Skip to main content
Journal cover image

Equivalence of 2 effective graft-versus-host disease prophylaxis regimens: results of a prospective double-blind randomized trial.

Publication ,  Journal Article
Chao, NJ; Snyder, DS; Jain, M; Wong, RM; Niland, JC; Negrin, RS; Long, GD; Hu, WW; Stockerl-Goldstein, KE; Johnston, LJ; Amylon, MD; Parker, P ...
Published in: Biol Blood Marrow Transplant
2000

We have previously demonstrated a decrease in the incidence of acute graft-versus-host disease (GVHD) with the addition of methotrexate (MTX) to cyclosporine (CSP) and prednisone (PSE) chemotherapy in patients with leukemia. We have now completed a prospective randomized trial comparing the 3-drug regimen (CSP/MTX/PSE, including 3 doses of MTX) to the standard 2-drug regimen (CSP/MTX, including 4 doses of MTX) to investigate the benefit of PSE used up front for the prevention of acute and chronic GVHD. In the trial, 193 patients were randomized and 186 were included in the final analysis. All patients received a bone marrow graft from a fully histocompatible sibling donor. The preparatory regimen consisted of fractionated total-body irradiation (fTBI) and etoposide in all but 13 patients, who received fTBI and cyclophosphamide. The patients were randomized to receive either CSP/MTX/PSE or CSP/MTX. The 2 groups were well balanced with respect to diagnosis, disease stage, age, donor-recipient sex, and parity. In an intent-to-treat analysis, the incidence of acute GVHD was 18% (95% confidence interval [CI] 12-28) for the CSP/MTX/PSE group compared with 20% (CI 10-26) for the CSP/,MTX group (P = .60), with a median follow up of 2.2 years. Overall survival was 65% for those receiving CSP/MTX/PSE and 72% for those receiving CSP/MTX (P = .10); the relapse rate was 15% for the CSP/MTX/PSE group and 12% for the CSP/MTX group (P = .83). The incidence of chronic GVHD was similar (46% versus 52%; P = .38), with a follow-up of 0.7 to 6.0 years. Of interest, 21 patients went off study due to GVHD (5 in the CSP/MTX/PSE group and 16 in the CSP/MITX group [P = .02]), and 11 patients went off study because of alveolar hemorrhage (3 in the CSP/MTX/PSE group and 8 in the CSP/MTX group [P = .22]). The addition of PSE did not result in a higher incidence of infectious complications, bacterial (66% versus 58%), viral (77% versus 66%), or fungal (20% versus 20%), in those receiving CSP/MTX/PSE versus CSP/MTX, respectively. These data suggest that the addition of PSE was associated with a somewhat lower incidence of early posttransplantation complications but did not have a positive impact on the incidence of acute or chronic GVHD or event-free or overall survival.

Duke Scholars

Published In

Biol Blood Marrow Transplant

DOI

ISSN

1083-8791

Publication Date

2000

Volume

6

Issue

3

Start / End Page

254 / 261

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Transplantation, Homologous
  • Survival Analysis
  • Prospective Studies
  • Prednisone
  • Middle Aged
  • Methotrexate
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive
  • Leukemia
  • Infant
 

Citation

APA
Chicago
ICMJE
MLA
NLM
Chao, N. J., Snyder, D. S., Jain, M., Wong, R. M., Niland, J. C., Negrin, R. S., … Bluzme, K. G. (2000). Equivalence of 2 effective graft-versus-host disease prophylaxis regimens: results of a prospective double-blind randomized trial. Biol Blood Marrow Transplant, 6(3), 254–261. https://doi.org/10.1016/s1083-8791(00)70007-3
Chao, N. J., D. S. Snyder, M. Jain, R. M. Wong, J. C. Niland, R. S. Negrin, G. D. Long, et al. “Equivalence of 2 effective graft-versus-host disease prophylaxis regimens: results of a prospective double-blind randomized trial.Biol Blood Marrow Transplant 6, no. 3 (2000): 254–61. https://doi.org/10.1016/s1083-8791(00)70007-3.
Chao NJ, Snyder DS, Jain M, Wong RM, Niland JC, Negrin RS, et al. Equivalence of 2 effective graft-versus-host disease prophylaxis regimens: results of a prospective double-blind randomized trial. Biol Blood Marrow Transplant. 2000;6(3):254–61.
Chao, N. J., et al. “Equivalence of 2 effective graft-versus-host disease prophylaxis regimens: results of a prospective double-blind randomized trial.Biol Blood Marrow Transplant, vol. 6, no. 3, 2000, pp. 254–61. Pubmed, doi:10.1016/s1083-8791(00)70007-3.
Chao NJ, Snyder DS, Jain M, Wong RM, Niland JC, Negrin RS, Long GD, Hu WW, Stockerl-Goldstein KE, Johnston LJ, Amylon MD, Tierney DK, O’Donnell MR, Nademanee AP, Parker P, Stein A, Molina A, Fung H, Kashyap A, Kohler S, Spielberger R, Krishnan A, Rodriguez R, Forman SJ, Bluzme KG. Equivalence of 2 effective graft-versus-host disease prophylaxis regimens: results of a prospective double-blind randomized trial. Biol Blood Marrow Transplant. 2000;6(3):254–261.
Journal cover image

Published In

Biol Blood Marrow Transplant

DOI

ISSN

1083-8791

Publication Date

2000

Volume

6

Issue

3

Start / End Page

254 / 261

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Transplantation, Homologous
  • Survival Analysis
  • Prospective Studies
  • Prednisone
  • Middle Aged
  • Methotrexate
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive
  • Leukemia
  • Infant