Randomized phase II trial of carminomycin versus 4'-epidoxorubicin in advanced breast cancer.
Rozencweig, M Ten Bokkel Huinink, W Cavalli, F Bruntsch, U Dombernowsky, P Høst, H Bramwell, Vivien H C Renard, G Van Glabbeke, M Decoster, G
Rozencweig, M
Ten Bokkel Huinink, W
Cavalli, F
Bruntsch, U
Dombernowsky, P
Høst, H
Bramwell, Vivien H C
Renard, G
Van Glabbeke, M
Decoster, G
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Abstract
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.
Affiliation
Description
Date
1984-04
Publisher
Collections
Keywords
Breast Cancer
Cancer Metastasis
Cancer Metastasis
Type
Article
Citation
Randomized phase II trial of carminomycin versus 4'-epidoxorubicin in advanced breast cancer. 1984, 2 (4):275-81 J Clin Oncol