Summary
Twenty patients with advanced malignant melanoma refractory to conventional chemotherapy, were entered into a Phase II study of epirubicin, one of the new doxorubicin analogues. The drug was given at a dose of 90 mg/m2 IV every 3 weeks. One partial response and three disease stabilizations were observed. Nausea and vomiting and alopecia were common. Mild to moderate leukopenia occurred in 6 patients. Three cases of reversible ST-T changes were recorded. The observed response rate of 5% with a 39.2% probability of a true response rate ≥ 10%, does not suggest that epirubicin, in the dose and schedule chosen, is active in metastatic malignant melanoma.
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Arcamone F, Penco S, Vigevani A, Redaelli S, Franchi G, Di Marco A, Casazza AM, Dasdia T, Formelli F, Necco A, Soranzo C: Synthesis and antitumor properties of new glycosides of daunomycinone and adriamycinone. J Med Chem 18:703–707, 1975
Casazza AM, Di Marco A, Bertazzoli C, Formelli F, Giuliani F, Pratesi G: Antitumor activity, toxicity, and pharmacological properties of 4′-epiadriamycin. Proceedings of the 10th International Congress of Chemotherapy, Zurich, Switzerland, Sept 1977, vol II, pp 1257–1260
Ganzina F: 4′-Epi-doxorubicin, a new analogue of doxorubicin: a preliminary overview of preclinical and clinical data. Cancer Treat Rev 10:1–22, 1983
Bonfante V, Bonadonna G, Villani F, Di Fronzo G, Martini A, Casazza AM: Preliminary phase I study of 4′-epi-adriamycin. Cancer Treat Rep 63:915–918, 1979
Schauer PK, Wittes RE, Gralla RJ, Casper ES, Young CW: A phase I trial of 4′-epi-adriamycin. Cancer Clin Trials 4:433–437, 1981
Miller AB, Hoogstraten B, Staquet M, Winkler A: Reporting results of cancer treatment. Cancer 47:207–214, 1981
Bonfante V, Villani F Bonadonna G: Toxic and therapeutic activity of 4′-epi-Doxorubicin. Tumori 68:105–111, 1982
Bellet RE, Mastrangelo MJ, Berd D, Lustbader E: Chemotherapy of metastatic malignant melanoma. In Clark WH, Goldman LI, Mastrangelo MJ (ed): Human Malignant Melanoma. Grune & Stratton, New York, 1979, pp 325–351
Hurteloup P, Cappellaere P, Armand JP, Mathè G: Phase II clinical evaluation of 4′-epi-doxorubicin. Cancer Treat Rep 67:337–341, 1983
Young CW, Wittes RE, Jain K, Casper ES: Clinical evaluation of 4-epi-doxorubicin. Proceedings of the 13th International Congress of Chemotherapy, Vienna, Austria, Aug–Sept 1983, Part 215, pp 13–16
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Lopez, M., Perno, CF., Papaldo, P. et al. Phase II study of epirubicin in advanced malignant melanoma. Invest New Drugs 2, 315–317 (1984). https://doi.org/10.1007/BF00175383
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DOI: https://doi.org/10.1007/BF00175383