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Efficacy of utidelone plus capecitabine versus capecitabine for heavily pretreated, anthracycline- and taxane-refractory metastatic breast cancer: final analysis of overall survival in a phase 3 randomised controlled trial.

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作者：
B. Xu [1,2,*1] * ; T. Sun[3] * ; Q. Zhang[4] * ; P. Zhang[1] * ; Z. Yuan[5] ; Z.Jiang[6] ; X. Wang[7] ; S. Cui[8] ; Y. Teng[9] ; X-C. Hu[10] ; J. Yang[11] ; H. Pan[12] ; Z. Tong[13] ; H. Li[14] ; Q. Yao[15] ; Y. Wang[16] ; Y. Yin[17] ; P. Sun[18] ; H.Zheng[19] ; J. Cheng[20] ; J. Lu[21] ; B. Zhang[22] ; C. Geng[23] ; J. Liu[24] ; K. Shen[25] ; S. Yu[26] ; H. Li[27] ; L.Tang[28] ; R. Qiu[28] ; the study group of BG01-1323L[1] ;
机构： [1]Department of Medical Oncology, National Cancer Centre/National Clinical Research Centre for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China [2]State Key Laboratory of Molecular Oncology, National Cancer Centre/Cancer Hospital, Chinese Academy of Medical Sciences, Beijing, China [3]Department of Internal Medicine, Cancer Hospital of China Medical University, Liaoning Cancer Hospital & Institute, Shenyang, China [4]Department of Medical Oncology, Harbin Medical University Cancer Hospital, Harbin, China [5]Department of Medical Oncology, Sun Yat-sen University Cancer Centre, Guangzhou, China [6]Department of Breast Cancer, The Fifth Medical Center, Chinese PLA General Hospital, Beijing, China [7]Department of Breast Medical Oncology, Zhejiang Cancer Hospital, Hangzhou, China [8]Breast Cancer Centre, Henan Cancer Hospital, Zhengzhou, China [9]Department of Medical Oncology, The First Hospital of China Medical University, Shenyang, China [10]Department of Medical Oncology, Fudan University Cancer Center, Shanghai, China [11]Department of Medical Oncology, The PLA General Hospital, Beijing, China [12]Department of Medical Oncology, Sir Run Shaw Hospital, School of Medicine, Zhejiang University, Hangzhou, China [13]Department of Breast Oncology, Tianjin Medical University Cancer Hospital, Tianjin, China [14]Department of Breast Oncology, Peking University Cancer Hospital, Beijing, China [15]Department of Medical Oncology, Nankai University Tianjing People's Hospital, Tianjing, China [16]Breast Cancer Center, Shandong Cancer Hospital Affiliated to Shandong University, Jinan, China [17]Department of Oncology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China [18]Department of Oncology, Qingdao University Yantai Yuhuangding Hospital, Yantai, China [19]Department of Medical Oncology, Sichuan University West China Hospital, Chengdu, China [20]Department of Oncology, Tongji Medical College Wuhan Union Hospital, Wuhan, China [21]Department of Breast Surgery, Shanghai Jiaotong University Renji Hospital, Shanghai, China [22]Department of Medical Oncology, Nantong Tumor Hospital, Nantong, China [23]Department of Breast Oncology, Hebei Medical University Tumor Hospital, Shijiazhuang, China [24]Department of Medical Oncology, Fujian Medical University Cancer Hospital, Fuzhou, China [25]Comprehensive Breast Health Center, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China [26]Cancer Center, Tongji Hospital, Huazhong University of Science and Technology, Wuhan, China [27]Department of Breast Surgery, Sichuan Cancer Hospital, Chengdu, China [28]Department of Research and Development, Beijing Biostar Technologies, Beijing, China
出处：
DOI： 10.1016/j.annonc.2020.10.600
ISSN：

关键词： utidelone capecitabine metastatic breast cancer overall survival anthracyclineand taxane-refractory

