Health-related quality of life in patients with advanced melanoma treated with ipilimumab: prognostic implications and changes during treatment.

Autor:	Aamdal E; Department of Oncology, Oslo University Hospital, Oslo, Norway; Institute of Clinical Medicine, Faculty of Medicine, University of Oslo, Oslo, Norway. Electronic address: eliaam@ous-hf.no., Skovlund E; Department of Public Health and Nursing, Norwegian University of Science and Technology, NTNU, Trondheim, Norway., Jacobsen KD; Department of Oncology, Oslo University Hospital, Oslo, Norway., Straume O; Department of Oncology and Medical Physics, Haukeland University Hospital, Bergen, Norway; Centre for Cancer Biomarkers, Department of Clinical Science, University of Bergen, Bergen, Norway., Kersten C; Research Unit, Sørlandet Hospital, Kristiansand, Norway; Department of Oncology, Akershus University Hospital, Lørenskog, Norway., Herlofsen O; Department of Oncology, Ålesund Hospital, Ålesund, Norway., Karlsen J; The Cancer Clinic, St. Olav's Hospital, Trondheim University Hospital, Trondheim, Norway., Hussain I; Department of Hematology and Oncology, Stavanger University Hospital, Stavanger, Norway., Amundsen A; Department of Oncology, University Hospital of North Norway, Tromsø, Norway., Dalhaug A; Department of Oncology and Palliative Medicine, Nordland Hospital, Bodø, Norway., Nyakas M; Department of Oncology, Oslo University Hospital, Oslo, Norway; Institute of Clinical Medicine, Faculty of Medicine, University of Oslo, Oslo, Norway., Hagene KT; Department of Oncology, Oslo University Hospital, Oslo, Norway., Holmsen K; Department of Oncology, Oslo University Hospital, Oslo, Norway., Aamdal S; Department of Oncology, Oslo University Hospital, Oslo, Norway; Institute of Clinical Medicine, Faculty of Medicine, University of Oslo, Oslo, Norway., Kaasa S; Department of Oncology, Oslo University Hospital, Oslo, Norway; Institute of Clinical Medicine, Faculty of Medicine, University of Oslo, Oslo, Norway., Guren TK; Department of Oncology, Oslo University Hospital, Oslo, Norway. Electronic address: http://www.twitter.com/TormodGuren., Kyte JA; Department of Oncology, Oslo University Hospital, Oslo, Norway; Department of Cancer Immunology, Institute of Cancer Research, Oslo University Hospital, Oslo, Norway. Electronic address: http://www.twitter.com/GroupKyte.
Jazyk:	angličtina
Zdroj:	ESMO open [ESMO Open] 2022 Oct; Vol. 7 (5), pp. 100588. Date of Electronic Publication: 2022 Sep 16.
DOI:	10.1016/j.esmoop.2022.100588
Abstrakt:	Background: We have previously reported that the safety and efficacy of ipilimumab in real-world patients with metastatic melanoma were comparable to clinical trials. Few studies have explored health-related quality of life (HRQL) in real-world populations receiving checkpoint inhibitors. This study reports HRQL in real-world patients receiving ipilimumab and assesses the prognostic value of patient-reported outcome measures. Patients and Methods: Ipi4 (NCT02068196) was a prospective, multicentre, interventional phase IV trial. Real-world patients (N = 151) with metastatic melanoma were treated with ipilimumab 3 mg/kg intravenously as labelled. HRQL was assessed by the European Organisation of Research and Treatment of Cancer Quality of Life Questionnaire at baseline and after 10-12 weeks. Results: The European Organisation of Research and Treatment of Cancer Quality of Life Questionnaire was completed by 93% (141/151 patients) at baseline, and by 82% at 10-12 weeks. Poor performance status and elevated C-reactive protein (CRP) were associated with worse baseline HRQL. Clinically relevant and statistically significant deteriorations in HRQL from baseline to weeks 10-12 were reported (P <0.05). Baseline physical functioning [hazard ratio (HR) 1.96, P = 0.016], role functioning (HR 2.15, P <0.001), fatigue (HR 1.60, P = 0.030), and appetite loss (HR 1.76, P = 0.012) were associated with poorer overall survival independent of performance status, lactate dehydrogenase (LDH), and CRP. We further developed a prognostic model, combining HRQL outcomes with performance status, LDH, and CRP. This model identified three groups with large and statistically significant differences in survival. Conclusions: Systemic inflammation is associated with impaired HRQL. During treatment with ipilimumab, HRQL deteriorated significantly. Combining HRQL outcomes with objective risk factors provided additional prognostic information that may aid clinical decision making. Competing Interests: Disclosure EA, KDJ, KTH, KH, SK, SA, and TKG have received clinical research support from the Norwegian Ministry of Health and Care Services. MN has received personal fees and honoraria for lectures and expert meetings from Bristol-Myers Squibb, Merck Sharpe and Dohme, Novartis, and Pierre Fabre. JAK has received honoraria for lectures and clinical research support from the Norwegian Ministry of Health and Care Services, Bristol-Myers Squibb, and Roche. OH reports honoraria for lectures from Bristol-Myers Squibb and Merck Sharpe and Dohme and research funding from Novartis. CK reports former employment with Roche. The remaining authors have declared no conflicts of interests. Data sharing The datasets generated during and analysed during the current trial are available from the corresponding author on reasonable request. Ethics approval and consent to participate The Ipi4 trial (https://clinicaltrials.gov/ct2/show/NCT02068196) was approved by the Regional Committee for Medical and Health Research Ethics South East (REC ID 2013/1518) and conducted in accordance with the ethical principles of the Declaration of Helsinki (1964). All patients provided written informed consent to participate in the trial. (Copyright © 2022 The Authors. Published by Elsevier Ltd.. All rights reserved.)
Databáze:	MEDLINE
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