WEDNESDAY, Nov. 23 (HealthDay News) -- The addition of capecitabine to a regimen with docetaxel, epirubicin, and cyclophosphamide does not significantly improve recurrence-free survival (RFS) in women with early breast cancer, according to a study published online Nov. 21 in the Journal of Clinical Oncology.
Heikki Joensuu, M.D., from Helsinki University Central Hospital in Finland, and colleagues investigated whether the addition of capecitabine into an adjuvant regimen with a taxane, an anthracycline, and cyclophosphamide improves outcomes for women with axillary node-positive or high-risk node-negative breast cancer. A total of 753 women were randomly assigned to receive docetaxel and capecitabine (TX) followed by cyclophosphamide, epirubicin, and capecitabine (CEX), while 747 women received docetaxel (T) followed by cyclophosphamide, epirubicin, and fluorouracil (CEF). The patients were followed for a median of 59 months and were assessed for RFS.
The investigators identified 214 RFS events during follow-up, with 96 and 118 local or distant recurrences or deaths in the TX/CEX and T/CEF groups, respectively. There was no significant difference in RFS among the two groups (hazard ratio [HR], 0.79; P = .087). A total of 56 and 75 patients from the TX/CEX and T/CEF groups, respectively, died during follow-up (HR, 0.73; P = .080). Women with triple-negative disease, and those with more than three metastatic axillary lymph nodes at the time of diagnosis, had significantly improved breast cancer-specific survival (HR, 0.64) and RFS with TX/CEX in exploratory analyses.
"The integration of capecitabine into a chemotherapy regimen containing docetaxel, epirubicin, and cyclophosphamide did not significantly improve RFS compared with a similar regimen without capecitabine," the authors write.
Several authors disclosed financial ties to Roche, Sanofi-Aventis, and AstraZeneca, which partially funded the study and manufacture the drugs used in the study.
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