Below are the first 10 and last 10 pages of uncorrected machine-read text (when available) of this chapter, followed by the top 30 algorithmically extracted key phrases from the chapter as a whole.
Intended to provide our own search engines and external engines with highly rich, chapter-representative searchable text on the opening pages of each chapter. Because it is UNCORRECTED material, please consider the following text as a useful but insufficient proxy for the authoritative book pages.
Do not use for reproduction, copying, pasting, or reading; exclusively for search engines.
OCR for page 65
Policy Issues in the Development of Personalized Medicine in Oncology: Workshop Summary References AHRQ (Agency for Healthcare Research and Quality). 2008. Impact of gene expression profiling tests on breast cancer outcomes. Rockville, MD: AHRQ. AMA (American Medical Association). 2009. CPT-current procedural terminology. http://www.ama-assn.org/ama/pub/physician-resources/solutions-managing-your-practice/coding-billing-insurance/cpt.shtml (accessed October 5, 2009). Amgen. 2008. Prescribing information. http://www.vectibix.com/prescribing_information/prescribing_information.html (accessed September 29, 2009). Andriole, G. L., E. D. Crawford, R. L. Grubb, III, S. S. Buys, D. Chia, T. R. Church, M. N. Fouad, E. P. Gelmann, P. A. Kvale, D. J. Reding, J. L. Weissfeld, L. A. Yokochi, B. O’Brien, J. D. Clapp, J. M. Rathmell, T. L. Riley, R. B. Hayes, B. S. Kramer, G. Izmirlian, A. B. Miller, P. F. Pinsky, P. C. Prorok, J. K. Gohagan, C. D. Berg, and P. P. T. the. 2009. Mortality Results from a Randomized Prostate-Cancer Screening Trial. New England Journal of Medicine 360(13):1310–1319. AstraZeneca. 2009. Iressa (gefitinib) recommended for approval for the treatment of non-small cell lung cancer in Europe http://www.astrazeneca.com/media/latest-press-releases/2009/iressa-chmp?itemId=5585247 (accessed September 8, 2009). Bild, A. H., G. Yao, J. T. Chang, Q. Wang, A. Potti, D. Chasse, M. B. Joshi, D. Harpole, J. M. Lancaster, A. Berchuck, J. A. Olson, Jr., J. R. Marks, H. K. Dressman, M. West, and J. R. Nevins. 2006. Oncogenic pathway signatures in human cancers as a guide to targeted therapies. Nature 439(7074):353–357. Blum, R., R. Elkon, S. Yaari, A. Zundelevich, J. Jacob-Hirsch, G. Rechavi, R. Shamir, and Y. Kloog. 2007. Gene expression signature of human cancer cell lines treated with the Ras inhibitor salirasib (S-Farnesylthiosalicylic acid). Cancer Research 67(7):3320–3328. Bossuyt, P. M., J. B. Reitsma, D. E. Bruns, C. A. Gatsonis, P. P. Glasziou, L. M. Irwig, J. G. Lijmer, D. Moher, D. Rennie, and H. C. W. de Vet. 2004. Towards complete and accurate reporting of studies of diagnostic accuracy: The STARD initiative. Family Practice 21(1):4–10.
