Summary
Idarubicin, a new analogue of daunorubicin, was administered to 27 patients with advanced breast cancer in a phase II trial. The drug was given orally at a dose of 30–35 mg/m2 every 3 weeks. Twenty-two patients were evaluable for response. All evaluable patients were previously treated with one or more chemotherapeutic regimens, including an anthracycline in more than 50% of the cases. Partial remissions were obtained in 5 patients, for a response rate of 23%. The median duration of response was 191 days. Mild nausea and vomiting were common. Diarrhea, which occurred in less than 50% of the patients, was usually short-lived. Alopecia was generally minimal. Myelosuppression was the dose-limiting toxic effect. Leukopenia was frequently seen, with full recovery by day 28 in 81 % of the courses. Thrombocytopenia was less common than leukopenia. Four cases of grade 1 acute cardiac toxicity were recorded. This study suggests that idarubicin can induce regressions in advanced carcinoma of the breast, and justifies further studies in combination with other agents.
This is a preview of subscription content, log in via an institution to check access.
Similar content being viewed by others
References
Arcamone F, Bernardi L, Giardino P, Patelli B, Di Marco A, Casazza AM, Pratesi P: Synthesis and antitumor activity of 4-demethoxydaunorubicin, 4-demethoxy-7,9-diepidaunorubicin, and their β anomers. Cancer Treat Rep 60:829–834, 1974
Casazza AM, Pratesi G, Giuliani F, Di Marco A: Antileukemic activity of 4-demethoxydaunorubicin in mice. Tumori 66:549–564, 1980
Di Marco A, Casazza AM, Pratesi G: Antitumor activity of 4-demethoxydaunorubicin administered orally. Cancer Treat Rep 61:893–895, 1977
Giuliani FC, Spreafico F, Casazza AM: Preclinical studies on new anthracyclines: antitumor, toxicologic and pharmacologic properties. In: Hansen HH (ed): Anthracyclines and Cancer Therapy. Excerpta Medica, Amsterdam, 1983, pp 193–207
Bonfante V, Ferrari L, Villani F, Bonadonna G: Phase I study of 4-demethoxydaunorubicin. Invest N Drugs 1:161–168, 1983
Kaplan S, Martini A, Varini M, Togni P, Cavalli F: Phase I trial of 4-demethoxydaunorubicin with single i.v. doses. Eur J Cancer Clin Oncol 18:1303–1306, 1982
Lambertenghi-Deliliers G, Pogliani E, Maiolo AT, Pacciarini MA, Polli EE: Therapeutic activity of 4-demethoxy-daunorubicin (idarubicin) in adult acute leukemia. Tumori 69:515–519, 1983
Rozencweig M, Piccart M, Beer M, Kaplan S, Cavalli F, Bonfante V, Bonadonna G: Phase I trials with oral 4-demethoxydaunorubicin. Proc 13th International Congress of Chemotherapy, Vienna, Austria, Aug–Sept 1983, Part 215, pp 45–47
Miller AB, Hoogstraten B, Staquet M, Winkler A: Reporting results of cancer treatment. Cancer 47:207–214, 1981
Tormey DC, Neifeld JP: Chemotherapeutic approaches to disseminated disease. In: Stoll BA (ed): Breast Cancer Management — Early and Late. William Heinemann Medical Books, London, 1977, pp 117–131
Bonadonna G: Adriamycin vs epirubicin in advanced breast cancer (Abstract). International Symposium on Advances in Anthracycline Chemotherapy: Epirubicin. Milan, June 1984, p 21
Coonley CJ, Warrel RP, Strauss DJ, Young CW: Clinical evaluation of 4-Demethoxydaunorubicin in patients with advanced malignant lymphomas. Cancer Treat Rep 67:949–950, 1983
Author information
Authors and Affiliations
Rights and permissions
About this article
Cite this article
Lopez, M., Di Lauro, L., Papaldo, P. et al. Phase II trial with oral idarubicin in advanced breast cancer. Invest New Drugs 4, 39–42 (1986). https://doi.org/10.1007/BF00172014
Issue Date:
DOI: https://doi.org/10.1007/BF00172014