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Effect of Capecitabine Maintenance Therapy Using Lower Dosage and Higher Frequency vs Observation on Disease-Free Survival among Patients with Early-Stage Triple-Negative Breast Cancer Who Had Received Standard Treatment: The SYSUCC-001 Randomized Clinical Trial
Wang, Xi1; Wang, Shu Sen2; Huang, Heng3; Cai, Li4; Zhao, Li5; Peng, Rou Jun6; Lin, Ying7; Tang, Jun1; Zeng, Jian8; Zhang, Le Hong9; Ke, Yong Li10; Wang, Xian Ming11; Liu, Xin Mei12; Chen, Qian Jun13; Zhang, An Qin14; Xu, Fei2; Bi, Xi Wen2; Huang, Jia Jia2; Li, Ji Bin15; Pang, Dan Mei16; Xue, Cong2; Shi, Yan Xia2; He, Zhen Yu17; Lin, Huan Xin17; An, Xin2; Xia, Wen2; Cao, Ye15; Guo, Ying15; Su, Yan Hong18; Hua, Xin2; Wang, Xin Yue2; Hong, Ruo Xi2; Jiang, Kui Kui2; Song, Chen Ge2; Huang, Zhang Zan2; Shi, Wei19; Zhong, Yong Yi2; Yuan, Zhong Yu2
2021-01-05
Source PublicationJAMA - Journal of the American Medical Association
ISSN0098-7484
Volume325Issue:1Pages:50-58
Abstract

Importance: Among all subtypes of breast cancer, triple-negative breast cancer has a relatively high relapse rate and poor outcome after standard treatment. Effective strategies to reduce the risk of relapse and death are needed. Objective: To evaluate the efficacy and adverse effects of low-dose capecitabine maintenance after standard adjuvant chemotherapy in early-stage triple-negative breast cancer. Design, Setting, and Participants: Randomized clinical trial conducted at 13 academic centers and clinical sites in China from April 2010 to December 2016 and final date of follow-up was April 30, 2020. Patients (n = 443) had early-stage triple-negative breast cancer and had completed standard adjuvant chemotherapy. Interventions: Eligible patients were randomized 1:1 to receive capecitabine (n = 222) at a dose of 650 mg/mtwice a day by mouth for 1 year without interruption or to observation (n = 221) after completion of standard adjuvant chemotherapy. Main Outcomes and Measures: The primary end point was disease-free survival. Secondary end points included distant disease-free survival, overall survival, locoregional recurrence-free survival, and adverse events. Results: Among 443 women who were randomized, 434 were included in the full analysis set (mean [SD] age, 46 [9.9] years; T1/T2 stage, 93.1%; node-negative, 61.8%) (98.0% completed the trial). After a median follow-up of 61 months (interquartile range, 44-82), 94 events were observed, including 38 events (37 recurrences and 32 deaths) in the capecitabine group and 56 events (56 recurrences and 40 deaths) in the observation group. The estimated 5-year disease-free survival was 82.8% in the capecitabine group and 73.0% in the observation group (hazard ratio [HR] for risk of recurrence or death, 0.64 [95% CI, 0.42-0.95]; P =.03). In the capecitabine group vs the observation group, the estimated 5-year distant disease-free survival was 85.8% vs 75.8% (HR for risk of distant metastasis or death, 0.60 [95% CI, 0.38-0.92]; P =.02), the estimated 5-year overall survival was 85.5% vs 81.3% (HR for risk of death, 0.75 [95% CI, 0.47-1.19]; P =.22), and the estimated 5-year locoregional recurrence-free survival was 85.0% vs 80.8% (HR for risk of locoregional recurrence or death, 0.72 [95% CI, 0.46-1.13]; P =.15). The most common capecitabine-related adverse event was hand-foot syndrome (45.2%), with 7.7% of patients experiencing a grade 3 event. Conclusions and Relevance: Among women with early-stage triple-negative breast cancer who received standard adjuvant treatment, low-dose capecitabine maintenance therapy for 1 year, compared with observation, resulted in significantly improved 5-year disease-free survival. 

