Risk of Cancer in Healthy Individuals After G-CSF, PEG-rHuMGDF?

[Guest guest]

[No causal link yet, but something to keep a watch on. However, risk

seems low in any case.]

Br J Haematol. 2006 Oct 19; [Epub ahead of print] Links

Haematological malignancies developing in previously healthy

individuals who received haematopoietic growth factors: report from

the Research on Adverse Drug Events and Reports (RADAR) project.

* CL, et al

VA Midwest Center for Health Services and Policy Research, the

Brown VA Medical Center, Department of Medicine, Northwestern

University, Chicago, IL, USA.

Pegylated recombinant human megakaryocyte growth and development

factor (PEG-rHuMGDF) and granulocyte colony-stimulating factor (G-CSF)

promote haematopoietic progenitor cell maturation. We reviewed the

findings for healthy volunteers/donors who developed haematological

malignancies following PEG-rHuMGDF or G-CSF administration.

Information was reviewed for three of 538 volunteers who received

PEG-rHuMGDF in clinical trials and two of 200 donors who underwent

G-CSF mobilised stem cell harvesting procedures for sibling stem cell

transplants. Mantle cell, diffuse large B-cell lymphoma and chronic

lymphocytic leukaemia were diagnosed 1-5 years after PEG-rHuMGDF

exposure among three volunteers. For one patient, thrombocytopenia due

to autoantibodies to PEG-rHuMGDF developed shortly after PEG-rHuMGDF

administration and persisted until chemotherapy was administered. All

three achieved complete remission, although one patient relapsed.

Acute myeloid leukaemia was diagnosed 4 and 5 years after G-CSF

mobilisation in two donors who underwent peripheral blood stem cell

donation for sibling allogeneic haematopoietic stem cell

transplantation. Following intensive chemotherapy, one died from acute

leukaemia and the second is in complete remission.

Controversy exists over the appropriateness of administering

haematopoietic growth factors to healthy individuals. While a causal

relationship with haematological malignancies cannot be demonstrated,

long-term follow-up among healthy individuals who receive

haematopoietic growth factors is needed.

PMID: 17054431 [PubMed - as supplied by publisher]