Phase II study of intravenous vinflunine after failure of first-line vinorelbine based regimen for advanced breast cancer

PurposeThis open label phase II study evaluated the safety and efficacy of vinflunine in patients with breast cancer previously treated with a vinorelbine-based regimen and who progressed during or within 6 months of completing this chemotherapy.Patients and methodsThirty eight patients received vinflunine 320 mg/m2 once every 3 weeks. The primary efficacy endpoint was overall response rate (ORR). Secondary endpoints included disease control rate (DCR), progression-free survival (PFS), overall survival (OS) and safety.ResultsORR was 8.3% (95% CI: 1.75–22.4) and DCR was 75% (95% CI: 57.8–87.9). PFS was 4.0 months (95% CI: 2.5–6.1) and OS was 13.6 months (95% CI: 8.7–18.9).Toxicities not hampering dose intensity were as expected neutropenia (75.6% of patients), fatigue (44.7%), constipation (28.9%) and abdominal pain (26.3%).ConclusionVinflunine demonstrated antitumour activity and can be safely administered in breast cancer patients refractory/resistant to vinorelbine.