期刊
CLINICAL LYMPHOMA MYELOMA & LEUKEMIA
卷 18, 期 2, 页码 136-+出版社
CIG MEDIA GROUP, LP
DOI: 10.1016/j.clml.2017.12.004
关键词
Anemia; Clinical trial; Hemoglobin; Response; Transfusion independence
资金
- Celgene Corporation (Summit, NJ)
- Celgene Corporation
Health-related quality of life (HRQoL) was evaluated among red blood cell transfusion-dependent patients with lower-risk non-del(5q) myelodysplastic syndromes (MDS) treated with lenalidomide (n = 160) or placebo (n = 79) in the phase III MDS-005 study. Lenalidomide did not worsen HRQoL; response to lenalidomide was associated with significant HRQoL improvement. Lenalidomide represents a treatment option for patients with lower-risk non-del(5q) MDS who are ineligible for or refractory to erythropoiesis-stimulating agents. 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.
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