Recombinant granulocyte-macrophage colony-stimulating factor after autologous bone marrow transplantation for lymphoid cancer

John Nemunaitis, Susan N. Rabinowe, Jack W. Singer, Philip Jay Bierman, Julie Marie Vose, Arnold S. Freedman, Nicole Onetto, Steven Gillis, Dagmar Oette, Morris Gold, C. Dean Buckner, John A. Hansen, Jerome Ritz, Frederick R. Appelbaum, James Olen Armitage, Lee M. Nadler

Research output: Contribution to journalArticle

388 Citations (Scopus)

Abstract

Background. The period of neutropenia after autologous bone marrow transplantation results in substantial morbidity and mortality. The results of previous phase I-II clinical trials suggest that recombinant human granulocytemacrophage colony-stimulating factor (rhGM-CSF) may accelerate neutrophil recovery and thereby reduce complications in patients after autologous bone marrow transplantation. Methods. We conducted a randomized, double-blind, placebo-controlled trial at three institutions. The study design and treatment schedules were identical, and the results were pooled for analysis. One hundred twenty-eight patients were enrolled. Sixty-five patients received rhGM-CSF in a two-hour intravenous infusion daily for 21 days, starting within four hours of the marrow infusion, and 63 patients received placebo. Results. No toxic effects specifically ascribed to rhGM-CSF were observed. The patients given rhGM-CSF had a recovery of the neutrophil count to 500×106 per liter 7 days earlier than the patients who received placebo (19 vs. 26 days, P<0.001), had fewer infections, required 3 fewer days of antibiotic administration (24 vs. 27 days, P = 0.009), and required 6 fewer days of initial hospitalization (median, 27 vs. 33 days; P = 0.01). There was no difference in the survival rate at day 100. Conclusions. In patients undergoing autologous bone marrow transplantation for lymphoid neoplasia, rhGM-CSF significantly lessens morbidity. Further studies will be required to establish its optimal dosage and schedule of administration. (N Engl J Med 1991; 324:1773–8.)

Original languageEnglish (US)
Pages (from-to)1773-1778
Number of pages6
JournalNew England Journal of Medicine
Volume324
Issue number25
DOIs
StatePublished - Jun 20 1991

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Autologous Transplantation
Granulocyte-Macrophage Colony-Stimulating Factor
Bone Marrow Transplantation
Colony-Stimulating Factors
Neoplasms
Placebos
Appointments and Schedules
Neutrophils
Morbidity
Phase II Clinical Trials
Clinical Trials, Phase I
Poisons
Neutropenia
Intravenous Infusions
Hospitalization
Survival Rate
Bone Marrow
Anti-Bacterial Agents
Mortality
Infection

ASJC Scopus subject areas

  • Medicine(all)

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Recombinant granulocyte-macrophage colony-stimulating factor after autologous bone marrow transplantation for lymphoid cancer. / Nemunaitis, John; Rabinowe, Susan N.; Singer, Jack W.; Bierman, Philip Jay; Vose, Julie Marie; Freedman, Arnold S.; Onetto, Nicole; Gillis, Steven; Oette, Dagmar; Gold, Morris; Buckner, C. Dean; Hansen, John A.; Ritz, Jerome; Appelbaum, Frederick R.; Armitage, James Olen; Nadler, Lee M.

In: New England Journal of Medicine, Vol. 324, No. 25, 20.06.1991, p. 1773-1778.

Research output: Contribution to journalArticle

Nemunaitis, J, Rabinowe, SN, Singer, JW, Bierman, PJ, Vose, JM, Freedman, AS, Onetto, N, Gillis, S, Oette, D, Gold, M, Buckner, CD, Hansen, JA, Ritz, J, Appelbaum, FR, Armitage, JO & Nadler, LM 1991, 'Recombinant granulocyte-macrophage colony-stimulating factor after autologous bone marrow transplantation for lymphoid cancer', New England Journal of Medicine, vol. 324, no. 25, pp. 1773-1778. https://doi.org/10.1056/NEJM199106203242504
Nemunaitis, John ; Rabinowe, Susan N. ; Singer, Jack W. ; Bierman, Philip Jay ; Vose, Julie Marie ; Freedman, Arnold S. ; Onetto, Nicole ; Gillis, Steven ; Oette, Dagmar ; Gold, Morris ; Buckner, C. Dean ; Hansen, John A. ; Ritz, Jerome ; Appelbaum, Frederick R. ; Armitage, James Olen ; Nadler, Lee M. / Recombinant granulocyte-macrophage colony-stimulating factor after autologous bone marrow transplantation for lymphoid cancer. In: New England Journal of Medicine. 1991 ; Vol. 324, No. 25. pp. 1773-1778.
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abstract = "Background. The period of neutropenia after autologous bone marrow transplantation results in substantial morbidity and mortality. The results of previous phase I-II clinical trials suggest that recombinant human granulocytemacrophage colony-stimulating factor (rhGM-CSF) may accelerate neutrophil recovery and thereby reduce complications in patients after autologous bone marrow transplantation. Methods. We conducted a randomized, double-blind, placebo-controlled trial at three institutions. The study design and treatment schedules were identical, and the results were pooled for analysis. One hundred twenty-eight patients were enrolled. Sixty-five patients received rhGM-CSF in a two-hour intravenous infusion daily for 21 days, starting within four hours of the marrow infusion, and 63 patients received placebo. Results. No toxic effects specifically ascribed to rhGM-CSF were observed. The patients given rhGM-CSF had a recovery of the neutrophil count to 500×106 per liter 7 days earlier than the patients who received placebo (19 vs. 26 days, P<0.001), had fewer infections, required 3 fewer days of antibiotic administration (24 vs. 27 days, P = 0.009), and required 6 fewer days of initial hospitalization (median, 27 vs. 33 days; P = 0.01). There was no difference in the survival rate at day 100. Conclusions. In patients undergoing autologous bone marrow transplantation for lymphoid neoplasia, rhGM-CSF significantly lessens morbidity. Further studies will be required to establish its optimal dosage and schedule of administration. (N Engl J Med 1991; 324:1773–8.)",
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T1 - Recombinant granulocyte-macrophage colony-stimulating factor after autologous bone marrow transplantation for lymphoid cancer

