Predictive biomarkers for personalised anti-cancer drug use: Discovery to clinical implementation

European Journal of Cancer

Volumn 46, Issue 5, 2010, Pages 869-879

  Alymani, Nayef A ^a   Smith, Murray D ^a   Williams, David J ^b   Petty, Russell D ^a,b  

^a Section of Translational Medical Sciences   (United Kingdom)

^b ABERDEEN ROYAL INFIRMARY   (United Kingdom)

Author keywords

Anti cancer agents; Biomarkers; Personalised therapy; Targeted Agents

Indexed keywords

ANTINEOPLASTIC AGENT; BIOLOGICAL MARKER; CETUXIMAB; EPIDERMAL GROWTH FACTOR RECEPTOR; EPIDERMAL GROWTH FACTOR RECEPTOR 2; ERLOTINIB; GEFITINIB; PANITUMUMAB; TRASTUZUMAB;

ARTICLE; BREAST CANCER; COLORECTAL CANCER; COST EFFECTIVENESS ANALYSIS; GENE MUTATION; HUMAN; LUNG NON SMALL CELL CANCER; ONCOGENE K RAS; PRACTICE GUIDELINE; PRIORITY JOURNAL; VALIDATION PROCESS;

ANTINEOPLASTIC AGENTS; CLINICAL TRIALS AS TOPIC; DRUG DISCOVERY; DRUG SCREENING ASSAYS, ANTITUMOR; HUMANS; INDIVIDUALIZED MEDICINE; NEOPLASMS; REPRODUCIBILITY OF RESULTS; TRANSLATIONAL RESEARCH; TUMOR MARKERS, BIOLOGICAL;

EID: 77649190855     PISSN: 09598049     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.ejca.2010.01.001     Document Type: Article

References (50)

