From genome to bedside: Are we lost in translation?

Breast

Volumn 22, Issue S2, 2013, Pages

  Hayes, Daniel F ^a  

^a UNIVERSITY OF MICHIGAN COMPREHENSIVE CANCER CENTER   (United States)

Author keywords

Omics based tests; Tumor biomarker tests

Indexed keywords

ANTINEOPLASTIC AGENT; EPIDERMAL GROWTH FACTOR RECEPTOR 2; ESTROGEN RECEPTOR; KI 67 ANTIGEN; PLASMINOGEN ACTIVATOR INHIBITOR 1; PROGESTERONE RECEPTOR; TAMOXIFEN; TUMOR MARKER; UROKINASE;

ADJUVANT THERAPY; ARTICLE; BIOASSAY; BREAST CANCER; CANCER ADJUVANT THERAPY; CANCER PROGNOSIS; CANCER RECURRENCE; CANCER RESEARCH; CLINICAL DECISION MAKING; CLINICAL PROTOCOL; DRUG RESPONSE; EVIDENCE BASED MEDICINE; FOOD AND DRUG ADMINISTRATION; GENOME ANALYSIS; HUMAN; INSTRUMENT VALIDATION; OUTCOME ASSESSMENT; PERSONALIZED MEDICINE; PRACTICE GUIDELINE; PREDICTION; PRIORITY JOURNAL; SEMANTICS;

OMICS-BASED TESTS; TUMOR BIOMARKER TESTS;

ANTINEOPLASTIC AGENTS, HORMONAL; BREAST NEOPLASMS; CASE-CONTROL STUDIES; CHEMOTHERAPY, ADJUVANT; COMBINED MODALITY THERAPY; FEMALE; GENOME; HUMANS; INDIVIDUALIZED MEDICINE; MASTECTOMY; NEOPLASM INVASIVENESS; NEOPLASM STAGING; PATIENT CARE; PATIENT SELECTION; PROGNOSIS; PROSPECTIVE STUDIES; RISK ASSESSMENT; SENSITIVITY AND SPECIFICITY; SURVIVAL ANALYSIS; TUMOR MARKERS, BIOLOGICAL;

EID: 84883392448     PISSN: 09609776     EISSN: 15323080     Source Type: Journal    
DOI: 10.1016/j.breast.2013.07.004     Document Type: Article

References (54)

