Combination chemotherapy with navelbine and continuous infusion of 5-fluorouracil in metastatic, chemotherapy refractory breast cancer

Background: The protracted continuous infusion (PCI) of 5-fluorouracil (5-F U) has proven in several studies an active and well tolerated treatment for advanced, pretreated breast cancer. Navelbine has also activity in this se tting. Patients and methods: Heavily pretreated patients with metastatic breast ca rcinoma were eligible for the study. Treatment consisted of 5-FU 250 mg/m(2 ) given as a PCI by an elastomeric pump and navelbine 20 mg/m(2) on days 1 and 8, every four weeks. Eighty-three patients (median age 54 years; range 32-82 years) entered the study. The median number of metastatic tumour site s was 2, with visceral involvement in 56 patients. Apart from five patients with contraindications, all patients had been pretreated with anthracyclin es. Thirty-one patients had received taxanes and seventy-four bolus 5-FU. Results: A median of 5 cycles (range 1-14) per patient was administered. Th e median duration of 5-FU infusion was 17 weeks (range, 4-90). In the 80 ev aluable patients (3 not yet evaluable) 12 complete remissions and 24 partia l remissions occurred (response rate, 45%). Median duration of response was 9 months. Toxicity was mild. Median survival was 20 months. Conclusions: PCI-5-FU combined with navelbine offers a reasonable chance of tumour regression with modest side effects in patients with heavily pretre ated breast cancer.