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Volumn 10, Issue 10, 2011, Pages 735-748

Integrating predictive biomarkers and classifiers into oncology clinical development programmes

Author keywords

[No Author keywords available]

Indexed keywords

CETUXIMAB; EPIDERMAL GROWTH FACTOR RECEPTOR; EPIDERMAL GROWTH FACTOR RECEPTOR 2; GEFITINIB; PANITUMUMAB; SORAFENIB; TRASTUZUMAB; TUMOR MARKER;

EID: 80053484515     PISSN: 14741776     EISSN: 14741784     Source Type: Journal    
DOI: 10.1038/nrd3550     Document Type: Review
Times cited : (91)

References (45)
  • 1
    • 84857106552 scopus 로고    scopus 로고
    • Incorporating health economics in guidelines and assessing resource impact
    • [online]
    • Incorporating health economics in guidelines and assessing resource impact. NICE Guidelines Manual [online] http://www.nice.org.uk/newsroom/ features/measuringeffectivenessandcosteffectivenesstheqaly. jsp (2005).
    • (2005) NICE Guidelines Manual
  • 6
    • 42649145667 scopus 로고    scopus 로고
    • Wild-type KRAS is required for panitumumab efficacy in patients with metastatic colorectal cancer
    • Amado, R. G. et al. Wild-type KRAS is required for panitumumab efficacy in patients with metastatic colorectal cancer. J. Clin. Oncol. 26, 1626-1634 (2008).
    • (2008) J. Clin. Oncol. , vol.26 , pp. 1626-1634
    • Amado, R.G.1
  • 7
    • 33646228635 scopus 로고    scopus 로고
    • KRAS mutation status is predictive of response to cetuximab therapy in colorectal cancer
    • Lievre, A. et al. KRAS mutation status is predictive of response to cetuximab therapy in colorectal cancer. Cancer Res. 66, 3992-3995 (2006).
    • (2006) Cancer Res. , vol.66 , pp. 3992-3995
    • Lievre, A.1
  • 8
    • 51649120733 scopus 로고    scopus 로고
    • KRAS status and efficacy of first-line treatment of patients with metastatic colorectal cancer (mCRC) with FOLFOX with or without cetuximab: The OPUS experience
    • Bokemeyer, C. et al. KRAS status and efficacy of first-line treatment of patients with metastatic colorectal cancer (mCRC) with FOLFOX with or without cetuximab: the OPUS experience. J. Clin. Oncol. Abstr. 26, 4000 (2008).
    • (2008) J. Clin. Oncol. Abstr. , vol.26 , pp. 4000
    • Bokemeyer, C.1
  • 9
    • 51649120733 scopus 로고    scopus 로고
    • KRAS status and efficacy in the first-line treatment of patients with metastatic colorectal cancer (mCRC) treated with FOLFIRI with or without cetuximab: The CRYSTAL experience
    • Van Cutsem, E. et al. KRAS status and efficacy in the first-line treatment of patients with metastatic colorectal cancer (mCRC) treated with FOLFIRI with or without cetuximab: the CRYSTAL experience. J. Clin. Oncol. Abstr. 26, 2 (2008).
    • (2008) J. Clin. Oncol. Abstr. , vol.26 , pp. 2
    • Van Cutsem, E.1
  • 10
    • 33744502855 scopus 로고    scopus 로고
    • Cancer biomarkers-an invitation to the table
    • Dalton, W. S. & Friend, S. H. Cancer biomarkers-an invitation to the table. Science 312, 1165-1168 (2006).
    • (2006) Science , vol.312 , pp. 1165-1168
    • Dalton, W.S.1    Friend, S.H.2
  • 11
    • 84857104367 scopus 로고    scopus 로고
    • Center for Business Intelligence 2nd Annual Forum on Oncology Commercialization Strategies [online lecture] (Philadelphia, Pennsylvania, USA; 12-13 January)
    • Beckman, R. A. Analyze the current biomarker-guided development paradigm: biomarkers are instrumental for any development in oncology. Center for Business Intelligence 2nd Annual Forum on Oncology Commercialization Strategies [online lecture], http://www.cbinet.com/compendiums/PC10168/Presentations/ Robert-Beckman-Pres.pdf (Philadelphia, Pennsylvania, USA; 12-13 January 2009).