摘要：
Primary analysis of the phase 3 trial BG01-1323L demonstrated that utidelone plus capecitabine significantly improved progression-free survival (PFS) and overall response rate (ORR) vs capecitabine alone in heavily pretreated patients with metastatic breast cancer (MBC). Here, we report the final overall survival (OS) analysis and updates of other endpoints. In total, 405 patients were randomised 2:1 to receive utidelone (30 mg/m2 IV daily, days 1-5, over 90 minutes) plus capecitabine (1000 mg/m2 orally bid, days 1-14) or capecitabine alone (1250 mg/m2 orally bid, days 1-14) every 21 days. The secondary endpoint, OS, was estimated using the Kaplan-Meier product-limit approach at a two-sided alpha level of 0.05 after the pre-specified 310 death events had been reached. Exploratory analyses of the primary endpoint, PFS, and the secondary endpoint, ORR, were also done. Safety was analysed in patients who had at least one dose of study drug. At the final OS analysis, the median duration of follow up was 19.6 months in the utidelone plus capecitabine group and 15.4 months in the capecitabine alone group. In the intention-to-treat population, 313 deaths had occurred at data cut-off, 203 of 270 patients in the combination group and 110 of 135 in the monotherapy group. Median OS in the combination group was 19.8 months compared with 16.0 months in the monotherapy group (hazard ratio [HR]=0.75, 95% CI 0.59-0.94, P=0.0142). The updated analysis of PFS and ORR showed that the combination therapy remained superior to monotherapy. Safety results were similar to those previously reported with respect to incidence, severity and specificity. No late-emerging toxicities or new safety concerns occurred. For heavily pretreated, anthracycline- and taxane-resistant MBC patients, utidelone plus capecitabine significantly improved OS vs capecitabine alone. These results support the use of utidelone plus capecitabine as a novel therapeutic regimen for patients with MBC. Copyright © 2020 European Society for Medical Oncology. Published by Elsevier Ltd. All rights reserved.

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出版当年[2021]版：
大类 | 1 区 医学
小类 | 1 区 肿瘤学
最新[2023]版：
大类 | 1 区 医学
小类 | 1 区 肿瘤学
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出版当年[2021]版：
Q1 ONCOLOGY
最新[2023]版：
Q1 ONCOLOGY

影响因子： 最新[2023版] 最新五年平均 出版当年[2021版] 出版当年五年平均 出版前一年[2020版] 出版后一年[2022版]

第一作者：
第一作者机构： [1]Department of Medical Oncology, National Cancer Centre/National Clinical Research Centre for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China [2]State Key Laboratory of Molecular Oncology, National Cancer Centre/Cancer Hospital, Chinese Academy of Medical Sciences, Beijing, China
共同第一作者：
通讯作者：
通讯机构： [1]Department of Medical Oncology, National Cancer Centre/National Clinical Research Centre for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China [2]State Key Laboratory of Molecular Oncology, National Cancer Centre/Cancer Hospital, Chinese Academy of Medical Sciences, Beijing, China [*1]Department of Medical Oncology, National Cancer Centre/ Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union MedicalCollege, No. 17, Panjiayuan Nanli, Chaoyang District, Beijing 100021, China.
推荐引用方式(GB/T 7714)：
B. Xu,T. Sun,Q. Zhang,et al.Efficacy of utidelone plus capecitabine versus capecitabine for heavily pretreated, anthracycline- and taxane-refractory metastatic breast cancer: final analysis of overall survival in a phase 3 randomised controlled trial.[J].ANNALS OF ONCOLOGY.2021,32(2):218-228.doi:10.1016/j.annonc.2020.10.600.
APA：
B. Xu,T. Sun,Q. Zhang,P. Zhang,Z. Yuan...&the study group of BG01-1323L.(2021).Efficacy of utidelone plus capecitabine versus capecitabine for heavily pretreated, anthracycline- and taxane-refractory metastatic breast cancer: final analysis of overall survival in a phase 3 randomised controlled trial..ANNALS OF ONCOLOGY,32,(2)
MLA：
B. Xu,et al."Efficacy of utidelone plus capecitabine versus capecitabine for heavily pretreated, anthracycline- and taxane-refractory metastatic breast cancer: final analysis of overall survival in a phase 3 randomised controlled trial.".ANNALS OF ONCOLOGY 32..2(2021):218-228

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