OCR for page 66
Policy Issues in the Development of Personalized Medicine in Oncology: Workshop Summary CAP (College of American Pathologists). 2007. HER2 and you: Guidelines provided by CAP and ASCO. Northfield, IL: CAP. Cartron, G., L. Dacheux, G. Salles, P. Solal-Celigny, P. Bardos, P. Colombat, and H. Watier. 2002. Therapeutic activity of humanized anti-CD20 monoclonal antibody and polymorphism in IgG Fc receptor Fc RIIIa gene. Blood 99(3):754–758. CDC (Centers for Disease Control and Prevention). 2009. Genomic translation: ACCE model process for evaluating genetic tests. http://www.cdc.gov/genomics/gtesting/ACCE/index.htm (accessed September 10, 2009). CFF (Cystic Fibrosis Foundation). 2009. Patient registry report. http://www.cff.org/research/ClinicalResearch/PatientRegistryReport/ (accessed September 28, 2009). CMS (Centers for Medicare & Medicaid Services). 2009a. Medicare claims processing manual. Chap. 16, laboratory services. http://www.cms.hhs.gov/manuals/Downloads/clm104c16.pdf (accessed September 17, 2009). CMS. 2009b. Medicare coverage database. http://www.cms.hhs.gov/mcd/indexes.asp (accessed September 28, 2009). CMS. 2009c. Proposed decision memo for pharmacogenomic testing for warfarin response (CAG-00400N). http://www.cms.hhs.gov/mcd/viewdraftdecisionmemo.asp?from2=viewdraftdecisionmemo.asp&id=224& (accessed September 24, 2009). Di Nicolantonio, F., M. Martini, F. Molinari, A. Sartore-Bianchi, S. Arena, P. Saletti, S. De Dosso, L. Mazzucchelli, M. Frattini, S. Siena, and A. Bardelli. 2008. Wild-type BRAC is required for response to panitumumab or cetuximab in metastatic colorectal cancer. Journal of Clinical Oncology 26(35):5705–5712. EGAPP Working Group (Evaluation of Genomic Applications in Practice and Prevention Working Group). 2009a. Recommendations from the EGAPP Working Group: Can tumor gene expression profiling improve outcomes in patients with breast cancer? Genetics in Medicine 11(1):66–73. EGAPP Working Group. 2009b. Recommendations from the EGAPP Working Group: Can UGT1A1 genotyping reduce morbidity and mortality in patients with metastatic colorectal cancer treated with irinotecan? Genetics in Medicine 11(1):15–20. FDA (Food and Drug Administration). 1997. Medical devices; classification/reclassification; restricted devices; analyte specific reagents—FDA. Final Rule. Federal Register 62(225):62243–62260. FDA. 2005. Drug-diagnostic co-development concept paper. Silver Spring, MD: FDA. FDA. 2007a. Commercially Distributed Analyte Specific Reagents (ASRs): Frequently asked questions. http://www.cytometry.org/website_pages/FDA%20ASR%20rule%202007.pdf (accessed September 19, 2009). FDA. 2007b. Draft guidance for industry, clinical laboratories, and FDA staff: In vitro diagnostic multivariate index assays. Rockville, MD: FDA. FDA. 2009a. Intercenter agreement between the Center for Drug Evaluation and Research and the Center for Devices and Radiological Health. http://www.fda.gov/CombinationProducts/JurisdictionalInformation/ucm121177.htm (accessed September 28, 2009). FDA. 2009b. Medical devices: General and special controls. http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/GeneralandSpecialControls/default.htm (accessed September 23, 2009). FDA. 2009c. Medical devices: In vitro diagnostics. http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/InVitroDiagnostics/default.htm (accessed September 23, 2009).
OCR for page 67
