PMID- 30770308
OWN - NLM
STAT- MEDLINE
DCOM- 20200520
LR  - 20200520
IS  - 2152-2669 (Electronic)
IS  - 2152-2669 (Linking)
VI  - 19
IP  - 4
DP  - 2019 Apr
TI  - Clinical Benefit-Risk Profile of Lenalidomide in Patients With Lower-risk 
      Myelodysplastic Syndromes Without del(5q): Results of a Phase III Trial.
PG  - 213-219.e4
LID - S2152-2650(18)31520-9 [pii]
LID - 10.1016/j.clml.2018.12.012 [doi]
AB  - BACKGROUND: In the phase III MDS-005 study of patients with lower-risk, 
      non-del(5q) myelodysplastic syndromes, lenalidomide was associated with a higher 
      rate of >/= 8 weeks red blood cell transfusion independence (RBC-TI) compared with 
      placebo, but also with a higher risk of hematologic adverse events (AEs). 
      PATIENTS AND METHODS: This analysis evaluated the ratio of clinical benefit-risk 
      in patients treated with lenalidomide or placebo, and assessed the effect of 
      lenalidomide dose reductions on response. Clinical benefit was a composite 
      endpoint defined as RBC-TI, transfusion reduction >/= 4 units packed red blood 
      cells, hemoglobin increase >/= 1.5 g/dL, or cytogenetic response. RESULTS: The rate 
      of clinical benefit was higher with lenalidomide than with placebo (31.9% vs. 
      3.8%). The ratio of response (RBC-TI and clinical benefit) to risk (hematologic 
      AEs) favored lenalidomide over placebo. Patients who underwent >/= 1 lenalidomide 
      dose reduction had a longer duration of treatment, received a higher cumulative 
      dose, and were more likely to experience clinical benefit versus patients without 
      dose reductions. CONCLUSION: Despite the occurrence of hematologic AEs, the 
      overall benefit-risk profile supported lenalidomide treatment. Appropriate 
      management of hematologic AEs by dose reductions may help patients with 
      myelodysplastic syndromes to remain on treatment and achieve clinical benefit.
CI  - Copyright (c) 2018. Published by Elsevier Inc.
FAU - Garcia-Manero, Guillermo
AU  - Garcia-Manero G
AD  - Department of Leukemia, MD Anderson Cancer Center, Houston, TX. Electronic 
      address: ggarciam@mdanderson.org.
FAU - Almeida, Antonio
AU  - Almeida A
AD  - Department of Hematology, Hospital da Luz, Lisbon, Portugal.
FAU - Fenaux, Pierre
AU  - Fenaux P
AD  - Service d'Hematologie Seniors, Hopital Saint-Louis, Universite Paris 7, Paris, 
      France.
FAU - Gattermann, Norbert
AU  - Gattermann N
AD  - Klinik fur Hamatologie, Onkologie und Klinische Immunologie, 
      Heinrich-Heine-Universitat, Dusseldorf, Germany.
FAU - Giagounidis, Aristoteles
AU  - Giagounidis A
AD  - Department of Oncology, Hematology and Palliative Care, Marien Hospital 
      Dusseldorf, Dusseldorf, Germany.
FAU - Goldberg, Stuart L
AU  - Goldberg SL
AD  - John Theurer Cancer Center, Hackensack University Medical Center, Hackensack, NJ.
FAU - Ozawa, Keiya
AU  - Ozawa K
AD  - The Institute of Medical Science, The University of Tokyo, Tokyo, Japan.
FAU - Weaver, Jerry
AU  - Weaver J
AD  - Celgene Corporation, Summit, NJ.
FAU - Santini, Valeria
AU  - Santini V
AD  - MDS Unit, AOU Careggi, University of Florence, Florence, Italy.
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20181221
PL  - United States
TA  - Clin Lymphoma Myeloma Leuk
JT  - Clinical lymphoma, myeloma & leukemia
JID - 101525386
RN  - 0 (Angiogenesis Inhibitors)
RN  - 0 (Hematinics)
RN  - 0 (Immunologic Factors)
RN  - F0P408N6V4 (Lenalidomide)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Angiogenesis Inhibitors/adverse effects/*therapeutic use
MH  - Dose-Response Relationship, Drug
MH  - Drug-Related Side Effects and Adverse Reactions
MH  - Erythrocyte Transfusion
MH  - Female
MH  - Hematinics/pharmacology
MH  - Humans
MH  - Immunologic Factors/adverse effects/*therapeutic use
MH  - Lenalidomide/adverse effects/*therapeutic use
MH  - Male
MH  - Middle Aged
MH  - Myelodysplastic Syndromes/blood/*drug therapy
MH  - Risk Assessment
MH  - Treatment Outcome
OTO - NOTNLM
OT  - Adverse events
OT  - Benefit-risk ratio
OT  - Dose reduction
OT  - Response
OT  - Treatment exposure
EDAT- 2019/02/17 06:00
MHDA- 2020/05/21 06:00
CRDT- 2019/02/17 06:00
PHST- 2018/10/29 00:00 [received]
PHST- 2018/12/15 00:00 [accepted]
PHST- 2019/02/17 06:00 [pubmed]
PHST- 2020/05/21 06:00 [medline]
PHST- 2019/02/17 06:00 [entrez]
AID - S2152-2650(18)31520-9 [pii]
AID - 10.1016/j.clml.2018.12.012 [doi]
PST - ppublish
SO  - Clin Lymphoma Myeloma Leuk. 2019 Apr;19(4):213-219.e4. doi: 
      10.1016/j.clml.2018.12.012. Epub 2018 Dec 21.