title: High-dose therapy and autologous stem-cell transplantation versus conventional-dose consolidation/maintenance therapy as postremission therapy for adult patients with lymphoblastic lymphoma: results of a randomized trial of the European Group for Blood and Marrow Transplantation and the United Kingdom Lymphoma Group.
abstract: OBJECTIVE
  To determine whether a combination of high-dose therapy and autologous stem-cell transplantation (ASCT) is superior to conventional-dose consolidation and maintenance chemotherapy as postremission therapy in adults with lymphoblastic lymphoma.
  
  
  METHODS
  One hundred nineteen patients were entered onto this prospective randomized trial from 37 centers. Patients received standard remission induction therapy, and responding patients were randomized either to continue with a conventional consolidation/maintenance protocol (CC) or to receive high-dose therapy and ASCT. In some centers, patients with HLA-identical sibling donors were registered on the trial but proceeded to allogeneic bone marrow transplantation (BMT) without randomization.
  
  
  RESULTS
  Of the 119 patients entered, 111 were assessable for response to induction therapy. The overall response rate was 82% (56% complete response, 26% partial response). Of the 98 patients eligible for randomization, 65 were randomized, 31 to ASCT and 34 to CC. Reasons for failure to randomize included patient refusal (12 patients), early progression or death on induction therapy (eight patients), excessive toxicity of induction regimen (six patients), and elective allogeneic BMT (12 patients). With a median follow-up of 37 months, the actuarial 3-year relapse-free survival rate is 24% for the CC arm and 55% for the ASCT arm (hazards ratio = 0.55 in favor of the ASCT arm; 95% confidence interval [CI], 0.29 to 1.04; P =.065). The corresponding figures for overall survival are 45% and 56%, respectively (hazards ratio = 0.87 in favor of the ASCT arm; 95% CI, 0.42 to 1.81; P =.71).
  
  
  CONCLUSIONS
  The use of ASCT in adults with lymphoblastic lymphoma in first remission produced a trend for improved relapse-free survival but did not improve overall survival compared with conventional-dose therapy in this small randomized trial.
authors.affiliation: Cancer Research Campaign Wessex Medical Oncology Unit, University of Southampton, Southampton, UK. john.sweetenham@uchsc.edu
authors.forename: J W
authors.initials: JW
authors.lastname: Sweetenham
authors.forename: G
authors.initials: G
authors.lastname: Santini
authors.forename: W
authors.initials: W
authors.lastname: Qian
authors.forename: M
authors.initials: M
authors.lastname: Guelfi
authors.forename: N
authors.initials: N
authors.lastname: Schmitz
authors.forename: S
authors.initials: S
authors.lastname: Simnett
authors.forename: A
authors.initials: A
authors.lastname: Nagler
authors.forename: H
authors.initials: H
authors.lastname: Holte
authors.forename: S
authors.initials: S
authors.lastname: Kvaloy
authors.forename: P
authors.initials: P
authors.lastname: Bruzzi
authors.forename: A H
authors.initials: AH
authors.lastname: Goldstone
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D016026:Bone Marrow Transplantation; D018572:Disease-Free Survival; D004305:Dose-Response Relationship, Drug; D005260:Female; D018380:Hematopoietic Stem Cell Transplantation; D006801:Humans; D008297:Male; D008875:Middle Aged; D054198:Precursor Cell Lymphoblastic Leukemia-Lymphoma / Q000188:drug therapy* / Q000473:pathology; D011446:Prospective Studies; D014182:Transplantation, Autologous; D014184:Transplantation, Homologous; D016896:Treatment Outcome