1. Peto R., Boreham J., Clarke M., Davies C., Beral V. UK and USA breast cancer deaths down 25% in year 2000 at ages 20-69 years. Lancet 2000, 355(9217):1822.
2. Berry D.A., Cronin K.A., Plevritis S.K., Fryback D.G., Clarke L., Zelen M., et al. Effect of screening and adjuvant therapy on mortality from breast cancer. NEngl J Med 2005 Oct 27, 353(17):1784-1792.
3. Ravdin P.M., Siminoff L.A., Davis G.J., Mercer M.B., Hewlett J., Gerson N., et al. Computer program to assist in making decisions about adjuvant therapy for women with early breast cancer. JClin Oncol 2001 Feb 15, 19(4):980-991.
4. Olivotto I.A., Bajdik C.D., Ravdin P.M., Speers C.H., Coldman A.J., Norris B.D., et al. Population-based validation of the prognostic model ADJUVANT! for early breast cancer. JClin Oncol 2005 Apr 20, 23(12):2716-2725.
5. Comparisons between different polychemotherapy regimens for early breast cancer: meta-analyses of long-term outcome among 100,000 women in 123 randomized trials. Lancet 2012, 379:432-444. Early Breast Cancer Trialists Collaborative Group T.
6. Muss H.B., Berry D.A., Cirrincione C., Budman D.R., Henderson I.C., Citron M.L., et al. Toxicity of older and younger patients treated with adjuvant chemotherapy for node-positive breast cancer: the Cancer and Leukemia Group B experience. JClin Oncol 2007 Aug 20, 25(24):3699-3704.
7. Lindley C., Vasa S., Sawyer T., Winer E. Quality of life and preferences for treatment following systemic adjuvant therapy for early stage breast cancer. JClin Oncol 1998, 16:1380-1387.
8. Henry N.L., Hayes D.F. Uses and abuses of tumor markers in the diagnosis, monitoring, and treatment of primary and metastatic breast cancer. Oncologist 2006 Jun, 11(6):541-552.
9. Altman D.G., Bossuyt P.M. Diagnostic (STARD) and prognostic (REMARK) studies. Med Clin (Barc) 2005 Dec 1, 125(Suppl.1):49-55.
10. Altman D.G., Lyman G.H. Methodological challenges in the evaluation of prognostic factors in breast cancer. Breast Cancer Res Treat 1998, 52(1-3):289-303.
11. Altman D.G., Riley R.D. Primer: an evidence-based approach to prognostic markers. Nat Clin Pract Oncol 2005 Sep, 2(9):466-472.
12. Altman D.G., Royston P. What do we mean by validating a prognostic model?. Stat Med 2000 Feb 29, 19(4):453-473.
13. Simon R. Roadmap for developing and validating therapeutically relevant genomic classifiers. JClin Oncol 2005 Oct 10, 23(29):7332-7341.
14. Simon R. Development and validation of therapeutically relevant multi-gene biomarker classifiers. JNatl Cancer Inst 2005 Jun 15, 97(12):866-867.
15. Simon R., Altman D.G. Statistical aspects of prognostic factor studies in oncology. Br J Cancer 1994, 69:979-985.
16. Pepe M.S., Longton G. Standardizing diagnostic markers to evaluate and compare their performance. Epidemiology 2005 Sep, 16(5):598-603.
17. McShane L., Hayes D.F. Publication of tumor marker research results: the necessity for complete and transparent reporting. JClin Oncol 2012, 30(334):4223-4232.
18. Harris L., Fritsche H., Mennel R., Norton L., Ravdin P., Taube S., et al. American Society of Clinical Oncology 2007 update of recommendations for the use of tumor markers in breast cancer. JClin Oncol 2007 Nov 20, 25(33):5287-5312.
19. Teutsch S.M., Bradley L.A., Palomaki G.E., Haddow J.E., Piper M., Calonge N., et al. The evaluation of genomic applications in practice and prevention (EGAPP) initiative: methods of the EGAPP Working Group. Genet Med 2009 Jan, 11(1):3-14.
20. Hayes D.F., Bast R.C., Desch C.E., Fritsche H., Kemeny N.E., Jessup J.M., et al. Tumor marker utility grading system: a framework to evaluate clinical utility of tumor markers. JNatl Cancer Inst 1996 Oct 16, 88(20):1456-1466.
