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

被引：13

作者：

Santini, Valeria ^{[1
]}

Almeida, Antonio ^{[2
]}

Giagounidis, Aristoteles ^{[3
]}

Platzbecker, Uwe ^{[4
]}

Buckstein, Rena ^{[5
]}

Beach, C. L. ^{[6
]}

Guo, Shien ^{[7
]}

Altincatal, Arman ^{[7
]}

Wu, Chengqing ^{[6
]}

Fenaux, Pierre ^{[8
]}

机构：

[1] Univ Florence, AOU Careggi, Largo Brambilla 3, I-50134 Florence, Italy

[2] Inst Portugues Oncol Francisco Gentil, Lisbon, Portugal

[3] Marien Hosp, Dusseldorf, Germany

[4] Tech Univ Dresden, Univ Hosp, Med Clin & Polyclin 1, Dresden, Germany

[5] Sunnybrook Hlth Sci Ctr, Toronto, ON, Canada

[6] Celgene Corp, Summit, NJ USA

[7] Evidera, Waltham, MA USA

[8] Univ Paris 07, Hop St Louis, Serv Hematol Sr, Paris, France

来源：

CLINICAL LYMPHOMA MYELOMA & LEUKEMIA | 2018年 / 18卷 / 02期

关键词：

Anemia; Clinical trial; Hemoglobin; Response; Transfusion independence; TRANSFUSION-DEPENDENT PATIENTS; RANDOMIZED PHASE-III; DARBEPOETIN ALPHA; PROGNOSTIC-FACTORS; HEMOGLOBIN LEVEL; MDS; EFFICACY; IMPACT; ERYTHROPOIETIN; SURVIVAL;

D O I：

10.1016/j.clml.2017.12.004

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

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.

引用

页码：136 / +

页数：16