Valeria Santini1, Antonio Almeida2, Aristoteles Giagounidis3, Uwe Platzbecker4, Rena Buckstein5, C L Beach6, Shien Guo7, Arman Altincatal7, Chengqing Wu6, Pierre Fenaux8. 1. AOU Careggi, University of Florence, Florence, Italy. Electronic address: valeria.santini@unifi.it. 2. Instituto Português de Oncologia de Lisboa Francisco Gentil, Lisbon, Portugal. 3. Marien Hospital Düsseldorf, Düsseldorf, Germany. 4. Medical Clinic and Polyclinic I, University Hospital, Technical University Dresden, Dresden, Germany. 5. Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada. 6. Celgene Corporation, Summit, NJ. 7. Evidera, Waltham, MA. 8. Service d'Hématologie Séniors, Hôpital Saint-Louis, Université Paris 7, Paris, France.
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.
RCT Entities:
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-TDpatients with lower-risk non-del(5q) MDS and response to lenalidomide was associated with significant improvements in HRQoL.
Authors: Hanneke J C M Wouters; Annette Conrads-Frank; Karin A Koinig; Alex Smith; Ge Yu; Theo de Witte; Bruce H R Wolffenbuttel; Gerwin Huls; Uwe Siebert; Reinhard Stauder; Melanie M van der Klauw Journal: Ann Hematol Date: 2021-09-02 Impact factor: 4.030
Authors: Johannes M Giesinger; Giorgio La Nasa; Francesco Sparano; Matthias Angermeyer; Emanuela Morelli; Olga Mulas; Fabio Efficace; Giovanni Caocci Journal: Clin Pract Epidemiol Ment Health Date: 2021-12-31