Low transplant mortality in allogeneic bone marrow transplantation for acute myeloid leukemia: A randomized study of low-dose cyclosporin versus low-dose cyclosporin and low-dose methotrexate

R. Zikos, M. T. Van Lint, F. Frassoni, T. Lamparelli, F. Gualandi, D. Occhini, N. Mordini, G. Berisso, S. Bregante, F. De Stefano, M. Soracco, V. Vitale, A. Bacigalupo

Research output: Contribution to journalArticle

Abstract

Sixty patients undergoing allogeneic bone marrow transplant for acute myeloid leukemia (AML) in first remission (CR1; n = 49) or more advanced phase (n = 11) were entered in a prospective trial of graft-versus-host disease (GvHD) prophylaxis: low-dose cyclosporin A (IdCSA; 1 mg/kg/d from day -1 to +20 day; n = 28) or IdCSA plus low-dose methotrexate (IdMTX; 10 mg/m2 for day +1, 8 mg/m2 for days +3, +6, and +11; n = 32) Primary end points were acute GvHD (aGvHD) and transplant-related mortality (TRM); secondary end points were relapse and survival. The conditioning regimen consisted of cyclophosphamide (120 mg/kg) and fractionated total body irradiation (3.3 Gy/d for 3 consecutive days). The actuarial risk of developing aGvHD grade I1-111 was 61% for IdCSA alone and 34% for IdCSA + IdMTX (P = .02). The actuarial risk of TRM at 1 year was 11% versus 13%, respectively, and older patients (≤29 years) had higher TRM than younger patients (22% v 5%, P= .01). The age effect was significant in the IdCSA group (P = .04) but not in the IdCSA + IdMTX group (P = .1). The median follow-up is 4.4 years, with an overall actuarial survival of 78% for CR1 patients and 36% for patients with advanced disease. For patients in CB1 the outcome of the two regimens was as follows: survival 77% versus 80% (P = .6), relapse 20% versus 9% (P = .1), and TRM 13% versus 17% (P = .6). This study suggests that TRM can be reduced in AML patients undergoing allogeneic marrow transplants with a mild conditioning regimen and low-dose immunosuppression, and this translates in a 78% 5-year survival for CR1 patients. Beyond CR1 the major obstacle remains leukemia relapse, which is not prevented by low-dose in vivo immunosuppression.

Original languageEnglish
Pages (from-to)3503-3508
Number of pages6
JournalBlood
Volume91
Issue number9
Publication statusPublished - May 1 1998

ASJC Scopus subject areas

  • Hematology

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