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A Phase II study on the safety and efficacy of a single dose of pegfilgrastim for mobilization and transplantation of autologous hematopoietic stem cells in pediatric oncohematology patients.
- Source :
-
Transfusion [Transfusion] 2011 Nov; Vol. 51 (11), pp. 2480-7. Date of Electronic Publication: 2011 May 04. - Publication Year :
- 2011
-
Abstract
- Background: Limited data are available on the use of pegfilgrastim in pediatric patients as a mobilizing agent in association with chemotherapy.<br />Study Design and Methods: This was a prospective, multicenter, Phase II study to evaluate the safety and efficacy of a single dose of 100 µg/kg pegfilgrastim in mobilizing peripheral blood stem cells (PBSCs) in pediatric patients. The primary endpoint of the study was the percentage of good mobilizers with pegfilgrastim (blood peak of CD34+ cells ≥ 20 × 10(6) /L). The results were compared with a historical control group.<br />Results: Thirty of 36 recruited patients were classified as good mobilizers (83%). The median value of circulating CD34+ at leukapheresis was 143 × 10(6) /L (range, 20 × 10(6) -1988 × 10(6) /L). No significant adverse effects were associated with the use of pegfilgrastim and no patient was withdrawn from using the drug. A blood peak of 20 × 10(6) /L or more CD34+ was observed in 33 of 36 control patients (92%) and the median CD34+ count at leukapheresis was 158 × 10(6) /kg (range, 28 × 10(6) -4529 × 10(6) /kg; p = 0.7). No significant differences were found between the two groups in terms of toxicity or other variables of mobilization. As at October 2008, 23 patients of the pegfilgrastim group and 32 patients of the filgrastim group underwent autologous transplant. No significant differences were found in terms of early toxicity, myeloid recovery, and Day 100 survival.<br />Conclusion: A single dose of 100 µg/kg pegfilgrastim was safe and effective for PBSC collection in pediatric patients. We suggest that these results support the use of pegfilgrastim for pediatric patients.<br /> (© 2011 American Association of Blood Banks.)
- Subjects :
- Adolescent
Adult
Child
Child, Preschool
Female
Filgrastim
Granulocyte Colony-Stimulating Factor adverse effects
Humans
Infant
Male
Polyethylene Glycols
Prospective Studies
Recombinant Proteins adverse effects
Recombinant Proteins pharmacology
Transplantation, Autologous
Granulocyte Colony-Stimulating Factor pharmacology
Hematopoietic Stem Cell Mobilization
Neoplasms therapy
Peripheral Blood Stem Cell Transplantation adverse effects
Subjects
Details
- Language :
- English
- ISSN :
- 1537-2995
- Volume :
- 51
- Issue :
- 11
- Database :
- MEDLINE
- Journal :
- Transfusion
- Publication Type :
- Academic Journal
- Accession number :
- 21542852
- Full Text :
- https://doi.org/10.1111/j.1537-2995.2011.03157.x