Vinorelbine, cisplatin and continuous infusion of 5-fluorouracil (ViFuP) in metastatic breast cancer patients: A phase II study

Purpose: Chemotherapy regimens for patients with advanced breast cancer or large primary tumours (including locally advanced disease) usually contain anthracyclines, taxanes or both. We investigated a multi-agent regimen for patients for whom anthracyclines and/or taxanes may not be suitable. We ass essed efficacy in terms of response rate and time to progression of a combi nation with continuous infusion 5-fluorouracil (5-FU), vinorelbine and cisp latin (ViFuP regimen), as a first or subsequent line treatment for metastat ic breast cancer patients. Patients and methods: One hundred consecutive patients with advanced breast cancer were treated with 5-FU 200 mg/m(2) administered continuously throug h a permanent central venous line; vinorelbine was given on days 1 and 3 at a dose of 20 mg and cisplatin was administered at 60 mg/m(2) on day one. T herapy was given every three weeks. The median age was 50 years (range 23-7 2). Fifty-two patients had received prior chemotherapy for metastatic breas t cancer, and sixty-one percent had previously received anthracyclines, thi rty-five percent taxanes and twenty-nine percent 5-FU as a bolus injection. All patients were assessable for toxicity, four patients were not assessab le for response. Results: There were four complete responses (4%). Forty-nine patients had a partial response (overall response rate, 55%; 95% confidence interval (CI) : 45%-65%). After a median follow-up of 10.2 months, median duration of res ponse is 5.2 months (range 1.5-20.7+ months), time to progression (TTP) is 6.8 months (range 0.3-24.7 months). Acute toxicity, including myelosuppress ion, was mild: only 18% of patients had grade 4 granulocytopenia and one pa tient experienced grade 4 diarrhea. Only 15% of patients had any non-hemato logical grade 3 toxicity including nausea (4%), stomatitis (4%), diarrhea ( 2%), fatigue (1%), fever (1%), photosensitivity (1%), hand-foot syndrome (1 %). Grade 2 alopecia was observed only in six patients (6%). Eleven patient s developed a right diaphragmatic supra elevation, while deep vein thrombos is, central venous catheter associated, occurred in eight patients. Conclusions: We identified a combination chemotherapy with noteworthy effic acy and well tolerated subjectively as either a first- or second-line treat ment for metastatic breast cancer patients. The regimen warrants further de velopment focusing on the comparison with either continuous administration of oral fluoropyrimidine derivatives.