A double-blind placebo-controlled trial of granulocyte colony-stimulating factor in elderly patients with previously untreated acute myeloid leukemia: A Southwest Oncology Group study (9031)
A double-blind placebo-controlled trial of granulocyte colony-stimulating factor in elderly patients with previously untreated acute myeloid leukemia: A Southwest Oncology Group study (9031)
复制标题
DOI：
10.1182/blood.v91.10.3607.3607_3607_3615
复制
发表时间：
1998-05-15
期刊：
影响因子：
20.3
通讯作者：
Appelbaum, FR
中科院分区：
文献类型：
--
作者：
Godwin, JE;Kopecky, KJ;Appelbaum, FR
年龄较大是急性髓系白血病（AML）的不良预后因素。这项双盲试验旨在检验粒细胞集落刺激因子 (G-CSF) 作为支持治疗可以改善老年 AML 患者治疗的假设。 234 名 55 岁或以上的形态学诊断为新发或继发性 AML、法美英 (FAB) M-0-M-7（不包括 M-3）的患者被随机分配至标准诱导方案（第 1 天至第 3 天静脉注射 45 mg/m(2) 柔红霉素 [IV]，第 1 天至第 3 天静脉注射 200 mg/m(2) 阿糖胞苷 (Ara-C)。 7) 加安慰剂或 G-CSF（400 μ g/m(2) IV，每日一次，持续 30 分钟）。这里报告了 211 例集中确诊的非 MB AML 病例的结果。两组在人口统计学、临床和血液学参数方面非常平衡，G-CSF 组的中位年龄为 68 岁，安慰剂组为 67 岁。 G-CSF 组的完全缓解 (CR) 率并没有显着提高：安慰剂组为 50%，G-CSF 组为 41%（单尾 P = .89）。中位总生存期也相似，安慰剂组为 9 个月（95% 置信区间 [CI]，7 至 10 个月），G-CSF 组为 6 个月（95% CI，3 至 8 个月）（P = .71）。我们发现 G-CSF 组的中性粒细胞恢复时间显着缩短 15% (P = .014)。 G-CSF 对血小板减少症的恢复 (P = .80) 或首次住院时间 (P = .27) 没有影响。当评估感染并发症时，G-CSF 对持续时间有有益影响，但对感染发生率没有影响。 G-CSF患者发烧的天数较少，抗生素的使用时间也较短。然而，记录的总感染频率或致命感染数量没有差异（19% 安慰剂 vs 20% G-CSF）。在这项针对老年 AML 患者的研究中，G-CSF 改善了中性粒细胞减少症持续时间和抗生素使用的临床参数，但没有改变 CR 率或生存率或缩短住院时间。 (C) 1998 年，美国血液学会。
Older age is a poor prognosis factor in acute myeloid leukemia (AML). This double-blind trial was designed to test the hypothesis that granulocyte colony-stimulating factor (G-CSF) used as supportive care could improve the treatment of elderly AML patients. Two hundred thirty-four patients 55 or more years of age with a morphologic diagnosis of de novo or secondary AML, French-American-British (FAB) M-0-M-7, excluding M-3, were randomly assigned to a standard induction regimen (daunorubicin at 45 mg/m(2) intravenously [IV] on days 1 through 3 and Ara-C at 200 mg/m(2) IV continuous infusion on days 1 through 7) plus either placebo or G-CSF (400 mu g/m(2) IV over 30 minutes once daily). Results are reported here for 211 centrally confirmed cases of non-MB AML. The two groups were well balanced in demographic, clinical, and hematological parameters, with median ages of 68 years in the G-CSF and 67 years in the placebo groups. The complete response (CR) rate was not significantly better in the G-CSF group: 50% in the placebo and 41% in the G-CSF group (one-tailed P = .89), Median overall survival was also similar, 9 months (95% confidence interval [CI], 7 to 10 months) in the placebo and 6 months (95% CI, 3 to 8 months) in the G-CSF arms (P = .71). We found a significant 15% reduction in the time to neutrophil recovery in the G-CSF group (P = .014). G-CSF had no impact on recovery from thrombocytopenia (P = .80) or duration of first hospitalization (P = .27). When infection complications were evaluated, G-CSF had a beneficial effect on the duration but not on incidence of infection. G-CSF patients had fewer days with fever and shorter duration of antibiotic use. However, there was no difference in the frequency of total documented infections or in the number of fatal infections (19% placebo v 20% G-CSF), In this study of elderly AML patients, G-CSF improved clinical parameters of duration of neutropenia and antibiotic use, but did not change CR rate or survival or shorten hospitalization. (C) 1998 by The American Society of Hematology.