Overview
The world’s population is aging, and it is estimated that by 2050, the number of people aged 65 and over will be 15% of the global total, which was just 5% in 1950 (United Nations 2019). Cancer is strongly associated with aging, so it is not a surprise that the majority of new diagnoses and cancer deaths occur in people over the age of 65 years (Hurria et al. 2014).
Despite statistics from all over the world showing a growing number of older patients with cancer, older adults are still underrepresented in cancer clinical trials. Because they may respond differently to cancer treatments compared to their younger counterparts (Hurria et al. 2015), this inevitably raises serious questions with regard to the efficacy and tolerability of cancer drugs in older people and, given the heterogeneity of the group, how to accurately define older patients and recruit them to clinical trials. The need to pay greater...
This is a preview of subscription content, log in via an institution to check access.
References
Audisio RA, Pope D, Ramesh HS et al (2008) Shall we operate? Preoperative assessment in elderly cancer patients (PACE) can help – a SIOG surgical task force prospective study. Crit Rev Oncol Hematol 65: 156–163. https://doi.org/10.1016/j.critrevonc.2007.11.001
Hurria A, Dale W, Mooney M et al (2014) Designing therapeutic clinical trials for older and frail adults with cancer: U13 conference recommendations. J Clin Oncol 32:2587–2594. https://doi.org/10.1200/JCO.2013.55.0418
Hurria A, Levit L, Dale W et al (2015) Improving the evidence base for treating older adults with cancer: American Society of Clinical Oncology statement. J Clin Oncol 33:3826–3833. https://doi.org/10.1200/JCO.2015.63.0319. Epub 2015 July 20
Le Saux O, Falandry C, Gan HK et al (2016) Inclusion of elderly patients in oncology clinical trials. Ann Oncol. https://doi.org/10.1093/annonc/mdw259
Lichtman S (2012a) Call for changes in clinical trial reporting of older patients with cancer. J Clin Oncol 30:893–894
Lichtman SM (2012b) Clinical trial design in older adults with cancer – the need for new paradigms. J Geriatr Oncol 3:368–375
Mohile S, Wildiers H (2012) A call for observational cohort studies in geriatric oncology. J Geriatr Oncol 3:291–293
Quinten C, Coens C, Ghislain I et al (2015) The effects of age on health-related quality of life in cancer populations: a pooled analysis of randomized controlled trials using the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 involving 6024 cancer patients. Eur J Cancer 51(18):2808–2819. https://doi.org/10.1016/j.ejca.2015.08.027. Epub 2015 Nov 19
Quinten C, Kenis C, Decoster L et al (2019) Determining clinically important differences in health-related quality of life in older patients with cancer undergoing chemotherapy or surgery. Qual Life Res 28(3): 663–676. https://doi.org/10.1007/s11136-018-2062-6. Epub 2018 Dec 3
Reuben DB, Rubenstein LV, Hirsch SH et al (1992) Value of functional status as a predictor of mortality: results of a prospective study. Am J Med 93:663–669. https://doi.org/10.1016/0002-9343(92)90200-u
Scher K, Hurria A (2012) Under-representation of older adults in cancer registration trials: known problem, little progress. J Clin Oncol 30:2036–2038. https://doi.org/10.1200/JCO.2012.41.6727. Epub 2012 Apr 30
Stolberg H, Norman G, Trop I (2004) Fundamentals of clinical research for radiologists. Randomized controlled trials. AJR 183:1539–1544
United Nations (2019) The world population prospects: the 2019 revision. The United Nations, New York. https://population.un.org/wpp/
Wheelwright S, Darlington AS, Fitzsimmons D et al (2013) International validation of the EORTC QLQ-ELD14 questionnaire for assessment of health-related quality of life elderly patients with cancer. Br J Cancer 109(4):852–858. https://doi.org/10.1038/bjc.2013.407. Epub 2013 July 18
Wildiers H, Highley MS, de Bruijn EA et al (2003) Pharmacology of anticancer drugs in the elderly population. Clin Pharmacokinet 42:1213–1242. https://doi.org/10.2165/00003088-200342140-00003
Wildiers H, Mauer M, Pallis A et al (2013) End points and trial design in geriatric oncology research: a Joint European Organisation for Research and Treatment of Cancer–Alliance for Clinical Trials in Oncology–International Society of Geriatric Oncology position article. J Clin Oncol 31(29):3711–3718. https://doi.org/10.1200/JCO.2013.49.6125. Epub 2013 Sept 9
Wildiers H, Tryfonidis K, Dal Lago L et al (2018) Pertuzumab and trastuzumab with or without metronomic chemotherapy for older patients with HER2-positive metastatic breast cancer (EORTC 75111-10114): an open-label, randomised, phase 2 trial from the Elderly Task Force/Breast Cancer Group. Lancet Oncol 19(3):323–336
Yellen SB, Cella DF, Leslie WT (1994) Age and clinical decision making in oncology patients. J Natl Cancer Inst 86:1766–1770. https://doi.org/10.1093/jnci/86.23.1766
Author information
Authors and Affiliations
Corresponding author
Editor information
Editors and Affiliations
Section Editor information
Rights and permissions
Copyright information
© 2020 Springer Nature Switzerland AG
About this entry
Cite this entry
Dubianski, R., Wildiers, H. (2020). Clinical Trial Design for Older Cancer Patients. In: Gu, D., Dupre, M. (eds) Encyclopedia of Gerontology and Population Aging. Springer, Cham. https://doi.org/10.1007/978-3-319-69892-2_763-1
Download citation
DOI: https://doi.org/10.1007/978-3-319-69892-2_763-1
Received:
Accepted:
Published:
Publisher Name: Springer, Cham
Print ISBN: 978-3-319-69892-2
Online ISBN: 978-3-319-69892-2
eBook Packages: Springer Reference Biomedicine and Life SciencesReference Module Biomedical and Life Sciences