medwireNews: Maintenance therapy with low-dose capecitabine significantly reduces the risk for relapse or death in women with early-stage triple-negative breast cancer (TNBC), show data from the phase 3 SYSUCC-001 trial.
The study was carried out in China and included 434 patients (median age 46 years) who had already undergone surgery and completed standard adjuvant chemotherapy. They were randomly assigned to receive oral capecitabine 650 mg/m2 twice daily (n = 221) or observation (n = 213) for 1 year.
Zhong-Yu Yuan (Sun Yat-sen University Cancer Center, Guangzhou) and co-investigators report that after a median 61 months of follow-up there had been 37 recurrences and 32 deaths in the capecitabine group and 56 recurrences and 40 deaths in the observation group.
Cox proportional hazards models showed that the 5-year risk for recurrence or death was a significant 36% lower in the capecitabine group than in the observation group, with estimated 5-year disease-free survival rates of 82.8% and 73.0%, respectively.
The estimated 5-year metastasis-free survival rates were 85.8% in the capecitabine group and 75.8% in the observation group, corresponding to a significant 40% lower risk for distant metastases or death with the maintenance therapy.
Conversely, there was no significant difference between the capecitabine and observation arms in estimated the 5-year overall survival rate (85.5 vs 81.3%) or the estimated 5-year locoregional recurrence-free survival rate (85.0 vs 80.8%).
Subgroup analyses showed that the findings were consistent by age, tumor size and grade, lymph node status, and chemotherapy regimen.
Writing in JAMA, Yuan and co-authors note that the capecitabine maintenance therapy “was tolerable for most women without significant treatment discontinuation due to toxicity.” Indeed, 82.8% of participants completed 1 year of treatment, and just 4.1% withdrew from the study due to unacceptable symptoms associated with hand–foot syndrome. Other reasons for withdrawal included patient’s choice (9.0%) and disease recurrence (3.6%).
Hand–foot syndrome was the most commonly reported adverse event, occurring in 45.2% of participants in the capecitabine group, with 7.7% of patients experiencing it as a grade 3 event.
In an accompanying editorial, Heather Parsons and Harold Burstein, both from the Dana-Farber Cancer Institute in Boston, Massachusetts, USA, say: “The findings from the SYSUCC-001 trial and other trials suggest that inclusion of capecitabine in addition to standard chemotherapy regimens can help women with triple-negative breast cancer achieve better outcomes in the long run.”
However, they note that questions remain over how to identify patients who will derive the most benefit from such treatment and suggest that measuring minimal residual disease could help guide decision-making.
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JAMA 2020; doi:10.1001/jama.2020.23370
JAMA 2020; doi:10.1001/jama.2020.23371