The FDA NIH Biomarkers, EndpointS, and Other Tools (BEST) Resource in Neuro-oncology

Overview

Journal Neuro Oncol

Publisher Oxford University Press

Specialties Neurology
Oncology

Date 2018 Jan 3

PMID 29294069

Citations 58

Authors

Daniel N Cagney

Joohee Sul

Raymond Y Huang

Keith L Ligon

Patrick Y Wen

Brian M Alexander

Affiliations

Soon will be listed here.

Abstract

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.

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References

Armstrong T, Wefel J, Wang M, Gilbert M, Won M, Bottomley A . 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 Clin Oncol. 2013; 31(32):4076-84. PMC: 3816957. DOI: 10.1200/JCO.2013.49.6067. View

Colman H, Zhang L, Sulman E, McDonald J, Shooshtari N, Rivera A . A multigene predictor of outcome in glioblastoma. Neuro Oncol. 2010; 12(1):49-57. PMC: 2940562. DOI: 10.1093/neuonc/nop007. View

Gilbert M, Dignam J, Armstrong T, Wefel J, Blumenthal D, Vogelbaum M . A randomized trial of bevacizumab for newly diagnosed glioblastoma. N Engl J Med. 2014; 370(8):699-708. PMC: 4201043. DOI: 10.1056/NEJMoa1308573. View

Cairncross G, Wang M, Shaw E, Jenkins R, Brachman D, Buckner J . Phase III trial of chemoradiotherapy for anaplastic oligodendroglioma: long-term results of RTOG 9402. J Clin Oncol. 2012; 31(3):337-43. PMC: 3732012. DOI: 10.1200/JCO.2012.43.2674. View

Paldino M, Barboriak D . Fundamentals of quantitative dynamic contrast-enhanced MR imaging. Magn Reson Imaging Clin N Am. 2009; 17(2):277-89. DOI: 10.1016/j.mric.2009.01.007. View

Elbanan M, Amer A, Zinn P, Colen R . Imaging genomics of Glioblastoma: state of the art bridge between genomics and neuroradiology. Neuroimaging Clin N Am. 2014; 25(1):141-53. DOI: 10.1016/j.nic.2014.09.010. View

Louis D, Perry A, Reifenberger G, von Deimling A, Figarella-Branger D, Cavenee W . The 2016 World Health Organization Classification of Tumors of the Central Nervous System: a summary. Acta Neuropathol. 2016; 131(6):803-20. DOI: 10.1007/s00401-016-1545-1. View

Suzuki H, Aoki K, Chiba K, Sato Y, Shiozawa Y, Shiraishi Y . Mutational landscape and clonal architecture in grade II and III gliomas. Nat Genet. 2015; 47(5):458-68. DOI: 10.1038/ng.3273. View

Mabray M, Barajas Jr R, Cha S . Modern brain tumor imaging. Brain Tumor Res Treat. 2015; 3(1):8-23. PMC: 4426283. DOI: 10.14791/btrt.2015.3.1.8. View

10.

Chau C, Rixe O, Mcleod H, Figg W . Validation of analytic methods for biomarkers used in drug development. Clin Cancer Res. 2008; 14(19):5967-76. PMC: 2744124. DOI: 10.1158/1078-0432.CCR-07-4535. View

11.

Fouladi M, Perentesis J, Phillips C, Leary S, Reid J, McGovern R . A phase I trial of MK-2206 in children with refractory malignancies: a Children's Oncology Group study. Pediatr Blood Cancer. 2014; 61(7):1246-51. PMC: 4456022. DOI: 10.1002/pbc.25023. View

12.

Hygino da Cruz Jr L, Rodriguez I, Domingues R, Gasparetto E, Sorensen A . Pseudoprogression and pseudoresponse: imaging challenges in the assessment of posttreatment glioma. AJNR Am J Neuroradiol. 2011; 32(11):1978-85. PMC: 7964401. DOI: 10.3174/ajnr.A2397. View

13.

Jones L, Cohen R, Mabe S, West M, Desjardins A, Vredenburgh J . Assessment of physical functioning in recurrent glioma: preliminary comparison of performance status to functional capacity testing. J Neurooncol. 2009; 94(1):79-85. DOI: 10.1007/s11060-009-9803-x. View

14.

Weller M, Stupp R, Reifenberger G, Brandes A, van den Bent M, Wick W . MGMT promoter methylation in malignant gliomas: ready for personalized medicine?. Nat Rev Neurol. 2009; 6(1):39-51. DOI: 10.1038/nrneurol.2009.197. View

15.

Sanson M, Marie Y, Paris S, Idbaih A, Laffaire J, Ducray F . Isocitrate dehydrogenase 1 codon 132 mutation is an important prognostic biomarker in gliomas. J Clin Oncol. 2009; 27(25):4150-4. DOI: 10.1200/JCO.2009.21.9832. View

16.

Esteller M, Garcia-Foncillas J, Andion E, Goodman S, Hidalgo O, Vanaclocha V . Inactivation of the DNA-repair gene MGMT and the clinical response of gliomas to alkylating agents. N Engl J Med. 2000; 343(19):1350-4. DOI: 10.1056/NEJM200011093431901. View

17.

Akers J, Ramakrishnan V, Kim R, Skog J, Nakano I, Pingle S . MiR-21 in the extracellular vesicles (EVs) of cerebrospinal fluid (CSF): a platform for glioblastoma biomarker development. PLoS One. 2013; 8(10):e78115. PMC: 3804457. DOI: 10.1371/journal.pone.0078115. View

18.

Malmstrom A, Gronberg B, Marosi C, Stupp R, Frappaz D, Schultz H . Temozolomide versus standard 6-week radiotherapy versus hypofractionated radiotherapy in patients older than 60 years with glioblastoma: the Nordic randomised, phase 3 trial. Lancet Oncol. 2012; 13(9):916-26. DOI: 10.1016/S1470-2045(12)70265-6. View

19.

Olson R, Brastianos P, Palma D . Prognostic and predictive value of epigenetic silencing of MGMT in patients with high grade gliomas: a systematic review and meta-analysis. J Neurooncol. 2011; 105(2):325-35. DOI: 10.1007/s11060-011-0594-5. View

20.

Macdonald D, Cascino T, Schold Jr S, Cairncross J . Response criteria for phase II studies of supratentorial malignant glioma. J Clin Oncol. 1990; 8(7):1277-80. DOI: 10.1200/JCO.1990.8.7.1277. View