Failure of three novel regimens to improve outcome for patients with relapsed or refractory acute myeloid leukaemia: a report from the Eastern Cooperative Oncology Group.
Failure of three novel regimens to improve outcome for patients with relapsed or refractory acute myeloid leukaemia: a report from the Eastern Cooperative Oncology Group.
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DOI：
10.1111/j.1365-2141.2009.07917.x
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发表时间：
2010-01
影响因子：
6.5
通讯作者：
Eastern Cooperative Oncology Group Leukemia Committee
中科院分区：
文献类型：
--
作者：
Litzow MR;Othus M;Cripe LD;Gore SD;Lazarus HM;Lee SJ;Bennett JM;Paietta EM;Dewald GW;Rowe JM;Tallman MS;Eastern Cooperative Oncology Group Leukemia Committee
复发性急性髓细胞白血病（AML）的治疗仍然不令人满意。我们进行了一项II期随机试验，患者接受中等剂量阿糖胞苷4天，然后在第5天接受吉妥珠单抗奥佐霉素（A组），或联合柔红霉素脂质体3天（B组），或阿糖胞苷5天联合环磷酰胺3天和拓扑替康连续输注5天（C组）。符合条件的患者患有原发性难治性AML，缓解不到一年后首次复发，或第二次或更长时间复发。本试验的主要目的是在至少40%的患者中实现常规完全缓解（CR）或CR无血小板恢复（CRp）。82例合格患者的CR/CRp率分别为A组3/26例（12%）、B组2/29例（7%）和C组1/27例（4%）。在最初CR后6个月内复发或多次复发的患者均无反应。超过95%的患者随后死于AML。未发生非预期毒性。我们的结论是，这三种方案在治疗高危复发性或难治性AML方面都不够有效，需要进一步研究。该试验在http://www.clinicaltrials.gov上注册为#NCT00005962。
The treatment of relapsed acute myeloid leukemia (AML) remains unsatisfactory. We conducted a phase II randomized trial where patients received intermediate-dose cytarabine for four days followed by gemtuzumab ozogamicin on day 5 (Arm A), or combined with liposomal daunorubicin for three days (Arm B), or cytarabine given for five days combined with cyclophosphamide for three days and topotecan by continuous infusion for 5 days (Arm C). Eligible patients had primary refractory AML, a first relapse after a remission of less than one year, or a second or greater relapse. The primary objective of this trial was attainment of a conventional complete remission (CR) or a CR without platelet recovery (CRp) in at least 40% of patients. The CR/CRp rates for the 82 eligible patients were 3/26 (12%) in Arm A, 2/29 (7%) in Arm B, and 1/27 (4%) in Arm C. No patients who had relapsed within six months of initial CR or who had suffered multiple relapses responded. More than 95% of patients subsequently died of AML. No unexpected toxicities were encountered. We conclude that none of these three regimens were effective enough in the treatment of high-risk relapsed or refractory AML to warrant further study. This trial was registered at http://www.clinicaltrials.gov as #NCT00005962.
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影响因子：
20.3
作者：
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通讯作者：
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