title: Efficacy and toxicity of two schedules of bortezomib in patients with recurrent or refractory follicular lymphoma: a randomised phase II trial from the Groupe d'Etude des Lymphomes de l'Adulte (GELA).
abstract: OBJECTIVE
  Bortezomib has previously demonstrated activity in indolent lymphomas including follicular lymphoma with response rate ranging from 13% to 56%. However, the optimal schedule of bortezomib remains to be investigated in follicular lymphoma.
  
  
  METHODS
  We conducted a randomised phase II study where patients with follicular lymphoma in relapse or refractory receive either bortezomib 1.5 mg/m(2) biweekly on days 1, 4, 8 and 11 of a 21-day cycle (arm A) or 1.6 mg/m(2) weekly on days 1, 8, 15 and 22 of a 35-day cycle (arm B). An interim analysis was planned after 15 fully evaluable patients randomised in each treatment arm. If only five subjects or fewer respond, the treatment arm was concluded to be ineffective and was closed to inclusion.
  
  
  RESULTS
  Eighty-seven patients were included in the trial. Arm B was closed to inclusion after interim analysis. 15/50 patients (30%) in arm A and 8/37 patients (22%) in arm B achieved a response. Median duration of response was 16 and 15 months for arms A and B, respectively. Most drug-related adverse events (AEs) (all grades, all cycles) were mild.
  
  
  CONCLUSIONS
  This study demonstrates tolerability and durable clinical benefit of bortezomib when given at 1.5 mg/m(2) biweekly. Despite a higher response rate in the biweekly arm, no major difference in patient's outcome was observed between the two arms in the final analysis.
authors.affiliation: Institut de cancérologie Gustave Roussy, Villejuif, France. ribrag@igr.fr
authors.forename: Vincent
authors.initials: V
authors.lastname: Ribrag
authors.forename: Hervé
authors.initials: H
authors.lastname: Tilly
authors.forename: Olivier
authors.initials: O
authors.lastname: Casasnovas
authors.forename: André
authors.initials: A
authors.lastname: Bosly
authors.forename: Reda
authors.initials: R
authors.lastname: Bouabdallah
authors.forename: Richard
authors.initials: R
authors.lastname: Delarue
authors.forename: François
authors.initials: F
authors.lastname: Boue
authors.forename: Dominique
authors.initials: D
authors.lastname: Bron
authors.forename: Pierre
authors.initials: P
authors.lastname: Feugier
authors.forename: Corinne
authors.initials: C
authors.lastname: Haioun
authors.forename: Firtz
authors.initials: F
authors.lastname: Offner
authors.forename: Bertrand
authors.initials: B
authors.lastname: Coiffier
mesh_terms: D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D001897:Boronic Acids / Q000627:therapeutic use*; D000069286:Bortezomib; D015331:Cohort Studies; D019008:Drug Resistance, Neoplasm / Q000187:drug effects*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008224:Lymphoma, Follicular / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D008297:Male; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D060787:Neoplasm Grading; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D011379:Prognosis; D011719:Pyrazines / Q000627:therapeutic use*; D016879:Salvage Therapy; D015996:Survival Rate
chemical_list: D000970:Antineoplastic Agents; D001897:Boronic Acids; D011719:Pyrazines; D000069286:Bortezomib