Ipilimumab in a real-world population: A prospective Phase IV trial with long-term follow-up.

Autor: Aamdal E; Department of Oncology, Oslo University Hospital, Oslo, Norway.; Institute of Clinical Medicine, Faculty of Medicine, University of Oslo, Oslo, Norway.; Department of Oncology, Akershus University Hospital, Lørenskog, 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., 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, Norway., Nyakas M; Department of Oncology, Oslo University Hospital, Oslo, Norway.; Institute of Clinical Medicine, Faculty of Medicine, University of Oslo, Oslo, Norway., Schuster C; Department of Oncology and Medical Physics, Haukeland University Hospital, Bergen, Norway.; Centre for Cancer Biomarkers, Department of Clinical Science, University of Bergen, Bergen, Norway., Hagene KT; Department of Oncology, Oslo University Hospital, Oslo, Norway., Holmsen K; Department of Oncology, Oslo University Hospital, Oslo, Norway., Russnes HG; Department of Pathology, Oslo University Hospital, Oslo, Norway.; Department of Cancer Genetics, Institute for Cancer Research, Oslo University Hospital, Oslo, Norway., Skovlund E; Department of Public Health and Nursing, Norwegian University of Science and Technology, NTNU, Trondheim, Norway., Kaasa S; Department of Oncology, Oslo University Hospital, Oslo, Norway.; Institute of Clinical Medicine, Faculty of Medicine, University of Oslo, Oslo, Norway., Aamdal S; Department of Oncology, Oslo University Hospital, Oslo, Norway.; Institute of Clinical Medicine, Faculty of Medicine, University of Oslo, Oslo, Norway., Kyte JA; Department of Oncology, Oslo University Hospital, Oslo, Norway., Guren TK; Department of Oncology, Oslo University Hospital, Oslo, Norway.
Jazyk: angličtina
Zdroj: International journal of cancer [Int J Cancer] 2022 Jan 01; Vol. 150 (1), pp. 100-111. Date of Electronic Publication: 2021 Sep 09.
DOI: 10.1002/ijc.33768
Abstrakt: Ipilimumab was the first treatment that improved survival in advanced melanoma. Efficacy and toxicity in a real-world setting may differ from clinical trials, due to more liberal eligibility criteria and less intensive monitoring. Moreover, high costs and lack of biomarkers have raised cost-benefit concerns about ipilimumab in national healthcare systems and limited its use. Here, we report the prospective, interventional study, Ipi4 (NCT02068196), which aimed to investigate the toxicity and efficacy of ipilimumab in a real-world population with advanced melanoma. This national, multicentre, phase IV trial included 151 patients. Patients received ipilimumab 3 mg/kg intravenously and were followed for at least 5 years or until death. Treatment interruption or cessation occurred in 38%, most frequently due to disease progression (19%). Treatment-associated grade 3 to 4 toxicity was observed in 28% of patients, and immune-related toxicity in 56%. The overall response rate was 9%. Median overall survival was 12.1 months (95% CI: 8.3-15.9); and progression-free survival 2.7 months (95% CI: 2.6-2.8). After 5 years, 20% of patients were alive. In a landmark analysis from 6 months, improved survival was associated with objective response (HR 0.16, P = .001) and stable disease (HR 0.49, P = .005) compared to progressive disease. Poor performance status, elevated lactate dehydrogenase and C-reactive protein were identified as biomarkers. This prospective trial represents the longest reported follow-up of a real-world melanoma population treated with ipilimumab. Results indicate safety and efficacy comparable to phase III trials and suggest that the use of ipilimumab can be based on current cost-benefit estimates.
(© 2021 The Authors. International Journal of Cancer published by John Wiley & Sons Ltd on behalf of UICC.)
Databáze: MEDLINE
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