    • (2009) Analyze the Current Biomarker-guided Development Paradigm: Biomarkers Are Instrumental for Any Development in Oncology
    • Beckman, R.A.1
  • 12
    • 32944482229 scopus 로고    scopus 로고
    • Pharmacogenetics and pharmacogenomics in oncology therapeutic antibody development
    • Yan, L. & Beckman, R. A. Pharmacogenetics and pharmacogenomics in oncology therapeutic antibody development. Biotechniques 39, 565-568 (2005).
    • (2005) Biotechniques , vol.39 , pp. 565-568
    • Yan, L.1    Beckman, R.A.2
  • 13
    • 77449127150 scopus 로고    scopus 로고
    • Sources of bias in specimens for research about molecular markers for cancer
    • Ransohoff, D. F. & Gourlay, M. L. Sources of bias in specimens for research about molecular markers for cancer. J. Clin. Oncol. 28, 698-704 (2010).
    • (2010) J. Clin. Oncol. , vol.28 , pp. 698-704
    • Ransohoff, D.F.1    Gourlay, M.L.2
  • 14
    • 36749048184 scopus 로고    scopus 로고
    • Biomarkers in phase I oncology trials: Signal, noise, or expensive distraction?
    • DOI 10.1158/1078-0432.CCR-07-2133
    • Ratain, M. J. & Glassman, R. H. Biomarkers in Phase I oncology trials: signal, noise, or expensive distraction? Clin. Cancer Res. 13, 6545-6548 (2007). (Pubitemid 350206786)
    • (2007) Clinical Cancer Research , vol.13 , Issue.22 , pp. 6545-6548
    • Ratain, M.J.1    Glassman, R.H.2
  • 15
    • 73449107200 scopus 로고    scopus 로고
    • The future of drug development: Advancing clinical trial design
    • Orloff, J. et al. The future of drug development: advancing clinical trial design. Nature Rev. Drug Discov. 8, 949-957 (2009).
    • (2009) Nature Rev. Drug Discov. , vol.8 , pp. 949-957
    • Orloff, J.1
  • 16
    • 79957789708 scopus 로고    scopus 로고
    • Comparison of effect sizes associated with biomarkers reported in highly cited individual articles and in subsequent meta-analyses
    • Ioannidis, J. P. A. & Panagiotou, O. A. Comparison of effect sizes associated with biomarkers reported in highly cited individual articles and in subsequent meta-analyses. JAMA 305, 2200-2210 (2011).
    • (2011) JAMA , vol.305 , pp. 2200-2210
    • Ioannidis, J.P.A.1    Panagiotou, O.A.2
  • 17
    • 27744537954 scopus 로고    scopus 로고
    • Adaptive signature design: An adaptive clinical trial design for generating and prospectively testing a gene expression signature for sensitive patients
    • DOI 10.1158/1078-0432.CCR-05-0605
    • Freidlin, B. & Simon, R. Adaptive signature design: an adaptive clinical trial design for generating and prospectively testing a gene expression signature for sensitive patients. Clin. Cancer Res. 11, 7872-7878 (2005). (Pubitemid 41611633)
    • (2005) Clinical Cancer Research , vol.11 , Issue.21 , pp. 7872-7878
    • Freidlin, B.1    Simon, R.2
  • 18
    • 78650828263 scopus 로고    scopus 로고
    • Hypothesis testing in a confirmatory Phase III trial with a possible subset effect
    • Chen, C. & Beckman, R. A. Hypothesis testing in a confirmatory Phase III trial with a possible subset effect. Stat. Biopharm. Res. 1, 431-440 (2009).
