Dose dense adjuvant chemotherapy is the preferred treatment option in high-risk early breast cancer patients. We report the updated results of the MIG-1 study comparing the efficacy of fluorouracil, epirubicin and cyclophosphamide (FEC) regimen administered every 3 (FEC21) or every 2 (FEC14) weeks in early breast cancer patients.
In this Italian, open-label, multicentre phase III randomized trial, node positive and high-risk node negative breast cancer patients were randomised to receive 6 cycles of FEC21 or FEC14 (including support with a granulocyte colony-stimulating factor). The study primary end-point was overall survival (OS) and secondary end-point was event-free survival (EFS).
From November 1992 to June 1997, 1214 patients were randomly assigned to receive FEC14 (n = 604) or FEC21 (n = 610). Median follow-up was 15.8 years. 15-year OS was 68% (95% CI 64-72) in FEC21 group and 71% (95% CI 67-75) in FEC14 group (HR = 1.13; 95% CI 0.92-1.40; p = 0.25). 15-year EFS was 43% (95% CI 37-48) in FEC21 group and 47% (95% CI 41-52) in FEC14 group (HR = 1.13; 95%CI 0.94-1.35; p = 0.19). In a pre-planned subgroup analysis, among patients with hormone receptor-negative tumors, 15-year OS was 65% (95% CI 58-72) in FEC21 group and 70% (95% CI 63-77) in FEC14 group (HR = 1.34; 95% CI 0.94-1.92; p = 0.11; pinteraction=0.25); 15-year EFS was 43% (95% CI 33-52) in FEC21 group and 58% (95% CI 48-67) in FEC14 group (HR = 1.47; 95% CI 1.08-2.01; p = 0.016; pinteraction=0.02). No differences between the two regimes was observed in patients with hormone receptor-positive tumors.
Updated results from the MIG1 study did not show a significant benefit with the use of dose-dense FEC chemotherapy in early breast cancer patients; EFS was prolonged with the use of dose-dense chemotherapy in patients with hormone receptor-negative disease.
Mammella InterGruppo (MIG).
Associazione Italiana per la Ricerca sul Cancro (AIRC).
M. Benasso: Honoraria: Merck, MSD, Bristol Myers Squibb (outside the submitted work). M. Lambertini: Consultant: Teva; Honoraria: Theramex outside the submitted work. L. Del Mastro: Personal fees: Ipsen, Pfizer, Eli Lilly, Eisai, Roche, Novartis, GlaxoSmithKline, Amgen, Teva, Takeda outside the submitted work. All other authors have declared no conflicts of interest.