PMID- 23273434
OWN - NLM
STAT- MEDLINE
DCOM- 20130409
LR  - 20151119
IS  - 1879-0852 (Electronic)
IS  - 0959-8049 (Linking)
VI  - 49
IP  - 4
DP  - 2013 Mar
TI  - 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).
PG  - 904-10
LID - S0959-8049(12)00911-2 [pii]
LID - 10.1016/j.ejca.2012.11.015 [doi]
AB  - PURPOSE: 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. EXPERIMENTAL DESIGN: 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. CONCLUSION: 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.
CI  - Copyright (c) 2012 Elsevier Ltd. All rights reserved.
FAU - Ribrag, Vincent
AU  - Ribrag V
AD  - Institut de cancerologie Gustave Roussy, Villejuif, France. ribrag@igr.fr
FAU - Tilly, Herve
AU  - Tilly H
FAU - Casasnovas, Olivier
AU  - Casasnovas O
FAU - Bosly, Andre
AU  - Bosly A
FAU - Bouabdallah, Reda
AU  - Bouabdallah R
FAU - Delarue, Richard
AU  - Delarue R
FAU - Boue, Francois
AU  - Boue F
FAU - Bron, Dominique
AU  - Bron D
FAU - Feugier, Pierre
AU  - Feugier P
FAU - Haioun, Corinne
AU  - Haioun C
FAU - Offner, Firtz
AU  - Offner F
FAU - Coiffier, Bertrand
AU  - Coiffier B
LA  - eng
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20121225
PL  - England
TA  - Eur J Cancer
JT  - European journal of cancer (Oxford, England : 1990)
JID - 9005373
RN  - 0 (Antineoplastic Agents)
RN  - 0 (Boronic Acids)
RN  - 0 (Pyrazines)
RN  - 69G8BD63PP (Bortezomib)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Antineoplastic Agents/*therapeutic use
MH  - Boronic Acids/*therapeutic use
MH  - Bortezomib
MH  - Cohort Studies
MH  - Drug Resistance, Neoplasm/*drug effects
MH  - Female
MH  - Follow-Up Studies
MH  - Humans
MH  - Lymphoma, Follicular/*drug therapy/mortality/pathology
MH  - Male
MH  - Maximum Tolerated Dose
MH  - Middle Aged
MH  - Neoplasm Grading
MH  - Neoplasm Recurrence, Local/*drug therapy/mortality/pathology
MH  - Prognosis
MH  - Pyrazines/*therapeutic use
MH  - *Salvage Therapy
MH  - Survival Rate
EDAT- 2013/01/01 06:00
MHDA- 2013/04/10 06:00
CRDT- 2013/01/01 06:00
PHST- 2012/09/09 00:00 [received]
PHST- 2012/11/11 00:00 [revised]
PHST- 2012/11/14 00:00 [accepted]
PHST- 2013/01/01 06:00 [entrez]
PHST- 2013/01/01 06:00 [pubmed]
PHST- 2013/04/10 06:00 [medline]
AID - S0959-8049(12)00911-2 [pii]
AID - 10.1016/j.ejca.2012.11.015 [doi]
PST - ppublish
SO  - Eur J Cancer. 2013 Mar;49(4):904-10. doi: 10.1016/j.ejca.2012.11.015. Epub 2012 
      Dec 25.