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Annals of Oncology 12:95-100, 2001
© 2001 European Society for Medical Oncology

research-article

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

F. Nolè, E. Munzone, M. Mandalà, C. Catania, L. Orlando, M. G. Zampino, I. Minchella, M. Colleoni, G. Peruzzotti, E. Marrocco and A. Goldhirsch

Divison of Medical Oncology, European Institute of Oncology Milan, Italy

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

breast cancer, chemotherapy, cisplatin, continuous infusion fluorouracil, vinorelbine


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