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Volumn 2, Issue 6, 2016, Pages 772-779

Response rate as a regulatory end point in single-arm studies of advanced solid tumors

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[No Author keywords available]

Indexed keywords

ANTINEOPLASTIC AGENT;

EID: 85010654002     PISSN: 23742437     EISSN: 23742445     Source Type: Journal    
DOI: 10.1001/jamaoncol.2015.6315     Document Type: Article
Times cited : (37)

References (28)
  • 1
    • 78049425319 scopus 로고    scopus 로고
    • Anaplastic lymphoma kinase inhibition in non-small-cell lung cancer
    • Kwak EL, Bang Y-J, Camidge DR, et al. Anaplastic lymphoma kinase inhibition in non-small-cell lung cancer. N Engl J Med. 2010;363(18):1693-1703.
    • (2010) N Engl J Med , vol.363 , Issue.18 , pp. 1693-1703
    • Kwak, E.L.1    Bang, Y.-J.2    Camidge, D.R.3
  • 2
    • 77956030786 scopus 로고    scopus 로고
    • Inhibition of mutated, activated BRAF in metastatic melanoma
    • Flaherty KT, Puzanov I, Kim KB, et al. Inhibition of mutated, activated BRAF in metastatic melanoma. N Engl J Med. 2010;363(9):809-819.
    • (2010) N Engl J Med , vol.363 , Issue.9 , pp. 809-819
    • Flaherty, K.T.1    Puzanov, I.2    Kim, K.B.3
  • 3
    • 84884523966 scopus 로고    scopus 로고
    • Ibrutinib in relapsed chronic lymphocytic leukemia
    • Byrd JC, O'Brien S, James DF. Ibrutinib in relapsed chronic lymphocytic leukemia. N Engl J Med. 2013;369(13):1278-1279.
    • (2013) N Engl J Med , vol.369 , Issue.13 , pp. 1278-1279
    • Byrd, J.C.1    O'Brien, S.2    James, D.F.3
  • 4
    • 84887412695 scopus 로고    scopus 로고
    • Expediting drug development - The FDA's new "breakthrough therapy" designation
    • Sherman RE, Li J, Shapley S, Robb M,Woodcock J. Expediting drug development-the FDA's new "breakthrough therapy" designation. N Engl J Med. 2013;369(20):1877-1880.
    • (2013) N Engl J Med , vol.369 , Issue.20 , pp. 1877-1880
    • Sherman, R.E.1    Li, J.2    Shapley, S.3    Robb, M.4    Woodcock, J.5
  • 6
    • 84862776857 scopus 로고    scopus 로고
    • Identification of new ALK and RET gene fusions from colorectal and lung cancer biopsies
    • Lipson D, CapellettiM, Yelensky R, et al. Identification of new ALK and RET gene fusions from colorectal and lung cancer biopsies. Nat Med. 2012;18(3):382-384.
    • (2012) Nat Med , vol.18 , Issue.3 , pp. 382-384
    • Lipson, D.1    Capelletti, M.2    Yelensky, R.3
  • 7
    • 58149260596 scopus 로고    scopus 로고
    • KIT gene mutations and copy number in melanoma subtypes
    • Beadling C, Jacobson-Dunlop E, Hodi FS, et al. KIT gene mutations and copy number in melanoma subtypes. Clin Cancer Res. 2008;14(21):6821-6828.
    • (2008) Clin Cancer Res , vol.14 , Issue.21 , pp. 6821-6828
    • Beadling, C.1    Jacobson-Dunlop, E.2    Hodi, F.S.3
  • 8
    • 84941426631 scopus 로고    scopus 로고
    • Expedited programs for serious conditions: An update on breakthrough therapy designation
    • KwokM, Foster T, SteinbergM. Expedited programs for serious conditions: an update on breakthrough therapy designation. Clin Ther. 2015; 37(9):2104-2120.
    • (2015) Clin Ther , vol.37 , Issue.9 , pp. 2104-2120
    • Kwok, M.1    Foster, T.2    Steinberg, M.3
  • 9
    • 85010676644 scopus 로고    scopus 로고
    • A look ahead: How the FDA is adapting in the era of precision medicine
    • Accessed February 3, 2016
    • Cavallo J. A look ahead: how the FDA is adapting in the era of precision medicine. ASCO Post. 2013;4(17). http://www.ascopost.com/issues /november-1,-2013/a-look-ahead-how-the-fda-is -adapting-in-the-era-of-precision-medicine.aspx. Accessed February 3, 2016.
    • (2013) ASCO Post , vol.4 , Issue.17
    • Cavallo, J.1
  • 10
    • 84947259792 scopus 로고    scopus 로고
    • Trends in utilization of FDA expedited drug development and approval programs, 1987-2014: Cohort study
