Related Experiment Videos
Phase II study of recombinant human granulocyte colony-stimulating factor in children undergoing bone marrow
Insights
Filgrastim reduced fever days in children after autologous bone marrow transplants but delayed platelet and red blood cell recovery. No significant benefits were seen in allogeneic transplants.
Area of Science:
- Pediatric Hematology/Oncology
- Hematopoietic Stem Cell Transplantation
- Growth Factor Therapy
Background:
- Bone marrow transplantation (BMT) is a critical treatment for pediatric hematological disorders and solid tumors.
- Granulocyte colony-stimulating factor (filgrastim) is used to accelerate neutrophil recovery post-transplant.
- The efficacy and safety of filgrastim in pediatric BMT require further investigation.
Purpose of the Study:
- To evaluate the impact of filgrastim on myeloid reconstitution and clinical outcomes in children undergoing allogeneic or autologous BMT.
- To compare outcomes between children receiving filgrastim and a matched control group.
Main Methods:
- Prospective evaluation of 23 children receiving filgrastim (Group I) post-BMT.
- Comparison with a retrospective, matched cohort of 31 children not receiving filgrastim (Group II).
- Filgrastim administered at 5 mcg/Kg daily for 21 days or until neutrophil recovery.
Main Results:
- Similar myeloid reconstitution times between groups (13 vs 14 days).
- Delayed platelet and red blood cell recovery in the filgrastim group (p < .05 and p < .005, respectively).
- Reduced febrile days in children undergoing autologous BMT with filgrastim (6 vs 10 days, p < .05).
Conclusions:
- Filgrastim significantly reduced febrile days in pediatric autologous BMT but did not benefit allogeneic BMT.
- Filgrastim use was associated with delayed erythrocyte and platelet recovery.
- Further randomized studies are needed to determine the cost-benefit of filgrastim in pediatric BMT.
Abstract:
Twenty-three children with congenital or acquired hematological disorders and 8 children with solid tumors received filgrastim at a dose of 5 micrograms/Kg by a daily 2-hour infusion following allogeneic (18 cases) or autologous (13 cases) bone marrow transplantation (group I). The results were compared with those of a disease, age and type of transplant matched cohort of 31 children treated in the same institution who did not receive the growth factor (group II). Filgrastim treatment was started within 24 hours of completion of the marrow infusion and lasted for 21 consecutive days or until the absolute neutrophil count reached 10 x 10(9)/l for 3 consecutive days. Twelve variables were evaluated prospectively in Group I and retrospectively in Group II. Myeloid reconstitution with peripheral granulocyte counts > 0.5 x 10(9)/L was achieved at a median time of 13 days in group I and of 14 days in group II (p = ns). Platelet recovery to > 50 x 10(9)/L was slower in group I (43 vs 30 days: p < .05). Median time to last platelet and red blood cell infusion was higher in group I (33 vs 18 days for platelets, p < .05; 45 vs 25 for red blood cells, p < .005). Filgrastim-treated children undergoing autologous BMT had fewer days of fever (6 vs 10 days, p < .05). There was no significant toxicity ascribable to filgrastim. Clinically and microbiologically documented infections, days of antibiotic therapy, duration of total parenteral nutrition and median time in hospital were similar in both groups. We conclude that in children undergoing autologous BMT for malignancies, filgrastim significantly reduced the number of febrile days. Similar benefits were not observed in children undergoing allogeneic BMT. Children receiving filgrastim experienced a delay in erythrocyte and platelet recovery. A prospective randomized study is required to better define the cost-benefit of filgrastim in children undergoing autologous or allogeneic BMT.