    • (2009) Stat. Biopharm. Res. , vol.1 , pp. 431-440
    • Chen, C.1    Beckman, R.A.2
  • 19
    • 0037169361 scopus 로고    scopus 로고
    • Cancer modeling in the modern era: Progress and challenges
    • DOI 10.1016/S0092-8674(02)00621-9
    • Van Dyke, T. & Jacks, T. Cancer modeling in the modern era: progress and challenges. Cell 108, 135-144 (2002). (Pubitemid 34161134)
    • (2002) Cell , vol.108 , Issue.2 , pp. 135-144
    • Van Dyke, T.1    Jacks, T.2
  • 20
    • 1942518912 scopus 로고    scopus 로고
    • Clonogenic assay with established human tumour xenografts: Correlation of in vitro to in vivo activity as a basis for anticancer drug discovery
    • DOI 10.1016/j.ejca.2004.01.009, PII S0959804904001066
    • Fiebig, H. H., Maier, A. & Burger, A. M. Clonogenic assay with established human tumor xenografts: correlation of in vitro to in vivo activity as a basis for anticancer drug discovery. Eur. J. Cancer 40, 802-820 (2004). (Pubitemid 38519759)
    • (2004) European Journal of Cancer , vol.40 , Issue.6 , pp. 802-820
    • Fiebig, H.H.1    Maier, A.2    Burger, A.M.3
  • 21
    • 67650652432 scopus 로고    scopus 로고
    • I-SPY 2: An adaptive breast cancer trial design in the setting of neoadjuvant chemotherapy
    • Barker A. D. et al. I-SPY 2: an adaptive breast cancer trial design in the setting of neoadjuvant chemotherapy. Clin. Pharmacol. Ther. 86, 97-100 (2009).
    • (2009) Clin. Pharmacol. Ther. , vol.86 , pp. 97-100
    • Barker, A.D.1
  • 22
    • 78049355248 scopus 로고    scopus 로고
    • The BATTLE trial (Biomarker-integrated approaches of targeted therapy for lung Cancer Elimination): Personalizing therapy for lung cancer
    • (17-21 Apr) Washington DC, Philadelphia, USA; Abstract LB-1
    • Kim, E. S. et al. The BATTLE trial (Biomarker-integrated Approaches of Targeted Therapy for Lung Cancer Elimination): personalizing therapy for lung cancer. in Proceedings of the 101st Annual Meeting of the American Association for Cancer Research (17-21 Apr 2010; Washington DC, Philadelphia, USA; Abstract LB-1).
    • (2010) Proceedings of the 101st Annual Meeting of the American Association for Cancer Research
    • Kim, E.S.1
  • 23
    • 67649935089 scopus 로고    scopus 로고
    • Optimal cost-effective designs of proof of concept trials and associated go-no go decisions
    • Chen, C. & Beckman, R. A. Optimal cost-effective designs of proof of concept trials and associated go-no go decisions. Proc. Am. Stat. Assoc. 394-399 (2007).
    • (2007) Proc. Am. Stat. Assoc. , pp. 394-399
    • Chen, C.1    Beckman, R.A.2
  • 24
    • 78650851915 scopus 로고    scopus 로고
    • Optimal cost-effective go-no go decisions in late-stage oncology drug development
    • Chen, C. & Beckman, R. A. Optimal cost-effective go-no go decisions in late-stage oncology drug development. Stat. Biopharm. Res. 1, 159-169 (2009).
    • (2009) Stat. Biopharm. Res. , vol.1 , pp. 159-169
    • Chen, C.1    Beckman, R.A.2
  • 25
    • 67651027168 scopus 로고    scopus 로고
    • Optimal cost-effective designs of Phase II proof of concept trials and associated go-no go decisions
    • Chen, C. & Beckman, R. A. Optimal cost-effective designs of Phase II proof of concept trials and associated go-no go decisions. J. Biopharm. Stat. 19, 424-436 (2009).
    • (2009) J. Biopharm. Stat. , vol.19 , pp. 424-436
    • Chen, C.1    Beckman, R.A.2
  • 26
    • 0029036753 scopus 로고
    • Investigating a sequence of randomized Phase II trials to discover promising treatments
    • Strauss, N. & Simon, R. Investigating a sequence of randomized Phase II trials to discover promising treatments. Stat. Med. 14, 1479-1489 (1995).
