Human granulocyte colony-stimulating factor after induction chemotherapy in children with acute lymphoblastic leukemia

Ching Hon Pui, James M. Boyett, Walter T. Hughes, Gaston K. Rivera, Michael L. Hancock, John T. Sandlund, Timothy Synold, Mary V. Relling, Raul C. Ribeiro, William M. Crist, William E. Evans

Research output: Contribution to journalArticle

Abstract

Background: Recombinant human granulocyte colony-stimulating factor (G- CSF, or filgrastim) hastens the recovery from neutropenia after intensive chemotherapy, but its role in the management of childhood leukemia is unclear. Methods: We randomly assigned 164 patients with acute lymphoblastic leukemia (age range, 2 months to 17 years) to receive placebo or G-CSF (10 μg per kilogram of body weight per day subcutaneously), beginning one day after the completion of remission-induction therapy and continuing until the neutrophil count was greater than or equal to 1000 per cubic millimeter for two days. The clinical and laboratory effects of this therapy were documented for 21 days. The area under the plasma G-CSF concentration-time curve was measured on days 1 and 7 in both groups. Results: Responses to the growth factor could be assessed in 148 patients (73 in the G-CSF group and 75 in the placebo group). G-CSF treatment did not significantly lower the rate of hospitalization for febrile neutropenia (58 percent in the G-CSF group vs. 68 percent in the placebo group; relative risk, 0.85; 95 percent confidence interval, 0.59 to 1.16), increase the likelihood of event-free survival at three years (83 percent in both groups), or decrease the number of severe infections (five in the G-CSF group vs. six in the placebo group). Patients treated with G-CSF had shorter median hospital stays (6 days vs. 10 days, P=0.011) and fewer documented infections (12 vs. 27, P=0.009). The median total costs of supportive care were similar in the G-CSF and placebo groups ($8,768 and $8,616, respectively). Among patients who did not have febrile neutropenia during the first week of G-CSF or placebo injections, higher systemic exposure to the growth factor on day 7 was significantly related to a lower probability of subsequent hospitalization (P=0.049). Conclusions: G- CSF treatment had some clinical benefit in children who received induction chemotherapy for acute lymphoblastic leukemia, but it did not reduce the rate of hospitalization for febrile neutropenia, prolong survival, or reduce the cost of supportive care.

Original languageEnglish (US)
Pages (from-to)1781-1787
Number of pages7
JournalNew England Journal of Medicine
Volume336
Issue number25
DOIs
StatePublished - 1997
Externally publishedYes

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Induction Chemotherapy
Granulocyte Colony-Stimulating Factor
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Placebos
Febrile Neutropenia
Hospitalization
Intercellular Signaling Peptides and Proteins
Remission Induction
Costs and Cost Analysis
Therapeutics
Infection
Neutropenia
Disease-Free Survival
Length of Stay
Leukemia
Neutrophils
Body Weight

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Pui, C. H., Boyett, J. M., Hughes, W. T., Rivera, G. K., Hancock, M. L., Sandlund, J. T., ... Evans, W. E. (1997). Human granulocyte colony-stimulating factor after induction chemotherapy in children with acute lymphoblastic leukemia. New England Journal of Medicine, 336(25), 1781-1787. https://doi.org/10.1056/NEJM199706193362503

Human granulocyte colony-stimulating factor after induction chemotherapy in children with acute lymphoblastic leukemia. / Pui, Ching Hon; Boyett, James M.; Hughes, Walter T.; Rivera, Gaston K.; Hancock, Michael L.; Sandlund, John T.; Synold, Timothy; Relling, Mary V.; Ribeiro, Raul C.; Crist, William M.; Evans, William E.

In: New England Journal of Medicine, Vol. 336, No. 25, 1997, p. 1781-1787.

Research output: Contribution to journalArticle

Pui, CH, Boyett, JM, Hughes, WT, Rivera, GK, Hancock, ML, Sandlund, JT, Synold, T, Relling, MV, Ribeiro, RC, Crist, WM & Evans, WE 1997, 'Human granulocyte colony-stimulating factor after induction chemotherapy in children with acute lymphoblastic leukemia', New England Journal of Medicine, vol. 336, no. 25, pp. 1781-1787. https://doi.org/10.1056/NEJM199706193362503
Pui, Ching Hon ; Boyett, James M. ; Hughes, Walter T. ; Rivera, Gaston K. ; Hancock, Michael L. ; Sandlund, John T. ; Synold, Timothy ; Relling, Mary V. ; Ribeiro, Raul C. ; Crist, William M. ; Evans, William E. / Human granulocyte colony-stimulating factor after induction chemotherapy in children with acute lymphoblastic leukemia. In: New England Journal of Medicine. 1997 ; Vol. 336, No. 25. pp. 1781-1787.
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abstract = "Background: Recombinant human granulocyte colony-stimulating factor (G- CSF, or filgrastim) hastens the recovery from neutropenia after intensive chemotherapy, but its role in the management of childhood leukemia is unclear. Methods: We randomly assigned 164 patients with acute lymphoblastic leukemia (age range, 2 months to 17 years) to receive placebo or G-CSF (10 μg per kilogram of body weight per day subcutaneously), beginning one day after the completion of remission-induction therapy and continuing until the neutrophil count was greater than or equal to 1000 per cubic millimeter for two days. The clinical and laboratory effects of this therapy were documented for 21 days. The area under the plasma G-CSF concentration-time curve was measured on days 1 and 7 in both groups. Results: Responses to the growth factor could be assessed in 148 patients (73 in the G-CSF group and 75 in the placebo group). G-CSF treatment did not significantly lower the rate of hospitalization for febrile neutropenia (58 percent in the G-CSF group vs. 68 percent in the placebo group; relative risk, 0.85; 95 percent confidence interval, 0.59 to 1.16), increase the likelihood of event-free survival at three years (83 percent in both groups), or decrease the number of severe infections (five in the G-CSF group vs. six in the placebo group). Patients treated with G-CSF had shorter median hospital stays (6 days vs. 10 days, P=0.011) and fewer documented infections (12 vs. 27, P=0.009). The median total costs of supportive care were similar in the G-CSF and placebo groups ($8,768 and $8,616, respectively). Among patients who did not have febrile neutropenia during the first week of G-CSF or placebo injections, higher systemic exposure to the growth factor on day 7 was significantly related to a lower probability of subsequent hospitalization (P=0.049). Conclusions: G- CSF treatment had some clinical benefit in children who received induction chemotherapy for acute lymphoblastic leukemia, but it did not reduce the rate of hospitalization for febrile neutropenia, prolong survival, or reduce the cost of supportive care.",
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T1 - Human granulocyte colony-stimulating factor after induction chemotherapy in children with acute lymphoblastic leukemia

