ACLARUBICIN IN THE TREATMENT OF ACUTE NONLYMPHOCYTIC LEUKEMIA REFRACTORY TO TREATMENT WITH DAUNORUBICIN AND CYTARABINE - A PHASE-II TRIAL

  • 1 January 1984
    • journal article
    • research article
    • Vol. 68  (10) , 1233-1238
Abstract
Aclarubicin (ARC) was administered in a prospective cooperative phase II trial to 44 patients with possibly refractory acute nonlymphocytic leukemia who were previously treated with daunorubicin and cytarabine. Induction treatment consisted of 80 mg/m2 of ACR i.v. daily for 3 days, followed by 80 mg/m2 i.v. daily for 2 days in patients not obtaining a complete remission (CR) after 2-4 wk. CR was observed in 8 patients (18%) and partial remission was observed in 6 (14%). On monthly maintenance chemotherapy with ACR and cytarabine, the duration of CR varied between 10 and 58 wk. Achievement of remission was not related to age, presence or absence of Auer bodies, cytogenetic characteristics, or previous response to daunorubicin and cytarabine. Side effects were nausea and vomiting observed in 86% and diarrhea in 34% of the patients, whereas mucositis and alopecia were uncommon. Disturbances of cardiac function arousing suspicion of acute ACR toxicity were observed in 7 patients. No case of chronic cardiotoxicity was observed, despite the fact that 20 patients received ACR doses > 400 mg/m2, with 7 of the 20 having had a previous daunorubicin dose > 400 mg/m2. As CR was obtained in 4 of 14 patients with primary therapy-resistant leukemia and in 2 of 16 patients with relapse and no response to re-treatment with daunorubicin and cytarabine, ACR does not seem to show clinical cross-resistance to daunorubicin. Evaluation of ACR in 1st-line chemotherapy of acute nonlymphocytic leukemia appears justified.