    • Kesselheim AS,Wang B, Franklin JM, Darrow JJ. Trends in utilization of FDA expedited drug development and approval programs, 1987-2014: cohort study. BMJ. 2015;351:h4633.
    • (2015) BMJ , vol.351 , pp. h4633
    • Kesselheim, A.S.1    Wang, B.2    Franklin, J.M.3    Darrow, J.J.4
  • 11
    • 0141617568 scopus 로고    scopus 로고
    • Is patient travel distance associated with survival on phase II clinical trials in oncology?
    • Lamont EB, Hayreh D, Pickett KE, et al. Is patient travel distance associated with survival on phase II clinical trials in oncology? J Natl Cancer Inst. 2003;95(18):1370-1375.
    • (2003) J Natl Cancer Inst , vol.95 , Issue.18 , pp. 1370-1375
    • Lamont, E.B.1    Hayreh, D.2    Pickett, K.E.3
  • 12
    • 84867696992 scopus 로고    scopus 로고
    • When progressive disease does not mean treatment failure: Reconsidering the criteria for progression
    • Oxnard GR, Morris MJ, Hodi FS, et al. When progressive disease does not mean treatment failure: reconsidering the criteria for progression. J Natl Cancer Inst. 2012;104(20):1534-1541.
    • (2012) J Natl Cancer Inst , vol.104 , Issue.20 , pp. 1534-1541
    • Oxnard, G.R.1    Morris, M.J.2    Hodi, F.S.3
  • 13
    • 84905216493 scopus 로고    scopus 로고
    • Evaluation of statistical designs in phase i expansion cohorts: The Dana-Farber/Harvard Cancer Center experience
    • dju163
    • Dahlberg SE, Shapiro GI, Clark JW, Johnson BE. Evaluation of statistical designs in phase I expansion cohorts: the Dana-Farber/Harvard Cancer Center experience. J Natl Cancer Inst. 2014;106(7):dju163.
    • (2014) J Natl Cancer Inst , vol.106 , Issue.7
    • Dahlberg, S.E.1    Shapiro, G.I.2    Clark, J.W.3    Johnson, B.E.4
  • 14
    • 84927126291 scopus 로고    scopus 로고
    • Overall response rate, progression-free survival, and overall survival with targeted and standard therapies in advanced non-small-cell lung cancer: US Food and Drug Administration trial-level and patient-level analyses
    • Blumenthal GM, Karuri SW, Zhang H, et al. Overall response rate, progression-free survival, and overall survival with targeted and standard therapies in advanced non-small-cell lung cancer: US Food and Drug Administration trial-level and patient-level analyses. J Clin Oncol. 2015;33(9): 1008-1014.
    • (2015) J Clin Oncol , vol.33 , Issue.9 , pp. 1008-1014
    • Blumenthal, G.M.1    Karuri, S.W.2    Zhang, H.3
  • 15
    • 84878802996 scopus 로고    scopus 로고
    • Characteristics of oncology clinical trials: Insights from a systematic analysis of ClinicalTrials.gov
    • Hirsch BR, Califf RM, Cheng SK, et al. Characteristics of oncology clinical trials: insights from a systematic analysis of ClinicalTrials.gov. JAMA Intern Med. 2013;173(11):972-979.
    • (2013) JAMA Intern Med , vol.173 , Issue.11 , pp. 972-979
    • Hirsch, B.R.1    Califf, R.M.2    Cheng, S.K.3
  • 16
    • 0034594628 scopus 로고    scopus 로고
    • New guidelines to evaluate the response to treatment in solid tumors
    • Therasse P, Arbuck SG, Eisenhauer EA, et al. New guidelines to evaluate the response to treatment in solid tumors. J Natl Cancer Inst. 2000; 92(3):205-216.
    • (2000) J Natl Cancer Inst , vol.92 , Issue.3 , pp. 205-216
    • Therasse, P.1    Arbuck, S.G.2    Eisenhauer, E.A.3
  • 17
    • 57849117384 scopus 로고    scopus 로고
    • New response evaluation criteria in solid tumours: Revised RECIST guideline (version 1.1)
    • Eisenhauer EA, Therasse P, Bogaerts J, et al. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer. 2009;45(2):228-247.
    • (2009) Eur J Cancer , vol.45 , Issue.2 , pp. 228-247
    • Eisenhauer, E.A.1    Therasse, P.2    Bogaerts, J.3
  • 18
    • 0037471438 scopus 로고    scopus 로고
    • Computational aspects of nonparametric smoothing with illustrations from the sm library
