FILM (5-fluorouracil, ifosfamide, leucovorin and mitomycin C), an alternative chemotherapy regimen suitable for the treatment of advanced breast cancer in the `out-patient' setting

Abstract

FILM, a combination of 5-fluorouracil (5-FU) 750 mg/m(2), ifosfamide 1 g/m(2), leucovorin 200 mg/m(2) and mitomycin C 6 mg/m(2) (alternate cycles), was administered to 24 chemo-naive patients with inoperable disease, locally advanced or metastatic. Up to 6 x 3-weekly cycles of FILM were administered on an out-patient basis. Responses included 8 patients in complete remission (CR) and 12 showing a partial response (PR) (83%). Following analysis of these results, the FILM regimen was introduced as a standard out-patient protocol at the North Middlesex Hospital, United Kingdom. A further 66 patients have been treated in this setting. Retrospective analysis of these data confirm the trial results and allow conclusions regarding tolerability, toxicity, duration of response and survival to be drawn from a total cohort of 90 patients. A total of 524 cycles have been administered. Nineteen cycles (4%) were delayed owing to slow recovery of white blood cells (WBC), but no dose reductions were necessary. Five blood transfusions were required for anaemia. The most frequent non-haematological toxicities included nausea, vomiting and fatigue. Of 80 patients treated for inoperable or locally advanced disease, 56 (70%) remain in remission, and 69 (86%) remain alive after 5 years.

Mitomycin C: a clinical update

“…Initial total response was 83% (CR + PR) among 24 patients. A group of 80 patients could be assessed at 5 years and 56 (70%) remained in remission and 69 (86%) were still alive (67). In a recent phase II study reported from Japan a single high dose of MMC added to CMF was found to enhance relapse free survival in the adjuvant treatment of premenopausal patients (68).…”