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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 III randomised controlled trial

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收录情况： ◇ SCIE

作者：
Xu, B.[1,2,*1] * ; Sun, T.[3] ; Zhang, Q.[4] ; Zhang, P.[1] ; Yuan, Z.[5] ; Jiang, Z.[6] ; Wang, X.[7] ; Cui, S.[8] ; Teng, Y.[9] ; Hu, X-C[10] ; Yang, J.[11] ; Pan, H.[12] ; Tong, Z.[13] ; Li, H.[14,27] ; Yao, Q.[15] ; Wang, Y.[16] ; Yin, Y.[17] ; Sun, P.[18] ; Zheng, H.[19] ; Cheng, J.[20] ; Lu, J.[21] ; Zhang, B.[22] ; Geng, C.[23] ; Liu, J.[24] ; Shen, K.[25] ; Yu, S.[26] ; Tang, L.[28] ; Qiu, R.[28] ;
单位： [1]Chinese Acad Med Sci & Peking Union Med Coll, Canc Hosp, Natl Clin Res Ctr Canc, Natl Canc Ctr,Dept Med Oncol, Beijing, Peoples R China [2]Chinese Acad Med Sci, Canc Hosp, Natl Canc Ctr, State Key Lab Mol Oncol, Beijing, Peoples R China [3]China Med Univ, Liaoning Canc Hosp & Inst, Canc Hosp, Dept Internal Med, Shenyang, Peoples R China [4]Harbin Med Univ Canc Hosp, Dept Med Oncol, Harbin, Peoples R China [5]Sun Yat Sen Univ Canc Ctr, Dept Med Oncol, Guangzhou, Peoples R China [6]Chinese Peoples Liberat Army Gen Hosp, Med Ctr 5, Dept Breast Canc, Beijing, Peoples R China [7]Zhejiang Canc Hosp, Dept Breast Med Oncol, Hangzhou, Peoples R China [8]Henan Canc Hosp, Breast Canc Ctr, Zhengzhou, Peoples R China [9]China Med Univ, Dept Med Oncol, Hosp 1, Shenyang, Peoples R China [10]Fudan Univ Canc Ctr, Dept Med Oncol, Shanghai, Peoples R China [11]Peoples Liberat Army Gen Hosp, Dept Med Oncol, Beijing, Peoples R China [12]Zhejiang Univ, Sir Run Shaw Hosp, Sch Med, Dept Med Oncol, Hangzhou, Peoples R China [13]Tianjin Med Univ Canc Hosp, Dept Breast Oncol, Tianjin, Peoples R China [14]Peking Univ Canc Hosp, Dept Breast Oncol, Beijing, Peoples R China [15]Nankai Univ, Dept Med Oncol, Tianjing Peoples Hosp, Tianjin, Peoples R China [16]Shandong Univ, Shandong Canc Hosp, Breast Canc Ctr, Jinan, Peoples R China [17]Nanjing Med Univ, Affiliated Hosp 1, Dept Oncol, Nanjing, Peoples R China [18]Qingdao Univ, Dept Oncol, Yantai Yuhuangding Hosp, Yantai, Peoples R China [19]Sichuan Univ, Dept Med Oncol, West China Hosp, Chengdu, Peoples R China [20]Wuhan Union Hosp, Dept Oncol, Tongji Med Coll, Wuhan, Peoples R China [21]Shanghai Jiao Tong Univ, Dept Breast Surg, Renji Hosp, Shanghai, Peoples R China [22]Nantong Tumor Hosp, Dept Med Oncol, Nantong, Peoples R China [23]Hebei Med Univ Tumor Hosp, Dept Breast Oncol, Shijiazhuang, Hebei, Peoples R China [24]Fujian Med Univ Canc Hosp, Dept Med Oncol, Fuzhou, Peoples R China [25]Shanghai Jiao Tong Univ, Ruijin Hosp, Comprehens Breast Hlth Ctr, Sch Med, Shanghai, Peoples R China [26]Huazhong Univ Sci & Technol, Tongji Hosp, Canc Ctr, Wuhan, Peoples R China [27]Sichuan Canc Hosp, Dept Breast Surg, Chengdu, Peoples R China [28]Beijing Biostar Technol, Dept Res & Dev, Beijing, Peoples R China
出处：
DOI： 10.1016/j.annonc.2020.10.600
ISSN：

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

摘要：
Background: Primary analysis of the phase III trial BG01-1323L demonstrated that utidelone plus capecitabine significantly improved progression-free survival (PFS) and overall response rate (ORR) versus 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. Patients and methods: In total, 405 patients were randomised 2:1 to receive utidelone (30 mg/m(2) IV daily, days 1-5, over 90 min) plus capecitabine (1000 mg/m(2) orally b.i.d., days 1-14) or capecitabine alone (1250 mg/m(2) orally b.i.d., days 1-14) every 21 days. The secondary endpoint, OS, was estimated using the KaplaneMeier product-limit approach at a two-sided alpha level of 0.05 after the prespecified 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. Results: 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) 1/4 0.75, 95% confidence intervals (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. Conclusions: For heavily-pretreated, anthracycline- and taxane-resistant MBC patients, utidelone plus capecitabine significantly improved OS versus capecitabine alone. These results support the use of utidelone plus capecitabine as a novel therapeutic regimen for patients with MBC.

基金：
Beijing Biostar Technologies, Beijing, China
语种：
外文
被引次数：
WOS：
PubmedID：
中科院(CAS)分区：
出版当年[2020]版：
大类 | 1 区 医学
小类 | 1 区 肿瘤学
最新[2025]版：
大类 | 1 区 医学
小类 | 1 区 肿瘤学
JCR分区：
出版当年[2019]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[2019版] 出版当年五年平均 出版前一年[2018版] 出版后一年[2020版]

第一作者：
第一作者单位： [1]Chinese Acad Med Sci & Peking Union Med Coll, Canc Hosp, Natl Clin Res Ctr Canc, Natl Canc Ctr,Dept Med Oncol, Beijing, Peoples R China [2]Chinese Acad Med Sci, Canc Hosp, Natl Canc Ctr, State Key Lab Mol Oncol, Beijing, Peoples R China [*1]Chinese Acad Med Sci & Peking Union Med Coll, Canc Hosp, Natl Canc Ctr, Dept Med Oncol, 17 Panjiayuan Nanli, Beijing 100021, Peoples R China
通讯作者：
通讯机构： [1]Chinese Acad Med Sci & Peking Union Med Coll, Canc Hosp, Natl Clin Res Ctr Canc, Natl Canc Ctr,Dept Med Oncol, Beijing, Peoples R China [2]Chinese Acad Med Sci, Canc Hosp, Natl Canc Ctr, State Key Lab Mol Oncol, Beijing, Peoples R China [*1]Chinese Acad Med Sci & Peking Union Med Coll, Canc Hosp, Natl Canc Ctr, Dept Med Oncol, 17 Panjiayuan Nanli, Beijing 100021, Peoples R China
推荐引用方式(GB/T 7714)：
Xu B.,Sun T.,Zhang Q.,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 III randomised controlled trial[J].ANNALS OF ONCOLOGY.2021,32(2):218-228.doi:10.1016/j.annonc.2020.10.600.
APA：
Xu, B.,Sun, T.,Zhang, Q.,Zhang, P.,Yuan, Z....&Qiu, R..(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 III randomised controlled trial.ANNALS OF ONCOLOGY,32,(2)
MLA：
Xu, B.,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 III randomised controlled trial".ANNALS OF ONCOLOGY 32..2(2021):218-228

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