Policy Issues in the Development of Personalized Medicine in Oncology: Workshop Summary FDA. 2009d. Medical devices: Postmarket requirements (devices). http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/default.htm (accessed September 23, 2009). Friend, S. H. 2009. Multiple biomarkers efficiently identify equivalent patient populations (which marker to use?/how will we know?). PowerPoint presentation, June 8. Washington, DC: Merck Research Laboratories. Genentech. 2008. Genentech, Inc. Citizen Petition: Regulation of In Vitro Diagnostic Tests. http://www.regulations.gov/search/Regs/home.html#documentDetail?R=09000064807d4a7e (accessed December 5, 2008). Genomic Health. 2009. Oncotype DX® guides individualized treatment decisions for more than 100,000 breast cancer patients worldwide. http://investor.genomichealth.com/releasedetail.cfm?ReleaseID=386285 (accessed September 3, 2009). Hayes, D. F., R. C. Bast, C. E. Desch, H. Fritsche, Jr., N. E. Kemeny, J. M. Jessup, G. Y. Locker, J. S. MacDonald, R. G. Mennel, L. Norton, P. Ravdin, S. Taube, and R. J. Winn. 1996. Tumor marker utility grading system: a framework to evaluate clinical utility of tumor markers.[see comment]. Journal of the National Cancer Institute 88(20):1456–1466. ImClone Systems. 2008. Highlights of prescribing information: Erbitux. http://packageinserts.bms.com/pi/pi_erbitux.pdf (accessed September 29, 2009). IOM (Institute of Medicine). 2007. Cancer biomarkers: The promises and challenges of improving detection and treatment. Washington, DC: The National Academies Press. Jonker, D. J., C. J. O’Callaghan, C. S. Karapetis, J. R. Zalcberg, D. Tu, H.-J. Au, S. R. Berry, M. Krahn, T. Price, R. J. Simes, N. C. Tebbutt, G. van Hazel, R. Wierzbicki, C. Langer, and M. J. Moore. 2007. Cetuximab for the treatment of colorectal cancer. New England Journal of Medicine 357(20):2040–2048. Jonker, D. J., C. Karapetis, C. Harbison, C. J. O’Callaghan, D. Tu, R. J. Simes, L. Xu, M. J. Moore, J. R. Zalcberg, and S. Khambata-Ford. 2009. High epiregulin (EREG) gene expression plus KRAS wild-type (WT) status as predictors of cetuximab benefit in the treatment of advanced colorectal cancer (ACRC): Results from NCIC CTG CO.17—A Phase III trial of cetuximab versus best supportive care (BSC). Journal of Clinical Oncology (Meeting Abstracts) 27(15S):4016. Khoury, M. J., M. Gwinn, P. W. Yoon, N. Dowling, C. A. Moore, and L. Bradley. 2007. The continuum of translation research in genomic medicine: How can we accelerate the appropriate integration of human genome discoveries into health care and disease prevention? Genetics in Medicine 9(10):665–674. Khoury, M. J., W. G. Feero, M. Reyes, T. Citrin, A. Freedman, D. Leonard, W. Burke, R. Coates, R. T. Croyle, K. Edwards, S. Kardia, C. McBride, T. Manolio, G. Randhawa, R. Rasooly, J. St. Pierre, and S. Terry. 2009a. The Genomic Applications in Practice and Prevention Network. Genetics in Medicine 11(7):488–494.
OCR for page 68
Policy Issues in the Development of Personalized Medicine in Oncology: Workshop Summary Khoury, M. J., C. M. McBride, S. D. Schully, J. P. A. Ioannidis, W. G. Feero, A. C. J. W. Janssens, M. Gwinn, D. G. Simons-Morton, J. M. Bernhardt, M. Cargill, S. J. Chanock, G. M. Church, R. J. Coates, F. S. Collins, R. T. Croyle, B. R. Davis, G. J. Downing, A. Duross, S. Friedman, M. H. Gail, G. S. Ginsburg, R. C. Green, M. H. Greene, P. Greenland, J. R. Gulcher, A. Hsu, K. L. Hudson, S. L. R. Kardia, P. L. Kimmel, M. S. Lauer, A. M. Miller, K. Offit, D. F. Ransohoff, J. S. Roberts, R. S. Rasooly, K. Stefansson, S. F. Terry, S. M. Teutsch, A. Trepanier, K. L. Wanke, J. S. Witte, and J. Xu. 2009b. The scientific foundation for personal genomics: Recommendations from a National Institutes of Health–Centers for Disease Control and Prevention multidisciplinary workshop. Genetics in Medicine 11(8):559–567. Levis, M., P. Brown, B. D. Smith, A. Stine, R. Pham, R. Stone, D. DeAngelo, I. Galinsky, F. Giles, E. Estey, H. Kantarjian, P. Cohen, Y. Wang, J. Roesel, J. E. Karp, and D. Small. 2006. Plasma inhibitory activity (PIA): a pharmacodynamic assay reveals insights into the basis for cytotoxic response to FLT3 inhibitors. Blood 108(10):3477–3483. Love/Avon Army of Women. 