Benefit of the Sequential Administration of Docetaxel after Standard FEC Regimen for Node-Positive Breast Cancer: Long-Term Follow-Up Results of the FNCLCC-PACS 01 Trial.

Abstract

Abstract Objective: To evaluate the long-term impact on disease-free survival (DFS) and on overall survival (OS) of the sequential administration of docetaxel (D) following FEC100 among patients (pts) with node positive, operable breast cancer.Patients and Methods: Pts with localized, resectable, non pre-treated, unilateral breast cancer were randomly assigned to receive either Arm A: 6 cycles of FEC100 (5FU/epirubicin/cyclophosphamide 500/100/500 mg/m² day 1, every 3 weeks), or Arm B: 3 cycles of FEC100 followed by 3 cycles of docetaxel (D) 100 mg/m² (day 1, every 3 weeks). First chemotherapy cycle was to be started no more than 42 days after surgery. Radiotherapy was mandatory after conservative surgery and hormone therapy was given for 5 years if tumors were positive for at least one hormone receptor. Main inclusion criteria were: age < 65 years, at least one positive node, no metastasis and normal cardiac, hematologic and renal functions. The main end-point of this prospective, non blinded, randomized, multicentre phase III trial was the 5-year DFS. These results have been already published (Roché et. al. J Clin Oncol. 2006 24(36):5664-71). Since this first analysis, survival data have been updated.Results: Between June 1997 and March 2000, 1999 pts were recruited. Main pts characteristics were well balanced between the 2 arms: median age 50 years, conservative surgery 57%, grade III 39%, both HR negative 21%, both HR positive 60%, 1-3 involved nodes 62%. Treatment was completed for 95% and 93.4% of pts in arms A and B, respectively.As of 15 April 2009, with a median long term follow-up of 92.8 months, 639 pts have experienced at least one event: 124 loco regional relapses, 421 metastasis, 68 contra lateral breast cancer, and 26 deaths as first event. A total number of 71 second cancers and 383 deaths have been registered.8-year DFS rates were 65.8% with FEC and 70.2% with FEC-D. Cox regression analysis adjusted for age and number of positive nodes showed a 15% reduction in the relative risk of relapse with FEC-D (HR = 0.846 [95%CI 0.724 – 0.988], p=0.03).8-year OS rates were 78% with FEC and 83.2% with FEC-D. Cox regression analysis adjusted for age and number of positive nodes showed a 25% reduction in the relative risk of death with FEC-D (HR = 0.754 [95%CI 0.616 – 0.922], p=0.006).Conclusion: Initial report of 5-year benefit in DFS and OS with sequential administration of FEC followed by D are fully confirmed at 8 years. Citation Information: Cancer Res 2009;69(24 Suppl):Abstract nr 603.