메뉴 건너뛰기




Volumn 15, Issue 8, 2013, Pages 972-978

Biomarker-based adaptive trials for patients with glioblastoma - Lessons from I-SPY 2

Author keywords

adaptive; Bayesian; biomarker; clinical trials; glioblastoma

Indexed keywords

BEVACIZUMAB; BIOLOGICAL MARKER; EPIDERMAL GROWTH FACTOR RECEPTOR 2; EPIDERMAL GROWTH FACTOR RECEPTOR 3; ESTROGEN RECEPTOR; ISOCITRATE DEHYDROGENASE 1; METHYLATED DNA PROTEIN CYSTEINE METHYLTRANSFERASE; PACLITAXEL; PROGESTERONE RECEPTOR; RINDOPEPIMUT; TEMOZOLOMIDE; TRASTUZUMAB;

EID: 84880694475     PISSN: 15228517     EISSN: 15235866     Source Type: Journal    
DOI: 10.1093/neuonc/not088     Document Type: Review
Times cited : (34)

References (48)
  • 1
    • 54549108740 scopus 로고    scopus 로고
    • Cancer genome atlas research network comprehensive genomic characterization defines human glioblastoma genes and core pathways
    • Cancer Genome Atlas Research Network Comprehensive genomic characterization defines human glioblastoma genes and core pathways. Nature. 2008;455(7216):1061-1068.
    • (2008) Nature , vol.455 , Issue.7216 , pp. 1061-1068
  • 2
    • 52949127312 scopus 로고    scopus 로고
    • An integrated genomic analysis of human glioblastoma multiforme
    • Parsons DW, Jones S, Zhang X, et al. An integrated genomic analysis of human glioblastoma multiforme. Science. 2008;321(5897):1807-1812.
    • (2008) Science , vol.321 , Issue.5897 , pp. 1807-1812
    • Parsons, D.W.1    Jones, S.2    Zhang, X.3
  • 3
    • 84859438491 scopus 로고    scopus 로고
    • Adaptive clinical trials in oncology
    • Berry DA. Adaptive clinical trials in oncology. Nat Rev Clin Oncol. 2011;9(4):199-207.
    • (2011) Nat Rev Clin Oncol. , vol.9 , Issue.4 , pp. 199-207
    • Berry, D.A.1
  • 4
    • 27244440177 scopus 로고    scopus 로고
    • Comparison of outcomes of phase II studies and subsequent randomized control studies using identical chemotherapeutic regimens
    • Zia MI, Siu LL, Pond GR, Chen EX. Comparison of outcomes of phase II studies and subsequent randomized control studies using identical chemotherapeutic regimens. J Clin Oncol. 2005;23(28):6982-6991.
    • (2005) J Clin Oncol. , vol.23 , Issue.28 , pp. 6982-6991
    • Zia, M.I.1    Siu, L.L.2    Pond, G.R.3    Chen, E.X.4
  • 5
    • 74549144459 scopus 로고    scopus 로고
    • Accessed October 7, 2012
    • FDA. Critical Path Initiative. http://www.fda.gov/ScienceResearch/ SpecialTopics/CriticalPathInitiative/ucm076689.htm. Accessed October 7, 2012.
    • Critical Path Initiative
  • 6
    • 33746551430 scopus 로고    scopus 로고
    • Accessed May 8, 2013
    • FDA. Critical path opportunities report. 2006; http://www.fda.gov/ downloads/ScienceResearch/SpecialTopics/CriticalPathInitiative/ CriticalPathOpportunitiesReports/UCM077254.pdf. Accessed May 8, 2013.
    • (2006) Critical Path Opportunities Report
  • 7
    • 79952079839 scopus 로고    scopus 로고
    • Adaptive clinical trials: The promise and the caution
    • Berry DA. Adaptive clinical trials: the promise and the caution. J Clin Oncol. 2011;29(6):606-609.
