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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.
- Source :
- JAMA: Journal of the American Medical Association; 1/5/2021, Vol. 325 Issue 1, p50-58, 9p
- Publication Year :
- 2021
-
Abstract
- <bold>Importance: </bold>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.<bold>Objective: </bold>To evaluate the efficacy and adverse effects of low-dose capecitabine maintenance after standard adjuvant chemotherapy in early-stage triple-negative breast cancer.<bold>Design, Setting, and Participants: </bold>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.<bold>Interventions: </bold>Eligible 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.<bold>Main Outcomes and Measures: </bold>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.<bold>Results: </bold>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.<bold>Conclusions and Relevance: </bold>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.<bold>Trial Registration: </bold>ClinicalTrials.gov Identifier: NCT01112826. [ABSTRACT FROM AUTHOR]
- Subjects :
- TRIPLE-negative breast cancer
BREAST cancer chemotherapy
ADJUVANT treatment of cancer
PROGRESSION-free survival
CANCER in women
RANDOMIZED controlled trials
HAND-foot syndrome
RESEARCH
SCIENTIFIC observation
CARCINOGENESIS
RESEARCH methodology
PROGNOSIS
EVALUATION research
MEDICAL cooperation
DRUG administration
TUMOR classification
COMPARATIVE studies
DRUG therapy
COMBINED modality therapy
MASTECTOMY
BREAST tumors
LONGITUDINAL method
TUMOR grading
Subjects
Details
- Language :
- English
- ISSN :
- 00987484
- Volume :
- 325
- Issue :
- 1
- Database :
- Complementary Index
- Journal :
- JAMA: Journal of the American Medical Association
- Publication Type :
- Academic Journal
- Accession number :
- 147994424
- Full Text :
- https://doi.org/10.1001/jama.2020.23370