A phase II study of mitoxantrone in acute leukemia.
A phase II study of mitoxantrone (Novantrone; dihydroxyanthracenedione) was conducted in 35 patients (22 male: 13 female) with acute leukemia. There were 35 evaluable cases with a mean age of 34 (range 8-61). Twenty-eight patients had acute non-lymphocytic leukemia (ANLL) and seven had acute lymphocytic leukemia (ALL). Mitoxantrone was administered intravenously 2-4 mg/m2 daily for five days and after the nadir a further 2-3 doses were added if necessary. All previously treated cases (22 patients) had been treated with anthracyclines; 13 had no previous treatment. Out of the 13 untreated cases there were six complete remissions (CRs) (46.2%) and five partial remissions (PRs) (38.5%), while out of 22 pretreated cases, four CRs (18.2%) and five PRs (22.7%) were obtained. In seven of the untreated cases the decrease of leukemic cells and neutrophil leukocytes were analysed. Mitoxantrone showed a longer duration of decrease and higher log decrease of leukemic cells in the bone marrow than daunorubicin or cytosine arabinoside. Seventy-three percent of patients showed gastrointestinal disturbances such as nausea or loss of appetite. In 38.1% SGPT elevation and in 8.8% abnormal ECG findings were observed. All side-effects were mild and reversible. From this data mitoxantrone seems a very promising agent in the treatment of acute leukemia and a phase III study is now being carried out.
D015250:Aclarubicin; D000208:Acute Disease; D000293:Adolescent; D000328:Adult; D000410:Alanine Transaminase / Q000097:blood; D000880:Anthraquinones / Q000009:adverse effects / Q000627:therapeutic use*; D000970:Antineoplastic Agents / Q000009:adverse effects; D002648:Child; D003630:Daunorubicin / Q000627:therapeutic use; D004317:Doxorubicin / Q000627:therapeutic use; D004341:Drug Evaluation; D004351:Drug Resistance; D004562:Electrocardiography; D005260:Female; D006801:Humans; D007938:Leukemia / Q000188:drug therapy*; D007945:Leukemia, Lymphoid / Q000188:drug therapy; D007958:Leukocyte Count / Q000187:drug effects; D008297:Male; D008875:Middle Aged; D008942:Mitoxantrone; D009279:Naphthacenes / Q000627:therapeutic use
D000880:Anthraquinones; D000970:Antineoplastic Agents; D009279:Naphthacenes; D015250:Aclarubicin; D004317:Doxorubicin; D008942:Mitoxantrone; D000410:Alanine Transaminase; D003630:Daunorubicin