    • (2011) J Clin Oncol. , vol.29 , Issue.6 , pp. 606-609
    • Berry, D.A.1
  • 10
    • 84866735197 scopus 로고    scopus 로고
    • An overview of the adaptive designs accelerating promising trials into treatments (ADAPT-IT) project
    • Meurer WJ, Lewis RJ, Tagle D, et al. An overview of the Adaptive Designs Accelerating Promising Trials Into Treatments (ADAPT-IT) project. Ann Emerg Med. 2012;60(4):451-457.
    • (2012) Ann Emerg Med. , vol.60 , Issue.4 , pp. 451-457
    • Meurer, W.J.1    Lewis, R.J.2    Tagle, D.3
  • 11
    • 79957857433 scopus 로고    scopus 로고
    • The BATTLE trial: Personalizing therapy for lung cancer
    • Kim ES, Herbst RS, Wistuba II, et al. The BATTLE trial: personalizing therapy for lung cancer. Cancer Disc. 2011;1(1):44-53.
    • (2011) Cancer Disc. , vol.1 , Issue.1 , pp. 44-53
    • Kim, E.S.1    Herbst, R.S.2    Wistuba, I.I.3
  • 12
    • 84856523576 scopus 로고    scopus 로고
    • Reports from the 2010 clinical and translational cancer research think tank meeting: Design strategies for personalized therapy trials
    • Berry DA, Herbst RS, Rubin EH. Reports from the 2010 Clinical and Translational Cancer Research Think Tank meeting: design strategies for personalized therapy trials. Clin Cancer Res. 2012; 18(3):638-644.
    • (2012) Clin Cancer Res. , vol.18 , Issue.3 , pp. 638-644
    • Berry, D.A.1    Herbst, R.S.2    Rubin, E.H.3
  • 13
    • 84860487114 scopus 로고    scopus 로고
    • Phase2trialdesigninneuro-oncology revisited: A report from the RANO group
    • Galanis E, Wu W, Cloughesy T, et al. Phase2trialdesigninneuro-oncology revisited: a report from the RANO group. Lancet Oncol. 2012; 13(5):e196-e204.
    • (2012) Lancet Oncol. , vol.13 , Issue.5
    • Galanis, E.1    Wu, W.2    Cloughesy, T.3
  • 14
    • 77951003656 scopus 로고    scopus 로고
    • Survival of patients with newly diagnosed glioblastoma treated with radiation and temozolomide in research studies in the United States
    • Grossman SA, Ye X, Piantadosi S, et al. Survival of patients with newly diagnosed glioblastoma treated with radiation and temozolomide in research studies in the United States. Clin Cancer Res. 2010;16(8): 2443-2449.
    • (2010) Clin Cancer Res. , vol.16 , Issue.8 , pp. 2443-2449
    • Grossman, S.A.1    Ye, X.2    Piantadosi, S.3
  • 15
    • 77951625266 scopus 로고    scopus 로고
    • Updated response assessment criteria for high-grade gliomas: Response assessment in neuro-oncology working group
    • Wen PY, Macdonald DR, Reardon DA, et al. Updated response assessment criteria for high-grade gliomas: Response Assessment in Neuro-Oncology working group. J Clin Oncol. 2010;28(11):1963-1972.
    • (2010) J Clin Oncol. , vol.28 , Issue.11 , pp. 1963-1972
    • Wen, P.Y.1    Macdonald, D.R.2    Reardon, D.A.3
  • 16
    • 77949673913 scopus 로고    scopus 로고
    • The design of phase II clinical trials testing cancer therapeutics: Consensus recommendations from the clinical trial design task force of the national cancer institute investigational drug steering committee
    • Seymour L, Ivy SP, Sargent D, et al. The design of phase II clinical trials testing cancer therapeutics: consensus recommendations from the clinical trial design task force of the National Cancer Institute investigational drug steering committee. Clin Cancer Res. 2010;16(6):1764-1769.
