The challenges of validating in precisionmedicine: The case of excision repair cross-complement group 1 diagnostic testing

Oncologist

Volumn 22, Issue 1, 2017, Pages 89-96

  Barsanti Innes, Brianna ^a   Hey, Spencer Phillips ^b,c   Kimmelman, Jonathan ^a  

^a MCGILL UNIVERSITY   (Canada)

^b BRIGHAM AND WOMEN S HOSPITAL   (United States)

^c HARVARD MEDICAL SCHOOL   (United States)

Author keywords

Biomarkers; Cancer; Ethics; Personalized medicine; Translation

Indexed keywords

BIOLOGICAL MARKER; CARBOPLATIN; CISPLATIN; DOCETAXEL; ETOPOSIDE; EXCISION REPAIR CROSS COMPLEMENTING PROTEIN 1; GEMCITABINE; IFOSFAMIDE; IRINOTECAN; MITOMYCIN; PLATINUM DERIVATIVE; DNA BINDING PROTEIN; ENDONUCLEASE; ERCC1 PROTEIN, HUMAN; PLATINUM; TUMOR MARKER;

ARTICLE; CANCER CHEMOTHERAPY; CLINICAL TRIAL (TOPIC); HUMAN; MULTICENTER STUDY (TOPIC); NON SMALL CELL LUNG CANCER; PERSONALIZED MEDICINE; PRIORITY JOURNAL; PROTEIN EXPRESSION; DNA REPAIR; GENETICS; PATHOLOGY;

BIOMARKERS, TUMOR; CARCINOMA, NON-SMALL-CELL LUNG; DNA REPAIR; DNA-BINDING PROTEINS; ENDONUCLEASES; HUMANS; PLATINUM; PRECISION MEDICINE;

EID: 85011391273     PISSN: 10837159     EISSN: 1549490X     Source Type: Journal    
DOI: 10.1634/theoncologist.2016-0188     Document Type: Article

References (69)

