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Amsacrine [4'-(9-Acridinylamino)-Methanesulfon-m-Anisidide] (m-AMSA) and 5-Azacytidine (AZA) for Remission Reinduction in Patients with Relapsed Adult Acute Nonlymphocytic Leukemia An ECOG Pilot Study

Kahn, S. Benham, M.D.; Spiers, Alexander, M.D.; Knospe, William H., M.D.; Soojian, Michael, M.D.; Click, John H., M.D.

American Journal of Clinical Oncology: February 1987 - Volume 10 - Issue 1 - p 78–81

Twenty-two évaluable adult patients with relapsed, acute nonlymphocytic leukemia (ANLL) were treated with the combination of amsacrine (m-AMSA.) and 5-azacytidine (AZA) as part of an Eastern Cooperative Oncology Group (ECOG) pilot study to evaluate efficacy and toxicity. Each drug was given in a dosage of 150 mg/m2 i.v. daily for 5 consecutive days. A complete response (CR) was obtained in 8 of 22 patients (36%) and a partial response was seen in two others, yielding an overall response rate of 45%. Median survival for all 22 patients was 2.5 months, but medium survival was 7.2 months (range 4.3–13 months) for those with a CR. Twelve of 22 died during the first 3 months, seven of these during the period of drug-induced aplasia. Moderate to severe toxicity included serious infection (16 of 22); nausea, vomiting, and diarrhea (19 of 22); and mucositis (10 of 22). There were four instances each of cardiac abnormalities and hepatic abnormalities but all reversed spontaneously. We conclude that this combination therapy cannot be recommended for further investigation in relapsed patients with ANLL since there was no notable increase in long-term survival and since there were 10 treatment-related deaths out of 22 patients.

From Hahnemann University (S.B.K., M.S.), Philadelphia, Pennsylvania (NIH grant CA13611); Albany Medical College (A.S.), Albany, New York (NIH grant CA06594); Rush-Presbyterian-St. Luke's Medical Center (W.H.K.), Chicago, Illinois (NIH grant CA25988); and Hospital of the University of Pennsylvania (J.H.G.), Philadelphia, Pennsylvania (NIH grant CA15488).

© Lippincott-Raven Publishers.