Dose-dense adjuvant chemotherapy in early breast cancer patients: 15-year results of the Phase 3 Mammella InterGruppo (MIG)-1 study
Mené en Italie sur 1 214 patientes atteintes d’un cancer du sein de stade précoce à haut risque de récidive, cet essai de phase III évalue l’efficacité, du point de vue de la survie globale et de la survie sans progression, d’une chimiothérapie adjuvante à doses intensifiées de fluorouracile, épirubicine et cyclophosphamide (durée médiane de suivi : 15,8 ans)
Background : Adjuvant chemotherapy is the standard of care in high-risk early breast cancer patients. Dose-dense should be the preferred schedule of administration. However, its long-term benefit is unknown. Methods : In the Italian multicentre Phase 3 randomised MIG-1 trial, node-positive and high-risk node- negative breast cancer patients were randomised to receive six cycles of adjuvant fluorouracil, epirubicin and cyclophosphamide regimen administered every 3 (FEC21) or 2 (FEC14) weeks. The primary endpoint was overall survival (OS), and the secondary endpoint was event-free survival (EFS). Results : From 1992 to 1997, 1214 patients were included. Median follow-up was 15.8 years. In all, 15-year OS was 71% and 68% in the FEC14 and FEC21 groups, respectively (HR?=?0.89; p?=?0.25). In all, 15-year EFS was 47% and 43% in the FEC14 and FEC21 groups, respectively (HR?=?0.87; p?=?0.18). In a pre-planned subgroup analysis, among patients with hormone receptor-negative tumours, 15-year OS was 70% and 65% in the FEC14 and FEC21 groups, respectively (HR?=?0.73; 95% CI: 0.51–1.06); 15-year EFS was 58% and 43% in the FEC14 and FEC21 groups, respectively (HR?=?0.70; 95% CI: 0.51–0.96). Conclusions : Updated results from the MIG-1 study are numerically in favour of dose-dense chemotherapy, and suggest a long-term benefit of this approach in high-risk early breast cancer patients.