Capecitabine Improves HER2-Negative Breast Cancer Survival After Post-Op Residual Disease

HER2-negative patients who do not have a complete pathological response after neoadjuvant chemotherapy and surgery may benefit from adjuvant capecitabine

medwireNews: Treatment with capecitabine significantly improves survival for HER2-negative breast cancer patients who have residual disease after neoadjuvant chemotherapy and surgery, phase III trial results suggest.

The CREATE-X study was discontinued after the planned interim analysis demonstrated that the addition of the 5-fluorouracil prodrug to postoperative chemotherapy met the primary endpoint of significantly improved disease-free survival compared with no capecitabine.

The 2-year rate of disease-free survival was 87.3 versus 80.5% with a hazard ratio [HR] of 0.688, reported Masakazu Toi, from Kyoto University Hospital in Japan and director of the Japan Breast Cancer Research Group, and co-authors at the San Antonio Breast Cancer Symposium in Texas, USA.

Overall survival was also significantly improved with capecitabine treatment, with 2-year rates of 96.2% versus 93.9% for no capecitabine, and a HR of 0.658.

The study included 902 HER2-negative patients who were randomly assigned to receive hormone therapy where appropriate and either eight cycles of capecitabine, at a twice-daily dose of 1250 mg/m2 for 2 weeks followed by 1 week off treatment, or no additional chemotherapy.

Grade 3 or 4 adverse events reported in the capecitabine arm of the study included hand–foot syndrome (11%), neutropenia (9%), diarrhoea (3%) and fatigue (1%) but all symptoms were described by the researchers as “controllable”.

Masakazu Toi commented on the results in a press release: “These data are exciting, because the side effects of the treatment were manageable and the benefit of capecitabine treatment was clear.”

The authors conclude: “The benefit to risk balance of the addition of 8 cycles of [capecitabine] to standard adjuvant therapy seems to be satisfied. This evidence might allow the development of personalized individualized treatment based on the response to primary systemic therapy.”


Toi M, Lee S-J, Lee ES, et al. Abstract S1-07. A phase III trial of adjuvant capecitabine in breast cancer patients with HER2-negative pathologic residual invasive disease after neoadjuvant chemotherapy (CREATE-X, JBCRG-04). Reported atSan Antonio Breast Cancer Symposium; San Antonio, Texas, USA: 8–12 December 2015.

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