Key clinical point: In patients with high-risk early breast cancer (BC), a dose-dense adjuvant chemotherapy improved disease-free survival (DFS), whereas the addition of fluorouracil to the chemotherapy regimen failed to demonstrate any survival benefits.
Major finding: After a median follow-up of 15.1 years, the median DFS was similar with and without the addition of fluorouracil to the combination therapy of epirubicin, cyclophosphamide, and paclitaxel (EC-P; log-rank P = .11) and was significantly improved in the dose-dense vs standard interval group (hazard ratio 0.77; P = .0004). The most common grade 3-4 adverse events were neutropenia and alopecia.
Study details : Findings are end of study results from the GIM2 trial including 2091 patients with node-positive early BC who were randomly assigned to receive standard-interval EC-P, standard-interval fluorouracil+EC-P (FEC-P), dose-dense EC-P, or dose-dense FEC-P.
Disclosures: This study was funded by Bristol-Myers Squibb, Pharmacia, Dompè Biotec Italy, Italian Ministry of Health, Fondazione Italiana per la Ricerca sul Cancro, and Alliance Against Cancer. The authors declared receiving fees, research grants, honoraria, or support for attending meetings or travel from several sources.
Source: Del Mastro L et al on behalf of the Gruppo Italiano Mammella Investigators. Fluorouracil and dose-dense adjuvant chemotherapy in patients with early-stage breast cancer (GIM2): End-of-study results from a randomised, phase 3 trial. Lancet Oncol. 2022; 23(12):1571-1582 (Nov 9). Doi: 10.1016/S1470-2045(22)00632-5