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Title: Patient-reported outcomes in KEYNOTE-006, a randomised study of pembrolizumab versus ipilimumab in patients with advanced melanoma
Austin Authors: Petrella, Teresa M;Robert, Caroline;Richtig, Erika;Miller, Wilson H Jr;Masucci, Giuseppe V;Walpole, Euan;Lebbe, Celeste;Steven, Neil;Middleton, Mark R;Hille, Darcy;Zhou, Wei;Ibrahim, Nageatte;Cebon, Jonathan S 
Affiliation: Sunnybrook Health Sciences Centre, University of Toronto, Toronto, ON, Canada
Gustave Roussy and Université Paris-Sud, France
Medical University of Graz, Graz, Austria
Segal Cancer Centre, Jewish General Hospital, Rossy Cancer Network, and McGill University, Montreal, QC, Canada
Karolinska Institute, Stockholm, Sweden
Princess Alexandra Hospital and The University of Queensland, Woolloongabba, Brisbane, Queensland, Australia
APHP, Dermatology and CIC, Université Paris Diderot, Hôpital Saint-Louis, Paris, France
Queen Elizabeth Hospital Birmingham, Mindelsohn Way, Birmingham, UK
The Churchill Hospital and The University of Oxford, Old Rd, Headington, Oxford, UK
Merck & Co., Inc., Kenilworth, NJ, USA
Olivia Newton-John Cancer Research Institute, Austin Health, School of Cancer Medicine, La Trobe University, Heidelberg, Victoria, Australia
Issue Date: Nov-2017 2017-10-04
Publication information: European Journal of Cancer 2017; 86: 115-124
Abstract: OBJECTIVE: Report results of patient-reported health-related quality of life (HRQoL) and symptoms from phase III KEYNOTE-006 study of pembrolizumab versus ipilimumab in patients with ipilimumab-naive advanced melanoma. PATIENTS AND METHODS: Patients received pembrolizumab 10 mg/kg every 2 (Q2W) or every 3 weeks (Q3W) for up to 2 years, or four cycles of ipilimumab 3 mg/kg Q3W. The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30) was administered at baseline and throughout the study. Patient-reported outcome (PRO) analyses were pre-specified exploratory endpoints; the primary PRO assessment was the score change from baseline to week 12 in EORTC QLQ-C30 global health status (GHS)/HRQoL score between the arms using constrained longitudinal data analysis. RESULTS: The PRO analysis population included 776 patients: pembrolizumab Q2W (n = 270); pembrolizumab Q3W (n = 266); ipilimumab (n = 240). Baseline GHS was similar across arms. QLQ-C30 compliance rates at week 12 were 87% (n = 214), 97% (n = 226), and 96% (n = 178), for the pembrolizumab Q2W, pembrolizumab Q3W, and ipilimumab arms, respectively. From baseline to week 12, GHS/HRQoL scores were better maintained with pembrolizumab than with ipilimumab (decrease of -1.9 and -2.5 for pembrolizumab versus -10.0 for ipilimumab; p < 0.001 for each pembrolizumab arm versus ipilimumab). Fewer patients treated with pembrolizumab experienced deterioration in GHS at week 12 (31% for pembrolizumab Q2W; 29% for Q3W and 44% for ipilimumab), with similar trends observed for individual functioning and symptoms scales. CONCLUSIONS: HRQoL was better maintained with pembrolizumab than with ipilimumab in patients with ipilimumab-naive advanced melanoma. CLINICALTRIALS. GOV IDENTIFIER: NCT01866319.
DOI: 10.1016/j.ejca.2017.08.032
PubMed URL:
Type: Journal Article
Subjects: Advanced melanoma
Health-related quality of life
Patient-reported outcomes
Appears in Collections:Journal articles

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