Validation des biomarqueurs, niveau de preuve et essais cliniques adaptatifs 27
3. Sturgeon CM, Hoffman BR, Chan DW, et al. (2008) National Academy of Clinical
l l
Biochemistry Laboratory Medicine Practice Guidelines for use of tumor markers in clinical
practice: quality requirements. Clin Chem 54(8): e1-e10
4. Altman DG, McShane LM, Sauerbrei W, Taube SE (2012) Reporting recommendations
for tumor marker prognostic studies (REMARK): explanation and elaboration. BMC
Medicine 29(10):51
5. Hayes DF, Bast RC, Desch CE, et al. (1996) Tumor marker utility grading system: a
l l
framework to evaluate clinical utility of tumor markers. JNCI 88(20): 1456-66
6. Hayes DF, Trock B, Harris AL (1998) Assessing the clinical impact of prognostic factors:
when is “statistically significant” clinically useful? Breast Cancer Res Treat 52(1-3): 305-19
7. Simon R, Paik S, Hayes D (2009) Use of archieved specimens in evaluation of prognostic
and predictive biomarkers. J Natl Cancer Inst 101(21): 1446-52
8. Luporsi E, Bellocq JP, Barrière J (2014) uPA/PAI-1, Oncotype DX™, MammaPrint®
Valeurs pronostique et prédictive pour une utilité clinique dans la prise en charge du cancer
du sein. Oncologie 16(4) : 196-20
9. Teutsch SM, Bradley LA, Palomaki GE, et al. (
l l 2009) The Evaluation of Genomic
Applications in Practice and Prevention (EGAPP) Initiative: methods of the EGAPP
Working Group. Genet Med 11(1): 3-14
10. Kellof HJ, Sigman CC (2012) Cancer biomarkers: selecting the right drug for the right
patient. Nat Rev Drug Discov 11: 201-14
11. Azim HA, Michirls S, Zagouri F, et al. (2013) Utility of prognostic genomic tests in breast
cancer practice: The IMPAKT 2012 Working Group Consensus Statement. Ann Oncol
24(3): 647-54
12. Beckman RA, Clark J, Chen C (2011) Integrating predictive biomarkers and classifiers
into oncology clinical development programmes. Nat Rev Drug Discov 10: 735-48
13. Rapport 2009 sur l’état des connaissances relatives aux biomarqueurs tissulaires uPA-PAI1,
Oncotype DX et MammaPrint dans la prise en charge du cancer du sein. Institut National
du Cancer 2009 (en cours d’actualisation 2013)
3. Sturgeon CM, Hoffman BR, Chan DW, et al. (2008) National Academy of Clinical
l l
Biochemistry Laboratory Medicine Practice Guidelines for use of tumor markers in clinical
practice: quality requirements. Clin Chem 54(8): e1-e10
4. Altman DG, McShane LM, Sauerbrei W, Taube SE (2012) Reporting recommendations
for tumor marker prognostic studies (REMARK): explanation and elaboration. BMC
Medicine 29(10):51
5. Hayes DF, Bast RC, Desch CE, et al. (1996) Tumor marker utility grading system: a
l l
framework to evaluate clinical utility of tumor markers. JNCI 88(20): 1456-66
6. Hayes DF, Trock B, Harris AL (1998) Assessing the clinical impact of prognostic factors:
when is “statistically significant” clinically useful? Breast Cancer Res Treat 52(1-3): 305-19
7. Simon R, Paik S, Hayes D (2009) Use of archieved specimens in evaluation of prognostic
and predictive biomarkers. J Natl Cancer Inst 101(21): 1446-52
8. Luporsi E, Bellocq JP, Barrière J (2014) uPA/PAI-1, Oncotype DX™, MammaPrint®
Valeurs pronostique et prédictive pour une utilité clinique dans la prise en charge du cancer
du sein. Oncologie 16(4) : 196-20
9. Teutsch SM, Bradley LA, Palomaki GE, et al. (
l l 2009) The Evaluation of Genomic
Applications in Practice and Prevention (EGAPP) Initiative: methods of the EGAPP
Working Group. Genet Med 11(1): 3-14
10. Kellof HJ, Sigman CC (2012) Cancer biomarkers: selecting the right drug for the right
patient. Nat Rev Drug Discov 11: 201-14
11. Azim HA, Michirls S, Zagouri F, et al. (2013) Utility of prognostic genomic tests in breast
cancer practice: The IMPAKT 2012 Working Group Consensus Statement. Ann Oncol
24(3): 647-54
12. Beckman RA, Clark J, Chen C (2011) Integrating predictive biomarkers and classifiers
into oncology clinical development programmes. Nat Rev Drug Discov 10: 735-48
13. Rapport 2009 sur l’état des connaissances relatives aux biomarqueurs tissulaires uPA-PAI1,
Oncotype DX et MammaPrint dans la prise en charge du cancer du sein. Institut National
du Cancer 2009 (en cours d’actualisation 2013)