    • (2010) Clin Cancer Res. , vol.16 , Issue.6 , pp. 1764-1769
    • Seymour, L.1    Ivy, S.P.2    Sargent, D.3
  • 17
    • 4043132499 scopus 로고    scopus 로고
    • Bayesian statistics and the efficiency and ethics of clinical trials
    • DOI 10.1214/088342304000000044, Bayes Then and Now
    • Berry DA. Bayesian statistics and the efficiency and ethics of clinical trials. Stat Sci. 2004;19(1):175-187. (Pubitemid 39056885)
    • (2004) Statistical Science , vol.19 , Issue.1 , pp. 175-187
    • Berry, D.A.1
  • 18
    • 0028887994 scopus 로고
    • Adaptiveassignmentversusbalanced randomization in clinical trials: A decision analysis
    • Berry DA, Eick SG. Adaptiveassignmentversusbalanced randomization in clinical trials: a decision analysis. Stat Med. 1995;14(3):231-246.
    • (1995) Stat Med. , vol.14 , Issue.3 , pp. 231-246
    • Berry, D.A.1    Eick, S.G.2
  • 19
    • 0027220453 scopus 로고
    • A case for Bayesianism in clinical trials
    • discussion 1395-1404
    • Berry DA. A case for Bayesianism in clinical trials. Stat Med. 1993;12(15-16):1377-1393; discussion 1395-1404.
    • (1993) Stat Med. , vol.12 , Issue.15-16 , pp. 1377-1393
    • Berry, D.A.1
  • 21
    • 79551557586 scopus 로고    scopus 로고
    • Incorporation of biomarker assessment in novel clinical trial designs: Personalizing brain tumor treatments
    • Galanis E, Wu W, Sarkaria J, et al. Incorporation of biomarker assessment in novel clinical trial designs: personalizing brain tumor treatments. Curr Oncol Rep. 2011;13(1):42-49.
    • (2011) Curr Oncol Rep. , vol.13 , Issue.1 , pp. 42-49
    • Galanis, E.1    Wu, W.2    Sarkaria, J.3
  • 24
    • 73649123907 scopus 로고    scopus 로고
    • Integrated genomic analysis identifies clinically relevant subtypes of glioblastoma characterized by abnormalities in PDGFRA, IDH1, EGFR, and NF1
    • Verhaak RG, Hoadley KA, Purdom E, et al. Integrated genomic analysis identifies clinically relevant subtypes of glioblastoma characterized by abnormalities in PDGFRA, IDH1, EGFR, and NF1. Cancer Cell. 2010; 17(1):98-110.
    • (2010) Cancer Cell , vol.17 , Issue.1 , pp. 98-110
    • Verhaak, R.G.1    Hoadley, K.A.2    Purdom, E.3
  • 25
    • 75749115909 scopus 로고    scopus 로고
    • Amultigene predictorofoutcome in glioblastoma
    • Colman H, Zhang L, Sulman EP, et al. Amultigene predictorofoutcome in glioblastoma. Neuro Oncol. 2010;12(1):49-57.
    • (2010) Neuro Oncol. , vol.12 , Issue.1 , pp. 49-57
    • Colman, H.1    Zhang, L.2    Sulman, E.P.3
  • 26
    • 80053555279 scopus 로고    scopus 로고
    • Role of isocitrate dehydrogenase in glioma
    • Alexander BM, Mehta MP. Role of isocitrate dehydrogenase in glioma. Expert Rev Neurother. 2011;11(10):1399-1409.
    • (2011) Expert Rev Neurother. , vol.11 , Issue.10 , pp. 1399-1409
    • Alexander, B.M.1    Mehta, M.P.2
  • 27
    • 78651082266 scopus 로고    scopus 로고
    • Patients with IDH1 wild type an-aplastic astrocytomas exhibit worse prognosis than IDH1-mutated glioblastomas, and IDH1 mutation status accounts for the unfavorable prognostic effect of higher age: Implications for classification of gliomas
    • Hartmann C, Hentschel B, Wick W, et al. Patients with IDH1 wild type an-aplastic astrocytomas exhibit worse prognosis than IDH1-mutated glioblastomas, and IDH1 mutation status accounts for the unfavorable prognostic effect of higher age: implications for classification of gliomas. Acta Neuropathol. 2010;120(6):707-718.
