Incorporation of biomarker assessment in novel clinical trial designs: Personalizing brain tumor treatments

Current Oncology Reports

Volumn 13, Issue 1, 2011, Pages 42-49

  Galanis, Evanthia ^a   Wu, Wenting ^a   Sarkaria, Jann ^a   Chang, Susan M ^b   Colman, Howard ^c   Sargent, Daniel ^a   Reardon, David A ^d  

^a MAYO CLINIC   (United States)

^b UNIVERSITY OF CALIFORNIA   (United States)

^c UNIVERSITY OF UTAH SCHOOL OF MEDICINE   (United States)

^d DUKE UNIVERSITY MEDICAL CENTER   (United States)

Author keywords

Adaptive design; Biomarker enrichment design; Biomarkers; Glioma; Marker by treatment interaction design; Neurooncology trials

Indexed keywords

BEVACIZUMAB; BIOLOGICAL MARKER; ERLOTINIB; LOMUSTINE; MK 4827; NICOTINAMIDE ADENINE DINUCLEOTIDE ADENOSINE DIPHOSPHATE RIBOSYLTRANSFERASE INHIBITOR; PROCARBAZINE; TEMOZOLOMIDE; UNCLASSIFIED DRUG; VINCRISTINE;

ARTICLE; ASTROCYTOMA; BRAIN TUMOR; CANCER RADIOTHERAPY; CANCER RESEARCH; CANCER SURVIVAL; CHROMOSOME DELETION; CHROMOSOME DELETION 19Q; CHROMOSOME DELETION 1P; DNA METHYLATION; DRUG DOSE COMPARISON; EGFRVIII GENE; GENE; GENE EXPRESSION PROFILING; GLIOBLASTOMA; HUMAN; METHODOLOGY; MGMT GENE; MICROARRAY ANALYSIS; OLIGODENDROGLIOMA; OVERALL SURVIVAL; PERSONALIZED MEDICINE; PHARMACOGENETICS; PREDICTION; PROGNOSIS; PROGRESSION FREE SURVIVAL; PROMOTER REGION; PTEN GENE;

ANTINEOPLASTIC PROTOCOLS; BRAIN NEOPLASMS; CLINICAL TRIALS AS TOPIC; HUMANS; INDIVIDUALIZED MEDICINE; MOLECULAR BIOLOGY; RESEARCH DESIGN; TUMOR MARKERS, BIOLOGICAL;

EID: 79551557586     PISSN: 15233790     EISSN: None     Source Type: Journal    
DOI: 10.1007/s11912-010-0144-x     Document Type: Article

References (28)

