Abstract PD01-02: Integration of Capecitabine into Anthracycline-and Taxane-Based Adjuvant Therapy for Triple-Negative Early Breast Cancer: Final Subgroup Analysis of the FinXX Study

Abstract

Abstract Background: Standard adjuvant chemotherapy regimens for patients with moderate-to-high risk early breast cancer typically contain a taxane, an anthracycline and cyclophosphamide. The randomised, phase III FinXX study aimed to investigate whether the integration of capecitabine into such a regimen enhances outcome. Here we present final 5-year exploratory analyses from the subgroup of patients with triple-negative early breast cancer (TNBC). Methods: Patients aged 18-65 years, with histologically confirmed invasive node positive breast cancer or node negative progesterone receptor negative breast cancer > 20 mm, and with a WHO performance status of 0 or 1, with no previous neoadjuvant chemotherapy were randomised. Patients received 3 x XT (capecitabine 900mg/m2 bid d1-15 + docetaxel 60mg/m2 d1)≥3 x CEX (cyclophosphamide 600mg/m2 d1, + epirubicin 75mg/m2 d1 + X 900mg/m2 bid d1-15, q3w) or 3 x T (80mg/m2 d1)≥3 x CEF (C 600mg/m2 d1, E 75mg/m2 d1, 5-FU 600mg/m2 d1, q3w). The primary endpoint was RFS, defined as the time from randomisation to the first time the patient is recorded as having disease recurrence or the date of death if the patient dies due to causes other than disease recurrence. Secondary endpoints included overall survival and safety. Results: Between January 2004 and May 2007, 1,500 women from Finland and Sweden were randomised (XT→CEX n=753, T→CEF n=747). Of these, 202 patients (13.5%) had TNBC (XT→CEX n=93, T→CEF n=109). After a median follow-up of 59 months, RFS was significantly improved in the TNBC XT→CEX arm versus control (HR 0.48, 95% CI 0.26-0.88; p=0.018). The following endpoints were also significant: 5-year RFS in patients with TNBC versus those without TNBC (HR 0.50, 95% CI 0.36-0.69; P<0.001); 5-year distant disease-free survival in TNBC patients receiving XT→CEX versus control (HR 0.51, p=0.035); overall survival in TNBC patients receiving XT→CEX versus control (HR 0.42, p=0.019). Conclusions: The FinXX trial is the first to report the efficacy of capecitabine in combination with anthracycline-/taxane-containing therapy in the adjuvant treatment of early breast cancer. The exploratory subgroup analysis shows that XT→CEX is more effective than T→CEF in triple-negative BC, a population with a high unmet need; XT→CEX versus control resulted in a significant improvement in RFS and OS after 5 years. Citation Information: Cancer Res 2010;70(24 Suppl):Abstract nr PD01-02.