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EORTC workshop on clinical trial methodology in older individuals with a diagnosis of solid tumors

EORTC workshop on clinical trial methodology in older individuals with a diagnosis of solid tumors
EORTC workshop on clinical trial methodology in older individuals with a diagnosis of solid tumors
Background: due to the aging of the population, the number of older patients diagnosed with a malignant disease is increasing. A multidisciplinary approach to the senior adult cancer patient is mandatory, to assure optimal diagnosis and therapeutic management.

Design: european Organisation for Research and Treatment of Cancer (EORTC) has currently defined senior adult oncology as one of its priorities and has established an active Elderly Task Force (ETF). Under the auspices of the EORTC, the ETF organized a workshop on clinical trial methodology in older cancer patients and in this article, we present the conclusions of this workshop.

Results: besides the ‘classical’ efficacy end points, quality of life, functional status and independence of the patient should be assessed in clinical trials in older patients. The participants of the workshop agreed on the use of a minimum dataset for the assessment of global health and functional status in older cancer patients. The panel also recommended that optimization of collaboration with pharmaceutical industry requires reporting of age-related data (subgroup analyses of clinical trials, age-related pooled analyses and obligatory post-marketing studies in vulnerable and frail older patients).

Conclusion: the identification of proper clinical outcomes and the validation of geriatric screening tools are needed for conducting sound and comparable clinical trials
1569-8041
1922-1926
Pallis, A.G.
ce934307-9bb7-4d49-9db3-5e3822f1e202
Ring, A.
94c4eca4-5896-4af8-9686-be343647223f
Fortpied, C.
3cd3139e-14e7-4535-b813-14c554b951a0
Penninckx, B
aa250907-d02d-4e9e-92b0-c93bb1e54240
Van Nes, M.C.
17fe45cd-26f4-4a7d-855a-7534a3c3e547
Wedding, U.
5d5c7ed1-cc90-471f-a9aa-92b929aab015
Vonminckwitz, G.
4e74cda8-5caa-439a-a33b-cd671c2c9d11
Johnson, C.D.
e50aa9cd-8c61-4fe3-a0b3-f51cc3a6c74a
Wyld, L.
73c19ad2-612a-4094-bf2e-26ed376a500e
Timmer-Bonte, A.
f0b50be6-d3a7-4da1-af4d-d884c6ddb96a
Bonnetain, F.
095e18af-0680-4d99-a2e1-998c891c3a77
Repetto, L.
bd2ddd5e-b67e-4add-8fc7-1717c7cb7e4e
Aapro, M.
046e4b77-867f-4535-8c2f-d8228e786dca
Luciani, A.
b840c23a-f88a-4de3-bb23-b2920f5416d2
Wildiers, H.
c4d44682-eec0-4a12-b0e5-fb036d91193b
European Organisation for Research and Treatment of Cancer Elderly Task Force
Pallis, A.G.
ce934307-9bb7-4d49-9db3-5e3822f1e202
Ring, A.
94c4eca4-5896-4af8-9686-be343647223f
Fortpied, C.
3cd3139e-14e7-4535-b813-14c554b951a0
Penninckx, B
aa250907-d02d-4e9e-92b0-c93bb1e54240
Van Nes, M.C.
17fe45cd-26f4-4a7d-855a-7534a3c3e547
Wedding, U.
5d5c7ed1-cc90-471f-a9aa-92b929aab015
Vonminckwitz, G.
4e74cda8-5caa-439a-a33b-cd671c2c9d11
Johnson, C.D.
e50aa9cd-8c61-4fe3-a0b3-f51cc3a6c74a
Wyld, L.
73c19ad2-612a-4094-bf2e-26ed376a500e
Timmer-Bonte, A.
f0b50be6-d3a7-4da1-af4d-d884c6ddb96a
Bonnetain, F.
095e18af-0680-4d99-a2e1-998c891c3a77
Repetto, L.
bd2ddd5e-b67e-4add-8fc7-1717c7cb7e4e
Aapro, M.
046e4b77-867f-4535-8c2f-d8228e786dca
Luciani, A.
b840c23a-f88a-4de3-bb23-b2920f5416d2
Wildiers, H.
c4d44682-eec0-4a12-b0e5-fb036d91193b

Pallis, A.G., Ring, A., Fortpied, C., Penninckx, B, Van Nes, M.C., Wedding, U., Vonminckwitz, G., Johnson, C.D., Wyld, L., Timmer-Bonte, A., Bonnetain, F., Repetto, L., Aapro, M., Luciani, A. and Wildiers, H. , European Organisation for Research and Treatment of Cancer Elderly Task Force (2011) EORTC workshop on clinical trial methodology in older individuals with a diagnosis of solid tumors. Annals of Oncology, 22 (8), 1922-1926. (doi:10.1093/annonc/mdq687). (PMID:21266517)

Record type: Article

Abstract

Background: due to the aging of the population, the number of older patients diagnosed with a malignant disease is increasing. A multidisciplinary approach to the senior adult cancer patient is mandatory, to assure optimal diagnosis and therapeutic management.

Design: european Organisation for Research and Treatment of Cancer (EORTC) has currently defined senior adult oncology as one of its priorities and has established an active Elderly Task Force (ETF). Under the auspices of the EORTC, the ETF organized a workshop on clinical trial methodology in older cancer patients and in this article, we present the conclusions of this workshop.

Results: besides the ‘classical’ efficacy end points, quality of life, functional status and independence of the patient should be assessed in clinical trials in older patients. The participants of the workshop agreed on the use of a minimum dataset for the assessment of global health and functional status in older cancer patients. The panel also recommended that optimization of collaboration with pharmaceutical industry requires reporting of age-related data (subgroup analyses of clinical trials, age-related pooled analyses and obligatory post-marketing studies in vulnerable and frail older patients).

Conclusion: the identification of proper clinical outcomes and the validation of geriatric screening tools are needed for conducting sound and comparable clinical trials

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More information

Published date: August 2011
Organisations: Cancer Sciences

Identifiers

Local EPrints ID: 202969
URI: http://eprints.soton.ac.uk/id/eprint/202969
ISSN: 1569-8041
PURE UUID: caa233c6-f8ab-4d45-a58d-5978341dddf2

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Date deposited: 10 Nov 2011 12:22
Last modified: 14 Mar 2024 04:26

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Contributors

Author: A.G. Pallis
Author: A. Ring
Author: C. Fortpied
Author: B Penninckx
Author: M.C. Van Nes
Author: U. Wedding
Author: G. Vonminckwitz
Author: C.D. Johnson
Author: L. Wyld
Author: A. Timmer-Bonte
Author: F. Bonnetain
Author: L. Repetto
Author: M. Aapro
Author: A. Luciani
Author: H. Wildiers
Corporate Author: European Organisation for Research and Treatment of Cancer Elderly Task Force

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