Randomised trial of filgrastim-mobilised peripheral blood progenitor cell transplantation versus autologous bone-marrow transplantation in lymphoma patients

Lancet. 1996 Feb 10;347(8998):353-7. doi: 10.1016/s0140-6736(96)90536-x.

Abstract

Background: A randomised trial comparing filgrastim-mobilised peripheral blood progenitor cell (PBPC) transplants with autologous bone marrow transplantation (ABMT) for haematopoietic stem cell support has not been done. We compared the effects of filgrastim-mobilised PBPC or autologous bone marrow reinfused to lymphoma patients after high-dose chemotherapy in a prospective randomised multicentre trial.

Methods: The trial was done at six centres in three European countries. After high-dose chemotherapy (carmustine, etoposide, cytarabine, and melphalan [BEAM protocol]) 58 patients with advanced Hodgkin's disease or high-grade non-Hodgkin lymphoma received either filgrastim-mobilised PBPC (n = 27) or bone marrow (n = 31) for haemopoietic reconstitution.

Findings: The median number of days with platelet transfusions after grafting was 6 in the PBPC transplantation group and 10 in the ABMT group (estimate of treatment difference 5 days, 95% CI 3-7 days). Time to platelet recovery above 20 x 10(9)/L was 16 days in the PBPC transplantation group and 23 days in the ABMT group (p = 0.02). Time to neutrophil recovery above 0.5 x 10(9)/L was also reduced in the PBPC transplantation group (11 vs 14 days, p = 0.005). Patients randomised to PBPC transplantation needed fewer red blood cell transfusions (two vs three, p = 0.002) and spent less time in hospital (17 vs 23 days, p = 0.002). Early post-transplant morbidity and mortality as well as overall survival (median follow-up 311 days) were similar in both groups. There was no notable toxicity ascribed to filgrastim administration or the leucapheresis procedures.

Interpretation: In patients with lymphoma treated with high-dose chemotherapy, reinfusing filgrastim-mobilised PBPC instead of autologous bone marrow significantly reduced the number of platelet transfusions, the time to platelet and neutrophil recovery, and led to earlier discharge from hospital.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase III
  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use
  • Bone Marrow Transplantation*
  • Carmustine / administration & dosage
  • Combined Modality Therapy
  • Cytarabine / administration & dosage
  • Female
  • Filgrastim
  • Granulocyte Colony-Stimulating Factor / pharmacology*
  • Granulocyte Colony-Stimulating Factor / therapeutic use
  • Hematopoietic Stem Cell Transplantation*
  • Hodgkin Disease / mortality
  • Hodgkin Disease / therapy*
  • Humans
  • Leukocytes, Mononuclear / drug effects*
  • Lymphoma, Non-Hodgkin / mortality
  • Lymphoma, Non-Hodgkin / therapy*
  • Male
  • Melphalan / administration & dosage
  • Platelet Transfusion
  • Podophyllotoxin / administration & dosage
  • Prospective Studies
  • Recombinant Proteins / pharmacology
  • Recombinant Proteins / therapeutic use
  • Survival Analysis
  • Time Factors
  • Transplantation, Autologous

Substances

  • Recombinant Proteins
  • Cytarabine
  • Granulocyte Colony-Stimulating Factor
  • Podophyllotoxin
  • Filgrastim
  • Melphalan
  • Carmustine

Supplementary concepts

  • BEAM protocol