Abstract
We report health-related quality of life (HRQL) outcomes assessed using the Functional Assessment of Cancer Therapy-Anemia (FACT-An) among 167 RBC transfusion-dependent patients with IPSS Low-/Intermediate-1-risk del5q31 MDS treated with lenalidomide versus placebo in a randomized phase 3 clinical trial, MDS-004. Mean baseline to 12 week changes in FACT-An Total scores improved following treatment with lenalidomide 5 and 10mg (+5.7 and +5.7, respectively) versus placebo (-2.8) (both p<0.05). Clinically important changes in HRQL from baseline were observed at weeks 12, 24, 36, and 48 among RBC-TI≥26 week responders in both treatment groups. Lenalidomide treatment may be effective in improving HRQL outcomes.
Copyright © 2012 Elsevier Ltd. All rights reserved.
Publication types
-
Clinical Trial, Phase III
-
Randomized Controlled Trial
MeSH terms
-
Adult
-
Aged
-
Aged, 80 and over
-
Anemia, Macrocytic / complications*
-
Anemia, Macrocytic / therapy
-
Antineoplastic Agents / adverse effects
-
Antineoplastic Agents / therapeutic use
-
Blood Transfusion*
-
Chromosome Deletion
-
Chromosomes, Human, Pair 5
-
Combined Modality Therapy
-
Cross-Over Studies
-
Double-Blind Method
-
Female
-
Health Status
-
Humans
-
Lenalidomide
-
Male
-
Middle Aged
-
Myelodysplastic Syndromes / complications*
-
Myelodysplastic Syndromes / drug therapy
-
Myelodysplastic Syndromes / genetics
-
Myelodysplastic Syndromes / therapy*
-
Placebos
-
Quality of Life*
-
Risk
-
Severity of Illness Index
-
Thalidomide / adverse effects
-
Thalidomide / analogs & derivatives*
-
Thalidomide / therapeutic use
-
Treatment Outcome
Substances
-
Antineoplastic Agents
-
Placebos
-
Thalidomide
-
Lenalidomide
Supplementary concepts
-
Chromosome 5q Deletion Syndrome