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

• Published in: Biology of blood and marrow transplantation 2006-05, Vol.12 (5), p.560-565
• Main Authors: Bacigalupo, Andrea, Lamparelli, Teresa, Barisione, Giovanni, Bruzzi, Paolo, Guidi, Stefano, Alessandrino, Paolo Emilio, di Bartolomeo, Paolo, Oneto, Rosi, Bruno, Barbara, Sacchi, Nicoletta, van Lint, Maria Teresa, Bosi, Alberto
• Format: Article
• Language: English
• Subjects: Adolescent; Adult; Antilymphocyte Serum - therapeutic use; Antithymocyte globulin; Bone marrow transplantation; Bone Marrow Transplantation - adverse effects; Bone Marrow Transplantation - mortality; Cause of Death; Chronic Disease; Chronic lung dysfunction; 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; 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; Unrelated donors; Vital Capacity
• ISSN: 1083-8791; 1523-6536
• DOI: 10.1016/j.bbmt.2005.12.034

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 ≥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.