A feasibility study of simultaneous administration of gemtuzumab ozogamicin with intensive chemotherapy in induction and consolidation in younger patients with acute myeloid leukemia
A feasibility study of simultaneous administration of gemtuzumab ozogamicin with intensive chemotherapy in induction and consolidation in younger patients with acute myeloid leukemia
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DOI：
10.1182/blood-2003-05-1620
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发表时间：
2003-12-15
期刊：
影响因子：
20.3
通讯作者：
Milligan, DW
中科院分区：
文献类型：
--
作者：
Kell, WJ;Burnett, AK;Milligan, DW
作为英国医学研究委员会（MRC） AML15试验的前奏曲，在72例17至59岁的患者中评估了gemtuzumab ozogamicin （GO）联合强化化疗作为急性髓性白血病（AML）一线治疗的可行性。64例患者在第1天接受GO诱导化疗（DAT[柔红霉素，ara-C，硫鸟嘌呤]，DA[柔红霉素，ara-C]，或FLAG-Ida[氟达拉滨，ara-C, G-CSF，伊达柔红霉素]）。在疗程1时给予氧化石墨烯3mg /m(2)是可能的，但在疗程1时给予氧化石墨烯6mg /m(2)或连续疗程给予氧化石墨烯3mg /m(2)是不可行的，因为肝毒性和延迟造血恢复。31例患者接受MACE （amsacrine, ara-C, etoposide）或HidAC （HidAC）和氧化石墨烯（3mg /m(2)）巩固治疗，23例患者接受诱导和巩固治疗，对氧化石墨烯（3mg /m(2)）耐受良好。4级肝毒性和窦阻综合征在含硫鸟嘌呤组更为常见（P =.007）。86%的患者一期缓解。DA或FLAG-Ida与氧化石墨烯诱导在91%的患者中达到完全缓解，其中78%的患者在8个月时持续完全缓解。给予诱导（DA或FLAG-Ida）和巩固（MACE或HidAC）的氧化石墨烯耐受性良好。这些时间表目前正在MRC AML15在60岁以下患者中的试验中进行比较。(C) 2003年由美国血液病学会出版。
The feasibility of combining gemtuzumab ozogamicin (GO) with intensive chemotherapy as first-line treatment of acute myelold leukemia (AML) was assessed in 72 patients, aged 17 to 59 years, as a prelude to the United Kingdom Medical Research Council (MRC) AML15 trial. Sixty-four patients received induction chemotherapy (DAT [daunorubicin, ara-C, thioguanine], DA [daunorubicin, ara-C], or FLAG-Ida [fludarabine, ara-C, G-CSF, idarubicin]) with GO on day 1. It was possible to give GO 3 mg/m(2) with course 1, but 6 mg/m(2) with course 1 or GO in a dose of 3 mg/m(2) with consecutive courses was not feasible because of hepatotoxicity and delayed hematopoietic recovery. Thirty-one patients who were treated in consolidation with MACE (amsacrine, ara-C, etoposide) or HidAC (HidAC) and GO (3 mg/m(2)), and 23 in induction and consolidation, tolerated GO (3 mg/m(2)) well. Grade 4 liver toxicity and sinusoidal obstructive syndrome was more common in thioguanine-containing schedules (P =.007). Remission with course 1 was seen in 86% of patients. DA or FLAG-Ida with GO in induction achieved complete remission in 91% of patients and 78% of these patients are in continuous complete remission at 8 months. GO given with induction (DA or FLAG-Ida) and consolidation (MACE or HidAC) was well tolerated. These schedules are now being compared in the MRC AML15 trial in patients younger than 60 years. (C) 2003 by The American Society of Hematology.