References
Baselga, J., D. Tripathy, J. Mendelsohn, S. Baughman, C. C. Benz, L. Dantis, N. T. Sklarin, A. D. Seidman, C. A. Hudis, J. Moore, P. P. Rosen, T. Twaddell, I. C. Henderson, and L. Norton. 1999. Phase II study of weekly intravenous trastuzumab (herceptin) in patients with HER2/neu-overexpressing metastatic breast cancer. Seminars in Oncology 26(4 Suppl 12):78-83.
Benowitz, N. L., O. F. Pomerleau, C. S. Pomerleau, and P. Jacob, 3rd. 2003. Nicotine metabolite ratio as a predictor of cigarette consumption. Nicotine and Tobacco Research 5(5):621-624.
Berry, D. A., K. A. Cronin, S. K. Plevritis, D. G. Fryback, L. Clarke, M. Zelen, J. S. Mandelblatt, A. Y. Yakovlev, J. D. Habbema, and E. J. Feuer. 2005. Effect of screening and adjuvant therapy on mortality from breast cancer. New England Journal of Medicine 353(17):1784-1792.
Berry, D. A., C. Cirrincione, I. C. Henderson, M. L. Citron, D. R. Budman, L. J. Goldstein, S. Martino, E. A. Perez, H. B. Muss, L. Norton, C. Hudis, and E. P. Winer. 2006. Estrogen-receptor status and outcomes of modern chemotherapy for patients with node-positive breast cancer. Journal of the American Medical Association 295(14):1658-1667.
Brass, E. P. 2010. The gap between clinical trials and clinical practice: The use of pragmatic clinical trials to inform regulatory decision making. Clinical Pharmacology & Therapeutics 87(3):351-355.
de Jong, A. E., Y. M. Hendriks, J. H. Kleibeuker, S. Y. de Boer, A. Cats, G. Griffioen, F. M. Nagengast, F. G. Nelis, M. A. Rookus, and H. F. Vasen. 2006. Decrease in mortality in Lynch syndrome families because of surveillance. Gastroenterology 130(3):665-671.
Evans, W. K., A. Laupacis, K. Y. Gulenchyn, L. Levin, and M. Levine. 2009. Evidence-based approach to the introduction of positron emission tomography in Ontario, Canada. Journal of Clinical Oncology 27(33):5607-5613.
Goeree, R., and L. Levin. 2006. Building bridges between academic research and policy formulation: The PRUFE framework—an integral part of Ontario’s evidence-based HTPA process. Pharmacoeconomics 24(11):1143-1156.
Gonzales, D., S. I. Rennard, M. Nides, C. Oncken, S. Azoulay, C. B. Billing, E. J. Watsky, J. Gong, K. E. Williams, and K. R. Reeves. 2006. Varenicline, an α4β2 nicotinic acetylcholine receptor partial agonist, vs sustained-release bupropion and placebo for smoking cessation: A randomized controlled trial. Journal of the American Medical Association 296(1):47-55.
Harris, L., H. Fritsche, R. Mennel, L. Norton, P. Ravdin, S. Taube, M. R. Somerfield, D. F. Hayes, and R. C. Bast, Jr. 2007. American Society of Clinical Oncology 2007 update of recommendations for the use of tumor markers in breast cancer. Journal of Clinical Oncology 25(33):5287-5312.
Imperiale, T. F., D. R. Wagner, C. Y. Lin, G. N. Larkin, J. D. Rogge, and D. F. Ransohoff. 2000. Risk of advanced proximal neoplasms in asymptomatic adults according to the distal colorectal findings. New England Journal of Medicine 343(3):169-174.
Imperiale, T. F., E. A. Glowinski, C. Lin-Cooper, G. N. Larkin, J. D. Rogge, and D. F. Ransohoff. 2008. Five-year risk of colorectal neoplasia after negative screening colonoscopy. New England Journal of Medicine 359(12):1218-1224.
IOM (Institute of Medicine). 2010. The value of genetic and genomic technologies: Workshop summary. Washington, DC: The National Academies Press.
IOM. 2011. Establishing precompetitive collaborations to stimulate genomics-driven product development: Workshop summary. Washington, DC: The National Academies Press.
Jarvinen, H. J., M. Aarnio, H. Mustonen, K. Aktan-Collan, L. A. Aaltonen, P. Peltomaki, A. D. L. Chapelle, and J. P. Mecklin. 2000. Controlled 15-year trial on screening for colorectal cancer in families with hereditary nonpolyposis colorectal cancer. Gastroenterology 118(5):829-834.
Lee, J. J., and E. Chu. 2007. First-line use of anti-epidermal growth factor receptor monoclonal antibodies in metastatic colorectal cancer. Clinical Colorectal Cancer 6 (Suppl 2):S42-S46.