DOI10.1001/jama.2020.23370
URLView the original
Indexed BySCIE
Language英語English
WOS Research AreaGeneral & Internal Medicine
WOS SubjectMedicine, General & Internal
WOS IDWOS:000597421300001
Scopus ID2-s2.0-85097671695
Fulltext Access
Citation statistics
Cited Times [WOS]:56   [WOS Record]     [Related Records in WOS]
Document TypeJournal article
CollectionUniversity of Macau
Corresponding AuthorYuan, Zhong Yu
Affiliation1.Department of Breast Oncology, Sun Yat-sen University Cancer Center, The State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, Guangdong, China
2.Department of Medical Oncology, Sun Yat-sen University Cancer Center, The State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, Guangdong, China
3.Department of Breast Oncology, Lianjiang People's Hospital, Lianjiang, China
4.Department of Medical Oncology, The Affiliated Tumour Hospital of Harbin Medical University, Harbin, Heilongjiang, China
5.Department of Breast Oncology, Guangzhou First People Hospital, Guangzhou, Guangdong, China
6.Department of Integrated Therapy in Oncology, Sun Yat-sen University Cancer Center, The State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, Guangdong, China
7.Department of Breast Oncology, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, Guangdong, China
8.Department of Breast Oncology, The First Affiliated Hospital of Guangxi Medical University, Nanning, Guangxi, China
9.Department of Breast Oncology, The Second Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China
10.Department of Breast Oncology, General Hospital of Pla Guangzhou Military Area, Guangzhou, Guangdong, China
11.Department of Breast Oncology, Shenzhen Second People's Hospital, Shenzhen, Guangdong, China
12.Department of Breast Oncology, Haikou People's Hospital, Haikou, Hainan, China
13.Department of Breast Oncology, Traditional Chinese Medicine Hospital of Guangdong Province, Guangzhou, Guangdong, China
14.Department of Breast Oncology, Maternal and Child Health Care Hospital of Guangdong Province, Guangzhou, Guangdong, China
15.Department of Good Clinical Practice, Sun Yat-sen University Cancer Center, The State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, Guangdong, China
16.Department of Medical Oncology, Foshan First People's Hospital, Foshan, Guangdong, China
17.Department of Radiotherapy, Sun Yat-sen University Cancer Center, The State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, Guangdong, China
18.Karolinska Institutet, Stockholm, Sweden
19.State Key Laboratory of Quality Research in Chinese Medicine, Institute of Chinese Medical Sciences, University of Macau, Macao
First Author AffilicationCancer Centre
Corresponding Author AffilicationCancer Centre
Recommended Citation
GB/T 7714
Wang, Xi,Wang, Shu Sen,Huang, Heng,et al. Effect of Capecitabine Maintenance Therapy Using Lower Dosage and Higher Frequency vs Observation on Disease-Free Survival among Patients with Early-Stage Triple-Negative Breast Cancer Who Had Received Standard Treatment: The SYSUCC-001 Randomized Clinical Trial[J]. JAMA - Journal of the American Medical Association,2021,325(1):50-58.
APA Wang, Xi.,Wang, Shu Sen.,Huang, Heng.,Cai, Li.,Zhao, Li.,Peng, Rou Jun.,Lin, Ying.,Tang, Jun.,Zeng, Jian.,Zhang, Le Hong.,Ke, Yong Li.,Wang, Xian Ming.,Liu, Xin Mei.,Chen, Qian Jun.,Zhang, An Qin.,Xu, Fei.,Bi, Xi Wen.,Huang, Jia Jia.,Li, Ji Bin.,...&Yuan, Zhong Yu.(2021).Effect of Capecitabine Maintenance Therapy Using Lower Dosage and Higher Frequency vs Observation on Disease-Free Survival among Patients with Early-Stage Triple-Negative Breast Cancer Who Had Received Standard Treatment: The SYSUCC-001 Randomized Clinical Trial.JAMA - Journal of the American Medical Association,325(1),50-58.
MLA Wang, Xi,et al."Effect of Capecitabine Maintenance Therapy Using Lower Dosage and Higher Frequency vs Observation on Disease-Free Survival among Patients with Early-Stage Triple-Negative Breast Cancer Who Had Received Standard Treatment: The SYSUCC-001 Randomized Clinical Trial".JAMA - Journal of the American Medical Association 325.1(2021):50-58.
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