Randomized trial of recombinant human granulocyte-macrophage colony-stimulating factor in pediatric patients receiving intensive myelosuppressive chemotherapy.
Randomized trial of recombinant human granulocyte-macrophage colony-stimulating factor in pediatric patients receiving intensive myelosuppressive chemotherapy.
复制标题
重组人粒细胞-巨噬细胞集落刺激因子在接受强化骨髓抑制化疗的儿科患者中的随机试验。
DOI：
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发表时间：
1996
影响因子：
45.3
通讯作者：
Marc E. Horowitz
中科院分区：
文献类型：
--
作者：
Leonard H. Wexler;Linda Weaver‐McClure;S. M. Steinberg;J. Jacobson;P. Jarosinski;Nilo A. Avila;P. A. Pizzo;Marc E. Horowitz
目的
目的：评价重组人粒细胞巨噬细胞集落刺激因子(GM-CSF)能否降低儿童和青壮年肉瘤患者强化联合放化疗方案的血液学毒性和支持性护理需求。
患者和方法
37例年龄1~25岁的新诊断患者被随机分成两组，每组18个周期。化疗结束后24小时开始用GM-CSF(5~15微克/公斤/天)皮下注射，每周期19天或至粒细胞绝对值(AGC)<或=500/微升，连续2天。
结果
GM-CSF使4级粒细胞减少的中位持续时间从9.0天(2~24天)降至7.0天(1~21天)(P<；0.0001)，但对粒细胞最低值的影响不明显。在感染并发症的发生率或类型、住院和抗菌治疗的发生率或持续时间、对化疗的反应、无事件或总存活率方面没有差异。GM-CSF与更严重和更持久的血小板减少相关(血小板最低点中位数，29,500/微升[范围，3,000至288,000]v 59,000/微升[范围，3,000至309,000]，P<；.0001；中位恢复时间；75,000/微升，16.0天[范围，0至61]对14.0天[范围，0至38]，P<；.0001)。
结论
GM-CSF对强化多药化疗后严重粒细胞减少的程度或持续时间没有临床意义的减少，但与恶化的血小板减少有关。GM-CSF也不能减少住院的需要或发热性中性粒细胞减少症和感染性并发症的发生率。我们的结论是，对于这种强度的方案，使用这种药物所带来的成本和增加的毒性是不合理的，因为它的临床益处微乎其微。
PURPOSE
To evaluate whether recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF) reduces the hematologic toxicities and supportive care requirements of an intensive combination chemoradiotherapy regimen in pediatric and young adult sarcoma patients.
PATIENTS AND METHODS
Thirty-seven newly diagnosed patients age 1 to 25 years were randomized to receive 18 cycles of chemotherapy alone or with GM-CSF beginning in cycle 3. GM-CSF (5 to 15 micrograms/kg/d subcutaneously) was begun 24 hours after the completion of chemotherapy and continued through day 19 of each cycle or until the absolute granulocyte count (AGC) was > or = 500/microliter on 2 consecutive days.
RESULTS
GM-CSF reduced the median duration of grade 4 granulocytopenia from 9.0 days (range, 2 to 24) to 7.0 days (range, 1 to 21) (P < .0001), but did not significantly affect the grade of granulocyte nadir. No differences were seen in the incidence or types of infectious complications, incidence or duration of hospitalization and antimicrobial therapy, response to chemotherapy, or event-free or overall survival. GM-CSF was associated with more severe and protracted thrombocytopenia (median platelet nadir, 29,500/microliter [range, 3,000 to 288,000] v 59,000/microliter [range, 3,000 to 309,000], P < .0001; median time to recovery > 75,000/microliter, 16.0 days [range, 0 to 61] v 14.0 days [range, 0 to 38], P < .0001).
CONCLUSION
GM-CSF does not produce clinically meaningful reductions in the degree or duration of severe granulocytopenia following intensive multiagent chemotherapy, but is associated with worsened thrombocytopenia. GM-CSF also does not reduce the need for hospitalization or the incidence of febrile neutropenia and infectious complications. We conclude that the costs and increased toxicities associated with the use of this agent are not justified by its minimal clinical benefit for regimens of this level of intensity.
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影响因子：
20.3
作者：
Nemunaitis,J;Anasetti,C;Storb,R;Bianco,JA;Buckner,CD;Onetto,N;Martin,P;Sanders,J;Sullivan,K;Mori,M
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DOI：
10.1093/jnci/81.18.1370
发表时间：
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期刊：
Journal of the National Cancer Institute
影响因子：
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作者：
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影响因子：
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DOI：
10.1002/mpo.2950230403
发表时间：
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期刊：
Medical and pediatric oncology
影响因子：
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影响因子：
20.3
作者：
Nemunaitis,J;Buckner,CD;Appelbaum,FR;Higano,CS;Mori,M;Bianco,J;Epstein,C;Lipani,J;Hansen,J;Storb,R
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Storb,R