Levin, L., R. Goeree, N. Sikich, B. Jorgensen, M. C. Brouwers, T. Easty, and C. Zahn. 2007. Establishing a comprehensive continuum from an evidentiary base to policy development for health technologies: The Ontario experience. International Journal of Technology Assessment in Health Care 23(3):299-309.
Malaiyandi, V., S. D. Goodz, E. M. Sellers, and R. F. Tyndale. 2006. CYP2A6 genotype, phenotype, and the use of nicotine metabolites as biomarkers during ad libitum smoking. Cancer Epidemiology, Biomarkers & Prevention 15(10):1812-1819.
Marchionni, L., R. F. Wilson, S. S. Marinopoulos, A. C. Wolff, G. Parmigiani, E. B. Bass, and S. N. Goodman. 2008. Impact of gene expression profiling tests on breast cancer outcomes. Evidence report/technology assessment no. 160. (prepared by the Johns Hopkins University Evidence-Based Practice Center under contract no. 290-02-0018). Agency for Healthcare Research and Quality Publication No. 08-E002 January.
MAS (Medical Advisory Secretariat). 2010. Endovascular repair of abdominal aortic aneurysms in low surgical risk patients: Rapid review. Toronto, ON: Medical Advisory Secretariat. Available at http://www.health.gov.on.ca/english/providers/program/mas/tech/rapid/pdf/rr_evar_20100113.pdf (accessed March 24, 2011).
Moss, A. J., W. Shimizu, A. A. Wilde, J. A. Towbin, W. Zareba, J. L. Robinson, M. Qi, G. M. Vincent, M. J. Ackerman, E. S. Kaufman, N. Hofman, R. Seth, S. Kamakura, Y. Miyamoto, I. Goldenberg, M. L. Andrews, and S. McNitt. 2007. Clinical aspects of type-1 long-QT syndrome by location, coding type, and biophysical function of mutations involving the KCNQ1 gene. Circulation 115(19):2481-2489.
Paik, S., S. Shak, G. Tang, C. Kim, J. Baker, M. Cronin, F. L. Baehner, M. G. Walker, D. Watson, T. Park, W. Hiller, E. R. Fisher, D. L. Wickerham, J. Bryant, and N. Wolmark. 2004a. A multigene assay to predict recurrence of tamoxifen-treated, node-negative breast cancer. New England Journal of Medicine 351(27):2817-2826.
Paik, S., S. Shak, G. Tang, C. Kim, J. Baker, M. Cronin, R. Baehner, M. Walker, D. Watson, J. Bryant, and N. Wolmark. 2004b. Risk classification of breast cancer patients by the recurrence score assay: Comparison to guidelines based on patient age, tumor size, and tumor grade. Paper read at 27th Annual San Antonio Breast Cancer Symposium, December 8-11, 2004, San Antonio, TX.
Paik, S., G. Tang, S. Shak, C. Kim, J. Baker, W. Kim, M. Cronin, F. L. Baehner, D. Watson, J. Bryant, J. P. Costantino, C. E. Geyer, Jr., D. L. Wickerham, and N. Wolmark. 2006. Gene expression and benefit of chemotherapy in women with node-negative, estrogen receptor-positive breast cancer. Journal of Clinical Oncology 24(23):3726-3734.
Palomaki, G. E., M. R. McClain, S. Melillo, H. L. Hampel, and S. N. Thibodeau. 2009. EGAPP supplementary evidence review: DNA testing strategies aimed at reducing morbidity and mortality from Lynch syndrome. Genetics in Medicine 11(1):42-65.
Pencina, M. J., R. B. D’Agostino, Sr., R. B. D’Agostino, Jr., and R. S. Vasan. 2008. Evaluating the added predictive ability of a new marker: From area under the ROC curve to reclassification and beyond. Statistics in Medicine 27(2):157-172; discussion 207-212.
Pepe, M. S., H. Janes, G. Longton, W. Leisenring, and P. Newcomb. 2004. Limitations of the odds ratio in gauging the performance of a diagnostic, prognostic, or screening marker. American Journal of Epidemiology 59(9):882-890.
Peto, R., J. Boreham, M. Clarke, C. Davies, and V. Beral. 2000. UK and USA breast cancer deaths down 25% in year 2000 at ages 20-69 years. Lancet 355(9217):1822.
Ray, R., R. F. Tyndale, and C. Lerman. 2009. Nicotine dependence pharmacogenetics: Role of genetic variation in nicotine-metabolizing enzymes. Journal of Neurogenetics 23(3):252-261.
Roden, D. M. 2008. Clinical practice. Long-QT syndrome. New England Journal of Medicine 358(2):169-176.
