First- and Second-Line Systemic Treatment of Acute Graft-versus-Host Disease: Recommendations of the American Society of Blood and Marrow Transplantation

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Presentation transcript:

First- and Second-Line Systemic Treatment of Acute Graft-versus-Host Disease: Recommendations of the American Society of Blood and Marrow Transplantation Paul J. Martin, J. Douglas Rizzo, John R. Wingard, Karen Ballen, Peter T. Curtin, Corey Cutler, Mark R. Litzow, Yago Nieto, Bipin N. Savani, Jeffrey R. Schriber, Paul J. Shaughnessy, Donna A. Wall, Paul A. Carpenter Biology of Blood and Marrow Transplantation Volume 18, Issue 8, Pages 1150-1163 (August 2012) DOI: 10.1016/j.bbmt.2012.04.005 Copyright © 2012 American Society for Blood and Marrow Transplantation Terms and Conditions

Figure 1 Relationship between number of patients enrolled and the Kaplan-Meier estimate of survival at 6 months for each study of initial systemic therapy. The horizontal line shows the weighted average 6-month survival estimate for all studies with standard-dose glucocorticoid treatment. Curved lines approximate the upper and lower boundaries of the 95% confidence interval for the weighted average at any given number of patients enrolled in a study. Squares indicate results of the experimental arms in phase 3 studies, and diamonds indicate results of prospective phase 2 studies and pilot studies. Points between the upper and lower boundaries identify studies with results that are statistically consistent with the weighted average. The point below the lower boundary identifies a study with outlier 6-month survival results that are statistically inconsistent with the weighted average. The asterisk indicates a phase III study that showed a statistically significant difference in survival between the 2 arms. Biology of Blood and Marrow Transplantation 2012 18, 1150-1163DOI: (10.1016/j.bbmt.2012.04.005) Copyright © 2012 American Society for Blood and Marrow Transplantation Terms and Conditions

Figure 2 Relationship between number of patients enrolled and the overall complete response (CR) rate for each study of initial systemic therapy. The horizontal line shows the overall CR rate for all studies with standard-dose glucocorticoid treatment. Curved lines approximate the 95% confidence limits for the overall CR rate at any given number of patients enrolled. Squares indicate results of the experimental arm in phase 3 studies, and diamonds indicate results of prospective phase 2 studies and pilot studies. The asterisk indicates a phase II study that showed a statistically significant improvement in the CR rate compared to historical controls at the same institution. Biology of Blood and Marrow Transplantation 2012 18, 1150-1163DOI: (10.1016/j.bbmt.2012.04.005) Copyright © 2012 American Society for Blood and Marrow Transplantation Terms and Conditions

Figure 3 Relationship between number of patients enrolled and the overall complete response/partial response (CR/PR) rate for each study of initial systemic therapy. The horizontal line shows the overall PR/CR rate for all studies with standard-dose glucocorticoid treatment. Curved lines approximate the 95% confidence limits for the overall PR/CR rate at any given number of patients enrolled. Squares indicate results of the experimental arm in phase 3 studies, and diamonds indicate results of prospective phase 2 studies and pilot studies. The asterisk indicates a phase III study that showed a statistically significant difference in the CR/PR rate between the 2 arms. Biology of Blood and Marrow Transplantation 2012 18, 1150-1163DOI: (10.1016/j.bbmt.2012.04.005) Copyright © 2012 American Society for Blood and Marrow Transplantation Terms and Conditions

Figure 4 Relationship between number of patients enrolled and the Kaplan-Meier estimate of survival at 6 months for each study of second-line therapy. The horizontal line shows the weighted average 6-month survival estimate for all studies. Curved lines approximate the 95% confidence limits for the weighted average at any given number of patients enrolled. Squares indicate prospective studies, and diamonds indicate retrospective studies. Biology of Blood and Marrow Transplantation 2012 18, 1150-1163DOI: (10.1016/j.bbmt.2012.04.005) Copyright © 2012 American Society for Blood and Marrow Transplantation Terms and Conditions

Figure 5 Relationship between number of patients enrolled and the overall complete response (CR) rate for each study of second-line therapy. The horizontal line shows the overall CR rate for all studies. Curved lines approximate the 95% confidence limits for the overall CR rate at any given number of patients enrolled. Squares indicate prospective studies, and diamonds indicate retrospective studies. Biology of Blood and Marrow Transplantation 2012 18, 1150-1163DOI: (10.1016/j.bbmt.2012.04.005) Copyright © 2012 American Society for Blood and Marrow Transplantation Terms and Conditions

Figure 6 Relationship between the number of patients enrolled and the complete response/partial response (CR/PR) rate for each study of second-line therapy. The horizontal line shows the overall PR/CR rate for all studies. Curved lines approximate the 95% confidence limits for the overall PR/CR rate at any given number of patients enrolled. Squares indicate prospective studies, and diamonds indicate retrospective studies. Biology of Blood and Marrow Transplantation 2012 18, 1150-1163DOI: (10.1016/j.bbmt.2012.04.005) Copyright © 2012 American Society for Blood and Marrow Transplantation Terms and Conditions