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European Journal of Cancer
Volume 46, Issue 5
, Pages 869-879
, March 2010
Predictive biomarkers for personalised anti-cancer drug use: Discovery to clinical implementation
References
- . New approaches to molecular cancer therapeutics. Nat Chem Biol. 2006;2(12):689–700
- NIH, Biomarkers Definitions Working Group. Biomarkers and surrogate endpoints: preferred definitions and conceptual framework. Clin Pharmacol Toxicol 2001;69(3):2020–27.
- . New science-based endpoints to accelerate oncology drug development. Eur J Cancer. 2005;41(4):491–501
- . Pharmacodynamic biomarkers for molecular cancer therapeutics. Adv Cancer Res. 2006;96:213–268[ate of Pubaton]
- . Biomarkers in cancer staging, prognosis and treatment selection. Nat Rev Cancer. 2005;5(11):845–856
- . 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. 2006;15(6):1078–1082
- . The cancer biomarker problem. Nature. 2008;452(7187):548–552
- Validation of analytic methods for biomarkers used in drug development. Clin Cancer Res. 2008;14(19):5967–5976
- Fit-for-purpose method development and validation for successful biomarker measurement. Pharm Res. 2006;23(2):312–328
- Biomarker method validation in anticancer drug development. Br J Pharmacol. 2008;153(4):646–656
- . Translating insights from the cancer genome into clinical practice. Nature. 2008;452(7187):553–563
- Gene expression profiling in non-small cell lung cancer: from molecular mechanisms to clinical application. Clin Cancer Res. 2004;10(10):3237–3248
- Tumor transcriptome reveals the predictive and prognostic impact of lysosomal protease inhibitors in non-small-cell lung cancer. J Clin Oncol. 2006;24(11):1729–1744
- . Enabling personalized cancer medicine through analysis of gene-expression patterns. Nature. 2008;452(7187):564–570
- 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].
- Challenges in cancer research and multifaceted approaches for cancer biomarker quest. FEBS Lett. 2009;583(11):1772–1784
- . The history of bioanalytical method validation and regulation: evolution of a guidance document on bioanalytical methods validation. AAPS Journal. 2007;9(1):[Arte Number: 5. ate of Pubaton]
- 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.
- FDA. Guidance for industry: bioanalytical method validation. 2001.
- . Good clinical laboratory practice (GCLP): a quality system for laboratories that undertake the analysis of samples from clinical trials. Suffolk, UK: British Association of Research Quality Assurance (BARQA); 2003;
- Method validation and measurement of biomarkers in nonclinical and clinical samples in drug development: a conference report. Pharm Res. 2005;22(4):499–511
- . Principles and applications of LC–MS in new drug discovery. Drug Discov Today. 2005;10(20):1357–1367
- Bioanalytical method validation for macromolecules in support of pharmacokinetic studies. Pharm Res. 2005;22(9):1425–1431
- Bioanalytical method validation – a revisit with a decade of progress. Pharm Res. 2000;17(12):1551–1557
- . 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. 2007;9:E117–E122
- Integration and use of biomarkers in drug development, regulations and clinical practice: a US regulatory perspective. Biomarkers Med. 2008;2(3):305–311
- Clinical trial designs for predictive marker validation in cancer treatment trials. J Clin Oncol. 2005;23(9):2020–2027
- Biomarkers for therapeutic efficacy. Eur J Cancer. 2007;5(5 Suppl.):129–142
- . Biomarker qualification pilot process at the US Food and Drug Administration. AAPS J. 2007;9(1):E105–E108
- . Process map proposal for the validation of genomic biomarkers. Pharmacogenomics. 2006;7(5):773–782
- Qualification of biomarkers for drug development in organ transplantation. Am J Transplant. 2008;8(2):267–270
- Erlotinib in lung cancer – molecular and clinical predictors of outcome. N Engl J Med. 2005;353(2):133–144
- . Matching patients with drugs: triumphs and challenges. Personalized Med. 2006;3(3):335–344
- . Needs and challenges in translational medicine: filling the gap between basic research and clinical applications. ISTISAN Congr. 2008;08(C7):
- Different strategies of sequential and combination chemotherapy for patients with poor prognosis advanced colorectal cancer (MRC FOCUS): a randomised controlled trial. Lancet. 2007;370(9582):143–152
- Predictive biomarkers of chemotherapy efficacy in colorectal cancer: results from the UK MRC FOCUS trial. J Clin Oncol. 2008;26(16):2690–2698
- REporting recommendations for tumour MARKer prognostic studies (REMARK). Eur J Cancer. 2005;41(12):1690–1696
- Tumor marker utility grading system: a framework to evaluate clinical utility of tumor markers. J Natl Cancer Inst. 1996;88(20):1456–1466[see comment]
- A cost-effectiveness approach to the qualification and acceptance of biomarkers. Nat Rev Drug Discovery. 2006;5(11):897–902
- . Biomarkers and surrogate end points for fit-for-purpose development and regulatory evaluation of new drugs. Clin Pharmacol Ther. 2007;81(1):104–107
- . Cancer biomarkers: knowing the present and predicting the future. Future Oncol. 2005;1(1):37–50
- . Current issues in ER and HER2 testing by IHC in breast cancer. Mod Pathol. 2008;21:S8–S15
- 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. 2009;27(18S):LBA4509;[Meeting Abstracts]
- EGFR mutations in lung cancer: correlation with clinical response to gefitinib therapy. Science. 2004;304(5676):1497–1500
- Gefitinib or carboplatin-paclitaxel in pulmonary adenocarcinoma. N Engl J Med. 2009;361(10):947–957
- K-ras mutations and benefit from cetuximab in advanced colorectal cancer. N Engl J Med. 2008;359(17):1757–1765
- KRAS wild-type state predicts survival and is associated to early radiological response in metastatic colorectal cancer treated with cetuximab. Ann Oncol. 2008;19(3):508–515
- Clinical relevance of KRAS mutation detection in metastatic colorectal cancer treated by cetuximab plus chemotherapy. Br J Cancer. 2007;96(8):1166–1169
- KRAS mutation status is predictive of response to cetuximab therapy in colorectal cancer. Cancer Res. 2006;66(8):3992–3995
- 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. 2008;9(10):962–972
PII: S0959-8049(10)00002-X
doi: 10.1016/j.ejca.2010.01.001
© 2010 Elsevier Ltd. All rights reserved.
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European Journal of Cancer
Volume 46, Issue 5
, Pages 869-879
, March 2010
