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Title: Changes in the use of end points in clinical trials for elderly cancer patients over time.
Austin Authors: Le Saux, O;Falandry, C;Gan, Hui K ;You, B;Freyer, G;Péron, J
Affiliation: Medical Oncology Department, Institut de Cancérologie des Hospices Civils de Lyon (IC-HCL), Pierre-Bénite
Faculté de Médecine Lyon-Sud, Lyon 1 University, EMR 3738, Oullins
Geriatric Oncology Department, Centre Hospitalier Lyon Sud, Pierre-Bénite
CarMen Biomedical Research Laboratory (Cardiovascular Diseases, Metabolism, Diabetology and Nutrition) INSERM UMR 1060, Université de Lyon, Oullins, France
Olivia Newton-John Cancer Research Institute, Heidelberg, Victoria, Australia
School of Cancer Medicine, La Trobe University, Heidelberg
Department of Medicine, Melbourne University, Melbourne, Australia
Statistics Unit, Hospices Civils de Lyon, Pierre-Bénite
CNRS, UMR 5558 Biometry and Evolutionary Biology Laboratory, Université Lyon 1, Villeurbanne, France
Issue Date: 1-Oct-2017
Publication information: Annals of oncology 2017; 28(10): 2606-2611
Abstract: Physicians need well-addressed clinical trials assessing benefits and harm of treatments to avoid under-treatment or over-treatment of elderly patients. The main objectives of this report were to present an overview of end points used in clinical trials dedicated to elderly patients; and to assess the evolution in chosen end points before and after the creation of the International Society of Geriatric Oncology in the early 2000s. All phases I, II and III trials dedicated to the treatment of cancer among elderly patients published between 2001 and 2004 and between 2011 and 2014 were reviewed. All phase III clinical trials assessing cancer treatments among adults in the same periods were also reviewed to identify subgroup analyses of elderly patients among these trials. Among phase III trials dedicated to elderly patients, overall survival was a common primary end point. Interestingly, tumor centered end points were very common in the first time period and very uncommon in the second time period, whereas composite end points were very uncommon in the first time period but very common in the second time period. Concerningly, disease-specific survival was very infrequently reported in dedicated clinical trials of elderly patients despite their importance in evaluating competing risk of death from non-oncology causes. The use of patient-reported outcomes (PROs) as a primary end point remained very uncommon but the reporting of PROs as a secondary end point tended to increase in the second time period, from 19% to 33% (P = 0.10). Functional status was infrequently reported. During the past decade, the use of clinically meaningful end points such as PROs and functional status in elderly patients remained moderate. Yet, the use of PROs as a secondary end point tended to increase between the two time periods.
DOI: 10.1093/annonc/mdx354
PubMed URL: 28961850
Type: Journal Article
Subjects: elderly
end points
geriatric oncology
Appears in Collections:Journal articles

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