Human granulocyte colony-stimulating factor in children with high-risk acute lymphoblastic leukemia

A Children's Cancer Group Study

John A. Heath, Peter G. Steinherz, Arnold Altman, Harland Sather, Suresh Jhanwar, Steven Halpern, Richard Pieters, Narayan Shah, Laurel Steinherz, Raymond Tannous, William Terry, Michael E. Trigg

Research output: Contribution to journalArticle

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Abstract

Purpose: 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). Patients and Methods: 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 μg/kg/day) during either induction or initial consolidation. A crossover study analysis was done on the 259 patients who completed both phases of therapy. Results: The mean time to neutrophil recovery (≥ 0.5 × 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. Conclusion: Children with high-risk ALL do not appear to benefit from prophylactic G-CSF.

Original languageEnglish (US)
Pages (from-to)1612-1617
Number of pages6
JournalJournal of Clinical Oncology
Volume21
Issue number8
DOIs
StatePublished - Apr 15 2003
Externally publishedYes

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Granulocyte Colony-Stimulating Factor
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Neoplasms
Disease-Free Survival
Asparaginase
Drug Therapy
Febrile Neutropenia
Daunorubicin
Survival
Vincristine
Prednisone
Cyclophosphamide
Cross-Over Studies
Hospitalization
Neutrophils
Therapeutics
Brain
Infection
Pharmaceutical Preparations

All Science Journal Classification (ASJC) codes

  • Oncology
  • Cancer Research

Cite this

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. / Human granulocyte colony-stimulating factor in children with high-risk acute lymphoblastic leukemia : A Children's Cancer Group Study. In: Journal of Clinical Oncology. 2003 ; Vol. 21, No. 8. pp. 1612-1617.
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title = "Human granulocyte colony-stimulating factor in children with high-risk acute lymphoblastic leukemia: A Children's Cancer Group Study",
abstract = "Purpose: 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). Patients and Methods: 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 μg/kg/day) during either induction or initial consolidation. A crossover study analysis was done on the 259 patients who completed both phases of therapy. Results: The mean time to neutrophil recovery (≥ 0.5 × 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. Conclusion: Children with high-risk ALL do not appear to benefit from prophylactic G-CSF.",
author = "Heath, {John A.} and Steinherz, {Peter G.} and Arnold Altman and Harland Sather and Suresh Jhanwar and Steven Halpern and Richard Pieters and Narayan Shah and Laurel Steinherz and Raymond Tannous and William Terry and Trigg, {Michael E.}",
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Heath, JA, Steinherz, PG, Altman, A, Sather, H, Jhanwar, S, Halpern, S, Pieters, R, Shah, N, Steinherz, L, Tannous, R, Terry, W & Trigg, ME 2003, 'Human granulocyte colony-stimulating factor in children with high-risk acute lymphoblastic leukemia: A Children's Cancer Group Study', Journal of Clinical Oncology, vol. 21, no. 8, pp. 1612-1617. https://doi.org/10.1200/JCO.2003.07.129

Human granulocyte colony-stimulating factor in children with high-risk acute lymphoblastic leukemia : A Children's Cancer Group Study. / 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.

In: Journal of Clinical Oncology, Vol. 21, No. 8, 15.04.2003, p. 1612-1617.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Human granulocyte colony-stimulating factor in children with high-risk acute lymphoblastic leukemia

T2 - A Children's Cancer Group Study

AU - Heath, John A.

AU - Steinherz, Peter G.

AU - Altman, Arnold

AU - Sather, Harland

AU - Jhanwar, Suresh

AU - Halpern, Steven

AU - Pieters, Richard

AU - Shah, Narayan

AU - Steinherz, Laurel

AU - Tannous, Raymond

AU - Terry, William

AU - Trigg, Michael E.

PY - 2003/4/15

Y1 - 2003/4/15

N2 - Purpose: 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). Patients and Methods: 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 μg/kg/day) during either induction or initial consolidation. A crossover study analysis was done on the 259 patients who completed both phases of therapy. Results: The mean time to neutrophil recovery (≥ 0.5 × 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. Conclusion: Children with high-risk ALL do not appear to benefit from prophylactic G-CSF.

AB - Purpose: 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). Patients and Methods: 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 μg/kg/day) during either induction or initial consolidation. A crossover study analysis was done on the 259 patients who completed both phases of therapy. Results: The mean time to neutrophil recovery (≥ 0.5 × 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. Conclusion: Children with high-risk ALL do not appear to benefit from prophylactic G-CSF.

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DO - 10.1200/JCO.2003.07.129

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EP - 1617

JO - Journal of Clinical Oncology

JF - Journal of Clinical Oncology

SN - 0732-183X

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