1. ME Hammond SE Taube 2002 Issues and barriers to development of clinically useful tumor markers: a development pathway proposal Semin Oncol 29 213 221 10.1053/sonc.2002.32896 12063674 (Pubitemid 34620438)
2. DF Hayes RC Bast CE Desch, et al. 1996 Tumor marker utility grading system: a framework to evaluate clinical utility of tumor markers J Natl Cancer Inst 88 1456 1466 1:STN:280:DyaK28vjvVKlsg%3D%3D 10.1093/jnci/88.20.1456 8841020 (Pubitemid 26340047)
3. DF Hayes B Trock AL Harris 1998 Assessing the clinical impact of prognostic factors: when is "statistically significant" clinically useful? Breast Cancer Res Treat 52 305 319 1:STN:280:DyaK1M7mtl2ksA%3D%3D 10.1023/A:1006197805041 10066089 (Pubitemid 29056102)
4. R Simon DG Altman 1994 Statistical aspects of prognostic factor studies in oncology Br J Cancer 69 979 985 1:STN:280:DyaK2c3lslCmtw%3D%3D 8198989
5. IK Mellinghoff MY Wang I Vivanco, et al. 2005 Molecular determinants of the response of glioblastomas to EGFR kinase inhibitors N Engl J Med 353 2012 2024 1:CAS:528:DC%2BD2MXht1SrtrrE 10.1056/NEJMoa051918 16282176 (Pubitemid 41609094)
6. MJ van den Bent AA Brandes R Rampling, et al. 2009 Randomized phase II trial of erlotinib versus temozolomide or carmustine in recurrent glioblastoma: EORTC brain tumor group study 26034 J Clin Oncol 27 1268 1274 10.1200/JCO.2008.17.5984 19204207
7. J Felsberg A Erkwoh MC Sabel, et al. 2004 Oligodendroglial tumors: refinement of candidate regions on chromosome arm 1p and correlation of 1p/19q status with survival Brain Pathol 14 121 130 1:CAS:528:DC%2BD2cXkvFCgs7Y%3D 10.1111/j.1750-3639.2004.tb00044.x 15193024
8. RB Jenkins H Blair KV Ballman, et al. 2006 A t(1;19)(q10;p10) mediates the combined deletions of 1p and 19q and predicts a better prognosis of patients with oligodendroglioma Cancer Res 66 9852 9861 1:CAS:528:DC%2BD28XhtVyiur3I 10.1158/0008-5472.CAN-06-1796 17047046 (Pubitemid 44672036)
9. MJ van den Bent LH Looijenga K Langenberg, et al. 2003 Chromosomal anomalies in oligodendroglial tumors are correlated with clinical features Cancer 97 1276 1284 10.1002/cncr.11187 12599236 (Pubitemid 36237315)
10. KB Fallon CA Palmer KA Roth, et al. 2004 Prognostic value of 1p, 19q, 9p, 10q, and EGFR-FISH analyses in recurrent oligodendrogliomas J Neuropathol Exp Neurol 63 314 322 1:CAS:528:DC%2BD2cXjs1Wgs78%3D 15099021
11. JS Smith A Perry TJ Borell, et al. 2000 Alterations of chromosome arms 1p and 19q as predictors of survival in oligodendrogliomas, astrocytomas, and mixed oligoastrocytomas J Clin Oncol 18 636 645 1:STN:280:DC%2BD3c7itVyrsA%3D%3D 10653879
12. G Cairncross B Berkey E Shaw, et al. 2006 Phase III trial of chemotherapy plus radiotherapy compared with radiotherapy alone for pure and mixed anaplastic oligodendroglioma: Intergroup Radiation Therapy Oncology Group Trial 9402 J Clin Oncol 24 2707 2714 1:CAS:528:DC%2BD28XntV2hurg%3D 10.1200/JCO.2005.04.3414 16782910 (Pubitemid 46630566)
13. MJ van den Bent AF Carpentier AA Brandes, et al. 2006 Adjuvant procarbazine, lomustine, and vincristine improves progression-free survival but not overall survival in newly diagnosed anaplastic oligodendrogliomas and oligoastrocytomas: a randomized European Organisation for Research and Treatment of Cancer phase III trial J Clin Oncol 24 2715 2722 10.1200/JCO.2005.04.6078 16782911 (Pubitemid 46630567)
14. R Stupp WP Mason MJ van den Bent, et al. 2005 Radiotherapy plus concomitant and adjuvant temozolomide for glioblastoma N Engl J Med 352 987 996 1:CAS:528:DC%2BD2MXit1Wksbk%3D 10.1056/NEJMoa043330 15758009 (Pubitemid 40349501)