1. Hayes DF, Allen J, Compton C et al. Breaking a vicious cycle. Sci Transl Med 2013;5:196cm6.
2. Altaha R, Liang X, Yu JJ et al. Excision repair cross complementing-group: 1. Gene expression and platinum resistance. Int J Mol Med 2004;14:959-970.
3. Olaussen KA, Dunant A, Fouret P et al. DNA repair by ERCC1 in non-small-cell lung cancer and cisplatin-based adjuvant chemotherapy. N Engl J Med 2006;355:983-991.
4. Bonanno L. Predictive models for customizing chemotherapy in advanced non-small cell lung cancer (NSCLC). Transl Lung Cancer Res 2013;2: 160-171.
5. Hubner RA, Riley RD, Billingham LJ et al. Excision repair cross-complementation group 1 (ERCC1) status and lung cancer outcomes: A meta-analysis of published studies and recommendations. PLoS One 2011;6:e25164.
6. Besse B, Olaussen KA, Soria JC. ERCC1 and RRM1: Ready for primetime? J Clin Oncol 2013;31: 1050-1060.
7. Roth JA, Carlson JJ. Prognostic role of ERCC1 in advanced non-small-cell lung cancer: A systematic review and meta-analysis. Clin Lung Cancer 2011; 12:393-401.
8. Simon RM, Paik S, Hayes DF. Use of archived specimens in evaluation of prognostic and predictive biomarkers. J Natl Cancer Inst 2009;101: 1446-1452.
9. Hey SP, Heilig CM, Weijer C. Accumulating evidence and research organization (AERO) model: A new tool for representing, analyzing, and planning a translational research program. Trials 2013;14: 159.
10. Wachters FM, Wong LS, Timens W et al. ERCC1, hRad51, and BRCA1 protein expression in relation to tumour response and survival of stage III/IV NSCLC patients treated with chemotherapy. Lung Cancer 2005;50:211-219.
11. Fujii T, Toyooka S, Ichimura K et al. ERCC1 protein expression predictsthe response of cisplatin-based neoadjuvant chemotherapy in non-small-cell lung cancer. Lung Cancer 2008;59:377-384.
12. Lee HW, Choi YW, Han JH et al. Expression of excision repair cross-complementation group 1 protein predicts poor outcome in advanced non small cell lung cancer patients treated with platinum-based doublet chemotherapy. Lung Cancer 2009;65: 377-382.
13. Bepler G, Williams C, Schell MJ et al. Randomized international phase III trial of ERCC1 and RRM1 expression-based chemotherapy versus gemcitabine/carboplatin in advanced non-small-cell lung cancer. J Clin Oncol 2013;31:2404-2412.
14. Ozdemir O, Ozdemir P, Veral A et al. ERCC1 expression does not predict survival and treatment response in advanced stage non-small cell lung cancer cases treated with platinum based chemotherapy. Asian Pac J Cancer Prev 2013;14:4679-4683.
15. Tiseo M, Bordi P, Bortesi B et al. ERCC1/BRCA1 expression and gene polymorphisms as prognostic and predictive factors in advanced NSCLC treated with or without cisplatin. Br J Cancer 2013;108: 1695-1703.
16. Vassalou H, Stathopoulos E, Fiolitaki G et al. Excision-repair-cross-complement-1 protein as a prognostic factor in patients with advanced nonsmall cell lung cancer treated with platinum-based first-line chemotherapy. Lung Cancer 2013;82: 324-329.
17. Yan D, Wei P, An G et al. Prognostic potential of ERCC1 protein expression and clinicopathologic factors in stage III/N2 non-small cell lung cancer. J Cardiothorac Surg 2013;8:149.
18. Lord RV, Brabender J, Gandara D et al. Low ERCC1 expression correlates with prolonged survival after cisplatin plus gemcitabine chemotherapy in non-small cell lung cancer. Clin Cancer Res 2002;8: 2286-2291.
19. Ceppi P, Volante M, Novello S et al. ERCC1 and RRM1 gene expressions but not EGFRare predictive of shorter survival in advanced non-small-cell lung cancer treated with cisplatin and gemcitabine. Ann Oncol 2006;17:1818-1825.
20. Booton R, Ward T, Ashcroft L et al. ERCC1 mRNA expression is not associated with response and survival after platinum-based chemotherapy regimens in advanced non-small cell lung cancer. J Thorac Oncol 2007;2:902-906.
21. Simon G, Sharma A, Li X et al. Feasibility and efficacy of molecular analysis-directed individualized therapy in advanced non-small-cell lung cancer. J Clin Oncol 2007;25:2741-2746.
22. Ren S, Zhou S, Zhang L et al. High-level mRNA of excision repair cross-complementation group 1 gene is associated with poor outcome of platinum-based doublet chemotherapy of advanced nonsmall cell lung cancer patients. Cancer Invest 2010;28: 1078-1083.
