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Phase I-II Study of Epirubicin in Multiple Myeloma¹

Divisions of Hematology and Oncology, Department of Medicine, Maine Medical Center, Portland, Maine 04102 [D. C. C., T. J. E.]; Adria Laboratories, Columbus, Ohio 43216-6529 [R. G., F. B. O.]; and Divisions of Hematology and Oncology, Portsmouth Hospital, Portsmouth, New Hampshire 03801 [H. L. S., S. D. P.]

Forty patients with relapsed (26) or refractory (14) myeloma were treated with epirubicin of doses of 75, 90, 105, and 120 mg/m² in groups of 6 or more patients to test for response, maximum tolerated dose, and toxicity. Thirteen patients had received prior doxorubicin and were included in the dose findings part of the study only. Staging was I (1), II (5), and III (34). Partial responses were seen in 5 patients (18.5%) (duration 1.5, 2, 2.5, 10, and 18 months) not previously treated with doxorubicin. No responses were seen in patients treated with prior anthracycline. Responses were not dependent upon dose level of epirubicin. Median nadir white blood cell count at the four-dose levels were 2,300, 1,000, 1,600, and 1,700/mm³ with median nadir granulocyte counts of 897, 720, 688, and 192/mm³. Fever/neutropenia was infrequently observed at the three lower dose levels but occurred in 6 of 10 patients at 120 mg/m². Platelet nadirs were 110,000, 83,000, 169,000, and 42,000/mm³. Nonhematological toxicity was not dose dependent and included alopecia (100%), nausea/vomiting (40%), and stomatitis (25%). Six patients had 0.10 changes in the resting ejection fraction with one patient developing congestive heart failure that responded to medical management. This patient had received prior doxorubicin and had a history of myocardial infarction.

Epirubicin can produce remissions in patients with previously treated myeloma who have not received prior doxorubicin. Since the response rate was not enhanced at 120/m² and since fever/neutropenia was seen regularly at this dose level, the recommended dose for further study is 105 mg/m².

¹ Presented in part at the Seventy-ninth Annual Meeting of the American Association for Cancer Research, New Orleans, May 1988.

² To whom requests for reprints should be addressed, at Divisions of Hematology and Oncology, Department of Medicine, Maine Medical Center, 22 Bramhall Street, Portland, ME 04102.

Received 5/20/88. Revised 7/ 6/88. Accepted 7/14/88.