National Academies Press: OpenBook
« Previous: 5 Advancing Molecular Diagnostics for Oncology
Suggested Citation:"References." Institute of Medicine. 2013. Genome-Based Diagnostics: Demonstrating Clinical Utility in Oncology: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18275.
×

References

ACS (American Cancer Society). 2011. Colorectal cancer facts and figures, 2011–2013. Atlanta, GA: American Cancer Society.

ACS. 2012. Cancer facts and figures, 2012. Atlanta, GA: American Cancer Society.

Altman, D. G., I. Simera, J. Hoey, D. Moher, and K. Schulz. 2008. EQUATOR: Reporting guidelines for health research. Lancet 371(9619):1149–1150.

Altman, D. G., L. M. McShane, W. Sauerbrei, and S. E. Taube. 2012. Reporting recommendations for tumor marker prognostic studies (REMARK): Explanation and elaboration. PLoS Medicine 9(5):e1001216.

Andre, F., L. M. McShane, S. Michiels, D. F. Ransohoff, D. G. Altman, J. S. Reis-Filho, D. F. Hayes, and L. Pusztai. 2011. Biomarker studies: A call for a comprehensive biomarker study registry. Nature Reviews Clinical Oncology 8(3):171–176.

Baggerly, K. A., and K. R. Coombes. 2009. Deriving chemosensitivity from cell lines: Forensic bioinformatics and reproducible research in high-throughput biology. Annals of Applied Statistics 3(4):1309–1334.

Bristow, R. E., R. S. Tomacruz, D. K. Armstrong, E. L. Trimble, and F. J. Montz. 2002. Survival effect of maximal cytoreductive surgery for advanced ovarian carcinoma during the platinum era: A meta-analysis. Journal of Clinical Oncology 20(5):1248–1259.

CDC (Centers for Disease Control and Prevention). 2011. Vital signs: Colorectal cancer screening, incidence, and mortality—United States, 2002–2010. Morbidity and Mortality Weekly Report 60(26):884–889.

CMS (Centers for Medicare & Medicaid Services). 2005. Demonstration of improved quality of care for cancer patients undergoing chemotherapy. Baltimore, MD: Centers for Medicare & Medicaid Services.

Cochrane, A. L. 1972. Effectiveness and efficiency: Random reflections on health services. London: Nuffield Provincial Hospitals Trust.

Suggested Citation:"References." Institute of Medicine. 2013. Genome-Based Diagnostics: Demonstrating Clinical Utility in Oncology: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18275.
×

Edelman, M. J., D. Watson, X. Wang, C. Morrison, R. A. Kratzke, S. Jewell, L. Hodgson, A. M. Mauer, A. Gajra, G. A. Masters, M. Bedor, E. E. Vokes, and M. J. Green. 2008. Eicosanoid modulation in advanced lung cancer: Cyclooxygenase-2 expression is a positive predictive factor for celecoxib + chemotherapy—Cancer and Leukemia Group B trial 30203. Journal of Clinical Oncology 26(6):848–855.

Elkin, E. B., D. A. Marshall, N. A. Kulin, I. L. Ferrusi, M. J. Hassett, U. Ladabaum, and K. A. Phillips. 2011. Economic evaluation of targeted cancer interventions: Critical review and recommendations. Genetics in Medicine 13(10):853–860.

Ferreira-Gonzalez, A., S. Teutsch, M. S. Williams, S. M. Au, K. T. Fitzgerald, P. S. Miller, and C. Fomous. 2008. U.S. system of oversight for genetic testing: A report from the Secretary’s Advisory Committee on Genetics, Health and Society. Personalized Medicine 5(5):521–528.

Freidlin, B., L. M. McShane, and E. L. Korn. 2010. Randomized clinical trials with biomarkers: Design issues. Journal of the National Cancer Institute 102(3):152–160.

Goff, B. A., J. W. Miller, B. Matthews, K. F. Trivers, C. H. Andrilla, D. M. Lishner, and L. M. Baldwin. 2011. Involvement of gynecologic oncologists in the treatment of patients with a suspicious ovarian mass. Obstetrics and Gynecology 118(4):854–862.

Harris, L., H. Fritsche, R. Mennel, L. Norton, P. Ravdin, S. Taube, M. R. Somerfield, D. F. Hayes, J. R. C. Bast, and American Society of Clinical Oncology. 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.