23. Joerger M, deJong D, Burylo A et al. Tubulin, BRCA1, ERCC1, Abraxas, RAP80 mRNA expression, p53/p21 immunohistochemistry and clinical out-come in patients with advanced non small-cell lung cancer receiving first-line platinum-gemcitabine chemotherapy. Lung Cancer 2011;74:310-317.
24. Zhang GB, Chen J, Wang LR et al. RRM1 and ERCC1 expression in peripheral blood versus tumor tissue in gemcitabine/carboplatin-treated advanced non-small cell lung cancer. Cancer Chemother Pharmacol 2012;69:1277-1287.
25. Jian-Wei B, Yi-Min M, Yu-Xia S et al. Expression levels of ERCC1 and RRM1 mRNA and clinical out-come of advanced non-small cell lung cancer. Pak J Med Sci 2013;29:1158-1161.
26. Hwang IG, Ahn MJ, Park BB et al. ERCC1 expression as a prognostic marker in N2(1) nonsmall-cell lung cancer patients treated with platinum-based neoadjuvant concurrent chemoradiotherapy. Cancer 2008;113:1379-1386.
27. Jeong SH, Jung JH, Han JH et al. Expression of Bcl-2 predicts outcome in locally advanced nonsmall cell lungcancer patients treated with cisplatin-based concurrent chemoradiotherapy. Lung Cancer 2010; 68:288-294.
28. Lee SH, Noh KB, Lee JS et al. Thymidylate synthase and ERCC1 as predictive markers in patients with pulmonary adenocarcinoma treated with pemetrexed and cisplatin. Lung Cancer 2013; 81:102-108.
29. Ota S, Ishii G, Goto K et al. Immunohistochemical expression of BCRP and ERCC1 in biopsy specimen predicts survival in advanced non-small cell lung cancer treated with cisplatin-based chemotherapy. Lung Cancer 2009;64:98-104.
30. Qiao H, Huang X, Guo H et al. ERCC1, RRM1 and TUBB3 mRNA expression on the tumor response and overall survival of non-small cell lung cancer treated with platinum-based chemotherapy. Pak J Med Sci 2014;30:1403-1408.
31. Sad LM, Younis SG, Elity MM. Prognostic and predictive role of ERCC1 protein expression in locally advanced stage III non-small cell lung cancer. Med Oncol 2014;31:58.
32. Su C, Zhou S, Zhang L et al. ERCC1, RRM1 and BRCA1 mRNA expression levels and clinical outcome of advanced non-small cell lung cancer. Med Oncol 2011;28:1411-1417.
33. Vilmar AC, Santoni-Rugiu E, Sorensen JB. ERCC1 and histopathology in advanced NSCLC patients randomized in a large multicenter phase III trial. Ann Oncol 2010;21:1817-1824.
34. Wang X, Zhao J, Yang L et al. Positive expression of ERCC1 predicts a poorer platinum-based treatment outcome in Chinese patients with advanced non-small-cell lung cancer. Med Oncol 2010;27: 484-490.
35. Yamashita F, Azuma K, Yoshida T et al. Prognostic value of EGFR mutation and ERCC1 in patients with non-small cell lungcancer undergoing platinum-based chemotherapy. PLoS One 2013;8:e71356.
36. Zhang H, Li J, Zhang Y et al. ERCC1 mRNA expression is associated with the clinical outcome of non-small cell lung cancer treated with platinum-based chemotherapy. Genet Mol Res 2014;13: 10215-10222.
37. Wang TB, Zhang NL, Wang SH et al. Expression of ERCC1 and BRCA1 predict the clinical outcome of non-small cell lung cancer in patients receiving platinum-based chemotherapy. Genet Mol Res 2014;13:3704-3710.
38. Haibe-Kains B, El-Hachem N, Birkbak NJ et al. Inconsistency in large pharmacogenomic studies. Nature 2013;504:389-393.
39. de Gramont A, Watson S, Ellis LM et al. Pragmatic issues in biomarkere valuation for targeted the rapies in cancer. Nat Rev Clin Oncol 2015;12: 197-212.
40. McShane LM, Cavenagh MM, Lively TG et al. Criteria for the use of omics-based predictors in clinical trials. Nature 2013;502:317-320.
41. Anagnostou VK, Welsh AW, Giltnane JM et al. Analytic variability in immunohistochemistry biomarker studies. Cancer Epidemiol Biomarkers Prev 2010;19:982-991.
42. Moore HM, Kelly AB, Jewell SD et al. Biospecimen reporting for improved studyquality (BRISQ). J Proteome Res 2011;10:3429-3438.
43. McShane LM, Altman DG, Sauerbrei W et al. Reporting recommendations for tumor marker prognostic studies (REMARK). J Natl Cancer Inst 2005;97: 1180-1184.
44. Bordeaux J, Welsh A, Agarwal S et al. Antibody validation. Biotechniques 2010;48:197-209.