AU - Pui, Ching Hon

AU - Boyett, James M.

AU - Hughes, Walter T.

AU - Rivera, Gaston K.

AU - Hancock, Michael L.

AU - Sandlund, John T.

AU - Synold, Timothy

AU - Relling, Mary V.

AU - Ribeiro, Raul C.

AU - Crist, William M.

AU - Evans, William E.

PY - 1997

Y1 - 1997

N2 - Background: Recombinant human granulocyte colony-stimulating factor (G- CSF, or filgrastim) hastens the recovery from neutropenia after intensive chemotherapy, but its role in the management of childhood leukemia is unclear. Methods: We randomly assigned 164 patients with acute lymphoblastic leukemia (age range, 2 months to 17 years) to receive placebo or G-CSF (10 μg per kilogram of body weight per day subcutaneously), beginning one day after the completion of remission-induction therapy and continuing until the neutrophil count was greater than or equal to 1000 per cubic millimeter for two days. The clinical and laboratory effects of this therapy were documented for 21 days. The area under the plasma G-CSF concentration-time curve was measured on days 1 and 7 in both groups. Results: Responses to the growth factor could be assessed in 148 patients (73 in the G-CSF group and 75 in the placebo group). G-CSF treatment did not significantly lower the rate of hospitalization for febrile neutropenia (58 percent in the G-CSF group vs. 68 percent in the placebo group; relative risk, 0.85; 95 percent confidence interval, 0.59 to 1.16), increase the likelihood of event-free survival at three years (83 percent in both groups), or decrease the number of severe infections (five in the G-CSF group vs. six in the placebo group). Patients treated with G-CSF had shorter median hospital stays (6 days vs. 10 days, P=0.011) and fewer documented infections (12 vs. 27, P=0.009). The median total costs of supportive care were similar in the G-CSF and placebo groups ($8,768 and $8,616, respectively). Among patients who did not have febrile neutropenia during the first week of G-CSF or placebo injections, higher systemic exposure to the growth factor on day 7 was significantly related to a lower probability of subsequent hospitalization (P=0.049). Conclusions: G- CSF treatment had some clinical benefit in children who received induction chemotherapy for acute lymphoblastic leukemia, but it did not reduce the rate of hospitalization for febrile neutropenia, prolong survival, or reduce the cost of supportive care.

AB - Background: Recombinant human granulocyte colony-stimulating factor (G- CSF, or filgrastim) hastens the recovery from neutropenia after intensive chemotherapy, but its role in the management of childhood leukemia is unclear. Methods: We randomly assigned 164 patients with acute lymphoblastic leukemia (age range, 2 months to 17 years) to receive placebo or G-CSF (10 μg per kilogram of body weight per day subcutaneously), beginning one day after the completion of remission-induction therapy and continuing until the neutrophil count was greater than or equal to 1000 per cubic millimeter for two days. The clinical and laboratory effects of this therapy were documented for 21 days. The area under the plasma G-CSF concentration-time curve was measured on days 1 and 7 in both groups. Results: Responses to the growth factor could be assessed in 148 patients (73 in the G-CSF group and 75 in the placebo group). G-CSF treatment did not significantly lower the rate of hospitalization for febrile neutropenia (58 percent in the G-CSF group vs. 68 percent in the placebo group; relative risk, 0.85; 95 percent confidence interval, 0.59 to 1.16), increase the likelihood of event-free survival at three years (83 percent in both groups), or decrease the number of severe infections (five in the G-CSF group vs. six in the placebo group). Patients treated with G-CSF had shorter median hospital stays (6 days vs. 10 days, P=0.011) and fewer documented infections (12 vs. 27, P=0.009). The median total costs of supportive care were similar in the G-CSF and placebo groups ($8,768 and $8,616, respectively). Among patients who did not have febrile neutropenia during the first week of G-CSF or placebo injections, higher systemic exposure to the growth factor on day 7 was significantly related to a lower probability of subsequent hospitalization (P=0.049). Conclusions: G- CSF treatment had some clinical benefit in children who received induction chemotherapy for acute lymphoblastic leukemia, but it did not reduce the rate of hospitalization for febrile neutropenia, prolong survival, or reduce the cost of supportive care.

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