Hayes, D. F., A. D. Thor, L. G. Dressler, D. Weaver, S. Edgerton, D. Cowan, G. Broadwater, L. J. Goldstein, S. Martino, J. N. Ingle, I. C. Henderson, L. Norton, E. P. Winer, C. A. Hudis, M. J. Ellis, D. A. Berry, and Cancer and Leukemia Group B Investigators. 2007. HER2 and response to paclitaxel in node-positive breast cancer. New England Journal of Medicine 357(15):1496–1506.

Henderson, I. C., D. A. Berry, G. D. Demetri, C. T. Cirrincione, L. J. Goldstein, S. Martino, J. N. Ingle, M. R. Cooper, D. F. Hayes, K. H. Tkaczuk, G. Fleming, J. F. Holland, D. B. Duggan, J. T. Carpenter, E. Frei, 3rd, R. L. Schilsky, W. C. Wood, H. B. Muss, and L. Norton. 2003. Improved outcomes from adding sequential paclitaxel but not from escalating doxorubicin dose in an adjuvant chemotherapy regimen for patients with nodepositive primary breast cancer. Journal of Clinical Oncology 21(6):976–983.

Howlader, N., A. M. Noone, M. Krapcho, N. Neyman, R. Aminou, S. F. Altekruse, C. L. Kosary, J. Ruhl, Z. Tatalovich, H. Cho, A. Mariotto, M. P. Eisner, D. R. Lewis, H. S. Chen, E. J. Feuer, and K. A. Cronin. 2012. SEER cancer statistics review, 1975–2009 (vintage 2009 populations). Bethesda, MD: National Cancer Institute.

Howlader, N., A. M. Noone, M. Krapcho, N. Neyman, S. F. Altekruse, C. L. Kosary, M. Yu, J. Ruhl, Z. Tatalovich, H. Cho, A. Mariotto, D. R. Lewis, H. S. Chen, E. J. Feuer, and K. A. Cronin (Eds.). 2013. SEER cancer statistics review, 1975–2010. Bethesda, MD: National Cancer Institute.

IOM (Institute of Medicine). 2009. Initial national priorities for comparative effectiveness research. Washington, DC: The National Academies Press.

IOM. 2011a. Generating evidence for genomic diagnostic test development: Workshop summary. Washington, DC: The National Academies Press.

IOM. 2011b. Clinical practice guidelines we can trust. Washington, DC: The National Academies Press.

IOM. 2011c. Finding what works in health care: Standards for systematic reviews. Washington, DC: The National Academies Press.

IOM. 2012a. Genome-based diagnostics: Clarifying pathways to clinical use: Workshop summary. Washington, DC: The National Academies Press.

IOM. 2012b. Evolution of translational omics: Lessons learned and the path forward. Washington, DC: The National Academies Press.

Suggested Citation:"References." Institute of Medicine. 2013. Genome-Based Diagnostics: Demonstrating Clinical Utility in Oncology: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18275.
×

IOM. 2012c. Genome-based therapeutics: Targeted drug discovery and development: Workshop summary. Washington, DC: The National Academies Press.

Jacobs, I., D. Oram, J. Fairbanks, J. Turner, C. Frost, and J. G. Grudzinskas. 1990. A risk of malignancy index incorporating CA 125, ultrasound and menopausal status for the accurate preoperative diagnosis of ovarian cancer. British Journal of Obstetrics and Gynaecology 97(10):922–929.

Ladabaum, U., G. Wang, J. Terdiman, A. Blanco, M. Kuppermann, C. R. Boland, J. Ford, E. Elkin, and K. A. Phillips. 2011. Strategies to identify the Lynch syndrome among patients with colorectal cancer: A cost-effectiveness analysis. Annals of Internal Medicine 155(2):69–79.

McShane, L. M., D. G. Altman, W. Sauerbrei, S. E. Taube, M. Gion, G. M. Clark. 2005. Reporting recommendations for tumor marker prognostic studies (REMARK). Nature Clinical Practice Urology 2(8):416–422.

Menon, U., A. Gentry-Maharaj, R. Hallett, A. Ryan, M. Burnell, A. Sharma, S. Lewis, S. Davies, S. Philpott, A. Lopes, K. Godfrey, D. Oram, J. Herod, K. Williamson, M. W. Seif, I. Scott, T. Mould, R. Woolas, J. Murdoch, S. Dobbs, N. N. Amso, S. Leeson, D. Cruickshank, A. McGuire, S. Campbell, L. Fallowfield, N. Singh, A. Dawnay, S. J. Skates, M. Parmar, and I. Jacobs. 2009. Sensitivity and specificity of multimodal and ultrasound screening for ovarian cancer, and stage distribution of detected cancers: Results of the prevalence screen of the UK collaborative trial of ovarian cancer screening (UKCTOCS). Lancet Oncology 10(4):327–340.

