The FDA NIH Biomarkers, EndpointS, and other Tools (BEST) resource in neuro-oncology

被引:103
作者
Cagney, Daniel N. [1 ]
Sul, Joohee [2 ]
Huang, Raymond Y. [3 ]
Ligon, Keith L. [4 ]
Wen, Patrick Y. [5 ]
Alexander, Brian M. [1 ]
机构
[1] Harvard Med Sch, Dana Farber Brigham & Womens Canc Ctr, Dept Radiat Oncol, Boston, MA USA
[2] US FDA, Off Hematol & Oncol Prod, Ctr Drug Evaluat & Res, Silver Spring, MD USA
[3] Harvard Med Sch, Brigham & Womens Hosp, Dept Radiol, Boston, MA USA
[4] Harvard Med Sch, Brigham & Womens Hosp, Dept Pathol, Boston, MA USA
[5] Harvard Med Sch, Dana Farber Brigham & Womens Canc Ctr, Ctr Neurooncol, Boston, MA USA
关键词
BEST glossary; biomarkers; endpoints; glioma; outcomes; PROGRESSION-FREE SURVIVAL; HIGH-GRADE GLIOMAS; NEWLY-DIAGNOSED GLIOBLASTOMA; BRAIN-TUMOR CELLS; PHASE-III TRIAL; OF-THE-ART; PERFORMANCE STATUS; CLINICAL-TRIALS; ISOCITRATE DEHYDROGENASE; OLIGODENDROGLIAL TUMORS;
D O I
10.1093/neuonc/nox242
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
In early 2016, the FDA and the National Institutes of Health (NIH) published the first version of the glossary included in the Biomarkers, EndpointS, and other Tools (BEST) resource. 1 The BEST glossary was constructed to harmonize and clarify terms used in translational science and medical product development and to provide a common language used for communication by those agencies. It is considered a "living" document that will be updated in the future. This review will discuss the main biomarker and clinical outcome categories contained in the BEST glossary as they apply to neuro-oncology, as well as the overlapping and hierarchical relationships among them.
引用
收藏
页码:1162 / 1172
页数:11
相关论文
共 84 条
[1]   THE EUROPEAN-ORGANIZATION-FOR-RESEARCH-AND-TREATMENT-OF-CANCER QLQ-C30 - A QUALITY-OF-LIFE INSTRUMENT FOR USE IN INTERNATIONAL CLINICAL-TRIALS IN ONCOLOGY [J].
AARONSON, NK ;
AHMEDZAI, S ;
BERGMAN, B ;
BULLINGER, M ;
CULL, A ;
DUEZ, NJ ;
FILIBERTI, A ;
FLECHTNER, H ;
FLEISHMAN, SB ;
DEHAES, JCJM ;
KAASA, S ;
KLEE, M ;
OSOBA, D ;
RAZAVI, D ;
ROFE, PB ;
SCHRAUB, S ;
SNEEUW, K ;
SULLIVAN, M ;
TAKEDA, F .
JOURNAL OF THE NATIONAL CANCER INSTITUTE, 1993, 85 (05) :365-376
[2]   The Potential of Radiomic-Based Phenotyping in PrecisionMedicine A Review [J].
Aerts, Hugo J. W. L. .
JAMA ONCOLOGY, 2016, 2 (12) :1636-1642
[3]   miR-21 in the Extracellular Vesicles (EVs) of Cerebrospinal Fluid (CSF): A Platform for Glioblastoma Biomarker Development [J].
Akers, Johnny C. ;
Ramakrishnan, Valya ;
Kim, Ryan ;
Skog, Johan ;
Nakano, Ichiro ;
Pingle, Sandeep ;
Kalinina, Juliya ;
Hua, Wei ;
Kesari, Santosh ;
Mao, Ying ;
Breakefield, Xandra O. ;
Hochberg, Fred H. ;
Van Meir, Erwin G. ;
Carter, Bob S. ;
Chen, Clark C. .
PLOS ONE, 2013, 8 (10)
[4]   Adult Glioblastoma [J].
Alexander, Brian M. ;
Cloughesy, Timothy F. .
JOURNAL OF CLINICAL ONCOLOGY, 2017, 35 (21) :2402-+
[5]   Progression-free survival: too much risk, not enough reward? [J].
Alexander, Brian M. ;
Trippa, Lorenzo .
NEURO-ONCOLOGY, 2014, 16 (05) :615-616
[6]  
Alexander BM, 2011, EXPERT REV NEUROTHER, V11, P1399, DOI [10.1586/ERN.11.134, 10.1586/ern.11.134]
[7]  
[Anonymous], 2016, BEST (Biomarkers, EndpointS, and other Tools) Resource
[8]   Net Clinical Benefit Analysis of Radiation Therapy Oncology Group 0525: A Phase III Trial Comparing Conventional Adjuvant Temozolomide With Dose-Intensive Temozolomide in Patients With Newly Diagnosed Glioblastoma [J].
Armstrong, Terri S. ;
Wefel, Jeffrey S. ;
Wang, Meihua ;
Gilbert, Mark R. ;
Won, Minhee ;
Bottomley, Andrew ;
Mendoza, Tito R. ;
Coens, Corneel ;
Werner-Wasik, Maria ;
Brachman, David G. ;
Choucair, Ali K. ;
Mehta, Minesh .
JOURNAL OF CLINICAL ONCOLOGY, 2013, 31 (32) :4076-+
[9]   Risk analysis of severe myelotoxicity with temozolomide: The effects of clinical and genetic factors [J].
Armstrong, Terri S. ;
Cao, Yumei ;
Scheurer, Michael E. ;
Vera-Bolanos, Elizabeth ;
Manning, Rochelle ;
Okcu, Mehmet F. ;
Bondy, Melissa ;
Zhou, Renke ;
Gilbert, Mark R. .
NEURO-ONCOLOGY, 2009, 11 (06) :825-832
[10]  
Armstrong TS, ONC NURS FOR 2005