Antithymocyte globulin for graft-versus-host disease prophylaxis in transplants from unrelated donors: 2 Randomized studies from Gruppo Italiano Trapianti Midollo Osseo (GITMO)

Andrea Bacigalupo, Teresa Lamparelli, Paolo Bruzzi, Stefano Guidi, Paolo Emilio Alessandrino, Paolo Di Bartolomeo, Rosa Oneto, Barbara Bruno, Mario Barbanti, Nicoletta Sacchi, Maria Teresa Van Lint, Alberto Bosi

Research output: Contribution to journalArticlepeer-review

Abstract

One hundred nine patients with hematologic malignancies, undergoing bone marrow transplants (BMT) from unrelated donors, were randomized in 2 consecutive trials to receive or not to receive antithymocyte globulin (ATG) in the conditioning regimen, as follows: (A) 54 patients (median age, 28 years; 39% with advanced disease) were randomized to no ATG (n = 25) versus 7.5 mg/kg rabbit ATG (Thymoglobulin; Sangstat, Lyon, France) (n = 29); (B) 55 patients (median age, 31 years, 71% with advanced disease) were randomized to no ATG (n = 28) versus 15 mg/kg rabbit ATG (n = 27). Grade III-IV graft-versus-host disease (GVHD) was diagnosed in 36% versus 41% (P = .8) in the first and in 50% versus 11% (P = .001) in the second trial. Transplant-related mortality (TRM), relapse, and actuarial 3-year survival rates were comparable in both trials. In fact, despite the reduction of GVHD in the second trial, a higher risk for lethal infections (30% vs 7%; P = .02) was seen in the arm given 15 mg/kg ATG. Extensive chronic GVHD developed overall more frequently in patients given no ATG (62% vs 39%; P = .04), as confirmed by multivariate analysis (P = .03). Time to 50 × 109/L platelets was comparable in the first trial (21 vs 24 days; P = .3) and delayed in the ATG arm in the second trial (23 vs 38 days; P = .02). These trials suggest that (1) 15 mg/kg ATG before BMT significantly reduces the risk for grade III-IV acute GVHD, (2) this does not translate to a reduction in TRM because of the increased risk for infections, and (3) though survival is unchanged, extensive chronic GVHD is significantly reduced in patients receiving ATG.

Original languageEnglish
Pages (from-to)2942-2947
Number of pages6
JournalBlood
Volume98
Issue number10
DOIs
Publication statusPublished - Nov 15 2001

ASJC Scopus subject areas

  • Hematology

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