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Phase II Study of Intravenous Idarubicin in Unfavorable Non-Hodgkin's Lymphoma¹

Division of Hematology, Department of Medicine, Maine Medical Center, Portland, Maine 04102 [D. C. C.]; Adria Laboratories, Columbus, Ohio 43216 [M. C. G., R. A. G.]; Division of Hematology/Oncology, Duke University Medical Center, Durham, North Carolina 27710 [J. C.]; Department of Medicine, James H. Quillen College of Medicine, East Tennessee State University, Johnson City, Tennessee 37614 [M. L. V.]; Division of Oncology, Department of Medicine, School of Medicine and University Hospital, Seattle, Washington 98018 [C. S. H.]; Don and Sybil Harrington Cancer Center, Amarillo, Texas 79106 [B. T. P.]; and Paducah, Kentucky 42006 [J. G.]

Idarubicin, a new analogue of daunorubicin, was administered i.v. at a dose of 15 mg/m² to 31 previously treated patients with unfavorable non-Hodgkin's lymphoma. Clinical characteristics included median age, 69 years; performance status, 1; and prior chemotherapeutic regimens, 1. Twenty of the patients were relapsing after prior therapy and 11 were refractory; 29 had received prior anthracycline or anthracenedione.

Responses were observed in 43% of patient (3 complete remission and 10 partial remission) with a median duration of 10+ months (2–29+ months). Idarubicin was well tolerated with nonhematological toxicities (nausea/vomiting, mucositis, and anorexia) seen in <50% of patients. Median hematological values during the first cycle for this dosage included WBC, 1,300/mm³; platelets, 129,000/mm³; and hemoglobin, 10.9 mg/dl. With dose escalation, hematological toxicity was dose limiting. Symptomatic cardiac toxicity was observed in one patient who had received maximum dose doxorubicin and radiotherapy. Median values for the cardiac ejection fraction during the full course of therapy for the entire group of patients were 0.62 (initial) and 0.60 (final).

Idarubicin in i.v. form is an active drug in previously treated patients with unfavorable non-Hodgkin's lymphoma.

¹ Presented at the 83rd Annual Meeting of the American Association for Cancer Research, May 20–23, 1992, San Diego, California (see Ref. 11).

² To whom requests should be addressed, at the Division of Hematology, Department of Medicine, Maine Medical Center, Portland, ME 04102.

Received 1/24/92. Accepted 5/ 6/92.