21. Simon R.M., Paik S., Hayes D.F. Use of archived specimens in evaluation of prognostic and predictive biomarkers. JNatl Cancer Inst 2009 Nov 4, 101(21):1446-1452.
22. Institute of Medicine Evolution of translational omics: lessons learned and the path forward 2012, The National Academies Press, Washington, D.C. C. Micheel, S. Nass, G.S. Omenn (Eds.).
23. Sargent D.J., Conley B.A., Allegra C., Collette L. Clinical trial designs for predictive marker validation in cancer treatment trials. JClin Oncol 2005 Mar 20, 23(9):2020-2027.
24. Freidlin B., McShane L.M., Korn E.L. Randomized clinical trials with biomarkers: design issues. JNatl Cancer Inst 2010 Feb 3, 102(3):152-160.
25. Freidlin B., McShane L.M., Polley M.Y., Korn E.L. Randomized phase II trial designs with biomarkers. JClin Oncol 2012 Sep 10, 30(26):3304-3309.
26. Andre F., McShane L.M., Michiels S., Ransohoff D.F., Altman D.G., Reis-Filho J.S., et al. Biomarker studies: a call for a comprehensive biomarker study registry. Nat Rev Clin Oncol 2011 Mar, 8(3):171-176.
27. McShane L.M., Altman D.G., Sauerbrei W., Taube S.E., Gion M., Clark G.M. Reporting recommendations for tumor marker prognostic studies (REMARK). JNatl Cancer Inst 2005 Aug 17, 97(16):1180-1184.
28. McShane L.M., Altman D.G., Sauerbrei W., Taube S.E., Gion M., Clark G.M. Reporting recommendations for tumor marker prognostic studies. JClin Oncol 2005 Dec 20, 23(36):9067-9072.
29. McShane L.M., Altman D.G., Sauerbrei W., Taube S.E., Gion M., Clark G.M. REporting recommendations for tumour MARKer prognostic studies (REMARK). Br J Cancer 2005 Aug 22, 93(4):387-391.
30. McShane L.M., Altman D.G., Sauerbrei W., Taube S.E., Gion M., Clark G.M. REporting recommendations for tumor MARKer prognostic studies (REMARK). Nat Clin Pract Oncol 2005 Aug, 2(8):416-422.
31. McShane L.M., Altman D.G., Sauerbrei W., Taube S.E., Gion M., Clark G.M. REporting recommendations for tumour MARKer prognostic studies (REMARK). Eur J Cancer 2005 Aug, 41(12):1690-1696.
32. McShane L.M., Altman D.G., Sauerbrei W., Taube S.E., Gion M., Clark G.M. REporting recommendations for tumor MARKer prognostic studies (REMARK). Breast Cancer Res Treat 2006 Nov, 100(2):229-235.
33. McShane L.M., Altman D.G., Sauerbrei W., Taube S.E., Gion M., Clark G.M. Reporting recommendations for tumor marker prognostic studies (remark). Exp Oncol 2006 Jun, 28(2):99-105.
34. Moore H.M., Kelly A., Jewell S.D., McShane L.M., Clark D.P., Greenspan R., et al. Biospecimen reporting for improved study quality. Biopreserv Biobank 2011 Apr, 9(1):57-70.
35. Moore H.M., Kelly A., McShane L.M., Vaught J. Biospecimen reporting for improved study quality (BRISQ). Clin Chim Acta 2012 Aug 16, 413(15-16):1305.
36. Moore H.M., Kelly A.B., Jewell S.D., McShane L.M., Clark D.P., Greenspan R., et al. Biospecimen reporting for improved study quality (BRISQ). JProteome Res 2011 Aug 5, 10(8):3429-3438.
37. Moore H.M., Kelly A.B., Jewell S.D., McShane L.M., Clark D.P., Greenspan R., et al. Biospecimen reporting for improved study quality (BRISQ). Cancer Cytopathol 2011 Apr 25, 119(2):92-101.
38. Soletormos G., Duffy M.J., Hayes D.F., Sturgeon C.M., Barak V., Bossuyt P.M., et al. Design of tumor biomarker-monitoring trials: a proposal by the European group on tumor markers. Clin Chem 2013 Jan, 59(1):52-59.
39. Wolff A.C., Hammond M.E., Schwartz J.N., Hagerty K.L., Allred D.C., Cote R.J., et al. American Society of Clinical Oncology/College of American Pathologists guideline recommendations for human epidermal growth factor receptor 2 testing in breast cancer. JClin Oncol 2007 Jan 1, 25(1):118-145.
