Randomized phase II trial of carminomycin versus 4'-epidoxorubicin in advanced breast cancer.

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Abstract
Evaluable patients (63) with advanced breast cancer were randomly allocated to receive 3 wk i.v. courses of carminomycin (18 mg/m2) or 4''-epidoxorubicin (90 mg/m2). The former yielded one (3%) partial response for 9 wk among 29 patients whereas, in the other arm, 9 (27%) of 34 patients achieved partial response for a median of 28 wk (range, 9-36 wk; P < 0.02). The major toxic effect of these anthracyclines was leukopenia with median white blood cell nadirs of 1600/.mu.l (range, 300-4000/.mu.l vs. 1800/.mu.l (range, 500-4300/.mu.l), respectively. Acute nonhematologic toxic effects were qualitatively similar but carminomycin produced significantly less gastrointestinal intolerance and alopecia. Patients whose disease failed to respond to 1st-line anthracycline received doxorubicin (60 mg/m2) every 3 wk. Four partial responses were obtained among 19 patients previously treated with carminomycin. Following 4''-epidoxorubicin therapy, 1 of 12 evaluable patients also attained partial response. Survival curves were not affected by the initial treatment option. Carminomycin has marginal activity against breast cancer whereas 4''-epidoxorubicin deserves further evaluation of its therapeutic index relative to doxorubicin. The design used in this trial appears attractive for prompt phase II evaluation of anthracycline analogs.