Meyer, R. 2011. Contrasting explanatory and pragmatic randomized controlled trials in oncology. http://meetinglibrary.asco.org/sites/meetinglibrary.asco.org/files/Educational%20Book/PDF%20Files/2011/zds00111000072.pdf (accessed October 8, 2013).

Molinaro, A. M., R. Simon, and R. M. Pfeiffer. 2005. Prediction error estimation: A comparison of resampling methods. Bioinformatics 21(15):3301–3307.

Moore, R. G., S. MacLaughlan, and J. R. C. Bast. 2010. Current state of biomarker development for clinical application in epithelial ovarian cancer. Gynecologic Oncology 116(2):240–245.

Moore, R. G., M. C. Miller, P. Disilvestro, L. M. Landrum, W. Gajewski, J. J. Ball, and S. J. Skates. 2011a. Evaluation of the diagnostic accuracy of the risk of ovarian malignancy algorithm in women with a pelvic mass. Obstetrics and Gynecology 118(2 Pt 1):280–288.

Moore, H. M., A. B. Kelly, S. D. Jewell, L. M. McShane, D. P. Clark, R. Greenspan, D. F. Hayes, P. Hainaut, P. Kim, E. A. Mansfield, O. Potapova, P. Riegman, Y. Rubinstein, E. Seijo, S. Somiari, P. Watson, H. U. Weier, C. Zhu, and J. Vaught. 2011b. Biospecimen reporting for improved study quality (BRISQ). Cancer Cytopathology 119(2):92–101.

Muggia, F. M., P. S. Braly, M. F. Brady, G. Sutton, T. H. Niemann, S. L. Lentz, R. D. Alvarez, P. R. Kucera, and J. M. Small. 2000. Phase III randomized study of cisplatin versus paclitaxel versus cisplatin and paclitaxel in patients with suboptimal stage III or IV ovarian cancer: A gynecologic oncology group study. Journal of Clinical Oncology 18(1):106–115.

Neuss, M. N., C. E. Desch, K. K. McNiff, P. D. Eisenberg, D. H. Gesme, J. O. Jacobson, M. Jahanzeb, J. J. Padberg, J. M. Rainey, J. J. Guo, and J. V. Simone. 2005. A process for measuring the quality of cancer care: The quality oncology practice initiative. Journal of Clinical Oncology 23(25):6233–6239.

Suggested Citation:"References." Institute of Medicine. 2013. Genome-Based Diagnostics: Demonstrating Clinical Utility in Oncology: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18275.
×

O’Connell, M. J., I. Lavery, G. Yothers, S. Paik, K. M. Clark-Langone, M. Lopatin, D. Watson, F. L. Baehner, S. Shak, J. Baker, J. W. Cowens, and N. Wolmark. 2010. Relationship between tumor gene expression and recurrence in four independent studies of patients with stage II/III colon cancer treated with surgery alone or surgery plus adjuvant fluorouracil plus leucovorin. Journal of Clinical Oncology 28(25):3937–3944.

Phillips, K. A. 2008. Closing the evidence gap in the use of emerging testing technologies in clinical practice. Journal of the American Medical Association 300(21):2542–2544.

PricewaterhouseCoopers. 2009. The new science of personalized medicine: Translating the promise into practice. http://www.pwc.com/us/en/healthcare/publications/personalizedmedicine.jhtml (accessed August 31, 2012).

Ramsey, S. D., D. Veenstra, S. R. Tunis, L. Garrison, J. J. Crowley, and L. H. Baker. 2011. How comparative effectiveness research can help advance “personalized medicine” in cancer treatment. Health Affairs 30(12):2259–2268.

Ramsey, S. D., W. E. Barlow, A. M. Gonzalez-Angulo, S. Tunis, L. Baker, J. Crowley, P. Deverka, D. Veenstra, and G. N. Hortobagyi. 2013. Integrating comparative effectiveness design elements and endpoints into a Phase III, randomized clinical trial (SWOG S1007) evaluating Oncotype DX-guided management for women with breast cancer involving lymph nodes. Contemporary Clinical Trials 34(1):1–9.

