PHASE-II CLINICAL-EVALUATION OF 4'-EPI-DOXORUBICIN

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  • 1 January 1983
    • journal article
    • research article
    • Vol. 67  (4) , 337-341
Abstract
4''-Epi-doxorubicin (4''e-Dx) was used as a single agent in a broad phase II study involving a variety of advanced metastatic tumors. A total of 115 patients were treated, of whom 93 were evaluable. The dosage was 75 mg/m2/cycle repeated every 21 days, with a maximal cumulative dose of 550 mg/m2. Nine responses were achieved in a total of 28 patients with breast cancer (32%). The response rate was 54% in breast cancer patients receiving 4''e-Dx as 1st-line treatment, 25% in patients prevously given chemotherapy without doxorubicin and 11% in patients previously given chemotherapy with doxorubicin. Some therapeutic activity was also detected in endometrial carcinoma, epidermoid carcinoma of the cervix, non-Hodgkin''s lymphoma, melanoma and skin epidermoid tumor, but the number of patients entered in the study with these various tumors was too limited to allow any statement on efficacy of 4''e-Dx. No treatment schedule with 4''e-Dx had to be interrupted because of toxicity. In a total of 373 evaluable cycles, only 3 acute reversible ECG abnormalities were recorded. In 16 of 109 evaluable patients there was some minor or moderate alteration of 1 or more of the 3 major blood cell parameters following 4''e-Dx therapy, requiring a postponement of the next cycle by .ltoreq. 10 days.