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A phase IIb, single arm, multicenter trial of sacituzumab govitecan in Chinese patients with metastatic triple-negative breast cancer who received at least two prior treatments

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WOS体系：
Pubmed体系：

收录情况： ◇ SCIE

作者：
Xu Binghe[1,*1] ; Ma Fei[1] ; Wang Tao[2] ; Wang Shusen[3] ; Tong Zhongsheng[4] ; Li Wei[5] ; Wu Xinhong[6] ; Wang Xiaojia[7] ; Sun Tao[8] ; Pan Yueyin[9] ; Yao Herui[10] ; Wang Xian[11] ; Luo Ting[12] ; Yang Jin[13] ; Zeng Xiaohua[14] ; Zhao Weihong[15] ; Cong Xiuyu Julie[16] ; Chen Jiongjie[16] ;
机构： [1]Department of Medical Oncology, National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China. [2]Department of Breast Cancer, The Fifth Medical Center of PLA General Hospital, Beijing, China. [3]Department of Medical Oncology, Sun Yet-Sen University Cancer Center, Guangzhou, China. [4]Department of Breast Cancer, Tianjin Medical University Cancer Institute and Hospital, Tianjin, China. [5]Department of Medical Oncology, The First Hospital of Jilin University, Changchun, China. [6]Department of Breast Oncology, Hubei Cancer Hospital, Wuhan, China. [7]Department of Breast Medical Oncology, Zhejiang Cancer Hospital, Hangzhou, China. [8]Department of Medical Oncology, Liaoning Cancer Hospital &Institute, Shenyang, China. [9]Department of Medical Oncology, Anhui Provincial Hospital, Hefei, China. [10]Department of Medical Oncology, Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University, Guangzhou, China. [11]Department of Medical Oncology, Sir Run Run Shaw Hospital, Hangzhou, China. [12]Department of Head, Neck and Mammary Gland Oncology, West China Hospital, Sichuan University, Chengdu, China. [13]Department of Medical Oncology, First Affiliated Hospital of Xian Jiaotong University, Xi'an, China. [14]Department of Breast Cancer Center, Chongqing University Cancer Hospital, Chongqing, China. [15]Department of Medical Oncology, Chinese PLA General Hospital, Beijing, China. [16]Everest Medicines, Shanghai, China.
出处：
DOI： 10.1002/ijc.34424
ISSN：

关键词： antibody drug conjugate China sacituzumab govitecan triple-negative breast cancer Trop-2

摘要：
Refractory or relapsing metastatic triple-negative breast cancer (mTNBC) has a poor prognosis. Sacituzumab govitecan (SG) is a novel antibody-drug conjugate, targeting human trophoblast cell-surface antigen 2 (Trop-2). This is the first report of SG's efficacy and safety in Chinese patients with mTNBC. EVER-132-001 (NCT04454437) was a multicenter, single-arm, Phase IIb study in Chinese patients with mTNBC who failed ≥2 prior chemotherapy regimens. Eligible patients received 10 mg/kg SG on Days 1 and 8 of each 21-day treatment cycle, until disease progression/unacceptable toxicity. The primary endpoint was objective response rate (ORR) assessed by the Independent Review Committee. Secondary endpoints included: duration of response (DOR), clinical benefit rate (CBR), progression-free survival (PFS), overall survival (OS), and safety. 80 female Chinese patients (median age 47.6 years; range 24-69.9 years) received ≥1 SG dose with a median of 8 treatment cycles by the cutoff date (August 6, 2021). Median number of prior systemic cancer treatments was 4.0 (range 2.0-8.0). ORR and CBR were reported 38.8% (95% confidence interval [CI]: 28.06-50.30) and 43.8% (95% CI: 32.68- 55.30) of patients, respectively. The median PFS was 5.55 months (95% CI: 4.14-N/A). SG-related Grade ≥3 treatment-emergent adverse events (TEAEs) were reported in 71.3%, the most common were neutrophil count decreased (62.5%), white blood cell count decreased (48.8%), and anemia (21.3%); 6.3% discontinued SG because of TEAEs. SG demonstrated substantial clinical activity in heavily pre-treated Chinese patients with mTNBC. The observed safety profile was generally manageable.This article is protected by copyright. All rights reserved.

基金：
EVEREST MEDICINES
语种：
外文
被引次数：
WOS：
PubmedID：
中科院(CAS)分区：
出版当年[2023]版：
大类 | 2 区 医学
小类 | 2 区 肿瘤学
最新[2023]版：
大类 | 2 区 医学
小类 | 2 区 肿瘤学
JCR分区：
出版当年[2023]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[2023版] 出版当年五年平均 出版前一年[2022版]

第一作者：
第一作者机构： [1]Department of Medical Oncology, National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China. [*1]Department of Medical Oncology, National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, No. 17, Panjiayuan Nanli, Chaoyang District, Beijing 100021, China.
通讯作者：
通讯机构： [1]Department of Medical Oncology, National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China. [*1]Department of Medical Oncology, National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, No. 17, Panjiayuan Nanli, Chaoyang District, Beijing 100021, China.
推荐引用方式(GB/T 7714)：
Xu Binghe,Ma Fei,Wang Tao,et al.A phase IIb, single arm, multicenter trial of sacituzumab govitecan in Chinese patients with metastatic triple-negative breast cancer who received at least two prior treatments[J].INTERNATIONAL JOURNAL OF CANCER.2023,152(10):2134-2144.doi:10.1002/ijc.34424.
APA：
Xu Binghe,Ma Fei,Wang Tao,Wang Shusen,Tong Zhongsheng...&Chen Jiongjie.(2023).A phase IIb, single arm, multicenter trial of sacituzumab govitecan in Chinese patients with metastatic triple-negative breast cancer who received at least two prior treatments.INTERNATIONAL JOURNAL OF CANCER,152,(10)
MLA：
Xu Binghe,et al."A phase IIb, single arm, multicenter trial of sacituzumab govitecan in Chinese patients with metastatic triple-negative breast cancer who received at least two prior treatments".INTERNATIONAL JOURNAL OF CANCER 152..10(2023):2134-2144

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