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Published in: Journal of Neuro-Oncology 2/2012

01-06-2012 | Methods and Clinical Tools for Outcome Assessments

Refining endpoints in brain tumor clinical trials

Authors: Christina A. Meyers, Edwin P. Rock, Howard A. Fine

Published in: Journal of Neuro-Oncology | Issue 2/2012

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Abstract

As targeted therapies advance treatment for brain tumors, standard clinical trial endpoints of survival, progression free survival and radiographic response have become insufficient to capture clinical benefit. Brain cancer is a malignancy with neurodegenerative features. In this setting prolongation of life and/or radiographic stability are less clinically meaningful if neurocognitive function substantially declines. Hence evaluation of new therapeutic strategies should routinely include periodic assessment of neurocognitive function.
Literature
1.
go back to reference Meyers CA, Hess KR, Yung WKA, Levin VA (2000) Cognitive function as a predictor of survival in patients with recurrent malignant glioma. J Clin Oncol 18:646–650PubMed Meyers CA, Hess KR, Yung WKA, Levin VA (2000) Cognitive function as a predictor of survival in patients with recurrent malignant glioma. J Clin Oncol 18:646–650PubMed
2.
go back to reference Meyers CA, Hess KR (2003) Multifaceted end points in brain tumor clinical trials: cognitive deterioration precedes MRI progression. Neuro Oncol 5:89–95PubMed Meyers CA, Hess KR (2003) Multifaceted end points in brain tumor clinical trials: cognitive deterioration precedes MRI progression. Neuro Oncol 5:89–95PubMed
3.
go back to reference Wen PY, Macdonald DR, Reardon DA et al (2010) Updated response assessment criteria for high-grade gliomas: response assessment in neuro-oncology working group. J Clin Oncol 28:1943–1972 Wen PY, Macdonald DR, Reardon DA et al (2010) Updated response assessment criteria for high-grade gliomas: response assessment in neuro-oncology working group. J Clin Oncol 28:1943–1972
4.
go back to reference O’Shaughnessy JA, Wittes RE, Burke G et al (1991) Commentary concerning demonstration of safety and efficacy of investigational anticancer agents in clinical trials. J Clin Oncol 9:2225–2232PubMed O’Shaughnessy JA, Wittes RE, Burke G et al (1991) Commentary concerning demonstration of safety and efficacy of investigational anticancer agents in clinical trials. J Clin Oncol 9:2225–2232PubMed
5.
go back to reference Brown PD, Jensen AW, Felton SJ et al (2006) Detrimental effects of tumor progression on cognitive function of patients with high-grade glioma. J Clin Oncol 24:5427–5433PubMedCrossRef Brown PD, Jensen AW, Felton SJ et al (2006) Detrimental effects of tumor progression on cognitive function of patients with high-grade glioma. J Clin Oncol 24:5427–5433PubMedCrossRef
6.
go back to reference Wefel JS, Cloughsey TF, Zazzali JL et al (2011) Neurocognitive function in patients with recurrent glioblastoma treated with bevacizumab. Neuro Oncol 13:660–668PubMedCrossRef Wefel JS, Cloughsey TF, Zazzali JL et al (2011) Neurocognitive function in patients with recurrent glioblastoma treated with bevacizumab. Neuro Oncol 13:660–668PubMedCrossRef
7.
go back to reference Meyers CA, Brown PD (2006) The role and relevance of neurocognitive assessment in clinical trials of patients with central nervous system tumors. J Clin Oncol 24:1305–1309PubMedCrossRef Meyers CA, Brown PD (2006) The role and relevance of neurocognitive assessment in clinical trials of patients with central nervous system tumors. J Clin Oncol 24:1305–1309PubMedCrossRef
8.
