title: Atorvastatin for the Prophylaxis of Acute Graft-versus-Host Disease in Patients Undergoing HLA-Matched Related Donor Allogeneic Hematopoietic Stem Cell Transplantation (allo-HCT).
abstract: 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% CI, 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.
authors.affiliation: Division of Hematology, Department of Medicine, The Ohio State University Comprehensive Cancer Center, Columbus, Ohio. Electronic address: yvonne.efebera@osumc.edu.
authors.forename: Yvonne A
authors.initials: YA
authors.lastname: Efebera
authors.affiliation: Division of Hematology, Department of Medicine, The Ohio State University Comprehensive Cancer Center, Columbus, Ohio; Health Informatics Institute College of Medicine, University of South Florida, Tampa, Florida.
authors.forename: Susan
authors.initials: S
authors.lastname: Geyer
authors.affiliation: Division of Hematology, Department of Medicine, The Ohio State University Comprehensive Cancer Center, Columbus, Ohio.
authors.forename: Leslie
authors.initials: L
authors.lastname: Andritsos
authors.affiliation: Division of Hematology, Department of Medicine, The Ohio State University Comprehensive Cancer Center, Columbus, Ohio.
authors.forename: Sumithira
authors.initials: S
authors.lastname: Vasu
authors.affiliation: Division of Hematology, Department of Medicine, The Ohio State University Comprehensive Cancer Center, Columbus, Ohio.
authors.forename: Samantha
authors.initials: S
authors.lastname: Jaglowski
authors.affiliation: Division of Hematology, Department of Medicine, The Ohio State University Comprehensive Cancer Center, Columbus, Ohio.
authors.forename: Anissa
authors.initials: A
authors.lastname: Bingman
authors.affiliation: Division of Hematology, Department of Medicine, The Ohio State University Comprehensive Cancer Center, Columbus, Ohio.
authors.forename: William
authors.initials: W
authors.lastname: Blum
authors.affiliation: Division of Hematology, Department of Medicine, The Ohio State University Comprehensive Cancer Center, Columbus, Ohio.
authors.forename: Rebecca
authors.initials: R
authors.lastname: Klisovic
authors.affiliation: Division of Hematology, Department of Medicine, The Ohio State University Comprehensive Cancer Center, Columbus, Ohio.
authors.forename: Craig C
authors.initials: CC
authors.lastname: Hofmeister
authors.affiliation: Division of Hematology, Department of Medicine, The Ohio State University Comprehensive Cancer Center, Columbus, Ohio.
authors.forename: Don M
authors.initials: DM
authors.lastname: Benson
authors.affiliation: Division of Hematology, Department of Medicine, The Ohio State University Comprehensive Cancer Center, Columbus, Ohio.
authors.forename: Sam
authors.initials: S
authors.lastname: Penza
authors.affiliation: Division of Hematology, Department of Medicine, The Ohio State University Comprehensive Cancer Center, Columbus, Ohio.
authors.forename: Patrick
authors.initials: P
authors.lastname: Elder
authors.affiliation: Division of Hematology, Department of Medicine, The Ohio State University Comprehensive Cancer Center, Columbus, Ohio.
authors.forename: Katie
authors.initials: K
authors.lastname: Cortright
authors.affiliation: Department of Pathology, The Ohio State University, Columbus, Ohio.
authors.forename: Rhonda
authors.initials: R
authors.lastname: Kitzler
authors.affiliation: Center for Biostatistics, Department of Biomedical Informatics, The Ohio State University, Columbus, Ohio.
authors.forename: Kevin
authors.initials: K
authors.lastname: Coombes
authors.affiliation: Division of Hematology, Department of Medicine, The Ohio State University Comprehensive Cancer Center, Columbus, Ohio.
authors.forename: Lynn
authors.initials: L
authors.lastname: O'Donnell
authors.affiliation: Division of Hematology, Department of Medicine, The Ohio State University Comprehensive Cancer Center, Columbus, Ohio.
authors.forename: Beth
authors.initials: B
authors.lastname: Daneault
authors.affiliation: Division of Hematology, Department of Medicine, The Ohio State University Comprehensive Cancer Center, Columbus, Ohio.
authors.forename: Hillary
authors.initials: H
authors.lastname: Bradbury
authors.affiliation: Center for Biostatistics, Department of Biomedical Informatics, The Ohio State University, Columbus, Ohio.
authors.forename: Jianying
authors.initials: J
authors.lastname: Zhang
authors.affiliation: Division of Hematology, Department of Medicine, The Ohio State University Comprehensive Cancer Center, Columbus, Ohio.
authors.forename: Xilin
authors.initials: X
authors.lastname: Chen
authors.affiliation: Division of Hematology, Department of Medicine, The Ohio State University Comprehensive Cancer Center, Columbus, Ohio.
authors.forename: Sabrina
authors.initials: S
authors.lastname: Garman
authors.affiliation: Division of Hematology, Department of Medicine, The Ohio State University Comprehensive Cancer Center, Columbus, Ohio.
authors.forename: Parvathi
authors.initials: P
authors.lastname: Ranganathan
authors.affiliation: Division of Hematology, Department of Medicine, The Ohio State University Comprehensive Cancer Center, Columbus, Ohio.
authors.forename: Xueyan
authors.initials: X
authors.lastname: Yu
authors.affiliation: Division of Hematology, Department of Medicine, The Ohio State University Comprehensive Cancer Center, Columbus, Ohio.
authors.forename: Jessica
authors.initials: J
authors.lastname: Hofstetter
authors.affiliation: Division of Hematology, Department of Medicine, The Ohio State University Comprehensive Cancer Center, Columbus, Ohio.
authors.forename: Jianhua
authors.initials: J
authors.lastname: Yu
authors.affiliation: Division of Hematology, Department of Medicine, The Ohio State University Comprehensive Cancer Center, Columbus, Ohio.
authors.forename: Ramiro
authors.initials: R
authors.lastname: Garzon
authors.affiliation: Department of Pathology, The Ohio State University, Columbus, Ohio.
authors.forename: Scott R
authors.initials: SR
authors.lastname: Scrape
authors.affiliation: Department of Pathology, The Ohio State University, Columbus, Ohio.
authors.forename: Gerard
authors.initials: G
authors.lastname: Lozanski
authors.affiliation: Division of Hematology, Department of Medicine, The Ohio State University Comprehensive Cancer Center, Columbus, Ohio.
authors.forename: Steven M
authors.initials: SM
authors.lastname: Devine
mesh_terms: D000208:Acute Disease; D000328:Adult; D000368:Aged; D064591:Allografts; D000069059:Atorvastatin / Q000008:administration & dosage*; D018572:Disease-Free Survival; D005260:Female; D006086:Graft vs Host Disease / Q000209:etiology / Q000401:mortality* / Q000517:prevention & control*; D018380:Hematopoietic Stem Cell Transplantation; D006650:Histocompatibility Testing; D006801:Humans; D008297:Male; D008875:Middle Aged; D015996:Survival Rate; D014019:Tissue Donors
chemical_list: D000069059:Atorvastatin
keywords: Allogeneic hematopoietic stem cell transplant; Atorvastatin; Graft-versus-host-disease