Spadea A, Petti M C, Aloespiriti M A, Avvisati G, De Gregoris C, Fazi P, Latagliata R, Amadori S, Mandelli F
Department of Human Biopathology, University La Sapienza, Rome, Italy.
Leuk Lymphoma. 1993 Feb;9(3):217-20. doi: 10.3109/10428199309147373.
Because of the lack of standard treatment in refractory and relapsed acute myelogenous leukemia (AML) several new drugs have been employed alone to evaluate their efficacy in this peculiar category of patient. Bisantrene, a new anthracene bishydrazone derivative, has shown antileukemic effect in phase I and II clinical trials with acceptable extrahaematological toxicity. Seven patients (six males and one female, median age 41.8 years) received Bisantrene (250 mg/sqm/daily 1-7) as a single agent in relapsed or refractory leukemia. 5 out of 7 patients achieved complete remission, one attained partial remission and one was resistant. However, haematological toxicity was severe with prolonged myelosuppression. Hepatic toxicity was the main extrahaematological side effect and occurred in 3 of 7 patients, however all of them recovered within 40 days. No cardiovascular dysfunction occurred although all the patients had been heavily previously treated with anthracyclines. Our data confirm that Bisantrere is active in relapsed and refractory AML and suggest the need for larger clinical trials to better evaluate its efficacy.
由于难治性和复发性急性髓性白血病（AML）缺乏标准治疗方法，几种新药已单独用于评估其在这类特殊患者中的疗效。双胺三嗪，一种新的蒽双腙衍生物，在I期和II期临床试验中显示出抗白血病作用，且血液学外毒性可接受。7例患者（6例男性，1例女性，中位年龄41.8岁）在复发或难治性白血病中接受双胺三嗪（250mg/平方米/每日，第1 - 7天）单药治疗。7例患者中有5例达到完全缓解，1例达到部分缓解，1例耐药。然而，血液学毒性严重，骨髓抑制持续时间长。肝毒性是主要的血液学外副作用，7例患者中有3例发生，但所有患者均在40天内恢复。尽管所有患者此前都曾大量接受过蒽环类药物治疗，但未发生心血管功能障碍。我们的数据证实双胺三嗪在复发和难治性AML中具有活性，并表明需要进行更大规模的临床试验以更好地评估其疗效。
