Atorvastatin for the Prophylaxis of Acute Graft-versus-Host Disease in Patients Undergoing HLA-Matched Related Donor Allogeneic Hematopoietic Stem Cell Transplantation (allo-HCT)

作者：Efebera Yvonne A^*; Geyer Susan; Andritsos Leslie; Vasu Sumithira; Jaglowski Samantha; Bingman Anissa; Blum William; Klisovic Rebecca; Hofmeister Craig C; Benson Don M; Penza Sam; Elder Patrick; Cortright Katie; Kitzler Rhonda; Coombes Kevin; O'Donnell Lynn; Daneault Beth; Bradbury Hillary; Zhang Jianying; Chen Xilin; Garman Sabrina; Ranganathan Parvathi; Yu Xueyan; Hofstetter Jessica; Yu Jianhua; Garzon Ramiro; Scrape Scott R; Lozanski Gerard; Devine Steven M

来源：Biology of Blood and Marrow Transplantation, 2016, 22(1): 71-79.

DOI：10.1016/j.bbmt.2015.07.034

• Atorvastatin
• Allogeneic hematopoietic stem cell transplant
• Graft-versus-host-disease

Statins possess potent immunomodulatory effects that may play a role in preventing acute graft-versus-host disease (aGVHD) after allogeneic hematopoietic cell transplantation (allo-HCT). We performed a phase II study of atorvastatin for aGVHD prophylaxis when given to allo-HCT recipients and their HLA-matched sibling donors. Atorvastatin (40 mg/day) was administered to sibling donors, beginning 14 days before the anticipated start of stem cell collection. Allo-HCT recipients (n = 40) received atorvastatin (40 mg/day) in addition to standard aGVHD prophylaxis. The primary endpoint was cumulative incidence of grades II to IV aGVHD at day 100. Atorvastatin was well tolerated, with no attributable grades III to IV toxicities in donors or their recipients. Day 100 and 180 cumulative incidences of grades II to IV aGVHD were 30% (95% confidence interval [CI], 17% to 45%) and 40% (95% CI, 25% to 55%), respectively. One-year cumulative incidence of chronic GVHD was 43% (95% CI, 32% to 69%). One-year nonrelapse mortality and relapse incidences were 5.5% (95% CI,.9% to 16.5%) and 38% (95% CI, 18% to 47%), respectively. One-year progression-free and overall survival rates were 54% (95% CI, 38% to 71%) and 82% (95% CI, 69% to 94%). One-year GVHD-free, relapse-free survival was 27% (95% Cl, 16% to 47%). These results did not differ from our historical control subjects (n = 96). Although safe and tolerable, the addition of atorvastatin did not appear to provide any benefit to standard GVHD prophylaxis alone.

• 出版日期2016-1