1. ¹Division of Hematology/Oncology, Northwestern University Feinberg School of Medicine, Chicago, IL, USA
2. ²The Robert H Lurie Comprehensive Cancer Center, Chicago, IL, USA
3. ³The VA Center for Management of Complex Chronic Care, Jesse Brown VA Medical Center, Chicago, IL, USA
4. ⁴Division of Geriatric Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL, USA

Correspondence: Dr CL Bennett, Division of Hematology/Oncology, Northwestern University Feinberg School of Medicine, 303 E, Chicago Avenue, Olson Pavilion, Suite 8-250, Chicago, IL 60611, USA. E-mail: cbenne@northwestern.edu

Received 26 September 2006; Revised 13 April 2007; Accepted 20 April 2007; Published online 11 June 2007.

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.