Thymoglobulin prevents chronic graft-versus-host disease, chronic lung dysfunction, and late transplant-related mortality: long-term follow-up of a randomized trial in patients undergoing unrelated donor transplantation

Biol Blood Marrow Transplant. 2006 May;12(5):560-5. doi: 10.1016/j.bbmt.2005.12.034.

Abstract

This is an update of a randomized study on antithymocyte globulin (ATG; Thymoglobulin) before transplantation in patients undergoing unmanipulated marrow transplantation from unrelated donors. The median follow-up for surviving patients is 5.7 years. At last follow-up, chronic graft-versus-host disease (GVHD) was scored in 60% of non-ATG and in 37% of ATG patients (P=.05), and extensive chronic GVHD was present in 41% and 15%, respectively (P=.01). Chronic lung dysfunction was diagnosed in 51% versus 19% of patients (P=.005). Forced vital capacity decreased significantly with time in non-ATG patients (P=.005), but not in patients who received ATG (P=.30). The proportion of patients with Karnofsky scores of >or=90% at 4 years was 57% versus 89% in non-ATG versus ATG patients (P=.03). The actuarial 6-year survival for all patients randomized was 31% versus 44% (non-ATG versus ATG; P=.80). The cumulative incidence of transplant-related mortality was 51% versus 41% (P=.70) and of relapse was 32% versus 40% (P=.90). For patients who survived 1 year, transplant-related mortality was 25% versus 3% (P=.03), and actuarial survival was 58% versus 85% (P=.09). In conclusion, the addition of ATG to cyclosporine/methotrexate provides significant protection against extensive chronic GVHD and chronic lung dysfunction, reduces late transplant mortality, and improves quality of life in patients undergoing unrelated donor transplantation.

Publication types

  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, N.I.H., Extramural

MeSH terms

  • Adolescent
  • Adult
  • Antilymphocyte Serum / therapeutic use*
  • Bone Marrow Transplantation / adverse effects
  • Bone Marrow Transplantation / mortality
  • Cause of Death
  • Chronic Disease
  • Cyclosporine / administration & dosage
  • Cyclosporine / therapeutic use
  • Drug Therapy, Combination
  • Female
  • Follow-Up Studies
  • Forced Expiratory Volume
  • Graft vs Host Disease / mortality
  • Graft vs Host Disease / prevention & control*
  • Humans
  • Immunosuppressive Agents / administration & dosage
  • Immunosuppressive Agents / therapeutic use*
  • Incidence
  • Karnofsky Performance Status
  • Leukemia / mortality
  • Leukemia / surgery
  • Life Tables
  • Lung Diseases / etiology
  • Lung Diseases / mortality
  • Lung Diseases / physiopathology
  • Lung Diseases / prevention & control*
  • Male
  • Methotrexate / administration & dosage
  • Methotrexate / therapeutic use
  • Middle Aged
  • Neural Tube Defects / mortality
  • Neural Tube Defects / surgery
  • Premedication*
  • Prospective Studies
  • Recurrence
  • Survival Analysis
  • T-Lymphocytes / immunology*
  • Transplantation, Homologous / adverse effects
  • Transplantation, Homologous / mortality
  • Treatment Outcome
  • Vital Capacity

Substances

  • Antilymphocyte Serum
  • Immunosuppressive Agents
  • Cyclosporine
  • Methotrexate