Clinical trials for precision oncology using next-generation sequencing

Personalized Medicine

Volumn 10, Issue 5, 2013, Pages 485-495

  Simon, Richard ^a   Polley, Eric ^a  

^a NATIONAL CANCER INSTITUTE   (United States)

Author keywords

cancer biomarker; cancer clinical trial; next generation sequencing; personalized medicine; precision medicine

Indexed keywords

CRIZOTINIB; VEMURAFENIB;

ACCURACY; ANTINEOPLASTIC ACTIVITY; CANCER SURVIVAL; CLINICAL TRIAL (TOPIC); COMPARATIVE GENOMIC HYBRIDIZATION; DNA SEQUENCE; GENOMICS; GOLD STANDARD; HEALTH CARE POLICY; HEALTH CARE QUALITY; HIGH THROUGHPUT SEQUENCING; HUMAN; INDEL MUTATION; MISSENSE MUTATION; ONCOLOGY; PHASE 1 CLINICAL TRIAL (TOPIC); PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); PRACTICE GUIDELINE; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; REVIEW;

EID: 84880206315     PISSN: 17410541     EISSN: 1744828X     Source Type: Journal    
DOI: 10.2217/pme.13.36     Document Type: Review

References (27)

1. Chapman PB, Hauschild A, Robert C et al. Improved survival with vemurafenib in melanoma with BRAF V600E mutation. N. Engl. J. Med. 364, 2507-2516 (2011
2. Shaw AT, Yeap BY, Solomon BJ et al. Effect of crizotinib on overall survival in patients with advanced non-small-cell lung cancer harbouring ALK gene rearrangement: A retrospective analysis. Lancet Oncol. 12, 1004-1012 (2011
3. Simon RM. Genomic Clinical Trials and Predictive Medicine. Cambridge University Press, Cambridge, UK (2012
4. Simon R. Clinical trials for predictive medicine. Stat. Med. 31, 3031-3040 (2012
5. Landany M, Pao W. Lung adenocarcinoma: Guiding EGFR-Targeted therapy and beyond. Mod. Pathol. 21, S16-S22 (2008
6. Schilsky RL. Target practice: Oncology drug development in the era of genomic medicine. Clin. Trials 4, 163-166 (2007
7. Jiang W, Freidlin B, Simon R. Biomarker-Adaptive threshold design: A procedure for evaluating treatment with possible biomarker-defined subset effect. J. Natl Cancer Inst. 99, 1036-1043 (2007
8. Sher HI, Nasso SF, Rubin E, Simon R. Adaptive clinical trials for simultaneous testing of matched diagnostics and therapeutics. Clin. Cancer Res. 17, 6634-6640 (2011
9. Pusztai L, Hess KR. Clinical trial design for microarray predictive marker discovery and assessment. Ann. Oncol. 15, 1731-1737 (2004
10. Jones CL, Holmgren E. An adaptive Simon two-stage design for Phase 2 studies of targeted therapies. Contemp. Clin. Trials 28, 654-661 (2007
11. Freidlin B, McShane LM, Polley MY, Korn EL. Randomized Phase II trial designs with biomarkers. J. Clin. Oncol. 30, 3304-3309 (2012
12. Kim ES, Herbst JJ, Wistuba II et al. The BATTLE trial: Personalizing therapy or lung cancer. Cancer Discov. 1, 44-53 (2011
13. Korn EL, Freidlin B. Outcome-Adaptive randomization: Is it useful? J. Clin. Oncol. 29, 771-776 (2011
14. Barker AD, Sigman CC, Kelloff GJ, Hylton NM, Berry DA, Esserman LJ. I-SPY 2: An adaptive breast cancer trial design in the setting of neoadjuvant hemotherapy. Clin. Pharmacol. Ther. 86, 97-100 (2009
15. Gargis AS, Kalman L, Berry MW et al. Assuring the quality of next-generation sequencing in clinical laboratory practice. Nat. Biotechnol. 30, 1033-1036 (2012
16. Stratton MR, Campbell PJ, Futreal PA. The cancer genome. Nature 458, 719-724 (2009
17. Martini M, Vecchione L, Siena S, Tejpar S, Bardelli A. Targeted therapies: How personal should we go? Nat. Rev. Clin. Oncol. 9, 87-97 (2012
18. Von Hoff DD, Stephenson JJ, Rosen P et al. Pilot study using molecular profiling of patients' tumors to find potential targets and select treatments for their refractory cancers. J. Clin. Oncol. 28, 4877-4883 (2010
19. Tsimberidou AM, Iskander NG, Hong DS et al. Personalized medicine in a Phase I clinical trials program: The MD Anderson Cancer Center Initiative. Clin. Cancer Res. 18, 6373-6383 (2012
20. Sequist LV, Heist RS, Shaw AT et al. Implementing multiplexed genotyping of non-small-cell lung cancers into routine clinical practice. Ann. Oncol. 22, 2616-2624 (2011
21. Nowak F, Soria JC, Calvo F. Tumour molecular profiling for deciding therapy -The French initiative. Nat. Rev. Clin. Oncol. 9, 479-486 (2012
22. Le Tourneau C, Kamal M, Tredan O et al. Designs and challenges for personalized medicine studies in oncology: Focus on the SHIVA trial. Target. Oncol. 7, 253-265 (2012
23. Arnedos M, Andre F, Farace F et al. The challenge to bring personalized cancer medicine from clinical trials into routine clinical practice: The case of the Institut Gustave Roussy. Mol. Oncol. 6, 204-210 (2012
24. Roychowdhury S, Iyer MK, Robinson DR et al. Personalized oncology through integrative high-Throughput sequencing: A pilot study. Sci. Transl. Med. 3, 1-10 (2011
25. Iyer G, Hanrahan AJ, Milowsky et al. Genome sequencing identifies a basis for everolimus sensitivity. Science 338, 221 (2012
26. Tran B, Dancey JE, Kamel-Reid S et al. Cancer genomics: Technology, discovery, and translation. J. Clin. Oncol. 30, 647-649 (2012
27. Levy MA, Lovly CM, Pao W. Translating genomic information into clinical medicine: Lung cancer as a paradigm. Genome Res. 22, 2101-2108 (2012