    • (1995) Stat. Med. , vol.14 , pp. 1479-1489
    • Strauss, N.1    Simon, R.2
  • 27
    • 76349100026 scopus 로고    scopus 로고
    • Randomized clinical trials with biomarkers: Design issues
    • Freidlin, B., McShane L. & Korn, E. L. Randomized clinical trials with biomarkers: design issues. J. Natl Cancer Inst. 102, 152-160 (2010).
    • (2010) J. Natl Cancer Inst. , vol.102 , pp. 152-160
    • Freidlin, B.1    McShane, L.2    Korn, E.L.3
  • 28
    • 47949114668 scopus 로고    scopus 로고
    • Detection of mutations in EGFR in circulating lung-cancer cells
    • Maheswaren, S. et al. Detection of mutations in EGFR in circulating lung-cancer cells. N. Engl. J. Med. 359, 366-377 (2008).
    • (2008) N. Engl. J. Med. , vol.359 , pp. 366-377
    • Maheswaren, S.1
  • 29
    • 35649022759 scopus 로고    scopus 로고
    • Surrogate end points for median overall survival in metastatic colorectal cancer: Literature-based analysis from 39 randomized controlled trials of first-line chemotherapy
    • DOI 10.1200/JCO.2006.08.1935
    • Tang, P. A., Bentsen, S. M, Chen, E. X. & Siu, L. L. Surrogate endpoints for median overall survival in metastatic colorectal cancer: literature-based analysis from 39 randomized controlled trials of first-line chemotherapy. J. Clin. Oncol. 25, 4562-4568 (2007). (Pubitemid 350035313)
    • (2007) Journal of Clinical Oncology , vol.25 , Issue.29 , pp. 4562-4568
    • Tang, P.A.1    Bentzen, S.M.2    Chen, E.X.3    Siu, L.L.4
  • 30
    • 70449420123 scopus 로고    scopus 로고
    • Use of archived specimens in evaluation of prognostic and predictive biomarkers
    • Simon, R. M., Paik, S. & Hayes, D. F. Use of archived specimens in evaluation of prognostic and predictive biomarkers. J. Natl Cancer Inst. 101, 1446-1452 (2009).
    • (2009) J. Natl Cancer Inst. , vol.101 , pp. 1446-1452
    • Simon, R.M.1    Paik, S.2    Hayes, D.F.3
  • 31
    • 74549207384 scopus 로고    scopus 로고
    • The cross-validated adaptive signature design
    • Freidlin, B., Jiang, W. & Simon, R. The cross-validated adaptive signature design. Clin. Cancer Res. 16, 691-698 (2010).
    • (2010) Clin. Cancer Res. , vol.16 , pp. 691-698
    • Freidlin, B.1    Jiang, W.2    Simon, R.3
  • 32
    • 58149151278 scopus 로고    scopus 로고
    • The use of genomics in clinical trial design
    • Simon, R. The use of genomics in clinical trial design. Clin. Cancer Res. 14, 5984-5993 (2008).
    • (2008) Clin. Cancer Res. , vol.14 , pp. 5984-5993
    • Simon, R.1
  • 33
    • 79957438038 scopus 로고    scopus 로고
    • Design and analysis considerations in clinical trials with a sensitive subpopulation
    • Zhao, Y. D., Dimitrienko, A. & Tamura, R. Design and analysis considerations in clinical trials with a sensitive subpopulation. Stat. Biopharm. Res. 2, 72-83 (2010).
    • (2010) Stat. Biopharm. Res. , vol.2 , pp. 72-83
    • Zhao, Y.D.1    Dimitrienko, A.2    Tamura, R.3
  • 34
    • 66149096269 scopus 로고    scopus 로고
    • Monitoring and predicting response to therapy with 18F-FDG PET in colorectal cancer: A systematic review
    • De Geus-Oei, L. F. et al. Monitoring and predicting response to therapy with 18F-FDG PET in colorectal cancer: a systematic review. J. Nuc. Med. 50, 43S-54S (2009).
