高级检索
当前位置: 首页 > 详情页

Adjuvant Capecitabine With Docetaxel and Cyclophosphamide Plus Epirubicin for Triple-Negative Breast Cancer (CBCSG010): An Open-Label, Randomized, Multicenter, Phase III Trial

文献详情

资源类型:
WOS体系:
Pubmed体系:

收录情况: ◇ SCIE ◇ CPCI(ISTP) ◇ 自然指数

单位: [1]Department of Breast Surgery, Fudan University Shanghai Cancer Center, Shanghai, People’s Republic of China [2]Department of Oncology, Shanghai Medical College, Fudan University, Key Laboratory of Breast Cancer in Shanghai, Shanghai, People’s Republic of China [3]Department of Breast Surgery, The Third Affiliated Hospital of Harbin Medical University, Harbin, Heilongjiang, People’s Republic of China [4]Department of Breast Surgery, Jilin Cancer Hospital and Institute, Changchun, Jilin, People’s Republic of China [5]Department of Breast Surgery, Southwest Hospital, Chongqing, Chongqing, People’s Republic of China [6]Department of Breast Surgery, Gansu Cancer Hospital, Lanzhou, Gansu, People’s Republic of China [7]Department of Breast Surgery, The Fourth Clinical Medical College of Hebei Medical University, Shijiazhuang, Hebei, People’s Republic of China [8]Department of Breast Surgery, The First Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang, People’s Republic of China [9]Department of Breast Surgery, Changhai Hospital of Shanghai, Shanghai, People’s Republic of China [10]Department of Breast Surgery, Cancer Hospital of Shantou Medical College, Shantou, Guangdong, People’s Republic of China [11]Department of Breast Surgery, The Third Affiliated Hospital of Nanchang University, Nanchang, Jiangxi, People’s Republic of China [12]Department of Breast Surgery, The International Peace Maternity and Child Health Hospital of China Welfare Institute, Shanghai, People’s Republic of China [13]Department of Breast Surgery, Henan Cancer Hospital Affiliated to Zhengzhou University, Zhengzhou, Henan, People’s Republic of China [14]Department of Breast Surgery, Medical College, The Second Affiliated Hospital of Xi’An Jiaotong University, Xi’an, Shanxi, People’s Republic of China [15]Department of Breast Surgery, The First Affiliated Hospital of Chongqing Medical University, Chongqing, Chongqing, People’s Republic of China [16]Department of Breast Surgery, Shanxi Cancer Hospital, Taiyuan, Shanxi, People’s Republic of China [17]Department of Oncology, Eastern Hospital of Suzhou Municipal Hospital, Suzhou, Jiangsu, People’s Republic of China [18]Department of Breast Surgery, Guangdong Provincial Hospital of Traditional Chinese Medicine, Guangzhou, Guangdong, People’s Republic of China [19]Department of General Surgery, Beijing Friendship Hospital, Capital Medical University, Beijing, People’s Republic of China [20]Department of Breast Surgery, Jiangsu Cancer Hospital, Suzhou, Jiangsu, People’s Republic of China [21]Department of Oncology, The First Hospital of Wenzhou Medical College, Wenzhou, Zhejiang, People’s Republic of China [22]Department of Breast Surgery, The First Hospital of Jilin University, Changchun, Jilin, People’s Republic of China [23]Department of General Surgery, The Second Affiliated Hospital of Soochow University, Suzhou, Jiangsu, People’s Republic of China [24]Department of Breast Surgery, Tianjin Medical University Cancer Institute and Hospital, Tianjin, People’s Republic of China [25]Department of General Surgery, The General Hospital of the People’s Liberation Army, Beijing, People’s Republic of China [26]Department of General Surgery, Zhongshan Hospital, Fudan University, Shanghai, People’s Republic of China [27]Department of Breast Surgery, Jiangsu Province Hospital, Suzhou, Jiangsu, People’s Republic of China [28]Department of Breast Surgery, The Second Affiliated Hospital of Harbin Medical University, Harbin, Heilongjiang, People’s Republic of China [29]Department of Breast Surgery, The First Hospital of China Medical University, Shenyang, Liaoning, People’s Republic of China [30]Department of Breast Surgery, The Second Affiliated Hospital of Zhongshan University, Guangzhou, Guangdong, People’s Republic of China [31]Department of Breast Surgery, Xinjiang Cancer Hospital, Wulumuqi, Xinjiang, People’s Republic of China [32]Department of Breast Surgery, Shanghai Sixth People’s Hospital, Shanghai, People’s Republic of China [33]Department of Medical Oncology, Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Beijing, People’s Republic of China [34]Department of Breast Surgery, Shanghai First Maternity and Infant Hospital Corporation, Shanghai, People’s Republic of China [35]Department of General Surgery, Shanghai General Hospital, Shanghai, People’s Republic of China [36]Department of Breast Surgery, Peking Union Medical College Hospital, Beijing, People’s Republic of China [37]Continuing Education and Technology Services Department, Chinese Anti-Cancer Association, Tianjin, People’s Republic of China [38]Department of Cancer Prevention, Fudan University Shanghai Cancer Center, and Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, People’s Republic of China
出处:
ISSN:

摘要:
PURPOSE Standard adjuvant chemotherapy for triple-negative breast cancer (TNBC) includes a taxane and an anthracycline. Concomitant capecitabine may be beneficial, but robust data to support this are lacking. The efficacy and safety of the addition of capecitabine into the TNBC adjuvant treatment regimen was evaluated. PATIENTS AND METHODS This randomized, open-label, phase III trial was conducted in China. Eligible female patients with early TNBC after definitive surgery were randomly assigned (1:1) to either capecitabine (3 cycles of capecitabine and docetaxel followed by 3 cycles of capecitabine, epirubicin, and cyclophosphamide) or control treatment (3 cycles of docetaxel followed by 3 cycles of fluorouracil, epirubicin, and cyclophosphamide). Randomization was centralized without stratification. The primary end point was disease-free survival (DFS). RESULTS Between June 2012 and December 2013, 636 patients with TNBC were screened, and 585 were randomly assigned to treatment (control, 288; capecitabine, 297). Median follow-up was 67 months. The 5-year DFS rate was higher for capecitabine than for control treatment (86.3% v 80.4%; hazard ratio, 0.66; 95% CI, 0.44 to 0.99; P = .044). Five-year overall survival rates were numerically higher but not significantly improved (capecitabine, 93.3%; control, 90.7%). Overall, 39.1% of patients had capecitabine dose reductions, and 8.4% reported grade >= 3 hand-foot syndrome. The most common grade >= 3 hematologic toxicities were neutropenia (capecitabine, 136 [45.8%]; control, 118 [41.0%]) and febrile neutropenia (capecitabine, 50 [16.8%]; control, 46 [16.0%]). Safety data were similar to the known capecitabine safety profile and generally comparable between arms. CONCLUSION Capecitabine when added to 3 cycles of docetaxel followed by 3 cycles of a 3-drug anthracycline combination containing capecitabine instead of fluorouracil significantly improved DFS in TNBC without new safety concerns.

基金:
语种:
被引次数:
WOS:
PubmedID:
中科院(CAS)分区:
出版当年[2019]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[2018]版:
Q1 ONCOLOGY
最新[2024]版:
Q1 ONCOLOGY

影响因子: 最新[2024版] 最新五年平均[2021-2025] 出版当年[2018版] 出版当年五年平均[2014-2018] 出版前一年[2017版] 出版后一年[2019版]

第一作者:
第一作者单位: [1]Department of Breast Surgery, Fudan University Shanghai Cancer Center, Shanghai, People’s Republic of China [2]Department of Oncology, Shanghai Medical College, Fudan University, Key Laboratory of Breast Cancer in Shanghai, Shanghai, People’s Republic of China
共同第一作者:
通讯作者:
通讯机构: [1]Department of Breast Surgery, Fudan University Shanghai Cancer Center, Shanghai, People’s Republic of China [2]Department of Oncology, Shanghai Medical College, Fudan University, Key Laboratory of Breast Cancer in Shanghai, Shanghai, People’s Republic of China [*1]Department of Breast Surgery, Fudan University Shanghai Cancer Center, and Department of Oncology, Shanghai Medical College, Fudan University, Key Laboratory of Breast Cancer in Shanghai, 270 Dong-An Rd, Shanghai 200032, People’s Republic of China
推荐引用方式(GB/T 7714):
APA:
MLA:

资源点击量:1320 今日访问量:0 总访问量:819 更新日期:2025-07-01 建议使用谷歌、火狐浏览器 常见问题

版权所有:重庆聚合科技有限公司 渝ICP备12007440号-3 地址:重庆市两江新区泰山大道西段8号坤恩国际商务中心16层(401121)