2009. About us. http://www.armyofwomen.org/aboutus (accessed September 10, 2009). Mass, R. 2009. Technology hurdles: Drug developer perspective. PowerPoint presentation, June 8. Washington, DC: Genentech, Inc. McShane, L. M., D. G. Altman, W. Suerbrei, S. E. Taube, M. Gion, G. M. Clark, and for the Statistics Subcommittee of the NCI—EORTC Working Group on Cancer Diagnostics. 2005. Reporting recommendations for tumor MARKer prognostic studies (Remark). Nature Clinical Practice Oncology 2(8):416–422. Meshinchi, S., T. A. Alonzo, D. L. Stirewalt, M. Zwaan, M. Zimmerman, D. Reinhardt, G. J. Kaspers, N. A. Heerema, R. Gerbing, B. J. Lange, and J. P. Radich. 2006. Clinical implications of FLT3 mutations in pediatric AML. Blood 108(12):3654–3661. NCI (National Cancer Institute). 2008. Personal genomics: Establishing the scientific foundation for using personal genome profiles for risk assessment, health promotion, and disease prevention. Bethesda, MD: NCI. NCI. 2009a. NCI guidelines for ARRA research and research infrastructure grand opportunities: Comparative effectiveness research in genomic and personalized medicine: Announcement number: RFA-OD-09-004. http://www.cancer.gov/pdf/recovery/004_cer_personalized_medicine.pdf (accessed September 24, 2009). NCI. 2009b. The TAILORx breast cancer trial: TAILORx: Testing personalized treatment for breast cancer. http://www.cancer.gov/clinicaltrials/digestpage/Tailorx (accessed September 16, 2009). 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. 2004. A multigene assay to predict recurrence of tamoxifen-treated, node-negative breast cancer. New England Journal of Medicine 351(27):2817–2826. 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.
OCR for page 69
Policy Issues in the Development of Personalized Medicine in Oncology: Workshop Summary Palomaki, G. E., L. A. Bradley, M. P. Douglas, K. Kolor, and W. D. Dotson. 2009. Can UGT1A1 genotyping reduce morbidity and mortality in patients with metastatic colorectal cancer treated with irinotecan? An evidence-based review. Genetics in Medicine 11(1):21–34. PGxHealth. 2009. The PGxpredict: Rituximab test: Helping individualize treatment for follicular non-Hodgkin’s lymphoma patients. http://www.pgxhealth.com/rituximab/ (accessed September 21, 2009). Phillips, K. A. 2008. Closing the evidence gap in the use of emerging testing technologies in clinical practice. JAMA 300(21):2542–2544. Roche. 2008. Herceptin given prior to surgery improves the chance of survival without relapse for women with HER2-positive breast cancer. http://www.roche.com/investors/ir_update/inv-update-2008-12-11.htm (accessed September 16, 2009). Romond, E. H., E. A. Perez, J. Bryant, V. J. Suman, C. E. Geyer, Jr., N. E. Davidson, E. Tan-Chiu, S. Martino, S. Paik, P. A. Kaufman, S. M. Swain, T. M. Pisansky, L. Fehrenbacher, L. A. Kutteh, V. G. Vogel, D. W. Visscher, G. Yothers, R. B. Jenkins, A. M. Brown, S. R. Dakhil, E. P. Mamounas, W. L. Lingle, P. M. Klein, J. N. Ingle, and N. Wolmark. 2005. Trastuzumab plus adjuvant chemotherapy for operable HER2-positive breast cancer. New England Journal of Medicine 353(16):1673–1684. SACGHS (Secretary’s Advisory Committee on Genetics, Health, and Society). 2006. Coverage and Reimbursement of Genetic Tests and Services. Bethesda, MD: SACGHS. SACGHS. 2008a. SACGHS—fifteenth meeting—Wednesday, February 13, 2008, Vol. II. Washington, DC: SACGHS. SACGHS. 2008b. U.S. system of oversight of genetic testing: A response to the charge of the Secretary of Health and Human Services. Bethesda, MD: SACGHS. SACGT (Secretary’s Advisory Committee on Genetic Testing). 2000a. Enhancing the oversight of genetic tests: Recommendations of the Secretary’s Advisory Committee on Genetic Testing. Bethesda, MD: SACGT. SACGT. 