As reported in the Journal of Clinical Oncology by Heikki Joensuu, MD, and colleagues, 15-year overall survival results from the Finland Capecitabine Trial (FinXX) showed that the addition of capecitabine to taxane/anthracycline adjuvant chemotherapy was associated with improved overall survival among patients with early breast cancer.
Study Details
In the open-label multicenter trial, 1,500 patients with axillary node–positive or high-risk node-negative disease were randomly assigned between January 2004 and May 2007 to receive TX-CEX (n = 753) or T-CEF (n = 747). TX-CEX consisted of three cycles of docetaxel (T) plus capecitabine (X) followed by three cycles of cyclophosphamide, epirubicin, and capecitabine (CEX). T-CEF consisted of three cycles of docetaxel followed by three cycles of cyclophosphamide, epirubicin, and fluorouracil (CEF).
Adjuvant trastuzumab was approved during the trial; following a protocol amendment to permit trastuzumab for patients with HER2-positive disease, 13% of patients in the TX-CEF group and 11% in the T-CEF group received trastuzumab. The current analysis is a protocol-scheduled analysis of overall survival on the basis of an approximately 15-year follow-up.
Heikki Joensuu, MD
Key Findings
As of data cut-off in December 2020, median follow-up among surviving patients was 15.3 years (interquartile range [IQR] = 14.5–16.1 years) in the TX-CEX group and 15.4 years (IQR = 14.8–16.0 years) in the T-CEF group.
Overall survival at 15 years was 77.6% in the TX-CEX group vs 73.3% in the T-CEF group (hazard ratio [HR] = 0.81, 95% confidence interval [CI] = 0.66–0.99, P = .037). Rates at 5 and 10 years were 92.7% vs 90.2% and 84.3% vs 82.3%.
In exploratory subgroup analyses, an increased benefit of TX-CEX vs T-CEF was observed among 171 vs 182 patients with estrogen receptor–negative disease (HR = 0.67, 95% CI = 0.46–0.99) and among 93 vs 109 with triple-negative disease (HR = 0.59, 95% CI = 0.36–0.97). Among patients with triple-negative disease, 5-, 10-, and 15-year survival rates were 88.2% vs 75.2%, 81.7% vs 69.7%, and 74.5% vs 64.2%.
The investigators concluded, “Addition of capecitabine to a chemotherapy regimen that contained docetaxel, epirubicin, and cyclophosphamide prolonged the survival of patients with early breast cancer.”
Dr. Joensuu, of Helsinki University Hospital and University of Helsinki, is the corresponding author for the Journal of Clinical Oncology article.
Disclosure: This study was supported by Roche, Sanofi, and AstraZeneca, Cancer Society of Finland, and others. For full disclosures of the study authors, visit ascopubs.org.
