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Phase II Study of Oral Idarubicin in Favorable Histology Non-Hodgkin's Lymphoma¹

Divisions of Hematology and Oncology, Department of Medicine, Maine Medical Center, Portland, Maine 04102 [D. C. C., D. M. H., T. J. E., B. M. D.], and Adria Laboratories, Columbus, Ohio 43216 [M. G., R. G.]

Idarubicin, a new analogue of daunorubicin, was administered p.o. for 3 consecutive days every 3 weeks at a dose of 45 mg/m² in 46 patients (45 eligible and evaluable) with previously treated, favorable histology, non-Hodgkin's lymphoma. Median clinical characteristics included an age of 66 years, a performance status of 1, and one prior chemotherapeutic regimen. Forty-one patients were relapsing from prior therapy, and 37 had stage IV disease. Patients with prior anthracycline therapy were excluded.

Responses were observed in 58% of patients (10 complete and 16 partial), with a median duration of 6+ months (2–41+ months). Idarubicin was well tolerated. Nonhematological toxicities (nausea/vomiting, mucositis/diarrhea, alopecia, and anorexia) were observed in 50% of patients. Median hematological values during the first cycle include a WBC of 4100/mm³ and a platelet count of 147,000/mm³. With dose escalation, hematological toxicity was the dose-limiting toxicity. Symptomatic cardiac toxicity was not observed. Median values for the resting left ventricular ejection fraction during the course of therapy were 0.65 (initial) and 0.63 (final). Idarubicin in oral form is an active drug in previously treated patients with favorable histology non-Hodgkin's lymphoma.

¹ Presented in part at the 81st Annual Meeting of the American Association for Cancer Research, Inc., Washington, DC, May 23–26, 1990.

² To whom requests for reprints should be addressed.

Received 4/ 9/90. Accepted 7/31/90.