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 x 3-weekly cycles of F ILM were administered on an outpatient basis. 5-fluorouracil 750 mg/m( 2), ifosfamide 1 g/m(2) and leucovorin 200 mg/m(2) were administered o n day 1 of each cycle. Mitomycin C 6 mg/m(2) was administered at alter nate cycles. Dose reduction and dose delay were allowed. Responses inc luded 5 pathologically confirmed complete remissions, 15 partial respo nses 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 neces sary; 2 blood transfusions were required for anaemia. The most frequen t 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.