A Phase II Study of Bortezomib Plus Prednisone for Initial Therapy of Chronic Graft- versus-Host Disease Alex F. Herrera, Haesook T. Kim, Bhavjot Bindra,

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Presentation transcript:

A Phase II Study of Bortezomib Plus Prednisone for Initial Therapy of Chronic Graft- versus-Host Disease Alex F. Herrera, Haesook T. Kim, Bhavjot Bindra, Kyle T. Jones, Edwin P. Alyea, Philippe Armand, Corey S. Cutler, Vincent T. Ho, Sarah Nikiforow, Bruce R. Blazar, Jerome Ritz, Joseph H. Antin, Robert J. Soiffer, John Koreth Biology of Blood and Marrow Transplantation Volume 20, Issue 11, Pages 1737-1743 (November 2014) DOI: 10.1016/j.bbmt.2014.06.040 Copyright © 2014 American Society for Blood and Marrow Transplantation Terms and Conditions

Figure 1 Heat map depicting baseline chronic GVHD involvement by organ site and week 15 response at all evaluable sites. Global and organ site chronic GVHD responses at week 15 (right panel) in each evaluable participant at each site of cGVHD involvement compared with baseline involvement (left panel), scored according to NIH consensus criteria. Two participants had early progression of liver cGVHD and came off study before week 15, liver organ scores at study withdrawal are included. Median provider-reported global cGVHD scores and NIH organ-site cGVHD scores at baseline and week 15 are included. Asterisk denotes statistically significant difference between baseline and week 15 (all P ≤ .02). Biology of Blood and Marrow Transplantation 2014 20, 1737-1743DOI: (10.1016/j.bbmt.2014.06.040) Copyright © 2014 American Society for Blood and Marrow Transplantation Terms and Conditions

Figure 2 Prednisone dose and additional cGVHD therapy over time. Prednisone dose at baseline, study week 15 (the completion of bortezomib therapy), 3 months after the completion of bortezomib therapy, and 1 year after the completion of bortezomib therapy. (A) Shows median prednisone dose in the cohort over time, Note: n = 22, n = 22, n = 18, n = 17, respectively. (B) Shows the prednisone dose and additional cGVHD therapy in each participant over time. Biology of Blood and Marrow Transplantation 2014 20, 1737-1743DOI: (10.1016/j.bbmt.2014.06.040) Copyright © 2014 American Society for Blood and Marrow Transplantation Terms and Conditions

Figure 3 Kaplan-Meier analysis of overall survival and relapse-free survival in the cohort over time. Biology of Blood and Marrow Transplantation 2014 20, 1737-1743DOI: (10.1016/j.bbmt.2014.06.040) Copyright © 2014 American Society for Blood and Marrow Transplantation Terms and Conditions

Figure 4 Immune correlates. (A) Shows median peripheral blood T, B, NK lymphocyte lineage counts. (B) Shows median peripheral blood total regulatory T cell count and Treg to Tcon ratio. (C) Shows median peripheral blood regulatory T cell subset counts. (D) Shows median peripheral blood total and dendritic cell subset cell counts on bortezomib and prednisone therapy. For all analyses, n = 21 at baseline; n = 18 at week 6, n = 19 at week 11, n = 19 at week 15, and n = 10 at 6 months after initial bortezomib dose. Cell counts were compared between time points using the Wilcoxon signed-rank test. Asterisk denotes statistically significant (P ≤ .05) change at a time point compared with baseline. Biology of Blood and Marrow Transplantation 2014 20, 1737-1743DOI: (10.1016/j.bbmt.2014.06.040) Copyright © 2014 American Society for Blood and Marrow Transplantation Terms and Conditions