Refining endpoints in brain tumor clinical trials

被引:0
作者
Christina A. Meyers
Edwin P. Rock
Howard A. Fine
机构
[1] M.D. Anderson Cancer Center,Department of Neuro
[2] Otsuka Pharmaceutical Development and Commercialization Inc,Oncology
[3] National Cancer Institute,Neuro
来源
Journal of Neuro-Oncology | 2012年 / 108卷
关键词
Brain cancer; Clinical trials; Neurocognitive function;
D O I
暂无
中图分类号
学科分类号
摘要
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.
引用
收藏
页码:227 / 230
页数:3
相关论文
共 39 条
[1]  
Meyers CA(2000)Cognitive function as a predictor of survival in patients with recurrent malignant glioma J Clin Oncol 18 646-650
[2]  
Hess KR(2003)Multifaceted end points in brain tumor clinical trials: cognitive deterioration precedes MRI progression Neuro Oncol 5 89-95
[3]  
Yung WKA(2010)Updated response assessment criteria for high-grade gliomas: response assessment in neuro-oncology working group J Clin Oncol 28 1943-1972
[4]  
Levin VA(1991)Commentary concerning demonstration of safety and efficacy of investigational anticancer agents in clinical trials J Clin Oncol 9 2225-2232
[5]  
Meyers CA(2006)Detrimental effects of tumor progression on cognitive function of patients with high-grade glioma J Clin Oncol 24 5427-5433
[6]  
Hess KR(2011)Neurocognitive function in patients with recurrent glioblastoma treated with bevacizumab Neuro Oncol 13 660-668
[7]  
Wen PY(2006)The role and relevance of neurocognitive assessment in clinical trials of patients with central nervous system tumors J Clin Oncol 24 1305-1309
[8]  
Macdonald DR(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 3557-3558
[9]  
Reardon DA(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 22 157-165
[10]  
O’Shaughnessy JA(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 77-84