Health-related quality of life outcomes of lenalidomide in transfusion-dependent patients with Low- or Intermediate-1-risk myelodysplastic syndromes with a chromosome 5q deletion: results from a randomized clinical trial.

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.

• Authors: Dennis A Revicki, Nancy A Brandenburg, Petra Muus, Ren Yu, Robert Knight, Pierre Fenaux
• Journal: Leukemia research (Leuk Res) Vol. 37 Issue 3 Pg. 259-65 (Mar 2013) ISSN: 1873-5835 [Electronic] England
• PMID: 23273538 (Publication Type: Clinical Trial, Phase III, Journal Article, Randomized Controlled Trial)
• Copyright: Copyright © 2012 Elsevier Ltd. All rights reserved.

Chemical References

• Antineoplastic Agents
• Placebos
• Thalidomide
• Lenalidomide

Topics

• Adult
• Aged
• Aged, 80 and over
• Anemia, Macrocytic (complications, therapy)
• Antineoplastic Agents (adverse effects, 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, drug therapy, genetics, therapy)
• Placebos
• Quality of Life
• Risk
• Severity of Illness Index
• Thalidomide (adverse effects, analogs & derivatives, therapeutic use)
• Treatment Outcome