Randomized, double-blind, placebo-controlled, phase III study of recombinant human granulocyte-macrophage colony-stimulating factor as adjunct to induction treatment of high-grade malignant non-Hodgkin's lymphomas [see comments]
Randomized, double-blind, placebo-controlled, phase III study of recombinant human granulocyte-macrophage colony-stimulating factor as adjunct to induction treatment of high-grade malignant non-Hodgkin's lymphomas [see comments]
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重组人粒细胞巨噬细胞集落刺激因子作为高级别恶性非霍奇金淋巴瘤诱导治疗辅助手段的随机、双盲、安慰剂对照 III 期研究 [见评论]
DOI：
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发表时间：
1993
期刊：
影响因子：
--
通讯作者：
W. Siegert
中科院分区：
文献类型：
--
作者：
H. Gerhartz;M. Engelhard;P. Meusers;G. Brittinger;W. Wilmanns;G. Schlimok;P. Mueller;D. Huhn;R. Musch;W. Siegert
我们评估了重组人粒细胞-巨噬细胞集落刺激因子（rhGM-CSF；Sandoz Pharma [巴塞尔，瑞士]/先灵葆雅[Kenilworth，新泽西]）作为改良（主要是环磷酰胺和阿霉素增加1.5倍）COP-BLAM方案的辅助疗法在高级恶性非霍奇金淋巴瘤（NHL）的主要治疗中的作用。患者（n = 182；II-IV 期；年龄，15 至 73 岁）在化疗后被随机皮下注射 rhGM-CSF（400 微克）或安慰剂 7 天。对接受至少 70% 研究药物的患者 (n = 125) 进行疗效分析。 rhGM-CSF 降低了临床相关感染的频率（28 比 69 例感染，16 比 30 例患者，P = .02），保持无感染的累积概率分别为 70% 和 48%（190 天时 P = .05 对数秩检验）。中性粒细胞减少症的持续时间（6 个疗程中的 5 个疗程中，P = .01）、发热天数（2.1 vs 4.0，P = .04）和感染住院天数（3.5 vs 8.0 天，P = .01）均显着减少。根据预后风险评估，治疗组的完全缓解 (CR) 率为 19 例中的 15 例 (79%)，而对照组的完全缓解率 (CR) 为 21 例中的 20 例 (95%) (P = .12)。在高风险组中，45 名治疗患者中有 31 名 (69%) 达到 CR，而对照组 52 名患者中有 25 名 (48%) (P = 0.04)。一年后未发现生存率有任何差异。只有注射部位反应（治疗组 45% vs 对照组 7%）和皮疹（26% vs 2%）在接受治疗的患者中发生频率更高 (n = 176)。这些数据表明，rhGM-CSF 在大多数 NHL 患者中具有良好的耐受性，可显着减少感染并改善反应。
We evaluated recombinant human granulocyte-macrophage colony- stimulating factor (rhGM-CSF; Sandoz Pharma [Basel, Switzerland]/Schering-Plough [Kenilworth, NJ]) as an adjunct to a modified (mainly cyclophosphamide and doxorubicin increased 1.5-fold) COP-BLAM regimen in the primary treatment of high-grade malignant non- Hodgkin9s lymphomas (NHL). Patients (n = 182; stage II-IV; age, 15 to 73 years) were randomized to rhGM-CSF (400 micrograms) or placebo for 7 days subcutaneously after chemotherapy. Efficacy was analyzed for patients receiving at least 70% of study medication (n = 125). The frequency of clinically relevant infection was reduced by rhGM-CSF (28 v 69 infections, 16 v 30 patients, P = .02) with a cumulative probability of remaining infection free in 70% versus 48% (P = .05 log rank test at 190 days). Periods of neutropenia (P = .01 in 5 of 6 courses), days with fever (2.1 v 4.0, P = .04) and days of hospitalization for infection (3.5 v 8.0 days, P = .01) were significantly reduced. Complete response (CR) rates, assessed by prognostic risk, were 15 of 19 (79%) in treated versus 20 of 21 (95%) in controls in the low-risk group (P = .12). In the high-risk group, 31 of 45 (69%) treated patients achieved CR versus 25 of 52 (48%) of controls (P = .04). No difference in survival has been seen after 1 year. Only injection site reactions (45% treated v 7% controls) and rash (26% v 2%) occurred more frequently in treated patients (n = 176). These data show that rhGM-CSF is well tolerated in most patients with NHL, significantly reduces infection, and improves response.
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影响因子：
50.5
作者：
FISHER, RI;GAYNOR, ER;MILLER, TP
通讯作者：
MILLER, TP
影响因子：
158.5
作者：
GORDON, LI;HARRINGTON, D;OCONNELL, M
通讯作者：
OCONNELL, M
影响因子：
158.5
作者：
ANTMAN, KS;GRIFFIN, JD;SCHNIPPER, LE
通讯作者：
SCHNIPPER, LE
影响因子：
45.3
作者：
KWAK, LW;HALPERN, J;HORNING, SJ
通讯作者：
HORNING, SJ
影响因子：
56.9
作者：
SOUZA, LM;BOONE, TC;WELTE, K
通讯作者：
WELTE, K