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.

Abstract

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 dexamethasone, 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, lenalidomide 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 associated 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.

• Authors: Michel Delforge, Leonard Minuk, Jean-Claude Eisenmann, Bertrand Arnulf, Letizia Canepa, Alberto Fragasso, Serge Leyvraz, Christian Langer, Yousef Ezaydi, Dan T Vogl, Pilar Giraldo-Castellano, Sung-Soo Yoon, Charles Zarnitsky, Martine Escoffre-Barbe, Bernard Lemieux, Kevin Song, Nizar Jacques Bahlis, Shien Guo, Mara Silva Monzini, Annette Ervin-Haynes, Vanessa Houck, Thierry Facon
• Journal: Haematologica (Haematologica) Vol. 100 Issue 6 Pg. 826-33 (Jun 2015) ISSN: 1592-8721 [Electronic] Italy
• PMID: 25769541 (Publication Type: Clinical Trial, Phase III, Comparative Study, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Copyright© Ferrata Storti Foundation.

Chemical References

• Thalidomide
• Dexamethasone
• Lenalidomide
• Melphalan
• Prednisone

Topics

• Aged
• Aged, 80 and over
• Antineoplastic Combined Chemotherapy Protocols (administration & dosage)
• Cross-Sectional Studies
• Dexamethasone (administration & dosage)
• Female
• Health Status
• Humans
• Lenalidomide
• Male
• Melphalan (administration & dosage)
• Multiple Myeloma (diagnosis, drug therapy, psychology)
• Prednisone (administration & dosage)
• Quality of Life (psychology)
• Thalidomide (administration & dosage, analogs & derivatives)