A phase II study of mitoxantrone in acute leukemia

✍ Scribed by Tohru Masaoka; Hirotoshi Shibata; Shigeru Oguma; Kiyoyasu Nagai; Teruo Kitani; Atsushi Horiuchi; Kojiro Yasunaga; Takeshi Yonezawa; Hiroya Kawagoe

• Publisher: Springer US
• Year: 1985
• Tongue: English
• Weight: 297 KB
• Volume: 3
• Category: Article
• ISSN: 0167-6997
• DOI: 10.1007/bf00174170

✦ Synopsis

A phase 1I study of mitoxantrone (Novantrone| dihydroxyanthracenedione) was conducted in 3.5 patients (22 male: 13 female) with acute leukemia. There were 35 cvaluable cases with a mean age of 34 (range 8-61). Twenty-eight patients had acute non-lymphocytic leukemia (ANLL) and seven had acute lymphocytic leukcmia (ALL). Mitoxantrone was administered intravenously 2-4 mg/m 2 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. Sevcnty-three percent of patients showed gastrointestinal disturbances such as nausca 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 111 study is now being carried out.