Five-Year Analysis of the FNCLCC-PACS04 Trial: FEC100 vs ED75 for the Adjuvant Treatment of Node Positive Breast Cancer.

Objective : To evaluate the combined administration of Docetaxel (D) and Epirubicin (E) versus FEC 100 on 5-year disease-free survival (DFS) among non metastatic lymph node-positive breast cancer patients (pts). Patients and Methods : Main inclusion criteria were: localized unilateral breast cancer, age Results: Between February 2001 and August 2004, 3,010 pts were randomized in France and Belgium. Pts characteristics were well balanced between the 2 arms: median age 50 years, post-menopausal status 48%, breast-conserving surgery 70%, tumor size >2cm 49%, SBR grade III 40%, both HRs negative 20%, both HRs positive 62%, 1-3 involved nodes 67%, HER2+ 19%. Treatment was completed for 96% of pts in both arms. Febrile neutropenia was reported for 2.0% and 6.4% of cycles respectively in Arms A and B. Grade 3-4 NCI-CTC neutropenia were reported for 34% and 9% of pts on day 21(Arms A and B). Other grade 3-4 toxicities were: leucopenia (35 vs 47%), thrombopenia (1.7 vs 0.3%), nausea/vomiting (14 vs 8%) and mucositis (3.2 vs 3.3%). No toxic death was reported.As of April 2009, the median follow-up was 59.3 months. Overall, 576 pts experienced at least one event: 103 loco-regional relapses, 398 metastasis, 46 contralateral breast cancer, and 29 deaths as first event. A total number of 35 second cancers and 288 deaths are registered. The 5-year DFS rates were 79.7% (95%CI: 77.4-81.7) and 81.7% (95%CI: 79.6-83.7) in arms A and B respectively (HR=0.89, 95%CI: 0.76-1.05, p=0.18). Multivariate Cox regression analysis, adjusted for age, tumor size, SBR grade, HRs and stratified for lymph node status, revealed a significant interaction term between treatment and HER2 (p=0.01).Five-year overall survival rates (OS) were 90.3% (95%CI: 88.5-91.8) with FEC and 90.1% (95%CI: 88.3-91.6) with ED (HR=1.07, 95%CI: 0.85-1.35, p=0.54). Conclusion : No advantage in DFS or OS was observed by combination of D to E when compared to standard FEC100. The best use of D in the adjuvant setting is still uncertain. Citation Information: Cancer Res 2009;69(24 Suppl):Abstract nr 602.