    • (2010) Acta Neuropathol. , vol.120 , Issue.6 , pp. 707-718
    • Hartmann, C.1    Hentschel, B.2    Wick, W.3
  • 28
    • 60849115270 scopus 로고    scopus 로고
    • IDH1 and IDH2 mutations in gliomas
    • Yan H, Parsons DW, Jin G, et al. IDH1 and IDH2 mutations in gliomas. N Engl J Med. 2009;360(8):765-773.
    • (2009) N Engl J Med. , vol.360 , Issue.8 , pp. 765-773
    • Yan, H.1    Parsons, D.W.2    Jin, G.3
  • 29
    • 84863091424 scopus 로고    scopus 로고
    • Temozolomide chemotherapy alone versus radiotherapy alone for malignant astrocytoma in the elderly: The NOA-08 randomised, phase 3 trial
    • Wick W, Platten M, Meisner C, et al. Temozolomide chemotherapy alone versus radiotherapy alone for malignant astrocytoma in the elderly: the NOA-08 randomised, phase 3 trial. Lancet Oncol. 2012;13(7): 707-715.
    • (2012) Lancet Oncol. , vol.13 , Issue.7 , pp. 707-715
    • Wick, W.1    Platten, M.2    Meisner, C.3
  • 30
    • 84866627568 scopus 로고    scopus 로고
    • Bayesianadaptiverandomized trialdesign for patients with recurrent glioblastoma
    • Trippa L, Lee EQ, Wen PY, et al. Bayesianadaptiverandomized trialdesign for patients with recurrent glioblastoma. J Clin Oncol. 2012;30(26): 3258-3263.
    • (2012) J Clin Oncol. , vol.30 , Issue.26 , pp. 3258-3263
    • Trippa, L.1    Lee, E.Q.2    Wen, P.Y.3
  • 31
    • 84880680508 scopus 로고    scopus 로고
    • (accessed September 13, 2012)
    • FDA. Table of pharmacogenomic biomarkersindrug labels. http://www.fda.gov/drugs/scienceresearch/researchareas/pharmacogenetics/ ucm083378.htm (accessed September 13, 2012).
    • Table of Pharmacogenomic Biomarkersindrug Labels
  • 32
    • 67650688162 scopus 로고    scopus 로고
    • The PEPvIII-KLH (CDX-110) vaccine in glioblastoma multiforme patients
    • Heimberger AB, Sampson JH. The PEPvIII-KLH (CDX-110) vaccine in glioblastoma multiforme patients. Exp Opin Biol Ther. 2009;9(8): 1087-1098.
    • (2009) Exp Opin Biol Ther. , vol.9 , Issue.8 , pp. 1087-1098
    • Heimberger, A.B.1    Sampson, J.H.2
  • 33
    • 0012890297 scopus 로고    scopus 로고
    • HER2 testing and correlation with efficacy of trastuzumab therapy
    • 1351-1352; discussion 1352, 1355-1358
    • Fornier M, Risio M, Van Poznak C, Seidman A. HER2 testing and correlation with efficacy of trastuzumab therapy. Oncology (Williston Park). 2002;16(10):1340-1348, 1351-1352; discussion 1352, 1355-1358.
    • (2002) Oncology (Williston Park) , vol.16 , Issue.10 , pp. 1340-1348
    • Fornier, M.1    Risio, M.2    Van Poznak, C.3    Seidman, A.4
  • 34
    • 33644861229 scopus 로고    scopus 로고
    • Bayesian clinical trials
    • Berry DA. Bayesian clinical trials. Nat Rev Drug Disc. 2006;5(1): 27-36.
