Health-related quality-of-life in patients with newly diagnosed multiple myeloma in the FIRST trial: Lenalidomide plus low-dose dexamethasone versus melphalan, prednisone, thalidomide

Delforge, M. ; Minuk, L. ; Eisenmann, J.C ; Arnulf, B. ; Canepa, L. ; Fragasso, A. ; Leyvraz, S. ; Langer, C. ; Ezaydi, Y. ; Vogl, D.T. ; Giraldo-Castellano, P. ; Yoon, S.S ; Zarnitsky, C. ; Escoffre-Barbe, M. ; Lemieux, B. ; Song, K. ; Bahlis, N.J. ; Guo, S. ; Monzini, M.S. ; Ervin-Haynes, A. ; Houck, V. ; Facon, T.

Resumen: We compared the health-related quality-of-life of patients with newly diagnosed multiple myeloma aged over 65 years or transplant-ineligible in the pivotal, phase III FIRST trial. Patients received: i) continuous lenalidomide and low-dose dexamethasone until disease progression; ii) fixed cycles of lenalidomide and low-dose dexamethasone for 18 months; or iii) fixed cycles of melphalan, prednisone, thalidomide for 18 months. Data were collected using the validated questionnaires (QLQ-MY20, QLQ-C30, and EQ-5D). The analysis focused on the EQ-5D utility value and six domains pre-selected for their perceived clinical relevance. Lenalidomide and low-dose dexametha- sone, and melphalan, prednisone, thalidomide improved patients’ health-related quality-of-life from baseline over the duration of the study across all pre-selected domains of the QLQ-C30 and EQ-5D. In the QLQ-MY20, lenalido- mide and low-dose dexamethasone demonstrated a significantly greater reduction in the Disease Symptoms domain compared with melphalan, prednisone, thalidomide at Month 3, and significantly lower scores for QLQ- MY20 Side Effects of Treatment at all post-baseline assessments except Month 18. Linear mixed-model repeated- measures analyses confirmed the results observed in the cross-sectional analysis. Continuous lenalidomide and low-dose dexamethasone delays disease progression versus melphalan, prednisone, thalidomide and has been asso- ciated with a clinically meaningful improvement in health-related quality-of-life. These results further establish continuous lenalidomide and low-dose dexamethasone as a new standard of care for initial therapy of myeloma by demonstrating superior health-related quality-of-life during treatment, compared with melphalan, prednisone, thalidomide.

Idioma: Inglés

DOI: 10.3324/haematol.2014.120121

Año: 2015

Publicado en: Haematologica 100, 6 (2015), 826-833
ISSN: 0390-6078

Factor impacto JCR: 6.671 (2015)

Categ. JCR: HEMATOLOGY rank: 4 / 70 = 0.057 (2015) - Q1 - T1

Factor impacto SCIMAGO: 2.959 - Hematology (Q1)

Tipo y forma: Article (Published version)