NYMC Faculty Publications
Mycophenolate mofetil Administered every 8 Hours in Combination with Tacrolimus is Efficacious in the Prophylaxis of Acute Graft Versus Host Disease in Childhood, Adolescent, and Young Adult Allogeneic Stem Cell Tansplantation Recipients
Journal Title
Pediatric Blood & Cancer
First Page
e27091
Document Type
Article
Publication Date
April 2018
Department
Pediatrics
Abstract
BACKGROUND: The optimal dose and schedule of mycophenolate mofetil (MMF) in pediatric allogeneic stem cell transplant recipients remains to be determined. We previously reported safety and pharmacokinetics of MMF at 900 mg/m(2) q6h dosing. This study was conducted to investigate the efficacy of tacrolimus plus q8h MMF dosing for acute graft versus host disease (GVHD) prophylaxis in a heterogeneous population of children, adolescent, young adult allogeneic stem cell transplant recipients, utilizing multiple allogeneic donor sources. PROCEDURE: GVHD prophylaxis consisted of tacrolimus 0.03-0.04 mg/kg/day intravenous continuous infusion or 0.12-0.16 mg/kg/day orally divided q8-12h and MMF 900 mg/m(2) /dose (max. 1.5 g) or 15 mg/kg/dose intravenous/orally (age >/=18 years) q8h starting on Day +1. MMF was discontinued on Day +30 or Day +60 in the absence of acute GVHD. Thirty-five children, adolescents, and young adult allogeneic stem cell transplant recipients with malignant and nonmalignant disorders were enrolled. RESULTS: Kaplan-Meier probability of grade II-IV and grade III-IV acute GVHD was 22.8% (CI95 : 5.2-47.9 [where CI stands for confidence interval]) and 5.7% (CI95 : 0-48.9), respectively. Probability of extensive and limited chronic GVHD was 22.6% (CI95 : 3.4-52.2) and 12.2% (CI95 : 0.3-45.7), respectively. Probability of 1 year overall survival was 82% (CI95 : 64.1-99.8). Myeloablative conditioning was predictive of higher risk of acute GVHD in the univariate analysis (P = 0.01, hazard ratio = 6.6, CI95 : 0.91-48). CONCLUSION: This study demonstrated a low probability of acute and chronic GVHD in a diverse cohort of childhood, adolescent, and young adult allogeneic stem cell transplant recipients following MMF q8h plus tacrolimus prophylaxis.
Recommended Citation
Militano, O., Ozkaynak, M., Mehta, B., van de Ven, C., Hamby, C., & Cairo, M. (2018). Mycophenolate mofetil Administered every 8 Hours in Combination with Tacrolimus is Efficacious in the Prophylaxis of Acute Graft Versus Host Disease in Childhood, Adolescent, and Young Adult Allogeneic Stem Cell Tansplantation Recipients. Pediatric Blood & Cancer, 65 (8), e27091. https://doi.org/10.1002/pbc.27091
