| Abstract
| - 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 assessed efficacy in terms of response rate and time to progression of a combination with continuous infusion 5-fluorouracil (5-FU), vinorelbine and cisplatin (ViFuP regimen), as a first or subsequent line treatment for metastatic breast cancer patients Patients and methods. One hundred consecutive patients with advanced breast cancer were treated with 5-FU 200 mg/m2 administered continuously through 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/m2 on day one Therapy was given every three weeks. The median age was 50 years (range 23-72) Fifty-two patients had received prior chemotherapy for metastatic breast cancer, and sixty-one percent had previously received anthracyclines, thirty-five percent taxanes and twenty-nine percent 5-FU as a bolus injection All patients were assessable for toxicity, four patients were not assessable for response Results There were four complete responses (4%). Fortynine patients had a partial response (overall response rate, 55%, 95% confidence interval (Cl) 45%-65%) After a median follow-up of 10 2 months, median duration of response is 52 months (range 1.5-20.7+ months), time to progression (TTP) is 6.8 months (range 0 3-24.7 months). Acute toxicity, including myelosuppression, was mild, only 18% of patients had grade 4 granulocytopenia and one patient experienced grade 4 diarrhea Only 15% of patients had any non-hematological 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 patients developed a right diaphragmatic supra elevation, while deep vein thrombosis, central venous catheter associated, occurred in eight patients. Conclusions We identified a combination chemotherapy with noteworthy efficacy and well tolerated subjectively as either a first- or second-line treatment for metastatic breast cancer patients The regimen warrants further development focusing on the comparison with either continuous administration of oral fluoropynmidine derivatives
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