1. Collins I., and Workman P. New approaches to molecular cancer therapeutics. Nat Chem Biol 2 12 (2006) 689-700
2. NIH, Biomarkers Definitions Working Group. Biomarkers and surrogate endpoints: preferred definitions and conceptual framework. Clin Pharmacol Toxicol 2001;69(3):2020-27.
3. Kelloff G.J., and Sigman C.C. New science-based endpoints to accelerate oncology drug development. Eur J Cancer 41 4 (2005) 491-501
4. Sarker D., and Workman P. Pharmacodynamic biomarkers for molecular cancer therapeutics. Adv Cancer Res 96 (2006) 213-268 [ate of Pubaton]
5. Ludwig J.A., and Weinstein J.N. Biomarkers in cancer staging, prognosis and treatment selection. Nat Rev Cancer 5 11 (2005) 845-856
6. Maruvada P., and Srivastava S. Joint National Cancer Institute-Food and Drug Administration workshop on research strategies, study designs, and statistical approaches to biomarker validation for cancer diagnosis and detection. Cancer Epidemiol Biomarkers Prev 15 6 (2006) 1078-1082
7. Sawyers C.L. The cancer biomarker problem. Nature 452 7187 (2008) 548-552
8. Chau C.H., Rixe O., McLeod H., et al. Validation of analytic methods for biomarkers used in drug development. Clin Cancer Res 14 19 (2008) 5967-5976
9. Lee J.W., Devanarayan V., Barrett Y.C., et al. Fit-for-purpose method development and validation for successful biomarker measurement. Pharm Res 23 2 (2006) 312-328
10. Cummings J., Ward T.H., Greystoke A., et al. Biomarker method validation in anticancer drug development. Br J Pharmacol 153 4 (2008) 646-656
11. Chin L., and Gray J.W. Translating insights from the cancer genome into clinical practice. Nature 452 7187 (2008) 553-563
12. Petty R.D., Nicolson M.C., Kerr K.M., et al. Gene expression profiling in non-small cell lung cancer: from molecular mechanisms to clinical application. Clin Cancer Res 10 10 (2004) 3237-3248
13. Petty R.D., Kerr K.M., Murray G.I., et al. Tumor transcriptome reveals the predictive and prognostic impact of lysosomal protease inhibitors in non-small-cell lung cancer. J Clin Oncol 24 11 (2006) 1729-1744
14. van't Veer L.J., and Bernards R. Enabling personalized cancer medicine through analysis of gene-expression patterns. Nature 452 7187 (2008) 564-570
15. Debucquoy A, Haustermans K, Daemen A, et al. Molecular response to cetuximab and efficacy of preoperative cetuximab-based chemoradiation in rectal cancer. J Clin Oncol 2009;(March) [ePublished Ahead of Print].
16. Martinkova J., Gadher S.J., Hajduch M., et al. Challenges in cancer research and multifaceted approaches for cancer biomarker quest. FEBS Lett 583 11 (2009) 1772-1784
17. Shah V.P. The history of bioanalytical method validation and regulation: evolution of a guidance document on bioanalytical methods validation. AAPS Journal 9 1 (2007) [Arte Number: 5. ate of Pubaton]
18. Fontaine N, Rosengren B. Directive 2001/20/EC of the european parliament and of the council: on the approximation of the laws, regulations and administrative provisions of the members states relating to the implementation of good clinical practice in the conduct of clinical trails on medicinal products for human use. OJEC 4-4-2001.
19. FDA. Guidance for industry: bioanalytical method validation. 2001.
20. Stiles T., Grant V., and Mawbey N. Good clinical laboratory practice (GCLP): a quality system for laboratories that undertake the analysis of samples from clinical trials (2003), British Association of Research Quality Assurance (BARQA), Suffolk, UK
21. Lee J.W., Weiner R.S., Sailstad J.M., et al. Method validation and measurement of biomarkers in nonclinical and clinical samples in drug development: a conference report. Pharm Res 22 4 (2005) 499-511
22. Korfmacher W.A. Principles and applications of LC-MS in new drug discovery. Drug Discov Today 10 20 (2005) 1357-1367
23. Smolec J., DeSilva B., Smith W., et al. Bioanalytical method validation for macromolecules in support of pharmacokinetic studies. Pharm Res 22 9 (2005) 1425-1431
24. Shah V.P., Midha K.K., Findlay J.W.A., et al. Bioanalytical method validation - a revisit with a decade of progress. Pharm Res 17 12 (2000) 1551-1557
25. Nowatzke W., and Wood E. Best practices during bioanalytical method validation for the characterisation of assay reagents and the evaluation of analyte stability in assay standards quality controls and study samples. AAPS J 9 (2007) E117-E122
