title: Rituximab purging and/or maintenance in patients undergoing autologous transplantation for relapsed follicular lymphoma: a prospective randomized trial from the lymphoma working party of the European group for blood and marrow transplantation.
abstract: OBJECTIVE
  The objective of this randomized trial was to assess the efficacy and safety of rituximab as in vivo purging before transplantation and as maintenance treatment immediately after high-dose chemotherapy and autologous stem-cell transplantation (HDC-ASCT) in patients with relapsed follicular lymphoma (FL).
  
  
  METHODS
  Patients with relapsed FL who achieved either complete or very good partial remission with salvage chemotherapy were randomly assigned using a factorial design to rituximab purging (P+; 375 mg/m(2) once per week for 4 weeks) or observation (NP) before HDC-ASCT and to maintenance rituximab (M+; 375 mg/m(2) once every 2 months for four infusions) or observation (NM).
  
  
  RESULTS
  From October 1999 to April 2006, 280 patients were enrolled. The median age was 51 years (range, 26 to 70 years), and baseline characteristics were well balanced between groups. On average, patients were 44 months (range, 3 to 464 months) from diagnosis, with 79% having received two lines and 15% three lines of prior therapy. Median follow-up was 8.3 years. In contrast to purging, 10-year progression-free survival (PFS) was 48% for P+ and 42% for NP groups (hazard ratio [HR], 0.80; 95% CI, 0.58 to 1.11; P = .18); maintenance had a significant effect on PFS (10-year PFS, 54% for M+ and 37% for NM; HR, 0.66; 95% CI, 0.47 to 0.91; P = .012). Overall survival (OS) was not improved by either rituximab purging or maintenance.
  
  
  CONCLUSIONS
  Rituximab maintenance after HDC-ASCT is safe and significantly prolongs PFS but not OS in patients undergoing transplantation for relapsed FL. Pretransplantation rituximab in vivo purging, even in rituximab-naive patients, failed to improve PFS or OS.
authors.affiliation: St George's University of London, Cranmer Terrace, London SW17 0QT, United Kingdom. rpetteng@sgul.ac.uk
authors.forename: Ruth
authors.initials: R
authors.lastname: Pettengell
authors.forename: Norbert
authors.initials: N
authors.lastname: Schmitz
authors.forename: Christian
authors.initials: C
authors.lastname: Gisselbrecht
authors.forename: Graeme
authors.initials: G
authors.lastname: Smith
authors.forename: William N
authors.initials: WN
authors.lastname: Patton
authors.forename: Bernd
authors.initials: B
authors.lastname: Metzner
authors.forename: Dolores
authors.initials: D
authors.lastname: Caballero
authors.forename: Herve
authors.initials: H
authors.lastname: Tilly
authors.forename: Jan A
authors.initials: JA
authors.lastname: Walewski
authors.forename: Isabelle
authors.initials: I
authors.lastname: Bence-Bruckler
authors.forename: Bik
authors.initials: B
authors.lastname: To
authors.forename: Christian H
authors.initials: CH
authors.lastname: Geisler
authors.forename: Rik
authors.initials: R
authors.lastname: Schots
authors.forename: Eva
authors.initials: E
authors.lastname: Kimby
authors.forename: Christian J
authors.initials: CJ
authors.lastname: Taverna
authors.forename: Tomás
authors.initials: T
authors.lastname: Kozák
authors.forename: Peter
authors.initials: P
authors.lastname: Dreger
authors.forename: Ruzena
authors.initials: R
authors.lastname: Uddin
authors.forename: Carmen
authors.initials: C
authors.lastname: Ruiz de Elvira
authors.forename: Anthony H
authors.initials: AH
authors.lastname: Goldstone
mesh_terms: D000328:Adult; D000368:Aged; D058846:Antibodies, Monoclonal, Murine-Derived / Q000627:therapeutic use*; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D016465:Bone Marrow Purging / Q000379:methods*; D003131:Combined Modality Therapy; D005260:Female; D006801:Humans; D008224:Lymphoma, Follicular / Q000188:drug therapy / Q000473:pathology / Q000601:surgery / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012008:Recurrence; D000069283:Rituximab; D016879:Salvage Therapy; D033581:Stem Cell Transplantation / Q000379:methods*; D014182:Transplantation, Autologous
chemical_list: D058846:Antibodies, Monoclonal, Murine-Derived; D000970:Antineoplastic Agents; D000069283:Rituximab