EPIRUBICIN VERSUS MITOXANTRONE IN COMBINATION CHEMOTHERAPY FOR METASTATIC BREAST-CANCER

As valid therapeutic alternatives to adriamycin, with a more favourabl e safety profile, epirubicin (E) and novantrone (N) were compared in c ombination with fluorouracil (F) and cyclophosphamide (C) in a prospec tive randomized clinical trial as first-line treatment for metastatic breast cancer (mbc). 158 women with mbc were randomly allocated to rec eive FEC or FNC regimen; the dosage in mg/m(2) was as follows: 500 for C and F, 75 for E and 10 for N. All drugs were administered iv. on da y 1 nd recycled on day 21. In 141 evaluable patients the response rate (CR + PR) was better in the FEC (43.6%) than in the FNC regimen (30.3 %) (95% C.I. of 32% to 55% versus 14% to 34%), without any statistical ly significant difference. Differences in response rate were significa ntly in favour of FEC group in previously untreated patients (57.6% ve rsus 25%, p=.02), and in postmenopausal women (46.1% versus 23.6%, p=. 01). No significant differences between the two treatment arms were ob served in terms of either time to progression or duration of response and survival. The most important dose-limiting toxicity was hematologi cal (leuko- and thrombocytopenia were significantly higher in FNC-trea ted patients). This differences in hematological toxicity sustained a significantly different incidence of delays in administering chemother apy courses, which precluded the administration of comparable does of all drugs in both groups. The incidence of complete alopecia was signi ficantly higher in FEC-treatment patients, while no clinical or instru mental evidence of CHF was observed with either regimen. Due to its mo re favourable therapeutic profile, the E-containing regime seesma suit able first-line treatment for previously untreated patients with mbc, while the FNC combination should be offered to women refusing hair los s.