26. Amur S., Frueh F., Lesko L.J., et al. Integration and use of biomarkers in drug development, regulations and clinical practice: a US regulatory perspective. Biomarkers Med 2 3 (2008) 305-311
27. Sargent D.J., Conley B.A., Allegra C., et al. Clinical trial designs for predictive marker validation in cancer treatment trials. J Clin Oncol 23 9 (2005) 2020-2027
28. Brunner N., Vang Nielsen K., Offenberg H., et al. Biomarkers for therapeutic efficacy. Eur J Cancer 5 5 Suppl. (2007) 129-142
29. Goodsaid F., and Frueh F. Biomarker qualification pilot process at the US Food and Drug Administration. AAPS J 9 1 (2007) E105-E108
30. Goodsaid F., and Frueh F. Process map proposal for the validation of genomic biomarkers. Pharmacogenomics 7 5 (2006) 773-782
31. Burckart G.J., Amur S., Goodsaid F.M., et al. Qualification of biomarkers for drug development in organ transplantation. Am J Transplant 8 2 (2008) 267-270
32. Tsao M.S., Sakurada A., Cutz J.C., et al. Erlotinib in lung cancer - molecular and clinical predictors of outcome. N Engl J Med 353 2 (2005) 133-144
33. Waring P.M. Matching patients with drugs: triumphs and challenges. Personalized Med 3 3 (2006) 335-344
34. Moretti F., and Belardelli F. Needs and challenges in translational medicine: filling the gap between basic research and clinical applications. ISTISAN Congr 08 C7 (2008)
35. Seymour M.T., Maughan T.S., Ledermann J.A., et al. Different strategies of sequential and combination chemotherapy for patients with poor prognosis advanced colorectal cancer (MRC FOCUS): a randomised controlled trial. Lancet 370 9582 (2007) 143-152
36. Braun M.S., Richman S.D., Quirke P., et al. Predictive biomarkers of chemotherapy efficacy in colorectal cancer: results from the UK MRC FOCUS trial. J Clin Oncol 26 16 (2008) 2690-2698
37. McShane L.M., Altman D.G., Sauerbrei W., et al. REporting recommendations for tumour MARKer prognostic studies (REMARK). Eur J Cancer 41 12 (2005) 1690-1696
38. Hayes D.F., Bast R.C., Desch C.E., et al. Tumor marker utility grading system: a framework to evaluate clinical utility of tumor markers. J Natl Cancer Inst 88 20 (1996) 1456-1466 [see comment]
39. Williams S.A., Slavin D.E., Wagner J.A., et al. A cost-effectiveness approach to the qualification and acceptance of biomarkers. Nat Rev Drug Discovery 5 11 (2006) 897-902
40. Wagner J.A., Williams S.A., and Webster C.J. Biomarkers and surrogate end points for fit-for-purpose development and regulatory evaluation of new drugs. Clin Pharmacol Ther 81 1 (2007) 104-107
41. Chatterjee S.K., and Zetter B.R. Cancer biomarkers: knowing the present and predicting the future. Future Oncol 1 1 (2005) 37-50
42. Gown A.M. Current issues in ER and HER2 testing by IHC in breast cancer. Mod Pathol 21 (2008) S8-S15
43. Van Cutsem E., Kang Y., Chung H., et al. Efficacy results from the ToGA trial: a phase III study of trastuzumab added to standard chemotherapy (CT) in first-line human epidermal growth factor receptor 2 (HER2)-positive advanced gastric cancer (GC). J Clin Oncol 27 18S (2009) LBA4509 [Meeting Abstracts]
44. Paez J.G., Janne P.A., Lee J.C., et al. EGFR mutations in lung cancer: correlation with clinical response to gefitinib therapy. Science 304 5676 (2004) 1497-1500
45. Mok T.S., Wu Y., Thongprasert S., et al. Gefitinib or carboplatin-paclitaxel in pulmonary adenocarcinoma. N Engl J Med 361 10 (2009) 947-957
46. Karapetis C.S., Khambata-Ford S., Jonker D.J., et al. K-ras mutations and benefit from cetuximab in advanced colorectal cancer. N Engl J Med 359 17 (2008) 1757-1765
47. De Roock W., Piessevaux H., De Schutter J., et al. KRAS wild-type state predicts survival and is associated to early radiological response in metastatic colorectal cancer treated with cetuximab. Ann Oncol 19 3 (2008) 508-515
48. Di Fiore F., Blanchard F., Charbonnier F., et al. Clinical relevance of KRAS mutation detection in metastatic colorectal cancer treated by cetuximab plus chemotherapy. Br J Cancer 96 8 (2007) 1166-1169
49. Lievre A., Bachet J.B., Le Corre D., et al. KRAS mutation status is predictive of response to cetuximab therapy in colorectal cancer. Cancer Res 66 8 (2006) 3992-3995
50. Linardou H., Dahabreh I.J., Kanaloupiti D., et al. Assessment of somatic k-RAS mutations as a mechanism associated with resistance to EGFR-targeted agents: a systematic review and meta-analysis of studies in advanced non-small-cell lung cancer and metastatic colorectal cancer. Lancet Oncol 9 10 (2008) 962-972