    • (2006) Nat Rev Drug Disc. , vol.5 , Issue.1 , pp. 27-36
    • Berry, D.A.1
  • 35
    • 84856522259 scopus 로고    scopus 로고
    • Pathologic complete response predicts recurrence-free survival more effectivelybycancer subset: Results from the I-SPY 1 TRIAL - Calgb 150007/150012, ACRIN 6657
    • Esserman LJ, Berry DA, Demichele A, et al. Pathologic complete response predicts recurrence-free survival more effectivelybycancer subset: results from the I-SPY 1 TRIAL - CALGB 150007/150012, ACRIN 6657. J Clin Oncol. 2012;30(26):3242-3249.
    • (2012) J Clin Oncol. , vol.30 , Issue.26 , pp. 3242-3249
    • Esserman, L.J.1    Berry, D.A.2    Demichele, A.3
  • 36
    • 84867101729 scopus 로고    scopus 로고
    • The impact of enrollment in clinical trials on survival of patients with glioblastoma
    • Shahar T, Nossek E, Steinberg DM, et al. The impact of enrollment in clinical trials on survival of patients with glioblastoma. J Clin Neurosci. 2012;19(11):1530-1534.
    • (2012) J Clin Neurosci. , vol.19 , Issue.11 , pp. 1530-1534
    • Shahar, T.1    Nossek, E.2    Steinberg, D.M.3
  • 37
    • 43749094544 scopus 로고    scopus 로고
    • MGMT promoter methylation status can predict the incidence and outcome of pseudoprogression after concomitant radiochemotherapy in newly diagnosed glioblastoma patients
    • Brandes AA, Franceschi E, Tosoni A, et al. MGMT promoter methylation status can predict the incidence and outcome of pseudoprogression after concomitant radiochemotherapy in newly diagnosed glioblastoma patients. J Clin Oncol. 2008;26(13):2192-2197.
    • (2008) J Clin Oncol. , vol.26 , Issue.13 , pp. 2192-2197
    • Brandes, A.A.1    Franceschi, E.2    Tosoni, A.3
  • 38
    • 84865191389 scopus 로고    scopus 로고
    • Chemotherapy response and recurrence-free survival in neoadjuvant breast cancer depends on biomarker profiles: Results from the I-SPY 1 TRIAL (CALGB 150007/150012; ACRIN 6657)
    • Esserman LJ, Berry DA, Cheang MC, et al. Chemotherapy response and recurrence-free survival in neoadjuvant breast cancer depends on biomarker profiles: results from the I-SPY 1 TRIAL (CALGB 150007/150012; ACRIN 6657). Breast Cancer Res Treat. 2012;132(3): 1049-1062.
    • (2012) Breast Cancer Res Treat. , vol.132 , Issue.3 , pp. 1049-1062
    • Esserman, L.J.1    Berry, D.A.2    Cheang, M.C.3
  • 39
    • 44849138808 scopus 로고    scopus 로고
    • Progression-free survival: An important end point in evaluating therapy for recurrent high-grade gliomas
    • Lamborn KR, Yung WK, Chang SM, et al. Progression-free survival: an important end point in evaluating therapy for recurrent high-grade gliomas. Neuro Oncol. 2008;10(2):162-170.
    • (2008) Neuro Oncol. , vol.10 , Issue.2 , pp. 162-170
    • Lamborn, K.R.1    Yung, W.K.2    Chang, S.M.3
  • 40
    • 77952317096 scopus 로고    scopus 로고
    • Six-month progression-free survival as an alternative primary efficacy endpoint to overall survival in newly diagnosed glioblastoma patients receiving temozolomide
    • Polley MY, Lamborn KR, Chang SM, Butowski N, Clarke JL, Prados M. Six-month progression-free survival as an alternative primary efficacy endpoint to overall survival in newly diagnosed glioblastoma patients receiving temozolomide. Neuro Oncol. 2010;12(3):274-282.