40. Wolff A.C., Hammond M.E., Schwartz J.N., Hagerty K.L., Allred D.C., Cote R.J., et al. American Society of Clinical Oncology/College of American Pathologists guideline recommendations for human epidermal growth factor receptor 2 testing in breast cancer. Arch Pathol Lab Med 2007, 131(1):18-43.
41. Hammond M.E., Hayes D.F., Dowsett M., Allred D.C., Hagerty K.L., Badve S., et al. American Society of Clinical Oncology/College of American Pathologists guideline recommendations for immunohistochemical testing of estrogen and progesterone receptors in breast cancer. JClin Oncol 2010 Jun 1, 28(16):2784-2795.
42. Hammond M.E., Hayes D.F., Dowsett M., Allred D.C., Hagerty K.L., Badve S., et al. American Society of Clinical Oncology/College of American Pathologists guideline recommendations for immunohistochemical testing of estrogen and progesterone receptors in breast cancer. Arch Pathol Lab Med 2010 Jun, 134(6):907-922.
43. Effects of chemotherapy and hormonal therapy for early breast cancer on recurrence and 15-year survival: an overview of the randomised trials. Lancet 2005 May, 365(9472):1687-1717. Early Breast Cancer Trialists' Collaborative Group.
44. Paik S., Shak S., Tang G., Kim C., Baker J., Cronin M., et al. Amulti-gene RT-PCR assay using fixed, paraffin-embedded tumor tissue to predict the likelihood of breast cancer recurrence in node negative, estrogen receptor positive, tamoxifen-treated patients. NEngl J Med 2004, 351:2817-2826.
45. Dowsett M., Cuzick J., Wale C., Forbes J., Mallon E.A., Salter J., et al. Prediction of risk of distant recurrence using the 21-gene recurrence score in node-negative and node-positive postmenopausal patients with breast cancer treated with anastrozole or tamoxifen: a TransATAC study. JClin Oncol 2010 Apr 10, 28(11):1829-1834.
46. Hayes D.F. Targeting adjuvant chemotherapy: a good idea that needs to be proven!. JClin Oncol 2012 Apr 20, 30(12):1264-1267.
47. Perou C.M., Sorlie T., Eisen M.B., van de Rijn M., Jeffrey S.S., Rees C.A., et al. Molecular portraits of human breast tumours. Nature 2000, 406(6797):747-752.
48. Coates A.S., Colleoni M., Goldhirsch A. Is adjuvant chemotherapy useful for women with luminal a breast cancer?. JClin Oncol 2012 Apr 20, 30(12):1260-1263.
49. Paik S., Tang G., Shak S., Kim C., Baker J., Kim W., et al. Gene expression and benefit of chemotherapy in women with node-negative, estrogen receptor-positive breast cancer. JClin Oncol 2006 May 23, 24:3726-3734.
50. Albain K.S., Barlow W.E., Shak S., Hortobagyi G.N., Livingston R.B., Yeh I.T., et al. Prognostic and predictive value of the 21-gene recurrence score assay in postmenopausal women with node-positive, oestrogen-receptor-positive breast cancer on chemotherapy: a retrospective analysis of a randomised trial. Lancet Oncol 2010 Jan, 11(1):55-65.
51. Dowsett M., Salter J., Zabaglo L., Mallon E., Howell A., Buzdar A.U., et al. Predictive algorithms for adjuvant therapy: TransATAC. Steroids 2011 Jul, 76(8):777-780.
52. Cuzick J., Dowsett M., Pineda S., Wale C., Salter J., Quinn E., et al. Prognostic value of a combined estrogen receptor, progesterone receptor, Ki-67, and human epidermal growth factor receptor 2 immunohistochemical score and comparison with the Genomic Health recurrence score in early breast cancer. JClin Oncol 2011 Nov 10, 29(32):4273-4278.
53. Dowsett M., Nielsen T.O., A'Hern R., Bartlett J., Coombes R.C., Cuzick J., et al. Assessment of ki67 in breast cancer: recommendations from the international ki67 in breast cancer working group. JNatl Cancer Inst 2011 Nov 16, 103(22):1656-1664.
54. Nielsen T.O., Polley M.-Y.C., Leung S.C.Y., Mauro G., Mastropasqua M.G., Zabaglo L.A., et al. An international Ki67 reproducibility study. Proceedings of the San Antonio Breast Cancer Symposium 2012.