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Cost effectiveness of day 5 G-CSF (Lenograstim) administration after PBSC transplantation: results of a SFGM-TC
D Valteau-Couanet1, C Faucher, A Aupérin
1Paediatrics Department, Institut Gustave Roussy, Villejuif, France. valteau@igr.fr
Insights
Granulocyte-colony stimulating factor (G-CSF) reduces neutropenia duration after autologous peripheral blood stem cell transplantation (APBSCT). Starting G-CSF on day 5 post-transplant is clinically and economically favored for adults and potentially children.
Area of Science:
- Hematology
- Oncology
- Pharmacology
Background:
- Autologous peripheral blood stem cell transplantation (APBSCT) is a critical procedure for treating various malignancies.
- Neutropenia following APBSCT increases infection risk and prolongs hospitalization.
- Granulocyte-colony stimulating factor (G-CSF) is used to mitigate neutropenia, but optimal administration timing requires investigation.
Purpose of the Study:
- To compare the efficacy of two G-CSF (Lenograstim) administration schedules (day 1 vs. day 5 post-APBSCT) against no G-CSF treatment.
- To evaluate the impact of G-CSF timing on neutropenia duration, thrombocytopenia, transfusion needs, and hospitalization in pediatric and adult patients.
- To assess clinical and cost-effectiveness of different G-CSF initiation timings.
Main Methods:
- A randomized controlled trial involving 240 patients (239 evaluable) with hematological malignancies or solid tumors undergoing APBSCT.
- Patients were stratified based on conditioning regimen (Busulfan, TBI) and graft CD34+ cell count.
- Intervention groups received Lenograstim 150 microg/m2/day starting on day 1 (G1) or day 5 (G5) post-APBSCT, or no G-CSF (G0).
Main Results:
- Both G-CSF groups (G1 and G5) showed a significantly shorter median duration of neutropenia compared to the G0 group (9-10 days vs. 13 days; P < 0.0001).
- No significant differences were observed in thrombocytopenia duration, transfusion support, or extra-hematological complications between the groups.
- Adult patients receiving G-CSF experienced significantly shorter post-transplant hospital stays.
Conclusions:
- Initiating G-CSF on day 5 post-APBSCT is clinically and economically advantageous for adults.
- This administration strategy may also be beneficial for pediatric patients, offering easier clinical management and similar costs.
- G-CSF administration significantly accelerates neutrophil recovery after APBSCT.
Abstract:
This randomised trial was designed to compare two groups treated with different G-CSF administration schedules with a third group receiving no G-CSF, after autologous peripheral blood stem cell transplantation (APBSCT). Children and adults with haematological malignancies or solid tumours were randomly assigned to receive either 150 microg/m2/day of Lenograstim starting on day 1 (G1) or on day 5 (G5) post APBSCT, or no Lenograstim (G0). Randomisation was stratified according to the conditioning regimen (Busulfan vs TBI vs no Busulfan and no TBI) and the graft CD 34+ cell count. A total of 240 patients were randomised; 239 were evaluable. All three patient groups were comparable. Median duration of neutropenia was 9 days (4-40), and 10 days (5-15) in the G1 and G5 groups, respectively, significantly shorter than in the G0 group, 13 days (7-36) (P < 0.0001). No difference was observed in the duration of thrombocytopenia, transfusion support and extra-haematological complications. The duration of post transplant hospitalisation was significantly shorter in adults who received G-CSF. Clinical and cost arguments favour the initiation of G-CSF on day 5 in adults. The same policy could be applied in children given that clinical management is easier and costs are similar.
