Adjuvant Capecitabine With Docetaxel and Cyclophosphamide Plus Epirubicin for Triple-Negative Breast Cancer (CBCSG010): An Open-Label, Randomized, Multicenter, Phase III Trial
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浙江大学医学院附属第一医院[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河南省肿瘤医院[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重庆医科大学附属第一医院[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广东省中医院[19]Department of General Surgery, Beijing Friendship Hospital, Capital Medical University, Beijing, People’s Republic of China临床科室国家中心普外分中心普外五科(综合普外科)首都医科大学附属北京友谊医院[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苏州大学附属第二医院[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江苏省人民医院[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
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:
Ministry of Education Innovation Team [IRT1223]; Shanghai Health System Joint Project of Key Disease [2013ZYJB0302]
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):
Li Junjie,Yu Keda,Pang Da,et al.Adjuvant Capecitabine With Docetaxel and Cyclophosphamide Plus Epirubicin for Triple-Negative Breast Cancer (CBCSG010): An Open-Label, Randomized, Multicenter, Phase III Trial[J].JOURNAL of CLINICAL ONCOLOGY.2020,38(16):1774-+.doi:10.1200/JCO.19.02474.
APA:
Li, Junjie,Yu, Keda,Pang, Da,Wang, Changqin,Jiang, Jun...&on behalf of the CBCSG010 Study Group.(2020).Adjuvant Capecitabine With Docetaxel and Cyclophosphamide Plus Epirubicin for Triple-Negative Breast Cancer (CBCSG010): An Open-Label, Randomized, Multicenter, Phase III Trial.JOURNAL of CLINICAL ONCOLOGY,38,(16)
MLA:
Li, Junjie,et al."Adjuvant Capecitabine With Docetaxel and Cyclophosphamide Plus Epirubicin for Triple-Negative Breast Cancer (CBCSG010): An Open-Label, Randomized, Multicenter, Phase III Trial".JOURNAL of CLINICAL ONCOLOGY 38..16(2020):1774-+