIP Medical Services,National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College,Beijing 100021,China [2]Department of Medical Oncology,National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College,Beijing 100021,China [3]Department of Comprehensive Oncology,Huanxing Cancer Hospital,Beijing 100026,China [4]Department of Medical Oncology and Clinical Trial Center,National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College,Beijing 100021,China

出　　处：《Cancer Biology & Medicine》2023年第4期287-296,共10页癌症生物学与医学（英文版）

基　　金：supported by grants from the National Key R&D Program of China(Grant No.2018YFC0115204);the National Natural Science Foundation of China(Grant No.81672634);the Chinese Society of Clinical Oncology Foundation(Grant No.Y-2019AZMS-0377);the Beijing Medical Award Foundation(Grant No.YXJL-2020-0941-0763);Beijing Hope Run Special Fund of Cancer Foundation of China(Grant No.LC2019B16);Beijing Xisike Clinical Oncology Research Foundation(Grant No.Y-pirrefabre202101-0008).

摘　　要：Objective:Endocrine therapy with fulvestrant has shown synergistic antitumor effects with some chemotherapy drugs in vitro.This study evaluated the efficacy and safety of fulvestrant with vinorelbine in patients with hormone receptor positive(HR+)/human epidermal growth factor receptor-2-negative(HER2−)recurrent or metastatic breast cancer.Methods:Patients were intramuscularly administered fulvestrant 500 mg(day 1 per cycle for 28 days)and oral vinorelbine(60 mg/m2 on days 1,8,and 15 of each cycle).The primary endpoint was progression-free survival(PFS).Secondary endpoints included overall survival,objective response rate,disease control rate,duration of response,and safety.Results:A total of 38 patients with HR+/HER2−advanced breast cancer included in the study were followed up for a median time of 25.1 months.The overall median PFS was 9.86 months[95%confidence interval(CI)7.2-23.13],and the median PFS of the first-line and the second-line treatment population was 20.73 months(95%CI 9.82 to NR)and 4.27 months(95%CI 3.68 to NR),respectively.Most adverse events reported were of grade 1/2,and none were of grade 4/5.Conclusions:This is the first exploratory study of a fulvestrant and oral vinorelbine regimen in the treatment of HR+/HER2−recurrent and metastatic breast cancer.The combination chemo-endocrine therapy was efficacious,safe,and promising for patients with HR+/HER2−advanced breast cancer.

关 键 词：HR+/HER2−breast cancer RECURRENCE metastasis FULVESTRANT oral vinorelbine 

分 类 号：R737.9[医药卫生—肿瘤]