A multicenter randomized phase III trial of vinorelbine/gemcitabine doublet versus capecitabine monotherapy in anthracycline- and taxane-pretreated women with metastatic breast cancer
Mené sur 74 patientes atteintes d'un cancer métastatique du sein, cet essai de phase III évalue l'efficacité et la toxicité de la vinorelbine en complément de la capécitabine
Background: The Breast Cancer Study Group of the Hellenic Oncology Research Group conducted a phase III trial of single-agent capecitabine versus the vinorelbine/gemcitabine doublet in patients with metastatic breast cancer (MBC) pretreated with anthracyclines and taxanes. The primary objective was to demonstrate superiority of combination treatment in terms of progression-free survival (PFS).Patients and methods: Women with MBC were randomly assigned to receive either capecitabine (Cap arm: 1250 mg/m2 twice daily, on days 1–14) or vinorelbine/gemcitabine doublet (VG arm: vinorelbine 25 mg/m2; gemcitabine 1000 mg/m2; both drugs on days 1 and 15).Results: Seventy-four women were treated on each arm and median PFS was 5.4 versus 5.2 months (P = 0.736), for VG and Cap, respectively. Median overall survival was 20.4 months for the VG arm and 22.4 months for the Cap arm (P = 0.319). Overall response rate was 28.4% in the VG arm and 24.3% in the Cap arm (P = 0.576). Both regimens were generally well tolerated. Neutropenia and fatigue were more common with VG arm and hand–foot syndrome with Cap arm.Conclusions: This trial failed to demonstrate superiority of vinorelbine/gemcitabine doublet over single-agent capecitabine in terms of PFS. Given the favorable toxicity and convenience of oral administration, single-agent capecitabine is recommended for compliant patients.