Journal of Clinical Oncology, Vol 2, 275-281, Copyright © 1984 by American Society of Clinical Oncology
Randomized phase II trial of carminomycin versus 4'-epidoxorubicin in advanced breast cancer
M Rozencweig, W ten Bokkel Huinink, F Cavalli, U Bruntsch, P Dombernowsky, H Host, V Bramwell, G Renard, M Van Glabbeke and G Decoster
Sixty-three evaluable patients with advanced breast cancer were randomly
allocated to receive three-week intravenous courses of carminomycin (18
mg/m2) or 4'-epidoxorubicin (90 mg/m2). The former yielded one (3%) partial
response for nine weeks among 29 patients whereas, in the other arm, nine
(27%) of 34 patients achieved partial response for a median of 28 weeks
(range, nine to 36 weeks; p less than 0.02). The major toxic effect of
these anthracyclines was leukopenia with median white blood cell nadirs of
1,600/microL (range, 300- 4,000/microL) versus 1,800/microL (range,
500-4,300/microL), respectively. Acute nonhematologic toxic effects were
qualitatively similar but carminomycin produced significantly less
gastrointestinal intolerance and alopecia. Patients whose disease failed to
respond to first-line anthracycline received doxorubicin (60 mg/m2) every
three weeks. Four partial responses were obtained among 19 patients
previously treated with carminomycin. Following 4'-epidoxorubicin therapy,
one 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.
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