Adjuvant tamoxifen switched to exemestane treatment in postmenopausal women with estrogen receptor-positive early breast cancer:A pragmatic,multicenter,and prospective clinical trial in China  

作　　者：Binghe Xu Huiping Li Zefei Jiang Lin Gu Jinhai Tang Hui Xie Yueyin Pan Yunjiang Liu Shude Cui Xiaojia Wang Li Cai Yiqiong Zhang Huadong Zhao Zhimin Shao 

机构地区：[1]Department of Medical Oncology,National Cancer Center/Cancer Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College,Beijing 100021,China [2]Key Laboratory of Carcinogenesis and Translational Research(Ministry of Education/Beijing),Department of Breast Oncology,Peking University Cancer Hospital&Institute,Beijing 100142,China [3]Department of Breast Cancer,the Fifth Medical Center of Chinese PLA General Hospital,Beijing 100071,China [4]Department of Breast Cancer,Tianjin Cancer Institute and Hospital,Tianjin 300060,China [5]Department of Breast Cancer,Jiangsu Provincial Hospital,Nanjing 210029,China [6]Department of Breast Cancer,the First Affliated Hospital of China University of Science and Technology,Hefei 230001,China [7]Department of Breast Cancer,the Fourth Hospital of Hebei Medical University,Shijiazhuang 050011,China [8]Department of Breast Cancer,Henan Cancer Hospital,Zhengzhou 450008,China [9]Department of Breast Cancer,Zhejiang Cancer Hospital,Hangzhou 310012,China [10]Department of Breast Cancer,Harbin Medical University Cancer Hospital,Harbin 150081,China [11]Department of Clinical Development,Pfizer(China)R&D Co.Ltd,Shanghai 201203,China [12]Department of Statistics,Pfizer(China)R&D Co.Ltd,Shanghai 201203,China [13]Department of Breast Surgery,Shanghai Cancer Center/Cancer Institute,Shanghai Medical College,Fudan University,Shanghai 200032,China

出　　处：《Chinese Journal of Cancer Research》2022年第6期592-600,共9页中国癌症研究（英文版）

基　　金：supported by Pfizer Inc。

摘　　要：Objective:This post-approval safety study assessed the efficacy and safety of exemestane after 2-3 years of tamoxifen treatment among postmenopausal women with estrogen receptor-positive(ER+)early breast cancer in China.Methods:Enrolled patients had received 2-3 years of tamoxifen and were then switched to exemestane for completion of 5 consecutive years of adjuvant endocrine therapy.The primary endpoint was the time from enrollment to the first occurrence of locoregional/distant recurrence of the primary breast cancer,appearance of a second primary or contralateral breast cancer,or death due to any cause.Other endpoints included the proportion of patients experiencing each event,incidence rate per annum,relationships between human epidermal growth factor receptor 2 status and time to event,and relationship between disease history variables and time to event.Results:Overall,558 patients were included in the full analysis set:397(71.1%)completed the study,20experienced an event,and 141 discontinued[47 owing to an adverse event(AE);37 no longer willing to participate].Median duration of treatment was 29.5(range,0.1-57.7)months.Median time to event was not reached.Eventfree survival probability at 36 months was 91.4%(95%CI,87.7%-95.1%).The event incidence over the total exposure time of exemestane therapy was 3.5 events/100 person-years(20/565).Multivariate analysis showed an association between tumor,lymph node,and metastasis stage at initial diagnosis and time to event[hazard ratio:1.532(95%CI,1.129-2.080);P=0.006].Most AEs were grade 1 or 2 in severity,with arthralgia(7.7%)being the most common treatment-related AE.Conclusions:This study supports the efficacy and safety of exemestane in postmenopausal Chinese women with ER+breast cancer previously treated with adjuvant tamoxifen for 2-3 years.No new safety signals were identified in the Chinese population.

关 键 词：Chinese early breast cancer EXEMESTANE TAMOXIFEN postmenopausal women estrogen receptor-positive 

分 类 号：R737.9[医药卫生—肿瘤]