title: 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.affiliation: Universitair Ziekenhuis Leuven, Campus Gasthuisberg, Leuven, Belgium michel.delforge@uzleuven.be.
authors.forename: Michel
authors.initials: M
authors.lastname: Delforge
authors.affiliation: London Health Sciences Centre, London, ON, Canada.
authors.forename: Leonard
authors.initials: L
authors.lastname: Minuk
authors.affiliation: Hôpital Emile Muller, Mulhouse, France.
authors.forename: Jean-Claude
authors.initials: JC
authors.lastname: Eisenmann
authors.affiliation: Hôpital Saint-Louis, Paris, France.
authors.forename: Bertrand
authors.initials: B
authors.lastname: Arnulf
authors.affiliation: Clinica Ematologica, A.O.U. San Martino di Genova, Italy.
authors.forename: Letizia
authors.initials: L
authors.lastname: Canepa
authors.affiliation: Unità Operativa di Oncoematologia, Ospedale di Matera, Italy.
authors.forename: Alberto
authors.initials: A
authors.lastname: Fragasso
authors.affiliation: Centre Hospitalier Universitaire Vaudois (CHUV), Lausanne, Switzerland.
authors.forename: Serge
authors.initials: S
authors.lastname: Leyvraz
authors.affiliation: Klinik für Innere Medizin III, Ulm, Germany.
authors.forename: Christian
authors.initials: C
authors.lastname: Langer
authors.affiliation: Royal Hallamshire Hospital, Sheffield, UK.
authors.forename: Yousef
authors.initials: Y
authors.lastname: Ezaydi
authors.affiliation: Abramson Cancer Center, University of Pennsylvania, Philadelphia, PA, USA.
authors.forename: Dan T
authors.initials: DT
authors.lastname: Vogl
authors.affiliation: CIBER Enfermedades Raras (CIBERER), Translational Research Unit, Miguel Servet University Hospital, Zaragoza, Spain.
authors.forename: Pilar
authors.initials: P
authors.lastname: Giraldo-Castellano
authors.affiliation: Seoul National University Hospital, Korea.
authors.forename: Sung-Soo
authors.initials: SS
authors.lastname: Yoon
authors.affiliation: Rhumatologie Nord, Hôpital J. Monod, Le Havre, France.
authors.forename: Charles
authors.initials: C
authors.lastname: Zarnitsky
authors.affiliation: CHRU Hôpital de Pontchaillou, Rennes, France.
authors.forename: Martine
authors.initials: M
authors.lastname: Escoffre-Barbe
authors.affiliation: CHUM Hôpital Notre-Dame, Montreal, QUE, Canada.
authors.forename: Bernard
authors.initials: B
authors.lastname: Lemieux
authors.affiliation: Vancouver General Hospital, Vancouver, BC, Canada.
authors.forename: Kevin
authors.initials: K
authors.lastname: Song
authors.affiliation: Tom Baker Cancer Centre - University of Calgary, Calgary, AL, Canada.
authors.forename: Nizar Jacques
authors.initials: NJ
authors.lastname: Bahlis
authors.affiliation: Evidera, Lexington, MA, USA.
authors.forename: Shien
authors.initials: S
authors.lastname: Guo
authors.affiliation: Celgene Corporation, Summit, NJ, USA.
authors.forename: Mara Silva
authors.initials: MS
authors.lastname: Monzini
authors.affiliation: Celgene Corporation, Summit, NJ, USA.
authors.forename: Annette
authors.initials: A
authors.lastname: Ervin-Haynes
authors.affiliation: Celgene Corporation, Summit, NJ, USA.
authors.forename: Vanessa
authors.initials: V
authors.lastname: Houck
authors.affiliation: Hôpital Claude Huriez, Lille, France.
authors.forename: Thierry
authors.initials: T
authors.lastname: Facon
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage*; D003430:Cross-Sectional Studies; D003907:Dexamethasone / Q000008:administration & dosage; D005260:Female; D006304:Health Status; D006801:Humans; D000077269:Lenalidomide; D008297:Male; D008558:Melphalan / Q000008:administration & dosage; D009101:Multiple Myeloma / Q000175:diagnosis* / Q000188:drug therapy* / Q000523:psychology; D011241:Prednisone / Q000008:administration & dosage; D011788:Quality of Life / Q000523:psychology; D013792:Thalidomide / Q000008:administration & dosage / Q000031:analogs & derivatives
chemical_list: D013792:Thalidomide; D003907:Dexamethasone; D000077269:Lenalidomide; D008558:Melphalan; D011241:Prednisone