    • (2010) Neuro Oncol. , vol.12 , Issue.3 , pp. 274-282
    • Polley, M.Y.1    Lamborn, K.R.2    Chang, S.M.3    Butowski, N.4    Clarke, J.L.5    Prados, M.6
  • 41
    • 34047238978 scopus 로고    scopus 로고
    • The relationship between six-month progression-free survival and 12-month overall survival end points for phase II trials in patients with glioblastoma multiforme
    • DOI 10.1215/15228517-2006-025
    • Ballman KV, Buckner JC, Brown PD, et al. The relationship between six-month progression-free survival and 12-month overall survival end points for phase II trials in patients with glioblastoma multiforme. Neuro Oncol. 2007;9(1):29-38. (Pubitemid 46543486)
    • (2007) Neuro-Oncology , vol.9 , Issue.1 , pp. 29-38
    • Ballman, K.V.1    Buckner, J.C.2    Brown, P.D.3    Giannini, C.4    Flynn, P.J.5    LaPlant, B.R.6    Jaeckle, K.A.7
  • 42
    • 84862856776 scopus 로고    scopus 로고
    • Reevaluating the imaging definition of tumor progression: Perfusion MRI quantifies recurrent glioblastoma tumor fraction, pseudoprogression, and radiation necrosistopredict survival
    • Hu LS, Eschbacher JM, Heiserman JE, et al. Reevaluating the imaging definition of tumor progression: perfusion MRI quantifies recurrent glioblastoma tumor fraction, pseudoprogression, and radiation necrosistopredict survival. Neuro Oncol. 2012;14(7):919-930.
    • (2012) Neuro Oncol. , vol.14 , Issue.7 , pp. 919-930
    • Hu, L.S.1    Eschbacher, J.M.2    Heiserman, J.E.3
  • 45
    • 33646245937 scopus 로고    scopus 로고
    • Adaptive designs in clinical drug development - An executive summary of the PhRMA working group
    • Gallo P, Chuang-Stein C, Dragalin V, Gaydos B, Krams M, Pinheiro J. Adaptive designs in clinical drug development - an executive summary of the PhRMA Working Group. J Biopharm Stat. 2006;16(3):275-283.
    • (2006) J Biopharm Stat. , vol.16 , Issue.3 , pp. 275-283
    • Gallo, P.1    Chuang-Stein, C.2    Dragalin, V.3    Gaydos, B.4    Krams, M.5    Pinheiro, J.6
  • 46
    • 84880649630 scopus 로고    scopus 로고
    • Foundation for the National Institutes of Health accessed May 8, 2013
    • Foundation for the National Institutes of Health. The Biomarkers Consortium - cancer steering committee. http://www.biomarkers consortium.org/steering-cancer.php (accessed May 8, 2013).
    • The Biomarkers Consortium - Cancer Steering Committee
  • 47
    • 84865740846 scopus 로고    scopus 로고
    • Worth adapting? Revisiting the usefulness of outcome-adaptive randomization
    • Lee JJ, Chen N, Yin G. Worth adapting? Revisiting the usefulness of outcome-adaptive randomization. Clin Cancer Res. 2012;18(17): 4498-4507.
    • (2012) Clin Cancer Res. , vol.18 , Issue.17 , pp. 4498-4507
    • Lee, J.J.1    Chen, N.2    Yin, G.3
  • 48
    • 84880657290 scopus 로고    scopus 로고
    • FDA's $25 million pitch for improving drug regulation
    • Accessed May 8, 2013
    • Couzin-Frankel J. FDA's $25 million pitch for improving drug regulation. Science Insider. 2010; http://news.sciencemag.org/scienceinsider/ 2010/10/fdas-25-million-pitch-for-improving.html0?. Accessed May 8, 2013.
    • (2010) Science Insider.
    • Couzin-Frankel, J.1


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.