Phase II trial of navelbine and fluorouracil as second-line chemotherapy in metastatic breast carcinoma.

Vinorelbine [Navelbine® (NVB); Fabre, Castres, France] is a semisynthetic vinca alkaloid. Efficacy and tolerance of vinorelbine were investigated in patients with metastatic breast carcinoma (MBC), with encouraging results, in several studies of first- or second-line therapy alone [1–3], and in combination with other drugs [4–6]. The effectiveness of 5-fluorouracil (5FU) in adenocarcinomas is well known [7]. Based on these results, we initiated a phase II trial of an NVB and 5FU combination in patients with MBC [8]. The aim was to explore the effectiveness and toxicity of this combination.