• Xi Wang, Shu-Sen Wang, Heng Huang, Li Cai, Li Zhao, Rou-Jun Peng, Ying Lin, Jun Tang, Jian Zeng, Le-Hong Zhang, Yong-Li Ke, Xian-Ming Wang, Xin-Mei Liu, Qian-Jun Chen, An-Qin Zhang, Fei Xu, Xi-Wen Bi, Jia-Jia Huang, Ji-Bin Li, Dan-Mei Pang, Cong Xue, Yan-Xia Shi, Zhen-Yu He, Huan-Xin Lin, Xin An, Wen Xia, Ye Cao, Ying Guo, Yan-Hong Su, Xin Hua, Xin-Yue Wang, Ruo-Xi Hong, Kui-Kui Jiang, Chen-Ge Song, Zhang-Zan Huang, Wei Shi, Yong-Yi Zhong, Zhong-Yu Yuan, and South China Breast Cancer Group (SCBCG).
• 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.
• JAMA. 2021 Jan 5; 325 (1): 50-58.

ImportanceAmong 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.ObjectiveTo 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 ParticipantsRandomized 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.InterventionsEligible patients were randomized 1:1 to receive capecitabine (n = 222) at a dose of 650 mg/m2 twice a day by mouth for 1 year without interruption or to observation (n = 221) after completion of standard adjuvant chemotherapy.Main Outcomes And MeasuresThe primary end point was disease-free survival. Secondary end points included distant disease-free survival, overall survival, locoregional recurrence-free survival, and adverse events.ResultsAmong 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 RelevanceAmong 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.Trial RegistrationClinicalTrials.gov Identifier: NCT01112826.

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