title: Immunologic Autograft Engineering and Survival in Non-Hodgkin Lymphoma.
abstract: Retrospective studies have reported that the collected and infused autograft absolute lymphocyte count (A-ALC) affects clinical outcomes after autologous peripheral hematopoietic stem cell transplantation (APHSCT). We hypothesized that manipulation of the apheresis machine to target a higher A-ALC dose would translate into prolonged progression-free survival (PFS) in patients with non-Hodgkin lymphoma (NHL) undergoing APHSCT. Between December 2007 and October 2010, we performed a double-blind, phase III, randomized study randomly assigning 122 patients with NHL to undergo collection with the Fenwal Amicus Apheresis system with our standard settings (mononuclear cells offset of 1.5 and RBC offset of 5.0) or at modified settings (mononuclear cells offset of 1.5 and RBC of 6.0). The primary endpoint was PFS. Neither PFS (hazard ratio [HR] of modified to standard, 1.13; 95% confidence interval [CI], .62 to 2.08; P = .70) nor overall survival (OS) (HR modified to standard, .85; 95% CI, .39 to 1.86; P = .68) were found to differ by collection method. Collection of A-ALC between both methods was similar. Both PFS (P = .0025; HR, 2.77; 95% CI, 1.39 to 5.52) and OS (P = .004; HR, 3.38; 95% CI, 1.27 to 9.01) were inferior in patients infused with an A-ALC < .5 × 10(9) lymphocytes/kg compared with patients infused with an A-ALC ≥ .5 × 10(9) lymphocytes/kg, regardless of the method of collection. We did not detect significant differences in clinical outcomes or in the A-ALC collection between the modified and the standard Fenwal Amicus settings; however, despite physician discretion on primary number of collections and range of cells infused, higher A-ALC infused dose were associated with better survival after APHSCT.
authors.affiliation: Division of Hematology, Department of Medicine, Mayo Clinic, Rochester, Minnesota. Electronic address: porrata.luis@mayo.edu.
authors.forename: Luis F
authors.initials: LF
authors.lastname: Porrata
authors.affiliation: Division of Transfusion Medicine, Department of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, Minnesota.
authors.forename: Edwin A
authors.initials: EA
authors.lastname: Burgstaler
authors.affiliation: Division of Transfusion Medicine, Department of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, Minnesota.
authors.forename: Jeffrey L
authors.initials: JL
authors.lastname: Winters
authors.affiliation: Division of Transfusion Medicine, Department of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, Minnesota.
authors.forename: Eapen K
authors.initials: EK
authors.lastname: Jacob
authors.affiliation: Division of Hematology, Department of Medicine, Mayo Clinic, Rochester, Minnesota; Division of Transfusion Medicine, Department of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, Minnesota.
authors.forename: Dennis A
authors.initials: DA
authors.lastname: Gastineau
authors.affiliation: Division of Biomedical Statistics and Informatics, Mayo Clinic, Rochester, Minnesota.
authors.forename: Vera J
authors.initials: VJ
authors.lastname: Suman
authors.affiliation: Division of Hematology, Department of Medicine, Mayo Clinic, Rochester, Minnesota.
authors.forename: David J
authors.initials: DJ
authors.lastname: Inwards
authors.affiliation: Division of Hematology, Department of Medicine, Mayo Clinic, Rochester, Minnesota.
authors.forename: Stephen M
authors.initials: SM
authors.lastname: Ansell
authors.affiliation: Division of Hematology, Department of Medicine, Mayo Clinic, Rochester, Minnesota.
authors.forename: Ivana N
authors.initials: IN
authors.lastname: Micallef
authors.affiliation: Division of Hematology, Department of Medicine, Mayo Clinic, Rochester, Minnesota.
authors.forename: Patrick B
authors.initials: PB
authors.lastname: Johnston
authors.affiliation: Division of Hematology, Department of Medicine, Mayo Clinic, Rochester, Minnesota.
authors.forename: Wendy
authors.initials: W
authors.lastname: Nevala
authors.affiliation: Division of Hematology, Department of Medicine, Mayo Clinic, Rochester, Minnesota.
authors.forename: Svetomir N
authors.initials: SN
authors.lastname: Markovic
mesh_terms: D064592:Autografts / Q000166:cytology* / Q000592:standards; D018572:Disease-Free Survival; D004311:Double-Blind Method; D005260:Female; D018380:Hematopoietic Stem Cell Transplantation / Q000379:methods / Q000401:mortality / Q000592:standards*; D006801:Humans; D007937:Leukapheresis / Q000379:methods* / Q000592:standards; D018655:Lymphocyte Count; D008228:Lymphoma, Non-Hodgkin / Q000401:mortality / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D016019:Survival Analysis
keywords: Apheresis machine; Autograft absolute lymphocyte count; Autologous peripheral hematopoietic blood stem cell transplantation; Non-Hodgkin lymphoma