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.

Hans Wildiers, Murielle Mauer, Athanasios Pallis, Arti Hurria, Supriya G. Mohile, Andrea Luciani, Giuseppe Curigliano, Martine Extermann, Stuart M. Lichtman, Karla Ballman, Harvey Jay Cohen, Hyman Muss, Ulrich Wedding

Research output: Contribution to journalArticle

121 Citations (Scopus)

Abstract

Selecting the most appropriate end points for clinical trials is important to assess the value of new treatment strategies. Well-established end points for clinical research exist in oncology but may not be as relevant to the older cancer population because of competing risks of death and potentially increased impact of therapy on global functioning and quality of life. This article discusses specific clinical end points and their advantages and disadvantages for older individuals. Randomized or single-arm phase II trials can provide insight into the range of efficacy and toxicity in older populations but ideally need to be confirmed in phase III trials, which are unfortunately often hindered by the severe heterogeneity of the older cancer population, difficulties with selection bias depending on inclusion criteria, physician perception, and barriers in willingness to participate. All clinical trials in oncology should be without an upper age limit to allow entry of eligible older adults. In settings where so-called standard therapy is not feasible, specific trials for older patients with cancer might be required, integrating meaningful measures of outcome. Not all questions can be answered in randomized clinical trials, and large observational cohort studies or registries within the community setting should be established (preferably in parallel to randomized trials) so that treatment patterns across different settings can be compared with impact on outcome. Obligatory integration of a comparable form of geriatric assessment is recommended in future studies, and regulatory organizations such as the European Medicines Agency and US Food and Drug Administration should require adequate collection of data on efficacy and toxicity of new drugs in fit and frail elderly subpopulations.

Original languageEnglish (US)
Pages (from-to)3711-3718
Number of pages8
JournalJournal of clinical oncology : official journal of the American Society of Clinical Oncology
Volume31
Issue number29
StatePublished - Oct 10 2013
Externally publishedYes

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Geriatrics
Clinical Trials
Organizations
Research
Neoplasms
Population
Geriatric Assessment
Frail Elderly
Selection Bias
United States Food and Drug Administration
Therapeutics
Drug-Related Side Effects and Adverse Reactions
Observational Studies
Registries
Cohort Studies
Randomized Controlled Trials
Quality of Life
Outcome Assessment (Health Care)
Physicians

ASJC Scopus subject areas

  • Medicine(all)

Cite this

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. / Wildiers, Hans; Mauer, Murielle; Pallis, Athanasios; Hurria, Arti; Mohile, Supriya G.; Luciani, Andrea; Curigliano, Giuseppe; Extermann, Martine; Lichtman, Stuart M.; Ballman, Karla; Cohen, Harvey Jay; Muss, Hyman; Wedding, Ulrich.

In: Journal of clinical oncology : official journal of the American Society of Clinical Oncology, Vol. 31, No. 29, 10.10.2013, p. 3711-3718.

Research output: Contribution to journalArticle

Wildiers, Hans ; Mauer, Murielle ; Pallis, Athanasios ; Hurria, Arti ; Mohile, Supriya G. ; Luciani, Andrea ; Curigliano, Giuseppe ; Extermann, Martine ; Lichtman, Stuart M. ; Ballman, Karla ; Cohen, Harvey Jay ; Muss, Hyman ; Wedding, Ulrich. / 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. In: Journal of clinical oncology : official journal of the American Society of Clinical Oncology. 2013 ; Vol. 31, No. 29. pp. 3711-3718.
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