- Joensuu H, Kellokumpu-Lehtinen PL, Huovinen R, et al. Adjuvant Capecitabine for Early Breast Cancer: 15-Year Overall Survival Results From a Randomized Trial. J Clin Oncol. 2022;40(10):1051-1058.
- Joensuu H, Kellokumpu-Lehtinen PL, Huovinen R, et al. Adjuvant capecitabine, docetaxel, cyclophosphamide, and epirubicin for early breast cancer: Final analysis of the randomized FinXX trial. J Clin Oncol. 2012;30(1):11-18.
- Joensuu H, Kellokumpu-Lehtinen PL, Huovinen R, et al. Adjuvant capecitabine in combination with docetaxel, epirubicin, and cyclophosphamide for early breast cancer: The randomized clinical FinXX trial. JAMA Oncol. 2017;3(6):793-800.
Background
What do we already know about this topic?
- Adjuvant chemotherapy improves the survival of patients with early breast cancer.
- Capecitabine, an oral prodrug of fluorouracil, is approved for the treatment of advanced breast cancer, but not for adjuvant treatment.
- In some experimental models, docetaxel, paclitaxel, and cyclophosphamide upregulate thymidine phosphorylase, the key enzyme that converts capecitabine to fluorouracil within tumors.
How was the study conducted?
- The randomized FinXX trial evaluated addition of capecitabine (X) to an adjuvant chemotherapy regimen consisting of docetaxel (T), followed by cyclophosphamide (C), epirubicin (E), and fluorouracil (F) in patients with axillary node-positive or high-risk node-negative early breast cancer.
- A total of 1,500 patients from 20 study sites were accrued between January 2004 and May 2007 and randomized to receive capecitabine-based adjuvant chemotherapy (TX-CEX, n=753) or the control regimen (T-CEF, n=747).
- This publication provides results from a planned overall survival analysis of 15-year follow-up.1
- Prespecified overall survival (OS) subgroup analyses were conducted for center, axillary node number, cancer estrogen receptor (ER) status, human epidermal growth factor receptor 2 (HER2) status, and tumor biological subgroup.
