Adding lomustine to idarubicin and cytarabine for induction chemotherapy in older patients with acute myeloid leukemia: the BGMT 95 trial results
Adding lomustine to idarubicin and cytarabine for induction chemotherapy in older patients with acute myeloid leukemia: the BGMT 95 trial results
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DOI：
10.3324/haematol.11068
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发表时间：
2007-10-01
期刊：
影响因子：
10.1
通讯作者：
Reiffers, Josy
中科院分区：
文献类型：
--
作者：
Pigneux, Arnaud;Perreau, Virginie;Reiffers, Josy
背景和目的老年患者急性髓系白血病（AML）的治疗仍不令人满意。针对老年患者的 BGMT 95 试验旨在通过在诱导时在 5+7 伊达比星和阿糖胞苷方案中添加第三种药物（洛莫司汀）并评估中等剂量阿糖胞苷作为巩固治疗来改善这些患者的预后。设计和方法进行了一项多中心随机试验，比较伊达比星和阿糖胞苷诱导治疗 5+7 (IC) 与相同药物加洛莫司汀 (CCNU) 的诱导治疗 (CCNU) 200 mg\m(2) 第 1 天口服 (ICL)。然后，完全缓解 (CR) 的患者被随机分配接受维持治疗或强化中等剂量阿糖胞苷和伊达比星，然后进行维持治疗。 结果 1995 年至 2001 年间，来自 10 个中心的 364 名患者（≥ 60 岁）被纳入研究。 IC 组患者的 CR 率为 58%，ICL 组患者的 CR 率为 67% (p=0.104)。中位总生存期 (OS) 分别为 7 个月和 12 个月 (p=0.05)，但 2 年 OS 没有统计学差异：ICL 组患者为 31 +/- 7%，而 IC 组患者为 24 +/- 6%。两种缓解后策略产生相似的结果。解释和结论在伊达比星和阿糖胞苷诱导治疗中添加洛莫司汀并没有统计学上改善老年 AML 患者的生存率。在巩固治疗中添加中等剂量阿糖胞苷并没有改善结果。
Background and ObjectivesTreatment of acute myeloid leukemia (AML) in older patients remains unsatisfactory. The BGMT 95 trial for older patients set out to improve the outcome of these patients by adding a third drug (lomustine) to a 5+7 idarubicin and cytarabine schedule at induction and evaluating intermediate-dose cytarabine as consolidation.Design and MethodsA multicenter randomized trial was performed comparing induction therapy with idarubicin and cytarabine, 5+7 (IC) to induction therapy with the same drugs plus lomustine (CCNU), 200 mg\m(2) orally on day 1 (ICL). Patients in complete remission (CR) were then randomized to receive either maintenance therapy or intensification with intermediate-dose cytarabine and idarubicin followed by maintenance therapy.ResultsBetween 1995 and 2001, 364 patients (>= 60 years) from ten centers were included. The CR rate was 58% for patients in the IC arm and 67% for patients in the ICL arm (p=0.104). The median overall survival (OS) was 7 and 12 months respectively (p=0.05), but OS at 2 years was not statistically different: 31 +/- 7% for patients in the ICL arm vs 24 +/- 6% for those in the IC arm. The two post-remission strategies yielded similar results.Interpretation and ConclusionsAdding lomustine to induction with idarubicin and cytarabine therapy did not statistically improve survival in elderly patients with AML. Adding intermediate-dose cytarabine to consolidation therapy did not improve outcome.