15. ME Hegi AC Diserens T Gorlia, et al. 2005 MGMT gene silencing and benefit from temozolomide in glioblastoma N Engl J Med 352 997 1003 1:CAS:528:DC%2BD2MXit1Wktro%3D 10.1056/NEJMoa043331 15758010 (Pubitemid 40349502)
16. R Stupp ME Hegi WP Mason, et al. 2009 Effects of radiotherapy with concomitant and adjuvant temozolomide versus radiotherapy alone on survival in glioblastoma in a randomised phase III study: 5-year analysis of the EORTC-NCIC trial Lancet Oncol 10 459 466 1:CAS:528:DC%2BD1MXlsVKhs74%3D 10.1016/S1470-2045(09)70025-7 19269895
17. W Wick C Hartmann C Engel, et al. 2009 NOA-04 randomized phase III trial of sequential radiochemotherapy of anaplastic glioma with procarbazine, lomustine, and vincristine or temozolomide J Clin Oncol 27 5874 5880 1:CAS:528:DC%2BC3cXhtVWis7g%3D 10.1200/JCO.2009.23.6497 19901110
18. MJ van den Bent HJ Dubbink M Sanson, et al. 2009 MGMT promoter methylation is prognostic but not predictive for outcome to adjuvant PCV chemotherapy in anaplastic oligodendroglial tumors: a report from EORTC Brain Tumor Group Study 26951 J Clin Oncol 27 5881 5886 10.1200/JCO.2009.24.1034 19901104
19. AA Brandes L Nicolardi A Tosoni, et al. 2006 Survival following adjuvant PCV or temozolomide for anaplastic astrocytoma Neuro Oncol 8 253 260 1:CAS:528:DC%2BD28Xot1agtLo%3D 10.1215/15228517-2006-005 16723632 (Pubitemid 46542650)
20. M Mollemann M Wolter J Felsberg, et al. 2005 Frequent promoter hypermethylation and low expression of the MGMT gene in oligodendroglial tumors Int J Cancer 113 379 385 10.1002/ijc.20575 15455350 (Pubitemid 40038704)
21. M Sanson Y Marie S Paris, et al. 2009 Isocitrate dehydrogenase 1 codon 132 mutation is an important prognostic biomarker in gliomas J Clin Oncol 27 4150 4154 1:CAS:528:DC%2BD1MXhtF2jtLrP 10.1200/JCO.2009.21.9832 19636000
22. DJ Sargent BA Conley C Allegra L Collette 2005 Clinical trial designs for predictive marker validation in cancer treatment trials J Clin Oncol 23 2020 2027 10.1200/JCO.2005.01.112 15774793 A discussion of clinical trial designs for predictive biomarker validation, with special emphasis on Marker by Treatment Interaction Design and the Marker-Based Strategy Design (Pubitemid 46211382)
23. MJ Clarke EA Mulligan PT Grogan, et al. 2009 Effective sensitization of temozolomide by ABT-888 is lost with development of temozolomide resistance in glioblastoma xenograft lines Mol Cancer Ther 8 407 414 1:CAS:528: DC%2BD1MXhvFamsbw%3D 10.1158/1535-7163.MCT-08-0854 19174557
24. HS Phillips S Kharbanda R Chen, et al. 2006 Molecular subclasses of high-grade glioma predict prognosis, delineate a pattern of disease progression, and resemble stages in neurogenesis Cancer Cell 9 157 173 1:CAS:528: DC%2BD28XivFWjtL4%3D 10.1016/j.ccr.2006.02.019 16530701 (Pubitemid 43357943)
25. RG Verhaak KA Hoadley E Purdom, et al. 2010 Integrated genomic analysis identifies clinically relevant subtypes of glioblastoma characterized by abnormalities in PDGFRA, IDH1, EGFR, and NF1 Cancer Cell 17 98 110 1:CAS:528:DC%2BC3cXkvFKgsL4%3D 10.1016/j.ccr.2009.12.020 20129251
26. H Colman L Zhang EP Sulman, et al. 2010 A multigene predictor of outcome in glioblastoma Neuro Oncol 12 49 57 1:CAS:528:DC%2BC3cXjvFCnt7c%3D 20150367
27. IA Cree CM Kurbacher A Lamont, et al. 2007 A prospective randomized controlled trial of tumour chemosensitivity assay directed chemotherapy versus physician's choice in patients with recurrent platinum-resistant ovarian cancer Anticancer Drugs 18 1093 1101 1:CAS:528:DC%2BD2sXptFCrtrg%3D 10.1097/CAD.0b013e3281de727e 17704660 (Pubitemid 47294903)
28. DA Berry 2006 Bayesian clinical trials Nat Rev Drug Discov 5 27 36 1:CAS:528:DC%2BD28Xmt1yqsw%3D%3D 10.1038/nrd1927 16485344 A discussion of adaptive designs and their potential to accelerate drug development