Hiddemann W, Kreutzmann H, Straif K, Ludwig W D, Donhuijsen-Ant R, Lengfelder E, Arlin Z, Büchner T
Onkologie. 1986 Jun;9(3):144-6. doi: 10.1159/000215989.
In a multi-institutional study 26 patients with refractory acute myeloid leukemia were entered into a phase I/II study of HD-ara-C and mitox. HD-ara-C 3 g/m2 q 12h was given by 3h infusion on days 1-4. Mitox was started at 12 mg/m2/d on days 3, 4 and 5, and escalated to 4 and 5 doses of 10 mg/m2/d on days 2-5 and 2-6, respectively. From 24 patients presently evaluable for response, 12 achieved a CR and 2 a PR. 7 patients died of infectious complications within the first 4 weeks of treatment while persistent AML was found in 3 cases. Except for one death, possibly related to acute cardiomyopathy, toxicity was mild to moderate consisting of nausea and vomiting, mucositis and diarrhea. These data indicate a high anti-leukemic activity of HD-ara-C/mitox in AML refractory against conventional chemotherapy.
在一项多机构研究中，26例难治性急性髓系白血病患者进入了高三尖杉酯碱（HD-ara-C）和米托蒽醌（mitox）的I/II期研究。HD-ara-C 3 g/m² 每12小时一次，于第1 - 4天通过3小时输注给药。米托蒽醌在第3、4和5天开始以12 mg/m²/天给药，并分别在第2 - 5天和第2 - 6天递增至4剂和5剂，剂量为10 mg/m²/天。在目前可评估反应的24例患者中，12例达到完全缓解（CR），2例达到部分缓解（PR）。7例患者在治疗的前4周内因感染并发症死亡，3例发现持续性急性髓系白血病。除1例可能与急性心肌病相关的死亡外，毒性为轻至中度，包括恶心、呕吐、粘膜炎和腹泻。这些数据表明HD-ara-C/米托蒽醌对常规化疗难治的急性髓系白血病具有高抗白血病活性。
