PMID- 24030098
OWN - NLM
STAT- MEDLINE
DCOM- 20140602
LR  - 20240323
IS  - 1569-8041 (Electronic)
IS  - 0923-7534 (Print)
IS  - 0923-7534 (Linking)
VI  - 24
IP  - 11
DP  - 2013 Nov
TI  - Long-term follow-up of lenalidomide in relapsed/refractory mantle cell lymphoma: 
      subset analysis of the NHL-003 study.
PG  - 2892-7
LID - 10.1093/annonc/mdt366 [doi]
AB  - BACKGROUND: Mantle cell lymphoma (MCL) is an uncommon type of non-Hodgkin 
      lymphoma with poor overall prognosis, requiring the development of new therapies. 
      Lenalidomide is an immunomodulatory agent demonstrating antitumor and 
      antiproliferative effects in MCL. We report results from a long-term subset 
      analysis of 57 patients with relapsed/refractory MCL from the NHL-003 phase II 
      multicenter study of single-agent lenalidomide in patients with aggressive 
      lymphoma DESIGN: Lenalidomide was administered orally 25 mg daily on days 1-21 
      every 28 days until progressive disease (PD) or intolerability. The primary end 
      point was overall response rate (ORR). RESULTS: Fifty-seven patients with 
      relapsed/refractory, advanced-stage MCL had a median of three prior therapies. 
      The ORR was 35% [complete response (CR)/CR unconfirmed (CRu) 12%], with a median 
      duration of response (DOR) of 16.3 months (not yet reached in patients with 
      CR/CRu) by blinded independent central review. The median time to first response 
      was 1.9 months. Median progression-free survival was 8.8 months, and overall 
      survival had not yet been reached. The most common grade 3/4 adverse events (AEs) 
      were neutropenia (46%), thrombocytopenia (30%), and anemia (13%). CONCLUSIONS: 
      These results show the activity of lenalidomide in heavily pretreated, 
      relapsed/refractory MCL. Responders had a durable response with manageable 
      side-effects. Clinical trial number posted on www.clinicaltrials.gov NCT00413036.
FAU - Zinzani, P L
AU  - Zinzani PL
AD  - Institute of Hematology 'Seragnoli', University of Bologna, Bologna, Italy.
FAU - Vose, J M
AU  - Vose JM
FAU - Czuczman, M S
AU  - Czuczman MS
FAU - Reeder, C B
AU  - Reeder CB
FAU - Haioun, C
AU  - Haioun C
FAU - Polikoff, J
AU  - Polikoff J
FAU - Tilly, H
AU  - Tilly H
FAU - Zhang, L
AU  - Zhang L
FAU - Prandi, K
AU  - Prandi K
FAU - Li, J
AU  - Li J
FAU - Witzig, T E
AU  - Witzig TE
LA  - eng
SI  - ClinicalTrials.gov/NCT00413036
GR  - P30 CA015083/CA/NCI NIH HHS/United States
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20130912
PL  - England
TA  - Ann Oncol
JT  - Annals of oncology : official journal of the European Society for Medical 
      Oncology
JID - 9007735
RN  - 4Z8R6ORS6L (Thalidomide)
RN  - F0P408N6V4 (Lenalidomide)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Disease-Free Survival
MH  - Drug Administration Schedule
MH  - Drug-Related Side Effects and Adverse Reactions/classification/*pathology
MH  - Female
MH  - Follow-Up Studies
MH  - Humans
MH  - Kaplan-Meier Estimate
MH  - Lenalidomide
MH  - Lymphoma, Mantle-Cell/*drug therapy/pathology
MH  - Male
MH  - Middle Aged
MH  - Neoplasm Recurrence, Local/*drug therapy/pathology
MH  - Neoplasm Staging
MH  - Recurrence
MH  - Thalidomide/administration & dosage/adverse effects/*analogs & derivatives
MH  - Treatment Outcome
PMC - PMC3811905
OTO - NOTNLM
OT  - lenalidomide
OT  - mantle cell lymphoma
OT  - non-Hodgkin lymphoma
EDAT- 2013/09/14 06:00
MHDA- 2014/06/03 06:00
PMCR- 2013/09/12
CRDT- 2013/09/14 06:00
PHST- 2013/09/14 06:00 [entrez]
PHST- 2013/09/14 06:00 [pubmed]
PHST- 2014/06/03 06:00 [medline]
PHST- 2013/09/12 00:00 [pmc-release]
AID - S0923-7534(19)37367-3 [pii]
AID - mdt366 [pii]
AID - 10.1093/annonc/mdt366 [doi]
PST - ppublish
SO  - Ann Oncol. 2013 Nov;24(11):2892-7. doi: 10.1093/annonc/mdt366. Epub 2013 Sep 12.