Pilot study of FILM (5-fluorouracil, ifosfamide, leucovorin and mitomycin C): an alternative chemotherapy regimen in the treatment of advanced breast cancer

A combination of 5-fluorouracil, ifosfamide, leucovorin and mitomycin C (FILM) was administered to 24 chemo-naive patients with metastatic, locally advanced or inoperable disease. Up to 6 × 3-weekly cycles of FILM were administered on an outpatient basis. 5-fluorouracil 750 mg/m2, ifosfamide 1 g/m2 and leucovorin 200 mg/m2 were administered on day 1 of each cycle. Mitomycin C 6 mg/m2 was administered at alternate cycles. Dose reduction and dose delay were allowed. Responses included 5 pathologically confirmed complete remissions, 15 partial responses and 4 progressive diseases (pCR + PR = 83%). Following completion of FILM, patients were offered mastectomy, radiotherapy or tamoxifen. Fifteen patients (63%) remain alive 3 years after FILM chemotherapy. FILM was well tolerated; 140 cycles were administered; 11 cycles were delayed due to slow recovery of WBC, but no dose reductions were necessary; 2 blood transfusions were required for anaemia. The most frequent non-haematological toxicities included nausea, vomiting and fatigue. These results are encouraging and suggest that FILM warrants further investigation for the treatment of advanced breast cancer.