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

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Abstract 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 < 65 years, at least one positive node, no metastasis, normal cardiac, hepatic, haematological and renal functions. Pts were randomized to receive on day 1 every 3 weeks either Arm A: 6 cycles of FEC100 (F and C, each at 500 mg/m², E 100 mg/m²); or Arm B, 6 cycles of ED (E and D, each at 75 mg/m²). G-CSF was mandatory for all subsequent cycles after either febrile neutropenia or treatment delay for neutropenia. Radiotherapy was given after conservative surgery. Hormone therapy was prescribed to pts with positive hormone receptors (HRs). Pts overexpressing HER2 were secondly randomized to sequential one year of trastuzumab or observation. Sample size calculation was based on an expected 10% absolute difference in 3–year DFS for HER2+ pts. Assuming a 20% prevalence of HER2 positivity, a total of 3,000 pts were to be randomised, allowing to detect an absolute difference of 6% in 5-year DFS in favour of one of the two chemotherapy regimens.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.

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