Heath John A, Steinherz Peter G, Altman Arnold, Sather Harland, Jhanwar Suresh, Halpern Steven, Pieters Richard, Shah Narayan, Steinherz Laurel, Tannous Raymond, Terry William, Trigg Michael E
Department of Pediatrics, Memorial Sloan-Kettering Cancer Center, 1275 York Avenue, New York, NY 10021, USA.
J Clin Oncol. 2003 Apr 15;21(8):1612-7. doi: 10.1200/JCO.2003.07.129.
To investigate the effect of granulocyte colony-stimulating factor (G-CSF) on hematopoietic toxicities, supportive care requirements, time to complete intensive therapy, and event-free survival (EFS) and overall survival (OS) in children with high-risk acute lymphoblastic leukemia (HR-ALL).
A total of 287 children with HR-ALL were randomly assigned to intensive chemotherapy regimens (New York I [NY I] or NY II) as part of the Children's Cancer Group (CCG)-1901 protocol. The induction phases consisted of five drugs (vincristine, prednisone, l-asparaginase, daunorubicin, and cyclophosphamide). Initial consolidation comprised six-agent chemotherapy combined with 18 Gy of total-brain irradiation. Patients were randomly assigned to receive G-CSF (5 microg/kg/day) during either induction or initial consolidation. A crossover study analysis was done on the 259 patients who completed both phases of therapy.
The mean time to neutrophil recovery (>/= 0.5 x 109/L) was reduced with G-CSF (16.7 v 19.1 days, P =.0003); however, patients who received G-CSF did not have significantly reduced episodes of febrile neutropenia (149 v 164, P =.41), positive blood cultures (57 v 61, P =.66), or serious infections (75 v 79, P =.62). Hospitalization (14.0 v 13.9 days, P =.87) and induction therapy completion times (NY I, 30.3 v 31.3 days, P =.11; NY II, 33.4 v 32.3 days, P =.40) were not significantly altered. There were no differences in 6-year EFS (P =.24) or OS (P =.54) between patients receiving or not receiving G-CSF on CCG-1901, NY I and NY II.
Children with high-risk ALL do not appear to benefit from prophylactic G-CSF.
探讨粒细胞集落刺激因子（G-CSF）对高危急性淋巴细胞白血病（HR-ALL）患儿造血毒性、支持治疗需求、完成强化治疗时间、无事件生存期（EFS）及总生存期（OS）的影响。
总共287例HR-ALL患儿被随机分配至强化化疗方案（纽约I [NY I]或NY II），作为儿童癌症组（CCG）-1901方案的一部分。诱导期由五种药物（长春新碱、泼尼松、L-门冬酰胺酶、柔红霉素和环磷酰胺）组成。初始巩固治疗包括六药联合化疗及18 Gy全脑照射。患者被随机分配在诱导期或初始巩固期接受G-CSF（5微克/千克/天）。对完成两个治疗阶段的259例患者进行了交叉研究分析。
使用G-CSF可缩短中性粒细胞恢复至≥0.5×10⁹/L的平均时间（16.7天对19.1天，P = 0.0003）；然而，接受G-CSF的患者发热性中性粒细胞减少发作次数（149次对164次，P = 0.41）、血培养阳性次数（57次对61次，P = 0.66）或严重感染次数（75次对79次，P = 0.62）并无显著减少。住院时间（14.0天对13.9天，P = 0.87）及诱导治疗完成时间（NY I，30.3天对31.3天，P = 0.11；NY II，33.4天对32.3天，P = 0.40）未发生显著改变。在CCG-1901、NY I和NY II中，接受或未接受G-CSF的患者6年EFS（P = 0.24）或OS（P = 0.54）无差异。
高危ALL患儿似乎未从预防性G-CSF中获益。