45. Andre F, McShane LM, Michiels S et al. Biomarker studies: A call for a comprehensive biomarker study registry. Nat Rev Clin Oncol 2011;8: 171-176.
46. The WIN Biomarker Studies Registry. Available at http://winbiomarkerstudies.com/.
47. Hayes DF, Bast RC, Desch CE et al. Tumor marker utility grading system: A framework to evaluate clinical utility of tumor markers. J Natl Cancer Inst 1996;88:1456-1466.
48. Hey S. Judging quality and coordination in biomarker diagnostic development. Theoria 2015;30: 207-227.
49. Niedernhofer LJ, Bhagwat N, Wood RD. ERCC1 and non-small-cell lung cancer. N Engl J Med 2007; 356:2538-2540.
50. Ma D, Baruch D, Shu Y et al. Using protein micro array technology to screen anti-ERCC1 monoclonal antibodies for specificity and applications in pathology. BMC Biotechnol 2012;12:88.
51. Friboulet L, Olaussen KA, Pignon JP et al. ERCC1 isoform expression and DNA repair in non-small-cell lung cancer. N Engl J Med 2013;368:1101-1110.
52. Daniele L, Cassoni P, Bacillo E et al. Epidermal growth factor receptor gene in primary tumor and metastatic sites from non-small cell lung cancer. J Thorac Oncol 2009;4:684-688.
53. Italiano A, Vandenbos FB, Otto J et al. Comparison of the epidermal growth factor receptor gene and protein in primary non-small-cell-lung cancer and metastatic sites: Implications for treatment with EGFR-inhibitors. Ann Oncol 2006;17: 981-985.
54. Weigelt B, Glas AM, Wessels LF et al. Gene expression profiles of primary breast tumors maintained in distant metastases. Proc Natl Acad Sci USA 2003;100:15901-15905.
55. Kang CH, Jang BG, Kim DW et al. Differences in the expression profiles of excision repair crosscom-plementation group 1, x-ray repair crosscomplemen-tation group 1, and betaIII-tubulin between primary non-small cell lung cancer and metastatic lymph nodes and the significance in mid-term survival. J Thorac Oncol 2009;4:1307-1312.
56. Gomez-Roca C, Raynaud CM, Penault-Llorca F et al. Differential expression of biomarkers in primary non-small cell lung cancer and metastatic sites. J Thorac Oncol 2009;4:1212-1220.
57. Vilmar A, Sørensen JB. Excision repair cross-complementation group 1 (ERCC1) in platinum-based treatment of non-small cell lung cancer with special emphasis on carboplatin: A review of current literature. Lung Cancer 2009;64:131-139.
58. National Cancer Institute. Non-Small Cell Lung Cancer Treatment (PDQ) Stage IV NSCLC Treatment. Available at http://www.cancer.gov/cancertopics/pdq/treatment/non-small-cell-lung/healthprofessional/. Accessed October 22, 2015.
59. Henry NL, Hayes DF. Uses and abuses of tumor markers in the diagnosis, monitoring, and treatment of primary and metastatic breast cancer. The Oncologist 2006;11:541-552.
60. Ballman KV. Biomarker: Predictive or prognostic? J Clin Oncol 2015;33:3968-3971.
61. ERCC1 Analysis in Non-Small Cell Lung Cancer. Available at http://www.integratedoncology.com/sites/default/files/Onc-757-v7-101315-Prognostic%20Therapeutic.pdf. Accessed October 22, 2015.
62. Testing P. Delivering Precision Medicine. Available at http://www.cancergenetics.com/pharmacogenomics-home/pgx-testing/oncology/. Accessed October 22, 2015.
63. ERCC1 Gene Expression Analysis Kit. Available at http://www.mobitec.com/cms/products/bio/09_ivd/Real-Time_PCR_Cancer_Diagnostic_Kits.html?=ADx-ER01. Accessed October 22, 2015.
64. Quest Diagnostics. ERCC1, IHC With Interpretation. Available at http://www.questdiagnostics.com/testcenter/TestDetail.action?ntc=16979. Accessed October 22, 2015.
65. ERCC1. Available at http://www.clarient.com/Test-Menu/ercc1. Accessed October 22, 2015.
66. Schneider JG, Farhadfar N, Sivapiragasam A et al. Commercial laboratory testing of excision repair cross-complementation group 1 expression in non-small cell lung cancer. The Oncologist 2014;19: 459-465.
67. Febbo PG, Ladanyi M, Aldape KD et al. NCCN Task Force report: Evaluating the clinical utility of tumor markers in oncology. J Natl Compr Canc Netw 2011;9(suppl 5):S1-S32.
68. Ettinger DS, Akerley W, Borghaei H et al. Non-small cell lung cancer, version 2.2013. J Natl Compr Canc Netw 2013;11:645-653.
69. Ettinger DS, Wood DE, Akerley W et al. NCCN guidelines insights: Non-small cell lung cancer, version 4.2016. J Natl Compr Canc Netw 2016;14: 255-264.