[Randomized trial comparing mitoxantrone with adriamycin in advanced breast cancer].

Between June, 1983 and December, 1984, 142 patients with metastatic breast cancer were enrolled in this controlled, multicentre trial. The patients were given cyclophosphamide (600 mg/m2) plus 5-fluorouracil (750 mg/m2) and either adriamycin (45 mg/m2) (CAF) or mitoxantrone (13 mg/m2) (CNF). All drugs were administered intravenously on the same day every 21 days. An objective response was obtained in 28 of the 66 assessable patients (42.8%) in the CAF group (with 9 complete responses) and in 30 of the 71 assessable patients (42.2%) in the CNF group (with 6 complete responses). At the moment, the median duration of response is 37+ weeks with CAF and 34+ weeks with CNF (n.s.). It is still too early to evaluate the duration of survival. The major toxicity was bone-marrow suppression which required delayed administration or dose reduction in 40-45% of the patients. Nausea and vomiting were of comparable frequency in both groups, but they appeared to be less severe with CNF. Alopecia was less frequent and less pronounced in the CNF group. Moderate and clinically non-significant reduction of left ventricular ejection fraction was observed at cardiac ultrasonography or scintigraphy in 6 (10%) CAF patients and 2 (3%) CNF patients. None of the patients developed heart failure. Our results show similar response rates and toxicity with CAF and CNF. However, the mitoxantrone-containing treatment had a slight advantage as regards alopecia and the severity of nausea and vomiting.

RCT Entities:   Population Interventions Outcomes