We investigated the activity and toxicity of a combination of vinorelbine (VNB), paclitaxel (PTX) and 5-fluorouracil (5-FU)
continuous infusion administered as first-line chemotherapy in metastatic breast cancer patients pretreated with adjuvant
anthracyclines. A total of 61 patients received a regimen consisting of VNB 25 mgm2 on days 1 and 15, PTX 60 mgm2 on days 1, 8
and 15 and continuous infusion of 5-FU at 200 mgm2 every day. Cycles were repeated every 28 days. Disease response was
evaluated by both RECIST and World Health Organization (WHO) criteria. Objective responses were recorded in 39 of 61 patients
(64.0%) assessed by WHO and in 36 of 50 patients (72.0%) assessable by RECIST criteria. Complete remission occurred in 15
(24.6%) and 14 patients (28.0%), respectively. The median time to progression and overall survival of entire population was 10.6 and
27.3 months, respectively, and median duration of complete response was 14.8 months. The dose-limiting toxicity was
myelosuppression (leucopenia grade 3/4 in 52.5% of patients). Grade 3/4 nonhaematologic toxicities included mucositis/diarrhoea in
13.1%, skin in 3.3% and cardiac in 1.6% of patients. Grade 2/3 neurotoxicity was observed in five patients (7.2%). The VNB, PTX and
5-FU continuous infusion combination regimen was active and manageable. Complete responses were frequent and durable.