AU - Nemunaitis, John

AU - Rabinowe, Susan N.

AU - Singer, Jack W.

AU - Bierman, Philip Jay

AU - Vose, Julie Marie

AU - Freedman, Arnold S.

AU - Onetto, Nicole

AU - Gillis, Steven

AU - Oette, Dagmar

AU - Gold, Morris

AU - Buckner, C. Dean

AU - Hansen, John A.

AU - Ritz, Jerome

AU - Appelbaum, Frederick R.

AU - Armitage, James Olen

AU - Nadler, Lee M.

PY - 1991/6/20

Y1 - 1991/6/20

N2 - Background. The period of neutropenia after autologous bone marrow transplantation results in substantial morbidity and mortality. The results of previous phase I-II clinical trials suggest that recombinant human granulocytemacrophage colony-stimulating factor (rhGM-CSF) may accelerate neutrophil recovery and thereby reduce complications in patients after autologous bone marrow transplantation. Methods. We conducted a randomized, double-blind, placebo-controlled trial at three institutions. The study design and treatment schedules were identical, and the results were pooled for analysis. One hundred twenty-eight patients were enrolled. Sixty-five patients received rhGM-CSF in a two-hour intravenous infusion daily for 21 days, starting within four hours of the marrow infusion, and 63 patients received placebo. Results. No toxic effects specifically ascribed to rhGM-CSF were observed. The patients given rhGM-CSF had a recovery of the neutrophil count to 500×106 per liter 7 days earlier than the patients who received placebo (19 vs. 26 days, P<0.001), had fewer infections, required 3 fewer days of antibiotic administration (24 vs. 27 days, P = 0.009), and required 6 fewer days of initial hospitalization (median, 27 vs. 33 days; P = 0.01). There was no difference in the survival rate at day 100. Conclusions. In patients undergoing autologous bone marrow transplantation for lymphoid neoplasia, rhGM-CSF significantly lessens morbidity. Further studies will be required to establish its optimal dosage and schedule of administration. (N Engl J Med 1991; 324:1773–8.)

AB - Background. The period of neutropenia after autologous bone marrow transplantation results in substantial morbidity and mortality. The results of previous phase I-II clinical trials suggest that recombinant human granulocytemacrophage colony-stimulating factor (rhGM-CSF) may accelerate neutrophil recovery and thereby reduce complications in patients after autologous bone marrow transplantation. Methods. We conducted a randomized, double-blind, placebo-controlled trial at three institutions. The study design and treatment schedules were identical, and the results were pooled for analysis. One hundred twenty-eight patients were enrolled. Sixty-five patients received rhGM-CSF in a two-hour intravenous infusion daily for 21 days, starting within four hours of the marrow infusion, and 63 patients received placebo. Results. No toxic effects specifically ascribed to rhGM-CSF were observed. The patients given rhGM-CSF had a recovery of the neutrophil count to 500×106 per liter 7 days earlier than the patients who received placebo (19 vs. 26 days, P<0.001), had fewer infections, required 3 fewer days of antibiotic administration (24 vs. 27 days, P = 0.009), and required 6 fewer days of initial hospitalization (median, 27 vs. 33 days; P = 0.01). There was no difference in the survival rate at day 100. Conclusions. In patients undergoing autologous bone marrow transplantation for lymphoid neoplasia, rhGM-CSF significantly lessens morbidity. Further studies will be required to establish its optimal dosage and schedule of administration. (N Engl J Med 1991; 324:1773–8.)

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