2000b. Highlights of the fifth meeting of the Secretary’s Advisory Committee on Genetic Testing. Bethesda, MD: Office of Biotechnology Activities, National Institutes of Health. Scaltriti, M., and J. Baselga. 2006. The epidermal growth factor receptor pathway: A model for targeted therapy. Clinical Cancer Research 12(18):5268–5272. Schadt, E. E., J. Lamb, X. Yang, J. Zhu, S. Edwards, D. Guhathakurta, S. K. Sieberts, S. Monks, M. Reitman, C. Zhang, P. Y. Lum, A. Leonardson, R. Thieringer, J. M. Metzger, L. Yang, J. Castle, H. Zhu, S. F. Kash, T. A. Drake, A. Sachs, and A. J. Lusis. 2005. An integrative genomics approach to infer causal associations between gene expression and disease. Nature Genetics 37(7):710–717. Schroder, F. H., J. Hugosson, M. J. Roobol, T. L. J. Tammela, S. Ciatto, V. Nelen, M. Kwiatkowski, M. Lujan, H. Lilja, M. Zappa, L. J. Denis, F. Recker, A. Berenguer, L. Maattanen, C. H. Bangma, G. Aus, A. Villers, X. Rebillard, T. van der Kwast, B. G. Blijenberg, S. M. Moss, H. J. de Koning, A. Auvinen, and E. I. the. 2009. Screening and Prostate-Cancer Mortality in a Randomized European Study. New England Journal of Medicine 360(13):1320–1328. Search Collaborative Group, E. Link, S. Parish, J. Armitage, L. Bowman, S. Heath, F. Matsuda, I. Gut, M. Lathrop, and R. Collins. 2008. SLCO1B1 variants and statin-induced myopathy—a genomewide study. New England Journal of Medicine 359(8):789–799.
OCR for page 70
Policy Issues in the Development of Personalized Medicine in Oncology: Workshop Summary Shak, S. 2009. Technological hurdles: Diagnostic developer perspective. PowerPoint presentation. Washington, DC: Genomic Health, Inc. Smith, B. D., M. Levis, M. Beran, F. Giles, H. Kantarjian, K. Berg, K. M. Murphy, T. Dauses, J. Allebach, and D. Small. 2004. Single-agent CEP-701, a novel FLT3 inhibitor, shows biologic and clinical activity in patients with relapsed or refractory acute myeloid leukemia. Blood 103(10):3669–3676. Sweet-Cordero, A., S. Mukherjee, A. Subramanian, H. You, J. J. Roix, C. Ladd-Acosta, J. Mesirov, T. R. Golub, and T. Jacks. 2005. An oncogenic KRAS2 expression signature identified by cross-species gene-expression analysis. Nature Genetics 37(1):48–55. 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 E. W. 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. van’t Veer, L. J., H. Dai, M. J. van de Vijver, Y. D. He, A. A. M. Hart, M. Mao, H. L. Peterse, K. van der Kooy, M. J. Marton, A. T. Witteveen, G. J. Schreiber, R. M. Kerkhoven, C. Roberts, P. S. Linsley, R. Bernards, and S. H. Friend. 2002. Gene expression profiling predicts clinical outcome of breast cancer. Nature 415(6871):530–536. Vose, J., F. Loberiza, J. Armitage, P. Bierman, R. Bociek, and D. Dornan. 2009. Effects of FCGR3A and FCGR2A polymorphisms on outcomes of patients with diffuse large B-cell lymphoma treated with CHOP-like chemotherapy versus CHOP-rituximab. Journal of Clinical Oncology (Meeting Abstracts) 27(15S): Abstract No: 8567. 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, D. F. Hayes, American Society of Clinical Oncology, and College of American Pathologists. 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. Woolf, S. H. 2008. The meaning of translational research and why it matters. JAMA 299(2):211–213. Yang, X., J. L. Deignan, H. Qi, J. Zhu, S. Qian, J. Zhong, G. Torosyan, S. Majid, B. Falkard, R. R. Kleinhanz, J. Karlsson, L. W. Castellani, S. Mumick, K. Wang, T. Xie, M. Coon, C. Zhang, D. Estrada-Smith, C. R. Farber, S. S. Wang, A. van Nas, A. Ghazalpour, B. Zhang, D. J. MacNeil, J. R. Lamb, K. M. Dipple, M. L. Reitman, M. Mehrabian, P. Y. Lum, E. E. Schadt, A. J. Lusis, and T. A. Drake. 2009. Validation of candidate causal genes for obesity that affect shared metabolic pathways and networks. Nature Genetics 41(4):415–423.