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

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.

• Authors: N Schmitz, D C Linch, P Dreger, A H Goldstone, M A Boogaerts, A Ferrant, H M Demuynck, H Link, A Zander, A Barge
• Journal: Lancet (London, England) (Lancet) Vol. 347 Issue 8998 Pg. 353-7 (Feb 10 1996) ISSN: 0140-6736 [Print] England
• PMID: 8598700 (Publication Type: Clinical Trial, Clinical Trial, Phase III, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial)

Chemical References

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

Topics

• 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, therapeutic use)
• Hematopoietic Stem Cell Transplantation
• Hodgkin Disease (mortality, therapy)
• Humans
• Leukocytes, Mononuclear (drug effects)
• Lymphoma, Non-Hodgkin (mortality, therapy)
• Male
• Melphalan (administration & dosage)
• Platelet Transfusion
• Podophyllotoxin (administration & dosage)
• Prospective Studies
• Recombinant Proteins (pharmacology, therapeutic use)
• Survival Analysis
• Time Factors
• Transplantation, Autologous