title: High-dose therapy and autologous blood stem-cell transplantation compared with conventional treatment in myeloma patients aged 55 to 65 years: long-term results of a randomized control trial from the Group Myelome-Autogreffe.
abstract: OBJECTIVE
  To study the impact of high-dose therapy (HDT) with autologous stem-cell support in patients with symptomatic multiple myeloma (MM) between the ages of 55 and 65 years.
  
  
  METHODS
  One hundred ninety patients between 55 and 65 years old who had newly diagnosed stage II or III MM were randomly assigned to receive either conventional chemotherapy (CCT; ie, monthly courses of a regimen of vincristine, melphalan, cyclophosphamide, and prednisone) or HDT and autologous blood stem-cell transplantation (using either melphalan alone 200 mg/m(2) intravenous [IV] or melphalan 140 mg/m(2) IV plus busulfan 16 mg/kg orally as pretransplantation cytoreduction).
  
  
  RESULTS
  Within a median follow-up of 120 months, median event-free survival (EFS) times were 25 and 19 months in the HDT and CCT groups, respectively. Median overall survival (OS) time was 47.8 months in the HDT group compared with 47.6 months in the CCT group. A trend to better EFS (P = .07) was observed in favor of HDT, whereas OS curves were not statistically different (P = .91). The period of time without symptoms, treatment, and treatment toxicity (TwiSTT) was significantly longer for the HDT patients than for the CCT patients (P = .03).
  
  
  CONCLUSIONS
  With a median follow-up time of approximately 10 years, this randomized trial confirmed a benefit of HDT in terms of EFS and TwiSTT but did not provide evidence for superiority of HDT over CCT in OS of patients aged 55 to 65 years with symptomatic newly diagnosed MM.
authors.affiliation: Immuno-Hematology Unit and Department of Biostatistics, Hôpital Saint Louis, Paris, France. jpfermand@yahoo.fr
authors.forename: Jean-Paul
authors.initials: JP
authors.lastname: Fermand
authors.forename: Sandrine
authors.initials: S
authors.lastname: Katsahian
authors.forename: Marine
authors.initials: M
authors.lastname: Divine
authors.forename: Veronique
authors.initials: V
authors.lastname: Leblond
authors.forename: Francois
authors.initials: F
authors.lastname: Dreyfus
authors.forename: Margaret
authors.initials: M
authors.lastname: Macro
authors.forename: Bertrand
authors.initials: B
authors.lastname: Arnulf
authors.forename: Bruno
authors.initials: B
authors.lastname: Royer
authors.forename: Xavier
authors.initials: X
authors.lastname: Mariette
authors.forename: Edouard
authors.initials: E
authors.lastname: Pertuiset
authors.forename: Coralie
authors.initials: C
authors.lastname: Belanger
authors.forename: Maud
authors.initials: M
authors.lastname: Janvier
authors.forename: Sylvie
authors.initials: S
authors.lastname: Chevret
authors.forename: Jean Claude
authors.initials: JC
authors.lastname: Brouet
authors.forename: Philippe
authors.initials: P
authors.lastname: Ravaud
mesh_terms: D000367:Age Factors; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002066:Busulfan / Q000008:administration & dosage; D003520:Cyclophosphamide / Q000008:administration & dosage; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008297:Male; D008558:Melphalan / Q000008:administration & dosage; D008875:Middle Aged; D009101:Multiple Myeloma / Q000188:drug therapy*; D036102:Peripheral Blood Stem Cell Transplantation; D011241:Prednisone / Q000008:administration & dosage; D014182:Transplantation, Autologous; D016896:Treatment Outcome; D014750:Vincristine / Q000008:administration & dosage
chemical_list: D014750:Vincristine; D003520:Cyclophosphamide; D002066:Busulfan; D008558:Melphalan; D011241:Prednisone