PMID- 23731832
OWN - NLM
STAT- MEDLINE
DCOM- 20131017
LR  - 20201215
IS  - 1879-0852 (Electronic)
IS  - 0959-8049 (Linking)
VI  - 49
IP  - 13
DP  - 2013 Sep
TI  - A phase 2, multicentre, single-arm, open-label study to evaluate the safety and 
      efficacy of single-agent lenalidomide (Revlimid) in subjects with relapsed or 
      refractory peripheral T-cell non-Hodgkin lymphoma: the EXPECT trial.
PG  - 2869-76
LID - S0959-8049(13)00363-8 [pii]
LID - 10.1016/j.ejca.2013.04.029 [doi]
AB  - BACKGROUND: This multicentre, single-arm, open-label phase 2 trial investigated 
      the efficacy and safety of lenalidomide monotherapy in patients with 
      relapsed/refractory peripheral T-cell lymphoma (PTCL). METHODS: Patients received 
      oral lenalidomide 25mg once daily on days 1-21 of each 28-day cycle for a maximum 
      of 24 months, until disease progression or development of unacceptable adverse 
      events (AEs). The primary end-point was efficacy; safety was evaluated as a 
      secondary end-point. This study was registered with ClinicalTrials.gov, number 
      NCT00655668. FINDINGS: A total of 54 patients with PTCL were treated. The overall 
      response rate was 22% (12 of 54), including complete response (CR) or unconfirmed 
      CR (CRu) in 11% of patients; 31% of patients with angioimmunoblastic T-cell 
      lymphoma (AITL) responded (CR/CRu in 15% of patients). The median 
      progression-free survival and median response duration were 2.5 and 3.6 months, 
      respectively, in the intent-to-treat population, and 4.6 and 3.5 months, 
      respectively, in patients with AITL. Thrombocytopenia and neutropenia were the 
      most common grade 3 or 4 haematological AEs, in 11 (20%) and 8 (15%) patients, 
      respectively. Overall, 19 patients (35%) experienced at least 1AE leading to 
      study dose interruption or reduction (commonly neutropenia or thrombocytopenia). 
      Serious AEs were observed in 54% of patients and 12 patients died during the 
      study; lymphoma progression (n=6); and acute respiratory distress syndrome, 
      dyspnea, lung infiltration, neutropenic sepsis, pneumonia and cerebral ischaemia 
      (n=1 each). INTERPRETATION: Lenalidomide exhibited single-agent activity in 
      heavily pretreated patients with PTCL, particularly in patients with AITL. Future 
      development is warranted in specific histologies, such as AITL, and in 
      combination with chemotherapy or other agents considered active in PTCL. FUNDING: 
      Celgene Corporation.
CI  - Copyright (c) 2013 Elsevier Ltd. All rights reserved.
FAU - Morschhauser, Franck
AU  - Morschhauser F
AD  - Department of Hematology, Hopital Claude Huriez, Lille, France.
FAU - Fitoussi, Olivier
AU  - Fitoussi O
FAU - Haioun, Corinne
AU  - Haioun C
FAU - Thieblemont, Catherine
AU  - Thieblemont C
FAU - Quach, Hang
AU  - Quach H
FAU - Delarue, Richard
AU  - Delarue R
FAU - Glaisner, Sylvie
AU  - Glaisner S
FAU - Gabarre, Jean
AU  - Gabarre J
FAU - Bosly, Andre
AU  - Bosly A
FAU - Lister, John
AU  - Lister J
FAU - Li, Ju
AU  - Li J
FAU - Coiffier, Bertrand
AU  - Coiffier B
LA  - eng
SI  - ClinicalTrials.gov/NCT00655668
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Multicenter Study
DEP - 20130531
PL  - England
TA  - Eur J Cancer
JT  - European journal of cancer (Oxford, England : 1990)
JID - 9005373
RN  - 0 (Angiogenesis Inhibitors)
RN  - 0 (Immunologic Factors)
RN  - 4Z8R6ORS6L (Thalidomide)
RN  - F0P408N6V4 (Lenalidomide)
SB  - IM
MH  - Administration, Oral
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Angiogenesis Inhibitors/administration & dosage/adverse effects/*therapeutic use
MH  - Disease Progression
MH  - Disease-Free Survival
MH  - Drug Administration Schedule
MH  - Early Termination of Clinical Trials
MH  - Europe
MH  - Female
MH  - Humans
MH  - Immunologic Factors/administration & dosage/adverse effects/*therapeutic use
MH  - Intention to Treat Analysis
MH  - Kaplan-Meier Estimate
MH  - Lenalidomide
MH  - Lymphoma, T-Cell, Peripheral/*drug therapy/mortality
MH  - Male
MH  - Middle Aged
MH  - Thalidomide/administration & dosage/adverse effects/*analogs & 
      derivatives/therapeutic use
MH  - Time Factors
MH  - Treatment Outcome
OTO - NOTNLM
OT  - EXPECT
OT  - Lenalidomide
OT  - Phase 2
OT  - T-cell non-Hodgkin lymphoma
EDAT- 2013/06/05 06:00
MHDA- 2013/10/18 06:00
CRDT- 2013/06/05 06:00
PHST- 2013/04/25 00:00 [received]
PHST- 2013/04/28 00:00 [accepted]
PHST- 2013/06/05 06:00 [entrez]
PHST- 2013/06/05 06:00 [pubmed]
PHST- 2013/10/18 06:00 [medline]
AID - S0959-8049(13)00363-8 [pii]
AID - 10.1016/j.ejca.2013.04.029 [doi]
PST - ppublish
SO  - Eur J Cancer. 2013 Sep;49(13):2869-76. doi: 10.1016/j.ejca.2013.04.029. Epub 2013 
      May 31.