PMID- 26763349
OWN - NLM
STAT- MEDLINE
DCOM- 20170106
LR  - 20200313
IS  - 1029-2403 (Electronic)
IS  - 1042-8194 (Print)
IS  - 1026-8022 (Linking)
VI  - 57
IP  - 6
DP  - 2016
TI  - Safety and efficacy of different lenalidomide starting doses in patients with 
      relapsed or refractory chronic lymphocytic leukemia: results of an international 
      multicenter double-blinded randomized phase II trial.
PG  - 1291-9
LID - 10.3109/10428194.2015.1128540 [doi]
AB  - The objective of this study was to evaluate the safety and efficacy of different 
      lenalidomide starting doses in patients with relapsed/refractory chronic 
      lymphocytic leukemia (CLL). CLL patients were randomized to receive lenalidomide 
      at initial doses of 5, 10, or 15 mg/d (N = 103). Doses were escalated by 5 mg 
      every 28-d up to a maximum of 25 mg/d; dose reductions in up to 5 mg decrements 
      were permitted. The most common grade >/=3 adverse events (AEs) were neutropenia 
      and thrombocytopenia. Ten patients died during therapy (four deaths considered as 
      related to lenalidomide); 12 patients experienced second primary malignancies. 
      The most common cause for treatment discontinuation was AEs. Overall response 
      rates were similar across arms. Progression-free survival and overall survival 
      rates were longer in patients who escalated treatment (to 15 or 20 mg/d) versus 
      those who did not. Lower starting doses allowed subsequent dose escalation of 
      lenalidomide while maintaining an acceptable tolerability profile in patients 
      with relapsed/refractory CLL.
FAU - Wendtner, Clemens M
AU  - Wendtner CM
AD  - a Klinikum Schwabing, Academic Teaching Hospital of University of Munich , Munich 
      , Germany ;
AD  - b Department I of Internal Medicine , University of Cologne , Cologne , Germany ;
FAU - Hallek, Michael
AU  - Hallek M
AD  - b Department I of Internal Medicine , University of Cologne , Cologne , Germany ;
AD  - c Cologne Cluster of Excellence in Cellular Stress Responses in Aging-Associated 
      Diseases (CECAD) , Cologne , Germany ;
FAU - Fraser, Graeme A M
AU  - Fraser GA
AD  - d Juravinski Cancer Centre, McMaster University , Hamilton , Ontario , Canada ;
FAU - Michallet, Anne-Sophie
AU  - Michallet AS
AD  - e Hospices Civils De Lyon, Centre Hospitalier Lyon Sud , Pierre Benite , Lyon , 
      France ;
FAU - Hillmen, Peter
AU  - Hillmen P
AD  - f St James's Institute of Oncology , Leeds , UK ;
FAU - Durig, Jan
AU  - Durig J
AD  - g University Hospital Essen , Essen , Germany ;
FAU - Kalaycio, Matt
AU  - Kalaycio M
AD  - h Cleveland Clinic , Cleveland , OH , USA ;
FAU - Gribben, John G
AU  - Gribben JG
AD  - i Barts Cancer Institute, Queen Mary, University of London , London , UK ;
FAU - Stilgenbauer, Stephan
AU  - Stilgenbauer S
AD  - j Department of Internal Medicine III , Ulm University , Ulm , Germany ;
FAU - Buhler, Andreas
AU  - Buhler A
AD  - j Department of Internal Medicine III , Ulm University , Ulm , Germany ;
FAU - Kipps, Thomas J
AU  - Kipps TJ
AD  - k University of California San Diego Moores Cancer Center , La Jolla , CA , USA ;
FAU - Purse, Brendan
AU  - Purse B
AD  - l Celgene Corporation , Summit , NJ , USA ;
FAU - Zhang, Jennie
AU  - Zhang J
AD  - l Celgene Corporation , Summit , NJ , USA ;
FAU - De Bedout, Sabine
AU  - De Bedout S
AD  - m Celgene Corporation , Boudry , Switzerland ;
FAU - Mei, Jay
AU  - Mei J
AD  - l Celgene Corporation , Summit , NJ , USA ;
FAU - Chanan-Khan, Asher
AU  - Chanan-Khan A
AD  - n Mayo Clinic , Jacksonville , FL , USA.
LA  - eng
GR  - P01 CA081534/CA/NCI NIH HHS/United States
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20160114
PL  - United States
TA  - Leuk Lymphoma
JT  - Leukemia & lymphoma
JID - 9007422
RN  - 0 (Antineoplastic Agents)
RN  - 0 (Immunologic Factors)
RN  - 4Z8R6ORS6L (Thalidomide)
RN  - F0P408N6V4 (Lenalidomide)
SB  - IM
CIN - Leuk Lymphoma. 2016;57(6):1247-8. PMID: 26732524
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Antineoplastic Agents/*administration & dosage/adverse effects
MH  - Drug Resistance, Neoplasm
MH  - Female
MH  - Humans
MH  - Immunologic Factors/*administration & dosage/adverse effects
MH  - Kaplan-Meier Estimate
MH  - Lenalidomide
MH  - Leukemia, Lymphocytic, Chronic, B-Cell/*drug therapy/mortality/*pathology
MH  - Male
MH  - Middle Aged
MH  - Neoplasm Staging
MH  - Recurrence
MH  - Retreatment
MH  - Thalidomide/administration & dosage/adverse effects/*analogs & derivatives
MH  - Treatment Outcome
PMC - PMC7063681
MID - NIHMS1561291
OTO - NOTNLM
OT  - CLL
OT  - Clinical trial
OT  - lenalidomide
OT  - phase II
COIS- Potential conflict of interest: Disclosure forms provided by the authors are 
      available with the full text of this article at 
      http://dx.doi.org/10.1080/10428194.2016.1195497.
EDAT- 2016/01/15 06:00
MHDA- 2017/01/07 06:00
PMCR- 2020/03/10
CRDT- 2016/01/15 06:00
PHST- 2016/01/15 06:00 [entrez]
PHST- 2016/01/15 06:00 [pubmed]
PHST- 2017/01/07 06:00 [medline]
PHST- 2020/03/10 00:00 [pmc-release]
AID - 10.3109/10428194.2015.1128540 [doi]
PST - ppublish
SO  - Leuk Lymphoma. 2016;57(6):1291-9. doi: 10.3109/10428194.2015.1128540. Epub 2016 
      Jan 14.