[Phase II study of AMSA in adults with acute therapy-refractory leukemias].
The acridine derivative AMSA, Amsacrine, is a new anticancer drug which was effective in patients with advanced AML and ALL in studies performed in USA. In a multicenter phase II trial we treated 27 patients with acute resistant leukemia with AMSA. All presented progressive disease following several drug combination regimens. Out of the 25 evaluable patients 5 were resistant to primary therapies, 13 were in 2nd relapse, 6 in 3rd, and 1 in 4th relapse. Dosage was 75 mg/m2, iv, day 1-7, all 3-5 weeks. On an average, only 76% of the planned dose per cycle could be given, due to severe leucopenia. From 21 patients with ALL, 1 CR and 3 PR were observed; the 3 patients with ALL presented 1 CR and 1 PR. 1 AUL showed progressive disease. In all patients a marked cell reduction could be observed in the peripheral blood. The general tolerance was good. The most important side-effect was bone-marrow toxicity, 48% (12/25) presented leucopenia less than or equal to 600/mm3, 5 (20%) had fatal septic complications. All 5 early death presented high initial leucocyte counts of greater than or equal to 32.000 mm3 as a common risk factor. In conclusion, AMSA is an effective drug in heavily pretreated patients with AML and ALL.
D000293:Adolescent; D000328:Adult; D000368:Aged; D000609:Aminoacridines / Q000008:administration & dosage*; D000677:Amsacrine; D000970:Antineoplastic Agents / Q000008:administration & dosage*; D004341:Drug Evaluation; D006801:Humans; D007945:Leukemia, Lymphoid / Q000188:drug therapy*; D015470:Leukemia, Myeloid, Acute / Q000188:drug therapy*; D008875:Middle Aged
D000609:Aminoacridines; D000970:Antineoplastic Agents; D000677:Amsacrine
Phase-II-Studie von AMSA bei Erwachsenen mit therapierefraktären akuten Leukämien.