title: Low non-relapse mortality and long-term preserved quality of life in older patients undergoing matched related donor allogeneic stem cell transplantation: a prospective multicenter phase II trial.
abstract: Allogeneic transplantation is a challenge in patients of advanced age because of a high risk of non-relapse mortality and potential long-lasting impairment of health-related quality of life. The development of reduced-intensity conditioning regimens has allowed the use of allogeneic transplantation in this population, but the optimal regimen remains undefined. We conducted a multicenter phase II trial evaluating the safety and efficacy of a reduced-intensity conditioning regimen combining fludarabine, intravenous busulfan, and rabbit antithymocyte globulins in patients older than 55 years of age transplanted from matched-related donor. In addition, health-related quality of life was prospectively measured. Seventy-five patients with a median age of 60 years (range 55-70) were analyzed. Grade III-IV acute and extensive chronic graft-versus-host diseases were found in 3% and 27% of patients, respectively. The day 100 and 1-year non-relapse mortality incidences were 1% and 9%, respectively. The cumulative incidences of relapse, progression-free survival and overall survival at two years were 36%, 51% and 67%, respectively, with a median follow up of 49 months. Global health-related quality of life, physical functioning, emotional functioning, and social functioning were not impaired compared to baseline for more than 75% of the patients (75%, 81.4%, 82.3%, and 75%, respectively). Thirty-four of the 46 (74%) progression-free patients at one year were living without persistent extensive chronic graft-versus-host disease. We conclude that the reduced-intensity conditioning regimen combining fludarabine, intravenous busulfan, and rabbit antithymocyte globulins is well tolerated in patients older than 55 years with low non-relapse mortality and long-term preserved quality of life.
authors.affiliation: Hematology Department, Transplantation Unit, Paoli Calmettes Institute, Marseille Centre de Recherche sur le Cancer de Marseille (CRCM), Inserm U 1068, Marseille Aix-Marseille University, Marseille blaised@ipc.unicancer.fr.
authors.forename: Didier
authors.initials: D
authors.lastname: Blaise
authors.affiliation: Hematology Department, Transplantation Unit, Paoli Calmettes Institute, Marseille Centre de Recherche sur le Cancer de Marseille (CRCM), Inserm U 1068, Marseille Aix-Marseille University, Marseille.
authors.forename: Raynier
authors.initials: R
authors.lastname: Devillier
authors.affiliation: Mixed Research Unit 912, Institute of Research and Development, National Institute of Health and Medical Research, Paoli Calmettes Institute, Aix-Marseille University, Marseille.
authors.forename: Anne-Gaëlle
authors.initials: AG
authors.lastname: Lecoroller-Sorriano
authors.affiliation: Clinical Trial Office and Biostatistics Unit, Paoli Calmettes Institute, Marseille.
authors.forename: Jean-Marie
authors.initials: JM
authors.lastname: Boher
authors.affiliation: Clinical Trial Office and Biostatistics Unit, Paoli Calmettes Institute, Marseille.
authors.forename: Agnès
authors.initials: A
authors.lastname: Boyer-Chammard
authors.affiliation: Hematology Department, Haut-Leveque Hospital and Bordeaux University Hospital Center, Pessac.
authors.forename: Reza
authors.initials: R
authors.lastname: Tabrizi
authors.affiliation: Hematology Department, University Hospital Center, Nantes.
authors.forename: Patrice
authors.initials: P
authors.lastname: Chevallier
authors.affiliation: Hematology Department, University Hospital Center, Montpellier.
authors.forename: Nathalie
authors.initials: N
authors.lastname: Fegueux
authors.affiliation: Hematology Department, University Hospital Center, Montpellier.
authors.forename: Anne
authors.initials: A
authors.lastname: Sirvent
authors.affiliation: Hematology Department, University Hospital Center, Lyon.
authors.forename: Mauricette
authors.initials: M
authors.lastname: Michallet
authors.affiliation: Hematology Department, University Hospital Center, Clermont-Ferrand.
authors.forename: Jacques-Olivier
authors.initials: JO
authors.lastname: Bay
authors.affiliation: Hematology Department, Transplantation Unit, Paoli Calmettes Institute, Marseille.
authors.forename: Sabine
authors.initials: S
authors.lastname: Fürst
authors.affiliation: Hematology Department, Transplantation Unit, Paoli Calmettes Institute, Marseille.
authors.forename: Jean
authors.initials: J
authors.lastname: El-Cheikh
authors.affiliation: Hematology Department, University Hospital Center, Montpellier.
authors.forename: Laure
authors.initials: L
authors.lastname: Vincent
authors.affiliation: Hematology Department, University Hospital Center, Nantes.
authors.forename: Thierry
authors.initials: T
authors.lastname: Guillaume
authors.affiliation: Hematology Department, University Hospital Center, Grenoble.
authors.forename: Caroline
authors.initials: C
authors.lastname: Regny
authors.affiliation: Hematology Department, Haut-Leveque Hospital and Bordeaux University Hospital Center, Pessac.
authors.forename: Noël
authors.initials: N
authors.lastname: Milpied
authors.affiliation: Hematology Department, Transplantation Unit, Paoli Calmettes Institute, Marseille.
authors.forename: Luca
authors.initials: L
authors.lastname: Castagna
authors.affiliation: Hematology Department, University Hospital Center, Nantes CRNCA, UMR 892 INSERM - 6299 CNRS, and Université de Nantes, Faculté de Médecine, Nantes, France Hematology and Cellular Therapy Unit, AP-HP, Université Paris 6, Hôpital Saint Antoine, Paris, France.
authors.forename: Mohamad
authors.initials: M
authors.lastname: Mohty
mesh_terms: D000368:Aged; D005260:Female; D005500:Follow-Up Studies; D006086:Graft vs Host Disease / Q000401:mortality*; D019337:Hematologic Neoplasms / Q000401:mortality* / Q000473:pathology / Q000628:therapy; D018380:Hematopoietic Stem Cell Transplantation / Q000401:mortality*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D011379:Prognosis; D011446:Prospective Studies; D011788:Quality of Life; D015996:Survival Rate; D019172:Transplantation Conditioning; D014184:Transplantation, Homologous