    • (2009) J. Nuc. Med. , vol.50
    • De Geus-Oei, L.F.1
  • 35
    • 31544469214 scopus 로고    scopus 로고
    • PET for response assessment in oncology: Radiotherapy and chemotherapy
    • DOI 10.1259/bjr/59640473
    • Weber, W. A. PET for response assessment in oncology: radiotherapy and chemotherapy. Br. J. Radiol. S28, 42-49 (2005). (Pubitemid 43154235)
    • (2005) British Journal of Radiology , vol.78 , Issue.SUPPL. 28 , pp. 42-49
    • Weber, W.A.1
  • 36
    • 40949146496 scopus 로고    scopus 로고
    • Interim futility analysis with intermediate endpoints
    • DOI 10.1177/1740774507086648
    • Goldman, B., LeBlanc, M. & Crowley, J. Interim futility analysis with intermediate endpoints. Clin. Trials 5, 14-22 (2008). (Pubitemid 351412367)
    • (2008) Clinical Trials , vol.5 , Issue.1 , pp. 14-22
    • Goldman, B.1    LeBlanc, M.2    Crowley, J.3
  • 37
    • 70349671467 scopus 로고    scopus 로고
    • A comparison of Phase II study strategies
    • Hunsicker, S., Zhao, Y. & Simon, R. M. A comparison of Phase II study strategies. Clin. Cancer Res. 15, 5950-5955 (2009).
    • (2009) Clin. Cancer Res. , vol.15 , pp. 5950-5955
    • Hunsicker, S.1    Zhao, Y.2    Simon, R.M.3
  • 38
    • 80053466152 scopus 로고    scopus 로고
    • On quantification of PFS effect for accelerated approval of oncology drugs
    • (in the press)
    • Chen, C. & Sun, L. On quantification of PFS effect for accelerated approval of oncology drugs. Stat. Biopharm. Res. 2011 (in the press).
    • (2011) Stat. Biopharm. Res.
    • Chen, C.1    Sun, L.2
  • 39
    • 69949102133 scopus 로고    scopus 로고
    • Confirmatory adaptive designs with Bayesian decision tools for a targeted therapy in oncology
    • Brannath, W. et al. Confirmatory adaptive designs with Bayesian decision tools for a targeted therapy in oncology. Stat. Med. 28, 1445-1463 (2009).
    • (2009) Stat. Med. , vol.28 , pp. 1445-1463
    • Brannath, W.1
  • 40
    • 33644861229 scopus 로고    scopus 로고
    • Bayesian clinical trials
    • Berry, D. A. Bayesian clinical trials. Nature Rev. Drug Discov. 5, 27-36 (2006).
    • (2006) Nature Rev. Drug Discov. , vol.5 , pp. 27-36
    • Berry, D.A.1
  • 41
    • 24944510799 scopus 로고    scopus 로고
    • Introduction to Bayesian methods III: Use and interpretation of Bayesian tools in design and analysis
    • DOI 10.1191/1740774505cn100oa
    • Berry, D. A. Introduction to Bayesian methods III: use and interpretation of Bayesian tools in design and analysis. Clin. Trials 2, 295-300 (2005). (Pubitemid 41306270)
    • (2005) Clinical Trials , vol.2 , Issue.4 , pp. 295-300
    • Berry, D.A.1
  • 42
    • 33748521268 scopus 로고    scopus 로고
    • Confirmatory seamless phase II/III clinical trials with hypotheses selection at interim: General concepts
    • DOI 10.1002/bimj.200510232
    • Bretz, F. et al. Confirmatory seamless Phase II/III clinical trials with hypotheses selection at interim: general concepts. Biom. J. 48, 623-634 (2006). (Pubitemid 44367905)
    • (2006) Biometrical Journal , vol.48 , Issue.4 , pp. 623-634
    • Bretz, F.1    Schmidli, H.2    Konig, F.3    Racine, A.4    Maurer, W.5
  • 43
    • 33748576736 scopus 로고    scopus 로고
    • Adaptive, group sequential and decision theoretic approaches to sample size determination
    • DOI 10.1002/sim.2638
    • Mehta, C. R. & Patel, N. R. Adaptive, group sequential and decision theoretic approaches to sample size determination. Stat. Med. 25, 3250-3269 (2006). (Pubitemid 44489392)
    • (2006) Statistics in Medicine , vol.25 , Issue.19 , pp. 3250-3269
    • Mehta, C.R.1    Patel, N.R.2


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