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: CONCLUSIONS: GOV IDENTIFIER: NCT01866319.
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Authors | Teresa M Petrella, Caroline Robert, Erika Richtig, Wilson H Miller Jr, Giuseppe V Masucci, Euan Walpole, Celeste Lebbe, Neil Steven, Mark R Middleton, Darcy Hille, Wei Zhou, Nageatte Ibrahim, Jonathan Cebon |
Journal | European journal of cancer (Oxford, England : 1990)
(Eur J Cancer)
Vol. 86
Pg. 115-124
(11 2017)
ISSN: 1879-0852 [Electronic] England |
PMID | 28987768
(Publication Type: Clinical Trial, Phase III, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Copyright | Copyright © 2017 The Author(s). Published by Elsevier Ltd.. All rights reserved. |
Chemical References |
- Antibodies, Monoclonal, Humanized
- Antineoplastic Agents, Immunological
- Ipilimumab
- pembrolizumab
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Topics |
- Antibodies, Monoclonal, Humanized
(adverse effects, therapeutic use)
- Antineoplastic Agents, Immunological
(adverse effects, therapeutic use)
- Female
- Health Status
- Humans
- Ipilimumab
(adverse effects, therapeutic use)
- Male
- Melanoma
(drug therapy, pathology)
- Middle Aged
- Patient Reported Outcome Measures
- Quality of Life
- Skin Neoplasms
(drug therapy, pathology)
- Time Factors
- Treatment Outcome
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