Outcomes in CCG-2961, a Children's Oncology Group Phase 3 Trial for untreated pediatric acute myeloid leukemia: a report from the Children's Oncology Group
Outcomes in CCG-2961, a Children's Oncology Group Phase 3 Trial for untreated pediatric acute myeloid leukemia: a report from the Children's Oncology Group
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DOI：
10.1182/blood-2007-04-084293
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发表时间：
2008-02-01
期刊：
影响因子：
20.3
通讯作者：
Alonzo, Todd A.
中科院分区：
文献类型：
--
作者：
Lange, Beverly J.;Smith, Franklin O.;Alonzo, Todd A.
CCG-2961将3种新药物（伊达比妥、氟达拉滨和白细胞介素-2）纳入一项III期AML试验，该试验采用强化定时缓解诱导/巩固和相关供体骨髓移植或高剂量阿糖胞苷强化治疗。在901例21岁以下的患者中，5年生存率为52%，无事件生存率为42%。生存率从1996年至1998年的44%提高到2000年至2002年的58%（P =.005），治疗相关死亡率从19%下降到12%（P =.025）。在5种药物诱导组合中，用伊达鲁肽部分替代道诺霉素，达到了88%的缓解率，与历史对照相似。在随机分配至5种药物再诱导或氟达拉滨/阿糖胞苷/依达拉滨的患者中，缓解后生存率为56%。对于有或没有相关供体的患者，5年无病生存率分别为61%和50%（P = 0.021）;生存率分别为68%和62%（P = 0.425）。供者可用性对inv（16）或t（8;21）细胞遗传学患者没有任何益处。阿糖胞苷强化治疗后，随机接受白细胞介素-2或不接受白细胞介素-2治疗的患者结局相似。预测低生存率的因素包括年龄大于16岁、非白色种族、缺乏相关供体、肥胖、白色血细胞计数大于100 000 x 10（9）/L、-7/7q-、-5/5q-和/或复杂核型。没有新的药物改善结果;经验可能有助于更好的结果时间。
CCG-2961 incorporated 3 new agents, idarubicin, fludarabine and interleukin-2, into a phase 3 AML trial using Intensive-timing remission induction/consolidation and related donor marrow transplantation or high-dose cytarabine intensification. Among 901 patients under age 21 years, 5-year survival was 52%, and event-free survival was 42%. Survival improved from 44% between 1996 and 1998 to 58% between 2000 and 2002 (P =.005), and treatment-related mortality declined from 19% to 12% (P =.025). Partial replacement of daunomycin with idarubicin in the 5-drug induction combination achieved a remission rate of 88%, similar to historical controls. Postremission survival was 56% in patients randomized to either 5-drug reinduction or fludarabine/ cytarabine/idarubicin. For patients with or without a related donor, respective 5-year disease-free survival was 61% and 50% (P =.021); respective survival was 68% and 62% (P =.425). Donor availability conferred no benefit on those with inv(16) or t(8;21) cytogenetics. After cytarabine intensification, patients randomized to interleukin-2 or none experienced similar outcomes. Factors predictive of inferior survival were age more than 16 years, non-white ethnicity, absence of related donor, obesity, white blood cell count more than 100 000 x 10(9)/L, -7/7q-, -5/5q-, and/or complex karyotype. No new agent improved outcomes; experience may have contributed to better results time.