Summary:
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 μg/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.
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Acknowledgements
We thank the Société Française de Greffe de Moëlle et de Thérapie Cellulaire for promoting this study and Lorna Saint Ange for editing. We thank the other investigators who participated in this study: Dr B Audhuy, Pr P Bordigoni, Pr P Colombat, Dr C Coze, Pr B Desablens, Dr V Gandemer, Dr P Henon, Dr F Lefrère, Pr M Michallet, Dr AM Peny and Pr D Plantaz. This study was performed by the Société Française de Greffe de Moelle et de Thérapie Cellulaire (SFGM-TC). This study was supported by Chugai & Aventis Pharmaceutical Co, Paris, France.
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Valteau-Couanet, D., Faucher, C., Aupérin, A. et al. Cost effectiveness of day 5 G-CSF (Lenograstim®) administration after PBSC transplantation: results of a SFGM-TC randomised trial. Bone Marrow Transplant 36, 547–552 (2005). https://doi.org/10.1038/sj.bmt.1705097
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DOI: https://doi.org/10.1038/sj.bmt.1705097
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