San Antonio, Texas—According to study findings presented at the 2019 San Antonio Breast Cancer Symposium, capecitabine administered concomitantly with standard adjuvant chemotherapy led to significant improvement in disease-free survival (DFS) among patients with triple-negative breast cancer (TNBC).

“Standard adjuvant chemotherapy for triple-negative breast cancer (TNBC) comprises a taxane and an anthracycline. Concomitant capecitabine may add efficacy benefits, but robust data are lacking,” said Junjie Li, MD, Department of Oncology, Shanghai Medical College, Fudan University, China, and colleagues, who conducted an open-label, phase 3 trial evaluating the safety and efficacy of capecitabine integration into the adjuvant treatment regimen for TNBC.

Between June 2012 and November 2013, a total of 585 patients with early TNBC who had undergone resection were randomized in a 1:1 ratio to receive therapy in 1 of 2 treatment arms.

A total of 297 patients received 3 cycles of capecitabine and docetaxel followed by 3 cycles of cyclophosphamide, epirubicin, and capecitabine (TX-XEC), whereas 288 received 3 cycles of docetaxel followed by 3 cycles of cyclophosphamide, epirubicin, and fluorouracil (T-FEC; control arm).

The primary end point of the study by Dr Li et al was DFS at 5 years.

Ultimately, 561 patients were treated per protocol, with 288 patients given TX-XEC and 273 given T-FEC. Follow-up lasted for a median of 67 months. Although the 5-year DFS with TX-XEC was 86.26% versus 80.23% with T-FEC (hazard ratio, 0.66; 95% CI, 0.44-0.98; P = .038), overall survival rates at 5 years were similar between the 2 arms (93.27% and 90.55%, respectively).

In total, approximately 39% of patients had capecitabine dose reductions and 8% had hand-foot syndrome of grade 3/4. Neutropenia and febrile neutropenia were the most common grade 3/4 hematologic toxicities occurring in patients given TX-XEC and TFEC (45.79% vs 41.32% and 16.5% vs 46 15.97%, respectively).

“Safety data were in line with the known capecitabine safety profile and generally comparable between arms,” Dr Li and colleagues said.

“Capecitabine, when administered concomitantly with standard adjuvant taxane/anthracycline chemotherapy, significantly improved DFS rates in TNBC, with no new safety concerns,” they concluded.—Hina Porcelli

Junjie Li, Keda Yu, Da Pang, et al. Adjuvant capecitabine in combination with docetaxel and cyclophosphamide plus epirubicin for triple-negative breast cancer (cbcsg010): An open-label, randomised, multicentre, phase 3 trial. Presented at: the 2019 San Antonio Breast Cancer Symposium; December 10-14, 2019; San Antonio, TX. Abstract GS1-08.