Granulocyte-colony stimulating factor administration to healthy individuals and persons with chronic neutropenia or cancer

An overview of safety considerations from the Research on Adverse Drug Events and Reports project

C. C. Tigue, June M McKoy, A. M. Evens, S. M. Trifilio, M. S. Tallman, C. L. Bennett*

*Corresponding author for this work

Research output: Contribution to journalReview article

125 Citations (Scopus)

Abstract

Granulocyte-colony stimulating factor (G-CSF) is widely administered to donors who provide peripheral blood stem cells (PBSC) for individuals who undergo hematopoietic stem cell transplants. Questions have been raised about the safety of G-CSF in this setting. Herein, the Research on Adverse Drug Events and Reports (RADAR) project investigators reviewed the literature on G-CSF-associated adverse events in healthy individuals or persons with chronic neutropenia or cancer. Toxicities identified included bone pain and rare instances of splenic rupture, allergic reactions, flares of underlying autoimmune disorders, lung injury and vascular events. Among healthy individuals, four patients developed splenic rupture shortly after G-CSF administration and three patients developed acute myeloid leukemia 1 to 5 years after G-CSF administration. Registry studies identified no increased risks of malignancy among healthy individuals who received G-CSF before PBSC harvesting. However, more than 2000 donors would have to be followed for 10 years to detect a 10-fold increase in leukemia risk. Our review identifies bone pain as the most common toxicity of G-CSF administration. There are questions about a causal relationship between G-CSF administration and acute leukemia, but more long-term safety data from database registries are needed to adequately evaluate such a relationship.

Original languageEnglish (US)
Pages (from-to)185-192
Number of pages8
JournalBone Marrow Transplantation
Volume40
Issue number3
DOIs
StatePublished - Aug 1 2007

Fingerprint

Granulocyte Colony-Stimulating Factor
Neutropenia
Drug-Related Side Effects and Adverse Reactions
Safety
Research
Neoplasms
Splenic Rupture
Registries
Leukemia
Tissue Donors
Bone and Bones
Pain
Lung Injury
Hematopoietic Stem Cells
Acute Myeloid Leukemia
Blood Vessels
Hypersensitivity
Research Personnel
Databases
Transplants

ASJC Scopus subject areas

  • Hematology
  • Transplantation

Cite this

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title = "Granulocyte-colony stimulating factor administration to healthy individuals and persons with chronic neutropenia or cancer: An overview of safety considerations from the Research on Adverse Drug Events and Reports project",
abstract = "Granulocyte-colony stimulating factor (G-CSF) is widely administered to donors who provide peripheral blood stem cells (PBSC) for individuals who undergo hematopoietic stem cell transplants. Questions have been raised about the safety of G-CSF in this setting. Herein, the Research on Adverse Drug Events and Reports (RADAR) project investigators reviewed the literature on G-CSF-associated adverse events in healthy individuals or persons with chronic neutropenia or cancer. Toxicities identified included bone pain and rare instances of splenic rupture, allergic reactions, flares of underlying autoimmune disorders, lung injury and vascular events. Among healthy individuals, four patients developed splenic rupture shortly after G-CSF administration and three patients developed acute myeloid leukemia 1 to 5 years after G-CSF administration. Registry studies identified no increased risks of malignancy among healthy individuals who received G-CSF before PBSC harvesting. However, more than 2000 donors would have to be followed for 10 years to detect a 10-fold increase in leukemia risk. Our review identifies bone pain as the most common toxicity of G-CSF administration. There are questions about a causal relationship between G-CSF administration and acute leukemia, but more long-term safety data from database registries are needed to adequately evaluate such a relationship.",
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Granulocyte-colony stimulating factor administration to healthy individuals and persons with chronic neutropenia or cancer : An overview of safety considerations from the Research on Adverse Drug Events and Reports project. / Tigue, C. C.; McKoy, June M; Evens, A. M.; Trifilio, S. M.; Tallman, M. S.; Bennett, C. L.

In: Bone Marrow Transplantation, Vol. 40, No. 3, 01.08.2007, p. 185-192.

Research output: Contribution to journalReview article

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T1 - Granulocyte-colony stimulating factor administration to healthy individuals and persons with chronic neutropenia or cancer

T2 - An overview of safety considerations from the Research on Adverse Drug Events and Reports project

AU - Tigue, C. C.

AU - McKoy, June M

AU - Evens, A. M.

AU - Trifilio, S. M.

AU - Tallman, M. S.

AU - Bennett, C. L.

PY - 2007/8/1

Y1 - 2007/8/1

N2 - Granulocyte-colony stimulating factor (G-CSF) is widely administered to donors who provide peripheral blood stem cells (PBSC) for individuals who undergo hematopoietic stem cell transplants. Questions have been raised about the safety of G-CSF in this setting. Herein, the Research on Adverse Drug Events and Reports (RADAR) project investigators reviewed the literature on G-CSF-associated adverse events in healthy individuals or persons with chronic neutropenia or cancer. Toxicities identified included bone pain and rare instances of splenic rupture, allergic reactions, flares of underlying autoimmune disorders, lung injury and vascular events. Among healthy individuals, four patients developed splenic rupture shortly after G-CSF administration and three patients developed acute myeloid leukemia 1 to 5 years after G-CSF administration. Registry studies identified no increased risks of malignancy among healthy individuals who received G-CSF before PBSC harvesting. However, more than 2000 donors would have to be followed for 10 years to detect a 10-fold increase in leukemia risk. Our review identifies bone pain as the most common toxicity of G-CSF administration. There are questions about a causal relationship between G-CSF administration and acute leukemia, but more long-term safety data from database registries are needed to adequately evaluate such a relationship.

AB - Granulocyte-colony stimulating factor (G-CSF) is widely administered to donors who provide peripheral blood stem cells (PBSC) for individuals who undergo hematopoietic stem cell transplants. Questions have been raised about the safety of G-CSF in this setting. Herein, the Research on Adverse Drug Events and Reports (RADAR) project investigators reviewed the literature on G-CSF-associated adverse events in healthy individuals or persons with chronic neutropenia or cancer. Toxicities identified included bone pain and rare instances of splenic rupture, allergic reactions, flares of underlying autoimmune disorders, lung injury and vascular events. Among healthy individuals, four patients developed splenic rupture shortly after G-CSF administration and three patients developed acute myeloid leukemia 1 to 5 years after G-CSF administration. Registry studies identified no increased risks of malignancy among healthy individuals who received G-CSF before PBSC harvesting. However, more than 2000 donors would have to be followed for 10 years to detect a 10-fold increase in leukemia risk. Our review identifies bone pain as the most common toxicity of G-CSF administration. There are questions about a causal relationship between G-CSF administration and acute leukemia, but more long-term safety data from database registries are needed to adequately evaluate such a relationship.

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