Haematological malignancies developing in previously healthy individuals who received haematopoietic growth factors: report from the Research on Adverse Drug Events and Reports (RADAR) project

被引:112
作者
Bennett, Charles L.
Evens, Andrew M.
Andritsos, Leslie A.
Balasubramanian, Lakshmi
Mai, Mark
Fisher, Matthew J.
Kuzel, Timothy M.
Angelotta, Cara
Mckoy, June M.
Vose, Julie M.
Bierman, Philip J.
Kuter, David J.
Trifilio, Steven M.
Devine, Steven M.
Tallman, Martin S.
机构
[1] Northwestern Univ, Feinberg Sch Med, Div Hematol Oncol, Dept Med, Chicago, IL 60611 USA
[2] Washington Univ, Sch Med, St Louis, MO 63130 USA
[3] Harvard Univ, Sch Med, Boston, MA 02114 USA
[4] Univ Nebraska, Sch Med, Omaha, NE 68583 USA
关键词
haematopoietic growth factors; megakaryocyte growth and development factor; granulocyte colony-stimulating factor; Research on Adverse Drug Events and Reports;
D O I
10.1111/j.1365-2141.2006.06312.x
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
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.
引用
收藏
页码:642 / 650
页数:9
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