Russo, P., F. S. Mennini, P. D. Siviero, and G. Rasi. 2010. Time to market and patient access to new oncology products in Italy: A multistep pathway from European context to regional health care providers. Annals of Oncology 21(10):2081–2087.

Saltz, L. B., D. Niedzwiecki, D. Hollis, R. M. Goldberg, A. Hantel, J. P. Thomas, A. L. Fields, and R. J. Mayer. 2007. Rinotecan fluorouracil plus leucovorin is not superior to fluorouracil plus leucovorin alone as adjuvant treatment for stage III colon cancer: Results of CALGB 89803. Journal of Clinical Oncology 25(23):3456–3461.

Scher, H. I., S. Halabi, I. Tannock, M. Morris, C. N. Sternberg, M. A. Carducci, M. A. Eisenberger, C. Higano, G. J. Bubley, R. Dreicer, D. Petrylak, P. Kantoff, E. Basch, W. K. Kelly, W. D. Figg, E. J. Small, T. M. Beer, G. Wilding, A. Martin, M. Hussain, and Prostate Cancer Clinical Trials Working Group. 2008. Design and end points of clinical trials for patients with progressive prostate cancer and castrate levels of testosterone: Recommendations of the Prostate Cancer Clinical Trials Working Group. Journal of Clinical Oncology 26(7):1148–1159.

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.

Skates, S. J. 2012. Ovarian cancer screening: Development of the risk of ovarian cancer algorithm (ROCA) and ROCA screening trials. International Journal of Gynecological Cancer 22(Suppl 1):S24–S26.

Smith, I. E. 2001. Efficacy and safety of herceptin in women with metastatic breast cancer: Results from pivotal clinical studies. Anticancer Drugs 12(Suppl 4):S3–S10.

Sparano, J. A., and L. J. Solin. 2010. Defining the clinical utility of gene expression assays in breast cancer: The intersection of science and art in clinical decision making. Journal of Clinical Oncology 28(10):1625–1627.

Subramanian, J., and R. Simon. 2010. Gene expression-based prognostic signatures in lung cancer: Ready for clinical use? Journal of the National Cancer Institute 102(7):464–474.

Teutsch, S. M., L. A. Bradley, G. E. Palomaki, J. E. Haddow, M. Piper, N. Calonge, W. D. Dotson, M. P. Douglas, A. O. Berg, and Evaluation of Genomic Applications in Practice and Prevention Working Group. 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.

Suggested Citation:"References." Institute of Medicine. 2013. Genome-Based Diagnostics: Demonstrating Clinical Utility in Oncology: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18275.
×

Ueland, F. R., C. P. Desimone, L. G. Seamon, R. A. Miller, S. Goodrich, I. Podzielinski, L. Sokoll, A. Smith, J. R. van Nagell, Jr., and Z. Zhang. 2011. Effectiveness of a multivariate index assay in the preoperative assessment of ovarian tumors. Obstetrics and Gynecology 117(6):1289–1297.

USPSTF (U.S. Preventive Services Task Force). 2012. Screening for Prostate Cancer: U.S. Preventive Services Task Force Recommendation Statement. Annals of Internal Medicine 157(2):120–134.

Vogel, V. G., J. P. Costantino, D. L. Wickerham, W. M. Cronin, R. S. Cecchini, J. N. Atkins, T. B. Bevers, L. Fehrenbacher, E. R. Pajon, Jr., J. L. Wade, 3rd, A. Robidoux, R. G. Margolese, J. James, S. M. Lippman, C. D. Runowicz, P. A. Ganz, S. E. Reis, W. McCaskill-Stevens, L. G. Ford, V. C. Jordan, N. Wolmark, and National Surgical Adjuvant Breast and Bowel Project. 2006. Effects of tamoxifen vs raloxifene on the risk of developing invasive breast cancer and other disease outcomes: The NSABP study of tamoxifen and raloxifene (STAR) P-2 trial. Journal of the American Medical Association 295(23):2727–2741.

Wong, W. B., S. D. Ramsey, W. E. Barlow, L. P. Garrison, Jr., and D. L. Veenstra. 2012. The value of comparative effectiveness research: Projected return on investment of the RxPONDER trial (SWOG S1007). Contemporary Clinical Trials 33(6):1117–1123.

