Cost effectiveness of day 5 G-CSF (Lenograstim) administration after PBSC transplantation: results of a SFGM-TC randomised trial

Bone Marrow Transplant. 2005 Sep;36(6):547-52. doi: 10.1038/sj.bmt.1705097.

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.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Blood Transfusion
  • Busulfan / therapeutic use
  • Child
  • Child, Preschool
  • Cost-Benefit Analysis
  • Drug Administration Schedule
  • Female
  • Granulocyte Colony-Stimulating Factor / administration & dosage*
  • Granulocyte Colony-Stimulating Factor / economics*
  • Hematologic Neoplasms / complications
  • Hematologic Neoplasms / therapy
  • Humans
  • Infant
  • Length of Stay
  • Lenograstim
  • Male
  • Middle Aged
  • Neoplasms / complications
  • Neoplasms / therapy
  • Neutropenia
  • Peripheral Blood Stem Cell Transplantation / adverse effects
  • Peripheral Blood Stem Cell Transplantation / economics*
  • Peripheral Blood Stem Cell Transplantation / methods
  • Recombinant Proteins / administration & dosage
  • Recombinant Proteins / economics
  • Thrombocytopenia
  • Transplantation Conditioning / methods
  • Transplantation, Autologous

Substances

  • Recombinant Proteins
  • Granulocyte Colony-Stimulating Factor
  • Lenograstim
  • Busulfan