Abstract S4-1: FinXX Final 5-Year Analysis: Results of the Randomised, Open-Label, Phase III Trial in Medium-to-High Risk Early Breast Cancer

Abstract

Abstract Background: The randomised, phase III FinXX trial (NCT00114816) investigated whether the integration of capecitabine (X) into a sequential docetaxel (T)→cyclophosphamide + epirubicin + 5-FU (CEF) adjuvant regimen might improve clinical outcome for patients with medium-to-high risk early breast cancer. The planned interim analysis after a median follow-up of 3 years found a significant recurrence-free survival (RFS) benefit with the X-containing regimen versus control (3-year RFS rate: 93% XTP→ukkalaCEX vs 89% T→CEF; hazard ratio 0.66 [95% CI: 0.47-0.94]; p=0.020) [Lancet Oncol 2009;10:1145-51]. Here we present final 5-year RFS data, the primary endpoint of the study. Methods: Eligible patients were aged 18-65 years, had a WHO performance status of 0 or 1 and histologically confirmed invasive breast cancer at medium-to-high risk of recurrence, defined as regional node-positive disease or node-negative disease with primary tumour diameter greater than 20mm and negative progesterone receptor assay. Previous neoadjuvant chemotherapy was not permitted. Patients were randomised in a 1:1 ratio to receive 3 cycles of T→3 cycles of CEF (T→CEF; T 80mg/m2 d1, q3w→C 600mg/m2 d1, E 75mg/m2 d1, F 600mg/m2 d1, q3w) or 3 cycles of XT→3 cycles of CEX (XT→CEX; X 900mg/m2 bid d1-15 + T 60mg/m2 d1, q3w→C 600mg/m2 d1, E 75mg/m2 d1, X 900mg/m2 bid d1-15, 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 were overall survival and safety. Results: Between January 2004 and May 2007, 1,500 women from Finland and Sweden were randomised to T→CEF (n=747) or XT→CEX (n=753). Final analysis of the primary endpoint will be presented after a median follow-up of 5 years and approximately 200 events. Data are expected in October 2010. Conclusions: The FinXX trial was the first to report the efficacy and safety of X in combination with anthracycline/taxane-containing therapy in the adjuvant treatment of early breast cancer. Final efficacy data are expected in October 2010. Citation Information: Cancer Res 2010;70(24 Suppl):Abstract nr S4-1.