Long-Term Safety of GM-CSF (Molgramostim) Administration After Allogeneic Bone Marrow Transplantation for Hematologic Malignancies: Five-Year Follow-Up of a Double-Blind Randomized Placebo-Controlled Study

Seema Singhal*, Ray Powles, Jennie Treleaven, Clive Horton, Jayesh Mehta

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

8 Scopus citations

Abstract

In a double-blind, randomized study performed between 1988 and 1990,40 patients undergoing allogeneic BMT from HLA-identical siblings for hematologic malignancies received 8 mg/kg/d rHuGM-CSF (molgramostim, n = 20) or placebo (n = 20) for 14 days. The median neutrophil count on day 14 was significantly higher in the GM-CSF group (1.90 vs 0.46 109/L, P<. 0001). The incidence of acute GVHD and transplant-related mortality were comparable. Only two deaths occurred after 6 months; one due to pulmonary fibrosis in the GM-CSF group on day 1591, and one due to relapse on day 1590 in the placebo group. The Karnofsky score of the 10 survivors, 3 in the placebo group and 7 in the GM-CSF group, is 90-100% (median 100%), and none has chronic GVHD requiring therapy. There was no evidence of increased relapse in the GM-CSF group with only two relapses occumng; both in the placebo group. With a follow-up of 4.5-6.8 years (median 5.5 years), these patients are amongst the longest surviving patients to have received a recombinant growth factor post-allo-graft. We conclude that the administration of GM-CSF after allogeneic BMT does not appear to be associated with an increased incidence of chronic GVHD or relapse, or of other adverse effects such as the development of myelodysplasia.

Original languageEnglish (US)
Pages (from-to)301-307
Number of pages7
JournalLeukemia and Lymphoma
Volume24
Issue number42067
DOIs
StatePublished - Jan 1 1997

Keywords

  • Allogeneic bone marrow transplantation
  • GM-CSF
  • Relapse
  • graft-versus-host disease
  • leukemia
  • molgramostim
  • myelodysplastic syndrome

ASJC Scopus subject areas

  • Hematology
  • Oncology
  • Cancer Research

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