Biology of Blood and Marrow Transplantation
Volume 12, Issue 5 , Pages 560-565, May 2006

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

  • Andrea Bacigalupo

      Affiliations

    • Divisione di Ematologia, Ospedale San Martino, Genova
    • Corresponding Author InformationCorrespondence and reprint requests: Andrea Bacigalupo, MD, Divisione Ematologia 2 (PAD 6/I), Ospedale San Martino, Largo Rosanna Benzi 10, 16132 Genova, Italy
  • ,
  • Teresa Lamparelli

      Affiliations

    • Divisione di Ematologia, Ospedale San Martino, Genova
  • ,
  • Giovanni Barisione

      Affiliations

    • U.O. Medicina Preventiva e del Lavoro Laboratorio di Fisiopatologia Respiratoria, Ospedale San Martino, Genova
  • ,
  • Paolo Bruzzi

      Affiliations

    • IST, Ospedale San Martino, Genova
  • ,
  • Stefano Guidi

      Affiliations

    • Dipartimento di Ematologia Ospedale di Careggi, Firenze
  • ,
  • Paolo Emilio Alessandrino

      Affiliations

    • Dipartimento di Ematologia, Policlinico San Matteo, Pavia
  • ,
  • Paolo di Bartolomeo

      Affiliations

    • Dipartimento di Ematologia, Ospedale Civille, Pescara
  • ,
  • Rosi Oneto

      Affiliations

    • Divisione di Ematologia, Ospedale San Martino, Genova
  • ,
  • Barbara Bruno

      Affiliations

    • Divisione di Ematologia, Ospedale San Martino, Genova
  • ,
  • Nicoletta Sacchi

      Affiliations

    • IBMDR, Ospedale Galliera, Genova, Italy
  • ,
  • Maria Teresa van Lint

      Affiliations

    • Divisione di Ematologia, Ospedale San Martino, Genova
  • ,
  • Alberto Bosi

      Affiliations

    • IST, Ospedale San Martino, Genova
  • ,
  • Gruppo Italiano Trapianti Midollo Osseo (GITMO)

Received 31 August 2005; accepted 15 December 2005.

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 ≥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.

Key words:  Leukemia , Bone marrow transplantation , Unrelated donors , Antithymocyte globulin , Chronic lung dysfunction

 

PII: S1083-8791(05)01416-3

doi:10.1016/j.bbmt.2005.12.034

Biology of Blood and Marrow Transplantation
Volume 12, Issue 5 , Pages 560-565, May 2006