Defibrotide for the Treatment of Severe Hepatic Veno-Occlusive Disease and Multiorgan Failure after Stem Cell Transplantation: A Multicenter, Randomized,

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Presentation transcript:

Defibrotide for the Treatment of Severe Hepatic Veno-Occlusive Disease and Multiorgan Failure after Stem Cell Transplantation: A Multicenter, Randomized, Dose-Finding Trial Paul G. Richardson, Robert J. Soiffer, Joseph H. Antin, Hajime Uno, Zhezhen Jin, Joanne Kurtzberg, Paul L. Martin, Gideon Steinbach, Karen F. Murray, Georgia B. Vogelsang, Allen R. Chen, Amrita Krishnan, Nancy A. Kernan, David E. Avigan, Thomas R. Spitzer, Howard M. Shulman, Donald N. Di Salvo, Carolyn Revta, Diane Warren, Parisa Momtaz, Gary Bradwin, L.J. Wei, Massimo Iacobelli, George B. McDonald, Eva C. Guinan Biology of Blood and Marrow Transplantation Volume 16, Issue 7, Pages 1005-1017 (July 2010) DOI: 10.1016/j.bbmt.2010.02.009 Copyright © 2010 American Society for Blood and Marrow Transplantation Terms and Conditions

Figure 1 Disposition of patients. Flowchart illustrating the progression of patients with severe hepatic VOD after HSCT by treatment group (arm A, 25 mg/kg/day i.v. defibrotide; arm B, 40 mg/kg/day i.v. defibrotide). Biology of Blood and Marrow Transplantation 2010 16, 1005-1017DOI: (10.1016/j.bbmt.2010.02.009) Copyright © 2010 American Society for Blood and Marrow Transplantation Terms and Conditions

Figure 2 Survival of patients with severe hepatic VOD by treatment arm post-HSCT (A) and after randomization (B) (treated population). Kaplan-Meier curves show survival distributions for patients in treatment arms A and B. Biology of Blood and Marrow Transplantation 2010 16, 1005-1017DOI: (10.1016/j.bbmt.2010.02.009) Copyright © 2010 American Society for Blood and Marrow Transplantation Terms and Conditions

Figure 3 Survival of patients with severe hepatic VOD by treatment arm for adult patients post-HSCT (A) and after randomization (B) and for pediatric patients post-HSCT (C) and after randomization (D) (treated population). Kaplan-Meier curves show survival distributions for patients aged ≥18 years and aged <18 years. Biology of Blood and Marrow Transplantation 2010 16, 1005-1017DOI: (10.1016/j.bbmt.2010.02.009) Copyright © 2010 American Society for Blood and Marrow Transplantation Terms and Conditions

Figure 4 Mean (standard deviation) PAI-1 (A) and total bilirubin (B) by treatment arm and outcome in patients with severe hepatic VOD treated with i.v. defibrotide. Bar charts illustrate PAI-1 levels (A) and total bilirubin levels (B) by CR/nonresponse, day +100 post-HSCT survival/nonsurvival, and treatment arm. D, day; NR, nonresponder. Biology of Blood and Marrow Transplantation 2010 16, 1005-1017DOI: (10.1016/j.bbmt.2010.02.009) Copyright © 2010 American Society for Blood and Marrow Transplantation Terms and Conditions