Artículo
Immunomodulatory Effect of Vitamin D after Allogeneic Stem Cell Transplantation: Results of a Prospective Multicenter Clinical Trial
Autor/es | Caballero Velázquez, Teresa
Montero, Isabel Sánchez Guijo, Fermín Parody, Rocío Saldana, Raquel Valcarcel, David Carrillo Vico, Antonio Márquez Malaver, Francisco J. Pérez Simón, José Antonio |
Departamento | Universidad de Sevilla. Departamento de Medicina |
Fecha de publicación | 2016-11-30 |
Fecha de depósito | 2024-07-18 |
Publicado en |
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Resumen | Purpose: We describe the results of a prospective multicenter phase I/II trial evaluating the impact of the use of vitamin D (VitD) from day −5 to +100 on the outcome of patients undergoing allogeneic transplantation ... Purpose: We describe the results of a prospective multicenter phase I/II trial evaluating the impact of the use of vitamin D (VitD) from day −5 to +100 on the outcome of patients undergoing allogeneic transplantation (EudraCT: 2010-023279-25; ClinicalTrials.gov: NCT02600988). Experimental Design: A total of 150 patients were included in three consecutive cohorts of 50 patients each group: control group (CG, not receive VitD); low-dose group (LdD, received 1,000 IU VitD daily); and high-dose group (HdD, 5,000 IU VitD daily). We measured levels of VitD, cytokines, and immune subpopulations after transplantation. Results: No significant differences were observed in terms of cumulative incidence of overall and grades 2–4 acute GVHD in terms of relapse, nonrelapse mortality, and overall survival. However, a significantly lower cumulative incidence of both overall and moderate plus severe chronic GVHD (cGVHD) at 1 year was observed in LdD (37.5% and 19.5%, respectively) and HdD (42.4% and 27%, respectively) as compared with CG (67.5% and 44.7%, respectively; P < 0.05). In multivariable analysis, treatment with VitD significantly decreased the risk of both overall (for LdD: HR = 0.31, P = 0.002; for HdD: HR = 0.36, P = 0.006) and moderate plus severe cGVHD (for LdD: HR = 0.22, P = 0.001; for HdD: HR = 0.33, P = 0.01). VitD modified the immune response, decreasing the number of B cells and naïve CD8 T cells, with a lower expression of CD40L. Conclusions: This is the first prospective trial that analyzes the effect of VitD postransplant. We observed a significantly lower incidence of cGVHD among patients receiving VitD. Interestingly, VitD modified the immune response after allo-SCT. Clin Cancer Res; 22(23); 5673–81. ©2016 AACR. |
Agencias financiadoras | Instituto de Salud Carlos III Ministerio de Sanidad. España RTICC |
Identificador del proyecto | RD12/0043/0012
CM10/00161 EC10-304 RD12/0036/0052 |
Cita | Caballero Velázquez, T., Montero, I., Sánchez Guijo, F., Parody, R., Saldana, R., Valcarcel, D.,...,Pérez Simón, J.A. (2016). Immunomodulatory Effect of Vitamin D after Allogeneic Stem Cell Transplantation: Results of a Prospective Multicenter Clinical Trial. Clinical Cancer Research, 22 (23), 5673-5681. https://doi.org/10.1158/1078-0432.CCR-16-0238. |
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