title: 90Y-ibritumomab tiuxetan, fludarabine, busulfan and antithymocyte globulin reduced-intensity allogeneic transplant conditioning for patients with advanced and high-risk B-cell lymphomas.
abstract: BACKGROUND
  Patients with advanced B-cell non-Hodgkin's lymphoma (NHL) refractory to initial chemotherapy or relapsing after autologous stem-cell transplantation have a poor prognosis. Allogeneic stem-cell transplantation after reduced-intensity conditioning (RIC) regimen can be a therapeutic option. However, the high incidence of relapse remains a challenging issue. We speculated that the incorporation of (90)Y-Ibritumomab tiuxetan into a fludarabine-based RIC regimen would improve the lymphoma control without overwhelming toxicity. Our aim was to evaluate the safety of (90)Y-Ibritumomab tiuxetan in association with such a regimen in a prospective multicenter phase II trial.
  
  
  METHODS
  Thirty-one patients with advanced lymphoma from five distinct institutions were included between February 2008 and October 2010. Thirty patients in complete or partial response after failure of a median of 3 (range, 2-4) previous chemotherapy regimens including autologous transplant in 29 were evaluable for nonrelapse mortality (NRM) at day 100 post-transplant that was the primary end point.
  
  
  RESULTS
  With a median follow-up of 32 months (range, 29-60 months), the 2-year event-free and overall survivals of the whole study group were both 80% [95 confidence interval (CI) 60.8% to 90.5%). The 100-day and 2-year post-transplant cumulative incidences of NRM were 3.3% (95% CI 0.2% to 14.9%) and 13.3% (95% CI 5.4% to 33.2%), respectively. The 2-year cumulative incidence of relapse was 6.7% (95% CI 1.7% to 25.4%). The cumulative incidences of grade II-IV and extensive chronic graft-versus-host disease were 27% and 14%, respectively.
  
  
  CONCLUSIONS
  For chemosensitive advanced high-risk B-cell lymphoma, the addition of (90)Y-Ibritumomab tiuxetan to a RIC regimen based on fludarabine, busulfan and antithymocyte globulin followed by allogeneic transplant is safe and highly effective. clinicaltrials.gov: NCT00607854.
authors.affiliation: Department of Hematology and Cellular Therapy, Haut-Leveque University Hospital, Bordeaux. Electronic address: krimo.bouabdallah@chu-bordeaux.fr.
authors.forename: K
authors.initials: K
authors.lastname: Bouabdallah
authors.affiliation: Department of Hematology, Institut Paoli Calmettes, Marseille.
authors.forename: S
authors.initials: S
authors.lastname: Furst
authors.affiliation: Methodological Support Unit in Clinical and Epidemiological Research (USMR), University Hospital, Bordeaux; Department of National Health Institute and Medical Research (INSERM U897, CIC-EC7), Bordeaux.
authors.forename: J
authors.initials: J
authors.lastname: Asselineau
authors.affiliation: Department of Hematology, University Hospital, Nantes.
authors.forename: P
authors.initials: P
authors.lastname: Chevalier
authors.affiliation: Department of Hematology, University Hospital, Clermont-Ferrand.
authors.forename: O
authors.initials: O
authors.lastname: Tournilhac
authors.affiliation: Department of Hematology, University Hospital, Montpellier.
authors.forename: P
authors.initials: P
authors.lastname: Ceballos
authors.affiliation: Department of Hematology and Cellular Therapy, Haut-Leveque University Hospital, Bordeaux.
authors.forename: S
authors.initials: S
authors.lastname: Vigouroux
authors.affiliation: Department of Hematology and Cellular Therapy, Haut-Leveque University Hospital, Bordeaux.
authors.forename: R
authors.initials: R
authors.lastname: Tabrizi
authors.affiliation: Methodological Support Unit in Clinical and Epidemiological Research (USMR), University Hospital, Bordeaux; Department of National Health Institute and Medical Research (INSERM U897, CIC-EC7), Bordeaux; Medical School Department, Bordeaux Segalen University, Bordeaux.
authors.forename: A
authors.initials: A
authors.lastname: Doussau
authors.affiliation: Department of Hematology, Institut Paoli Calmettes, Marseille.
authors.forename: R
authors.initials: R
authors.lastname: Bouabdallah
authors.affiliation: Department of Hematology, Saint-Antoine University Hospital, Paris.
authors.forename: M
authors.initials: M
authors.lastname: Mohty
authors.affiliation: Department of Hematology, University Hospital, Nantes; Department of National Health Institute and Medical Research (INSERM, UMR 892), Team 10, Nantes, France.
authors.forename: S
authors.initials: S
authors.lastname: Le Gouill
authors.affiliation: Department of Hematology, Institut Paoli Calmettes, Marseille.
authors.forename: D
authors.initials: D
authors.lastname: Blaise
authors.affiliation: Department of Hematology and Cellular Therapy, Haut-Leveque University Hospital, Bordeaux; Medical School Department, Bordeaux Segalen University, Bordeaux.
authors.forename: N
authors.initials: N
authors.lastname: Milpied
mesh_terms: D000328:Adult; D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D000961:Antilymphocyte Serum / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use; D002066:Busulfan / Q000627:therapeutic use*; D018572:Disease-Free Survival; D005260:Female; D006086:Graft vs Host Disease; D006801:Humans; D016393:Lymphoma, B-Cell / Q000188:drug therapy* / Q000601:surgery; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local; D011446:Prospective Studies; D016879:Salvage Therapy; D033581:Stem Cell Transplantation; D019172:Transplantation Conditioning; D014184:Transplantation, Homologous; D016896:Treatment Outcome; D014740:Vidarabine / Q000031:analogs & derivatives* / Q000627:therapeutic use
chemical_list: D000911:Antibodies, Monoclonal; D000961:Antilymphocyte Serum; C422802:ibritumomab tiuxetan; D014740:Vidarabine; D002066:Busulfan; C024352:fludarabine
keywords: 90Y-ibritumomab tiuxetan; aggressive lymphoma; allogeneic stem-cell transplantation