Phase I-II trial of mitoxantrone in acute leukemia.
Phase I-II trial of mitoxantrone in acute leukemia.
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米托蒽醌治疗急性白血病的 I-II 期试验。
DOI：
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发表时间：
1985
期刊：
影响因子：
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通讯作者：
G. Dukart
中科院分区：
文献类型：
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作者：
Z. Arlin;R. Silver;P. Cassileth;S. Armentrout;R. Gams;A. Daghestani;M. Coleman;I. Schoch;G. Dukart
在多机构试验中评估米托蒽醌，以确定治疗急性白血病的有效剂量，评估其毒性，并评估不同类型急性白血病的诱导率。57名患者接受了治疗。在24例接受米托蒽醌（10 mg/m2/d × 5）治疗的患者中，9例急性非淋巴细胞白血病（ANLL）复发患者中有1例缓解，5例急性淋巴细胞白血病复发患者中有1例缓解，7例急变型慢性粒细胞白血病患者中有1例缓解。在12 mg/m2/d × 5剂量下，16例复发ANLL患者中有7例缓解，6例复发急性淋巴细胞白血病患者中无1例缓解，5例急变慢性粒细胞白血病患者中有1例缓解。在两个剂量水平下，既往未能达到缓解的患者均无缓解。毒性反应包括恶心/呕吐、口腔炎和肝功能障碍。在接受治疗的57名患者中，有9名发生了心脏事件，但只有3名患者的心脏毒性具有临床意义。米托蒽醌12 mg/m2/日× 5是治疗急性非淋巴细胞白血病的有效剂量。需要将米托蒽醌与其他药物联合试验。
Mitoxantrone was evaluated in a multi-institution trial to define the effective dose for treating acute leukemia, to evaluate its toxicity, and to assess the induction rates for the different types of acute leukemia. Fifty-seven patients have been treated. Of the 24 patients receiving mitoxantrone (10 mg/m2/day X 5), one of nine with acute nonlymphoblastic leukemia (ANLL) in relapse, one of five with acute lymphoblastic leukemia in relapse, and one of seven with blastic chronic myelogenous leukemia achieved remission. At a dose of 12 mg/m2/day X 5, seven of 16 patients with ANLL in relapse, none of six with acute lymphoblastic leukemia in relapse, and one of five with blastic chronic myelogenous leukemia achieved remission. At both dose levels, there was no response in patients who had failed to achieve a prior remission. Toxic effects included nausea/vomiting, stomatitis, and hepatic dysfunction. Nine of the 57 patients treated experienced cardiac events but cardiac toxicity seemed clinically significant in only three. We conclude that mitoxantrone, at a dose of 12 mg/m2/day X 5, is effective therapy for ANLL. Trials combining mitoxantrone with other agents are needed.