go back to reference Meyers CA, Wefel JS (2003) The use of the Mini Mental State Examination to assess cognitive functioning in cancer trials: no ifs, ands, buts, or sensitivity. J Clin Oncol 21:3557–3558PubMedCrossRef Meyers CA, Wefel JS (2003) The use of the Mini Mental State Examination to assess cognitive functioning in cancer trials: no ifs, ands, buts, or sensitivity. J Clin Oncol 21:3557–3558PubMedCrossRef
9.
go back to reference Meyers CA, Smith JA, Bezjak A et al (2004) Neurocognitive function and progression in patients with brain metastases treated with whole brain radiation and motexafin gadolinium: results of a randomized phase III trial. J Clin Oncol 22:157–165PubMedCrossRef Meyers CA, Smith JA, Bezjak A et al (2004) Neurocognitive function and progression in patients with brain metastases treated with whole brain radiation and motexafin gadolinium: results of a randomized phase III trial. J Clin Oncol 22:157–165PubMedCrossRef
10.
go back to reference Wolfson AH, Bae K, Komaki R et al (2011) Primary analysis of a phase II randomized trial radiation therapy oncology group (RTOG) 0212: impact of different total doses and schedules of prophylactic cranial irradiation on chronic neurotoxicity and quality of life for patients with limited-disease small-cell lung cancer. Int J Radiat Oncol Biol Phys 81:77–84PubMedCrossRef Wolfson AH, Bae K, Komaki R et al (2011) Primary analysis of a phase II randomized trial radiation therapy oncology group (RTOG) 0212: impact of different total doses and schedules of prophylactic cranial irradiation on chronic neurotoxicity and quality of life for patients with limited-disease small-cell lung cancer. Int J Radiat Oncol Biol Phys 81:77–84PubMedCrossRef
11.
go back to reference Correa DD, Maron L, Harder H et al (2007) Cognitive functions in primary central nervous system lymphoma: literature review and assessment guidelines. Ann Oncol 18:1145–1151PubMedCrossRef Correa DD, Maron L, Harder H et al (2007) Cognitive functions in primary central nervous system lymphoma: literature review and assessment guidelines. Ann Oncol 18:1145–1151PubMedCrossRef
12.
go back to reference Wefel JS, Vardy J, Ahles T, Schagen SB (2011) International Cognition and Cancer Task Force recommendations to harmonise studies of cognitive function in patients with cancer. Lancet Oncol 12:703–708PubMedCrossRef Wefel JS, Vardy J, Ahles T, Schagen SB (2011) International Cognition and Cancer Task Force recommendations to harmonise studies of cognitive function in patients with cancer. Lancet Oncol 12:703–708PubMedCrossRef
13.
go back to reference Benedict RHB, Schretlen D, Groninger L, Brandt J (1998) Hopkins Verbal Learning Test–Revised: normative data and analysis of inter-form and test-retest reliability. Clin Neuropsychol 12:43–55CrossRef Benedict RHB, Schretlen D, Groninger L, Brandt J (1998) Hopkins Verbal Learning Test–Revised: normative data and analysis of inter-form and test-retest reliability. Clin Neuropsychol 12:43–55CrossRef
14.
go back to reference Benton AL, KdeS Hamsher (1989) Multilingual aphasia examination. AJA Associates, Iowa City Benton AL, KdeS Hamsher (1989) Multilingual aphasia examination. AJA Associates, Iowa City
15.
go back to reference Lezak MD, Howieson DB, Loring DW (2004) Neuropsychological assessment. Oxford University Press, New York Lezak MD, Howieson DB, Loring DW (2004) Neuropsychological assessment. Oxford University Press, New York
Metadata
Title
Refining endpoints in brain tumor clinical trials
Authors
Christina A. Meyers
Edwin P. Rock
Howard A. Fine
Publication date
01-06-2012
Publisher
Springer US
Published in
Journal of Neuro-Oncology / Issue 2/2012
Print ISSN: 0167-594X
Electronic ISSN: 1573-7373
DOI
https://doi.org/10.1007/s11060-012-0813-8

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