title: Rituximab maintenance therapy after autologous stem-cell transplantation in patients with relapsed CD20(+) diffuse large B-cell lymphoma: final analysis of the collaborative trial in relapsed aggressive lymphoma.
abstract: OBJECTIVE
  The standard treatment for relapsed diffuse large B-cell lymphoma (DLBCL) is salvage chemotherapy followed by high-dose therapy and autologous stem-cell transplantation (ASCT). The impact of maintenance rituximab after ASCT is not known.
  
  
  METHODS
  In total, 477 patients with CD20(+) DLBCL who were in their first relapse or refractory to initial therapy were randomly assigned to one of two salvage regimens. After three cycles of salvage chemotherapy, the responding patients received high-dose chemotherapy followed by ASCT. Then, 242 patients were randomly assigned to either rituximab every 2 months for 1 year or observation.
  
  
  RESULTS
  After ASCT, 122 patients received rituximab, and 120 patients were observed only. The median follow-up time was 44 months. The 4-year event-free survival (EFS) rates after ASCT were 52% and 53% for the rituximab and observation groups, respectively (P = .7). Treatment with rituximab was associated with a 15% attributable risk of serious adverse events after day 100, with more deaths (six deaths v three deaths in the observation arm). Several factors affected EFS after ASCT (P < .05), including relapsed disease within 12 months (EFS: 46% v 56% for relapsed disease after 12 months), secondary age-adjusted International Prognostic Index (saaIPI) more than 1 (EFS: 37% v 61% for saaIPI < 1), and prior treatment with rituximab (EFS: 47% v 59% for no prior rituximab). A significant difference in EFS between women (63%) and men (46%) was also observed in the rituximab group. In the Cox model for maintenance, the saaIPI was a significant prognostic factor (P < .001), as was male sex (P = .01).
  
  
  CONCLUSIONS
  In relapsed DLBCL, we observed no difference between the control group and the rituximab maintenance group and do not recommend rituximab after ASCT.
authors.affiliation: Hôpital Saint Louis, Paris, France. christian.gisselbrecht@sls.aphp.fr
authors.forename: Christian
authors.initials: C
authors.lastname: Gisselbrecht
authors.forename: Norbert
authors.initials: N
authors.lastname: Schmitz
authors.forename: Nicolas
authors.initials: N
authors.lastname: Mounier
authors.forename: Devinder
authors.initials: D
authors.lastname: Singh Gill
authors.forename: David C
authors.initials: DC
authors.lastname: Linch
authors.forename: Marek
authors.initials: M
authors.lastname: Trneny
authors.forename: Andre
authors.initials: A
authors.lastname: Bosly
authors.forename: Noel J
authors.initials: NJ
authors.lastname: Milpied
authors.forename: John
authors.initials: J
authors.lastname: Radford
authors.forename: Nicolas
authors.initials: N
authors.lastname: Ketterer
authors.forename: Ofer
authors.initials: O
authors.lastname: Shpilberg
authors.forename: Ulrich
authors.initials: U
authors.lastname: Dührsen
authors.forename: Hans
authors.initials: H
authors.lastname: Hagberg
authors.forename: David D
authors.initials: DD
authors.lastname: Ma
authors.forename: Andreas
authors.initials: A
authors.lastname: Viardot
authors.forename: Ray
authors.initials: R
authors.lastname: Lowenthal
authors.forename: Josette
authors.initials: J
authors.lastname: Brière
authors.forename: Gilles
authors.initials: G
authors.lastname: Salles
authors.forename: Craig H
authors.initials: CH
authors.lastname: Moskowitz
authors.forename: Bertram
authors.initials: B
authors.lastname: Glass
mesh_terms: D000328:Adult; D000368:Aged; D058846:Antibodies, Monoclonal, Murine-Derived / Q000009:adverse effects / Q000627:therapeutic use*; D018951:Antigens, CD20 / Q000096:biosynthesis; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D003131:Combined Modality Therapy; D018450:Disease Progression; D005260:Female; D018380:Hematopoietic Stem Cell Transplantation / Q000379:methods*; D006801:Humans; D016403:Lymphoma, Large B-Cell, Diffuse / Q000188:drug therapy* / Q000276:immunology / Q000473:pathology / Q000601:surgery*; D060046:Maintenance Chemotherapy; D008297:Male; D008875:Middle Aged; D012008:Recurrence; D012074:Remission Induction; D000069283:Rituximab; D016879:Salvage Therapy; D016019:Survival Analysis; D014182:Transplantation, Autologous; D055815:Young Adult
chemical_list: D058846:Antibodies, Monoclonal, Murine-Derived; D018951:Antigens, CD20; D000069283:Rituximab