Adjuvant capesitabine in combination with docetaxel (T), epirubicin (E), and cyclophosphamide (C) in the treatment of early breast cancer (BC): 10-year survival results from the randomized FinXX trial.

Abstract

1001 Background: The role of capecitabine (X) in the adjuvant treatment of BC is not established, and few long-term survival data are available. In an analysis of the Finland Capecitabine Trial (FinXX), based on a median FU of 59 months (JCO 2012;30:11-8), patients (pts) treated with X-containing adjuvant chemotherapy did not have significantly longer recurrence-free survival (RFS) as compared with the control group (HR 0.79, 95% CI 0.60-1.04, P= .087), but in an exploratory analysis a significant benefit emerged in the subset with triple negative BC (TNBC; ER-, PgR-, and HER2-; HR 0.48, 95% CI 0.26-0.88). Methods: Eligible pts had either axillary node-positive or high-risk node-negative BC (tumor >20 mm and PgR-). Pts were randomly assigned centrally either to 3 3-wkly cycles of docetaxel (T, 80 mg/m2) followed by 3 3-wkly cycles of C600 E75 F600 (T-CEF) or to 3 3-wkly cycles of TX (T60 , X1800 for dd. 1-15) followed by 3 3-wkly cycles of C600 E75 X1800 (TX-CEX). A total of 1,500 patients were entered to FinXX from 20 sites in Finland or Sweden between Jan 27, 2004, and May 29, 2007 (T-CEF, 747; TX-CEX, 753). Five pts withdrew consent. The data collection cut-off date for this preplanned analysis was Dec 31, 2015. Results: During a median FU of 10.3 yrs 142 RFS events occurred in the TX-CEX group and 161 in the T-CEF group (HR 0.85, 95% CI 0.68-1.07; P= .168), and 120 and 141 pts died, respectively (HR 0.83, 95% CI 0.65-1.06, P= .132; 92 vs. 113 pts died from BC). Pts with TNBC (n=202) had more favorable RFS (HR 0.43, 0.24-0.79: P= .007) and survival (HR 0.55, 0.31-0.96, P= .037) when treated with TX-CEX compared to T-CEF; no significant benefit was found in other ER/PgR/HER2-defined subgroups. The numbers of contralateral BCs (T-CEF, 24; TX-CEX, 28) and other second cancers (T-CEF, 41; TX-CEX, 35) were similar. AML was diagnosed in 4 pts. Conclusions: Integration of X to the taxane-anthracycline backbone did not prolong RFS or survival. The survival benefit in favor of TX-CEX had persisted in the TNBC subgroup, but this finding should be viewed with caution due to the small subgroup size and the exploratory nature of the analysis. Clinical trial information: NCT00114816.