title: Effect of nivolumab on health-related quality of life in patients with treatment-naïve advanced melanoma: results from the phase III CheckMate 066 study.
abstract: Nivolumab has shown significant survival benefit and a favorable safety profile compared with dacarbazine chemotherapy among treatment-naïve patients with metastatic melanoma in the CheckMate 066 phase III study. Results from the health-related quality of life (HRQoL) analyses from CheckMate 066 are presented.
  
  
  
  HRQoL was evaluated at baseline and every 6 weeks while on treatment using the European Organisation for Research and Treatment of Care (EORTC) Core Quality of Life Questionnaire (QLQ-C30) and the EuroQoL Five Dimensions Questionnaire (EQ-5D). Via a multi-step statistical plan, data were analyzed descriptively, cross-sectionally, and longitudinally, adjusting for baseline covariates, in patients having baseline plus ≥1 post-baseline assessment.
  
  
  
  Baseline-adjusted completion rates for all HRQoL questionnaires across treatment arms were 65% and 70% for dacarbazine and nivolumab, respectively, and remained similar throughout treatment. The mean baseline HRQoL scores were similar for patients treated with nivolumab and dacarbazine. Baseline HRQoL levels with nivolumab were maintained over time. This exploratory analysis showed a between-arm difference in favor of nivolumab on the EQ-5D utility index and clinically meaningful EQ-5D improvements from baseline at several time points for patients receiving nivolumab. Patients treated with nivolumab did not show increased symptom burden as assessed by the EORTC QLQ-C30. No HRQoL change was noted with dacarbazine patients up to week 43, although the high attrition rate after week 13 did not allow any meaningful analyses. Patients receiving nivolumab deteriorated significantly later than those receiving dacarbazine on several EORTC QLQ-C30 scales and the EQ-5D utility index.
  
  
  
  In addition to prolonged survival, these exploratory HRQoL results show that nivolumab maintains baseline HRQoL levels to provide long-term quality of survival benefit, compared with dacarbazine in patients with advanced melanoma.
authors.affiliation: Melanoma Institute Australia, The University of Sydney, and Mater Hospital, Sydney, Australia georgina.long@sydney.edu.au.
authors.forename: G V
authors.initials: GV
authors.lastname: Long
authors.affiliation: Gallipoli Medical Research Foundation and Princess Alexandra Hospital, Greenslopes, Australia.
authors.forename: V
authors.initials: V
authors.lastname: Atkinson
authors.affiliation: Istituto Nazionale Tumori Fondazione Pascale, Napoli, Italy.
authors.forename: P A
authors.initials: PA
authors.lastname: Ascierto
authors.affiliation: Gustave-Roussy, Paris, France.
authors.forename: C
authors.initials: C
authors.lastname: Robert
authors.affiliation: University Hospital Heidelberg and National Center for Tumor Diseases, Heidelberg, Germany.
authors.forename: J C
authors.initials: JC
authors.lastname: Hassel
authors.affiliation: Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Warsaw, Poland.
authors.forename: P
authors.initials: P
authors.lastname: Rutkowski
authors.affiliation: BC Cancer Agency, University of British Columbia, Vancouver, Canada.
authors.forename: K J
authors.initials: KJ
authors.lastname: Savage
authors.affiliation: Adelphi Values, Boston, MA, USA.
authors.forename: F
authors.initials: F
authors.lastname: Taylor
authors.affiliation: Adelphi Values, Boston, MA, USA.
authors.forename: C
authors.initials: C
authors.lastname: Coon
authors.affiliation: Bristol-Myers Squibb, Princeton, NJ, USA.
authors.forename: I
authors.initials: I
authors.lastname: Gilloteau
authors.affiliation: Bristol-Myers Squibb, Princeton, NJ, USA.
authors.forename: H B
authors.initials: HB
authors.lastname: Dastani
authors.affiliation: Bristol-Myers Squibb, Princeton, NJ, USA.
authors.forename: I M
authors.initials: IM
authors.lastname: Waxman
authors.affiliation: Duke Clinical Research Institute, Durham, NC, USA.
authors.forename: A P
authors.initials: AP
authors.lastname: Abernethy
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000911:Antibodies, Monoclonal / Q000008:administration & dosage* / Q000009:adverse effects; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000009:adverse effects; D060908:CTLA-4 Antigen / Q000235:genetics; D003606:Dacarbazine / Q000008:administration & dosage / Q000009:adverse effects; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008545:Melanoma / Q000188:drug therapy* / Q000453:epidemiology / Q000473:pathology; D008875:Middle Aged; D000077594:Nivolumab; D061026:Programmed Cell Death 1 Receptor / Q000235:genetics; D011788:Quality of Life; D011795:Surveys and Questionnaires
chemical_list: D000911:Antibodies, Monoclonal; D060908:CTLA-4 Antigen; C105992:PDCD1 protein, human; D061026:Programmed Cell Death 1 Receptor; D000077594:Nivolumab; D003606:Dacarbazine
keywords: advanced melanoma; health-related quality of life; nivolumab; programmed death-1 receptor