The Effect of Lenalidomide on Health-Related Quality of Life in Patients With Lower-Risk Non-del(5q) Myelodysplastic Syndromes: Results From the MDS-005 Study.

Abstract

BACKGROUND:

The phase III MDS-005 study compared lenalidomide versus placebo in red blood cell transfusion-dependent (RBC-TD) patients with lower-risk non-del(5q) myelodysplastic syndromes (MDS), ineligible/refractory to erythropoiesis-stimulating agents. Lenalidomide-treated patients were more likely to achieve transfusion independence (TI) ≥ 8 weeks (26.9% vs. 2.5%; P < .001) and hemoglobin increase ≥ 1.5 g/dL (19.4% vs. 2.5%) versus placebo.

PATIENTS AND METHODS:

Patients were randomized 2:1 to oral lenalidomide 10 mg once daily or placebo once daily (both on 28-day cycles). Patients with creatinine clearance 40 to 60 mL/min were given lenalidomide 5 mg once daily. Health-related quality of life (HRQoL), a predefined secondary end point, was assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 questionnaire at baseline, week 12, week 24, every 12 weeks thereafter, and at discontinuation.

RESULTS:

At week 24, lenalidomide was associated with benefit versus placebo across all 5 preselected questionnaire scales (fatigue, dyspnea, global quality of life, physical functioning, and emotional functioning). After adjustment for baseline scores, only emotional functioning achieved significance (P = .047). Further improvement versus baseline was observed for patients who continued lenalidomide after week 24. In post hoc analyses, achievement of TI ≥ 8 weeks was associated with significant improvements across all scales (P < .01); an increase in hemoglobin level correlated with significant improvements in all scales at week 24, except emotional functioning (P < .05).

CONCLUSION:

Lenalidomide did not adversely affect HRQoL in RBC-TD patients with lower-risk non-del(5q) MDS and response to lenalidomide was associated with significant improvements in HRQoL.

• Authors: Valeria Santini, Antonio Almeida, Aristoteles Giagounidis, Uwe Platzbecker, Rena Buckstein, C L Beach, Shien Guo, Arman Altincatal, Chengqing Wu, Pierre Fenaux
• Journal: Clinical lymphoma, myeloma & leukemia (Clin Lymphoma Myeloma Leuk) Vol. 18 Issue 2 Pg. 136-144.e7 (02 2018) ISSN: 2152-2669 [Electronic] United States
• PMID: 29429612 (Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2018 Elsevier Inc. All rights reserved.

Chemical References

• Angiogenesis Inhibitors
• Lenalidomide

Topics

• Adult
• Aged
• Aged, 80 and over
• Angiogenesis Inhibitors (therapeutic use)
• Chromosome Deletion
• Chromosomes, Human, Pair 5 (genetics)
• Disease Progression
• Double-Blind Method
• Female
• Humans
• Lenalidomide (therapeutic use)
• Male
• Middle Aged
• Myelodysplastic Syndromes (drug therapy, genetics, pathology)
• Outcome Assessment, Health Care (methods)
• Quality of Life
• Risk Factors
• Surveys and Questionnaires