    • Bowman AW, Azzalini A. Computational aspects of nonparametric smoothing with illustrations from the sm library. Comput Stat Data Anal. 2003;42(4):545-560.
    • (2003) Comput Stat Data Anal , vol.42 , Issue.4 , pp. 545-560
    • Bowman, A.W.1    Azzalini, A.2
  • 19
    • 34248974445 scopus 로고
    • Ordinal measures of association
    • Kruskal WH. Ordinal measures of association. J A Stat Assoc. 1958;53(284):814-861.
    • (1958) J A Stat Assoc , vol.53 , Issue.284 , pp. 814-861
    • Kruskal, W.H.1
  • 20
    • 0023710206 scopus 로고
    • Comparing the areas under two or more correlated receiver operating characteristic curves: A nonparametric approach
    • DeLong ER, DeLong DM, Clarke-Pearson DL. Comparing the areas under two or more correlated receiver operating characteristic curves: a nonparametric approach. Biometrics. 1988;44(3): 837-845.
    • (1988) Biometrics , vol.44 , Issue.3 , pp. 837-845
    • DeLong, E.R.1    DeLong, D.M.2    Clarke-Pearson, D.L.3
  • 21
    • 84868320526 scopus 로고    scopus 로고
    • Strategies for overcoming acquired resistance to epidermal growth factor receptor: Targeted therapies in lung cancer
    • Oxnard GR. Strategies for overcoming acquired resistance to epidermal growth factor receptor: targeted therapies in lung cancer. Arch Pathol Lab Med. 2012;136(10):1205-1209.
    • (2012) Arch Pathol Lab Med , vol.136 , Issue.10 , pp. 1205-1209
    • Oxnard, G.R.1
  • 22
    • 84928739294 scopus 로고    scopus 로고
    • AZD9291 in EGFR inhibitor-resistant non-small-cell lung cancer
    • Janne PA, Yang JC-H, Kim D-W, et al. AZD9291 in EGFR inhibitor-resistant non-small-cell lung cancer. N Engl J Med. 2015;372(18):1689-1699.
    • (2015) N Engl J Med , vol.372 , Issue.18 , pp. 1689-1699
    • Janne, P.A.1    Jc-H, Y.2    Kim, D.-W.3
  • 23
    • 84904898065 scopus 로고    scopus 로고
    • AZD9291, an irreversible EGFR TKI, overcomes T790M-mediated resistance to EGFR inhibitors in lung cancer
    • Cross DAE, Ashton SE, Ghiorghiu S, et al. AZD9291, an irreversible EGFR TKI, overcomes T790M-mediated resistance to EGFR inhibitors in lung cancer. Cancer Discov. 2014;4(9):1046-1061.
    • (2014) Cancer Discov , vol.4 , Issue.9 , pp. 1046-1061
    • Cross, D.A.E.1    Ashton, S.E.2    Ghiorghiu, S.3
  • 24
    • 84925230574 scopus 로고    scopus 로고
    • Dacomitinib as first-line treatment in patients with clinically or molecularly selected advanced non-small-cell lung cancer: A multicentre, open-label, phase 2 trial
    • Janne PA, Ou S-HI, Kim D-W, et al. Dacomitinib as first-line treatment in patients with clinically or molecularly selected advanced non-small-cell lung cancer: a multicentre, open-label, phase 2 trial. Lancet Oncol. 2014;15(13):1433-1441.
    • (2014) Lancet Oncol , vol.15 , Issue.13 , pp. 1433-1441
    • Janne, P.A.1    S-Hi, O.2    Kim, D.-W.3
  • 25
    • 84933074028 scopus 로고    scopus 로고
    • Spotlight on pembrolizumab in the treatment of advanced melanoma
    • Rajakulendran T, Adam DN. Spotlight on pembrolizumab in the treatment of advanced melanoma. Drug Des Devel Ther. 2015;9:2883-2886.
    • (2015) Drug des Devel Ther , vol.9 , pp. 2883-2886
    • Rajakulendran, T.1    Adam, D.N.2
  • 26
    • 0024536437 scopus 로고
    • Optimal two-stage designs for phase II clinical trials
    • Simon R. Optimal two-stage designs for phase II clinical trials. Control Clin Trials. 1989;10(1):1-10.
    • (1989) Control Clin Trials , vol.10 , Issue.1 , pp. 1-10
    • Simon, R.1
  • 28
    • 84911372597 scopus 로고    scopus 로고
    • Crizotinib in ROS1-rearranged non-small-cell lung cancer
    • Shaw AT, Ou S-HI, Bang Y-J, et al. Crizotinib in ROS1-rearranged non-small-cell lung cancer. N Engl J Med. 2014;371(21):1963-1971.
    • (2014) N Engl J Med , vol.371 , Issue.21 , pp. 1963-1971
    • Shaw, A.T.1    S-Hi, O.2    Bang, Y.-J.3


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.