Woodcock, J. 2010. Assessing the clinical utility of diagnostics used in drug therapy. Clinical Pharmacology and Therapeutics 88(6):765–773.

Suggested Citation:"References." Institute of Medicine. 2013. Genome-Based Diagnostics: Demonstrating Clinical Utility in Oncology: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18275.
×

This page intentionally left blank.

Suggested Citation:"References." Institute of Medicine. 2013. Genome-Based Diagnostics: Demonstrating Clinical Utility in Oncology: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18275.
×
Page 69
Suggested Citation:"References." Institute of Medicine. 2013. Genome-Based Diagnostics: Demonstrating Clinical Utility in Oncology: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18275.
×
Page 70
Suggested Citation:"References." Institute of Medicine. 2013. Genome-Based Diagnostics: Demonstrating Clinical Utility in Oncology: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18275.
×
Page 71
Suggested Citation:"References." Institute of Medicine. 2013. Genome-Based Diagnostics: Demonstrating Clinical Utility in Oncology: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18275.
×
Page 72
Suggested Citation:"References." Institute of Medicine. 2013. Genome-Based Diagnostics: Demonstrating Clinical Utility in Oncology: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18275.
×
Page 73
Suggested Citation:"References." Institute of Medicine. 2013. Genome-Based Diagnostics: Demonstrating Clinical Utility in Oncology: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18275.
×
Page 74
Next: Appendix A: Workshop Agenda »
Genome-Based Diagnostics: Demonstrating Clinical Utility in Oncology: Workshop Summary Get This Book
×
Buy Paperback | $38.00 Buy Ebook | $30.99
MyNAP members save 10% online.
Login or Register to save!
Download Free PDF

Genome-Based Diagnostics: Demonstrating Clinical Utility in Oncology is the summary of a workshop convened in May 2012 by the Roundtable on Translating Genomic-Based Research for Health and the Center for Medical Technology Policy of the Institute of Medicine to foster the identified need for further sustained dialogue between stakeholders regarding the clinical utility of molecular diagnostics. The workshop brought together a wide range of stakeholders, including patients, health care providers, policy makers, payers, diagnostic test developers, researchers, and guideline developers, to identify the challenges and opportunities in advancing the development and use of molecular diagnostic tests designed to guide the treatment and management of patients with cancer.

The sequencing of the human genome has greatly accelerated the process of linking specific genetic variants with disease. These findings have yielded a rapidly increasing number of molecular diagnostic tests designed to guide disease treatment and management. Many of these tests are aimed at determining the best treatments for specific forms of cancer, making oncology a valuable testing ground for the use of molecular diagnostic tests in medicine in general. Nevertheless, many questions surround the clinical value of molecular diagnostic tests, and their acceptance by clinicians, payers, and patients has been unpredictable. A major limiting factor for the use of these tests has been the lack of clear evidence of clinical utility. Genome-Based Diagnostics assesses the evidentiary requirements for clinical utility of molecular diagnostics used to guide treatment decisions for patients with cancer; discusses methodologies related to demonstrating these evidentiary requirements that meet the needs of all stakeholders; and considers innovative, sustainable research collaborations for generating evidence of clinical utility involving multiple stakeholders.

  1. ×

    Welcome to OpenBook!

    You're looking at OpenBook, NAP.edu's online reading room since 1999. Based on feedback from you, our users, we've made some improvements that make it easier than ever to read thousands of publications on our website.

    Do you want to take a quick tour of the OpenBook's features?

    No Thanks Take a Tour »
  2. ×

    Show this book's table of contents, where you can jump to any chapter by name.

    « Back Next »
  3. ×

    ...or use these buttons to go back to the previous chapter or skip to the next one.

    « Back Next »
  4. ×

    Jump up to the previous page or down to the next one. Also, you can type in a page number and press Enter to go directly to that page in the book.

    « Back Next »
  5. ×

    Switch between the Original Pages, where you can read the report as it appeared in print, and Text Pages for the web version, where you can highlight and search the text.

    « Back Next »
  6. ×

    To search the entire text of this book, type in your search term here and press Enter.

    « Back Next »
  7. ×

    Share a link to this book page on your preferred social network or via email.

    « Back Next »
  8. ×

    View our suggested citation for this chapter.

    « Back Next »
  9. ×

    Ready to take your reading offline? Click here to buy this book in print or download it as a free PDF, if available.

    « Back Next »
Stay Connected!