Schmeler, K. M., H. T. Lynch, L. M. Chen, M. F. Munsell, P. T. Soliman, M. B. Clark, M. S. Daniels, K. G. White, S. G. Boyd-Rogers, P. G. Conrad, K. Y. Yang, M. M. Rubin, C. C. Sun, B. M. Slomovitz, D. M. Gershenson, and K. H. Lu. 2006. Prophylactic surgery to reduce the risk of gynecologic cancers in the Lynch syndrome. New England Journal of Medicine 354(3):261-269.
Shao, Y. Y. 2010. Gefitinib or erlotinib in the treatment of advanced non-small cell lung cancer. Discovery Medicine 49(June 2010). Available at http://www.discoverymedicine.com/Yu-Yun-Shao/2010/06/19/gefitinib-or-erlotinib-in-the-treatment-of-advanced-non-smallcell-lung-cancer/(accessed March 25).
Simon, R. M., S. Paik, and D. F. Hayes. 2009. Use of archived specimens in evaluation of prognostic and predictive biomarkers. Journal of the National Cancer Institute 101(21):1446-1452.
Tarride, J. E., G. Blackhouse, G. De Rose, T. Novick, J. M. Bowen, R. Hopkins, D. O’Reilly, and R. Goeree. 2008. Cost-effectiveness analysis of elective endovascular repair compared with open surgical repair of abdominal aortic aneurysms for patients at a high surgical risk: A 1-year patient-level analysis conducted in Ontario, Canada. Journal of Vascular Surgery 48(4):779-787.
TEC (Blue Cross and Blue Shield Association Technology Evaluation Center). 2005. Gene expression profiling for managing breast cancer treatment. Technology Evaluation Center Assessment Program 20(3):1-5.
TEC. 2007. Epidermal growth factor receptor mutations and tyrosine kinase inhibitor therapy in advanced non-small-cell lung cancer. Technology Evaluation Center Assessment Program 22(6):1-22.
TEC. 2008a. Gene expression profiling of breast cancer to select women for adjuvant chemotherapy. Technology Evaluation Center Assessment Program 22(13):1-8.
TEC. 2008b. Genetic testing for long-QT syndrome. Technology Evaluation Center Assessment Program 22(9):1-5.
TEC. 2011. Epidermal growth factor receptor mutations and tyrosine kinase inhibitor therapy in advanced non-small-cell lung cancer. Technology Evaluation Center Assessment Program 25(6):1-30.
Teutsch, S. M., L. A. Bradley, G. E. Palomaki, J. E. Haddow, M. Piper, N. Calonge, W. D. Dotson, M. P. Douglas, and A. O. Berg. 2009. The Evaluation of Genomic Applications in Practice and Prevention (EGAPP) initiative: Methods of the EGAPP working group. Genetics in Medicine 11(1):3-14.
Tu, J. V., J. Bowen, M. Chiu, D. T. Ko, P. C. Austin, Y. He, R. Hopkins, J. E. Tarride, G. Blackhouse, C. Lazzam, E. A. Cohen, and R. Goeree. 2007. Effectiveness and safety of drug-eluting stents in Ontario. New England Journal of Medicine 357(14):1393-1402.
Villanueva, J., D. R. Shaffer, J. Philip, C. A. Chaparro, H. Erdjument-Bromage, A. B. Olshen, M. Fleisher, H. Lilja, E. Brogi, J. Boyd, M. Sanchez-Carbayo, E. C. Holland, C. Cordon-Cardo, H. I. Scher, and P. Tempst. 2006. Differential exoprotease activities confer tumorspecific serum peptidome patterns. Journal of Clinical Investigation 116(1):271-284.
Wolff, A. C., M. E. Hammond, J. N. Schwartz, K. L. Hagerty, D. C. Allred, R. J. Cote, M. Dowsett, P. L. Fitzgibbons, W. M. Hanna, A. Langer, L. M. McShane, S. Paik, M. D. Pegram, E. A. Perez, M. F. Press, A. Rhodes, C. Sturgeon, S. E. Taube, R. Tubbs, G. H. Vance, M. van de Vijver, T. M. Wheeler, and D. F. Hayes. 2007. American Society of Clinical Oncology/College of American Pathologists guideline recommendations for human epidermal growth factor receptor 2 testing in breast cancer. Journal of Clinical Oncology 25(1):118-145.
Zhu, C. Q., G. da Cunha Santos, K. Ding, A. Sakurada, J. C. Cutz, N. Liu, T. Zhang, P. Marrano, M. Whitehead, J. A. Squire, S. Kamel-Reid, L. Seymour, F. A. Shepherd, and M. S. Tsao. 2008. Role of KRAS and EGFR as biomarkers of response to erlotinib in National Cancer Institute of Canada Clinical Trials Group Study BR.21. Journal of Clinical Oncology 26(26):4268-4275.
Zujewski, J. A., and L. Kamin. 2008. Trial assessing individualized options for treatment for breast cancer: The TAILORx trial. Future Oncology 4(5):603-610.