Erttmann R, Bode U, Erb N, Forcadell de Dios P, Gutjahr P, Haas R, Kuhn N, Siewert H, Landbeck G
Universitäts-Kinderklinik Hamburg.
Klin Padiatr. 1988 May-Jun;200(3):200-4. doi: 10.1055/s-2008-1033709.
11 patients with refractory acute leukemia of childhood were treated with idarubicin per os. Bone marrow toxicity which was observed at a dose level of 60 mg/m2 p.o. (3 x 20 mg q 24 hrs p.o.) per 3 weeks was found to be the dose limiting factor. In contrast to the first phase I study of Tan et al. (16) the maximal tolerated dose in the present study was found to be lower at a level of 90 mg/m2 p.o. (3 x 30 mg/m2 p.o. q 24 hrs) per 3 weeks. Therefore, we recommend a dosage of 60 mg/m2 p.o. (3 x 20 mg/m2 p.o. q 24 hrs) per 3 weeks as a starting dose for phase II/III studies. 2 out of the 11 anthracycline pretreated patients (91-880 mg/m2) with acute leukemia reached a complete remission undergoing idarubicin p.o. as a single therapy.
11例儿童难治性急性白血病患者接受了口服伊达比星治疗。在每3周口服60mg/m²（每日3次，每次20mg，口服，每24小时一次）的剂量水平观察到骨髓毒性，这被发现是剂量限制因素。与Tan等人的I期研究（16）相比，本研究中的最大耐受剂量较低，为每3周口服90mg/m²（每日3次，每次30mg/m²，口服，每24小时一次）。因此，我们建议将每3周口服60mg/m²（每日3次，每次20mg/m²，口服，每24小时一次）作为II/III期研究的起始剂量。11例接受过蒽环类药物预处理（剂量为91 - 880mg/m²）的急性白血病患者中，有2例在接受口服伊达比星单药治疗后达到完全缓解。
