메뉴 건너뛰기




Volumn 16, Issue 1, 2015, Pages e43-e52

Outcomes and endpoints in cancer trials: Bridging the divide

Author keywords

[No Author keywords available]

Indexed keywords

CANCER INHIBITION; CANCER PATIENT; CANCER RESEARCH; CANCER SURVIVAL; CLINICAL PRACTICE; COMPUTER ASSISTED TOMOGRAPHY; COST EFFECTIVENESS ANALYSIS; DECISION MAKING; GENERAL PRACTITIONER; HEALTH SERVICE; HUMAN; NEOPLASM; ONCOLOGY; OUTCOME ASSESSMENT; PHASE 1 CLINICAL TRIAL (TOPIC); PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); POSITRON EMISSION TOMOGRAPHY; PRIORITY JOURNAL; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL (TOPIC); REVIEW; STUDY DESIGN; TREATMENT OUTCOME; TREATMENT RESPONSE; TUMOR VOLUME; BIOASSAY; CLINICAL TRIAL (TOPIC); DISEASE COURSE; DISEASE FREE SURVIVAL; METHODOLOGY; MORTALITY; NEOPLASMS; PATHOLOGY; PROCEDURES; TIME;

EID: 84924914921     PISSN: 14702045     EISSN: 14745488     Source Type: Journal    
DOI: 10.1016/S1470-2045(14)70380-8     Document Type: Review
Times cited : (83)

References (100)
  • 1
    • 37849023528 scopus 로고    scopus 로고
    • Reflections on medical oncology: 25 years of clinical trials-where have we come and where are we going?
    • Booth CM, Tannock I Reflections on medical oncology: 25 years of clinical trials-where have we come and where are we going?. J Clin Oncol 2008, 26:6-8.
    • (2008) J Clin Oncol , vol.26 , pp. 6-8
    • Booth, C.M.1    Tannock, I.2
  • 2
    • 84924916766 scopus 로고    scopus 로고
    • Outcomes and endpoints in trials of cancer therapy: the past, present, and future
    • Wilson MK, Karakasis K, Oza AM Outcomes and endpoints in trials of cancer therapy: the past, present, and future. Lancet Oncol 2014, 16:e32-e42.
    • (2014) Lancet Oncol , vol.16 , pp. e32-e42
    • Wilson, M.K.1    Karakasis, K.2    Oza, A.M.3
  • 3
    • 84873037003 scopus 로고    scopus 로고
    • Oncology drug development and approval of systemic anticancer therapy by the US Food and Drug Administration
    • Martell RE, Sermer D, Getz K, Kaitin KI Oncology drug development and approval of systemic anticancer therapy by the US Food and Drug Administration. Oncologist 2013, 18:104-111.
    • (2013) Oncologist , vol.18 , pp. 104-111
    • Martell, R.E.1    Sermer, D.2    Getz, K.3    Kaitin, K.I.4
  • 4
    • 77954629858 scopus 로고    scopus 로고
    • The role of the US Food and Drug Administration review process: clinical trial endpoints in oncology
    • McKee AE, Farrell AT, Pazdur R, Woodcock J The role of the US Food and Drug Administration review process: clinical trial endpoints in oncology. Oncologist 2010, 15(suppl):13-18.
    • (2010) Oncologist , vol.15 , pp. 13-18
    • McKee, A.E.1    Farrell, A.T.2    Pazdur, R.3    Woodcock, J.4
  • 6
    • 74949139051 scopus 로고    scopus 로고
    • Ultimate fate of oncology drugs approved by the us food and drug administration without a randomized trial
    • Tsimberidou AM, Braiteh F, Stewart DJ, Kurzrock R Ultimate fate of oncology drugs approved by the us food and drug administration without a randomized trial. J Clin Oncol 2009, 27:6243-6250.
    • (2009) J Clin Oncol , vol.27 , pp. 6243-6250
    • Tsimberidou, A.M.1    Braiteh, F.2    Stewart, D.J.3    Kurzrock, R.4
  • 7
    • 0037986306 scopus 로고    scopus 로고
    • End points and United States Food and Drug Administration approval of oncology drugs
    • Johnson JR, Williams G, Pazdur R End points and United States Food and Drug Administration approval of oncology drugs. J Clin Oncol 2003, 21:1404-1411.
    • (2003) J Clin Oncol , vol.21 , pp. 1404-1411
    • Johnson, J.R.1    Williams, G.2    Pazdur, R.3
  • 8
    • 84884368877 scopus 로고    scopus 로고
    • Influence of tumour micro-environment heterogeneity on therapeutic response
    • Junttila MR, de Sauvage FJ Influence of tumour micro-environment heterogeneity on therapeutic response. Nature 2013, 501:346-354.
    • (2013) Nature , vol.501 , pp. 346-354
    • Junttila, M.R.1    de Sauvage, F.J.2
  • 9
    • 47749118439 scopus 로고    scopus 로고
    • Endpoints for assessing drug activity in clinical trials
    • Pazdur R Endpoints for assessing drug activity in clinical trials. Oncologist 2008, 13(suppl):19-21.
    • (2008) Oncologist , vol.13 , pp. 19-21
    • Pazdur, R.1
  • 10
    • 78650402625 scopus 로고    scopus 로고
    • Explaining marginal benefits to patients, when "marginal" means additional but not necessarily small
    • Smith TJ, Hillner BE Explaining marginal benefits to patients, when "marginal" means additional but not necessarily small. Clin Cancer Res 2010, 16:5981-5986.
    • (2010) Clin Cancer Res , vol.16 , pp. 5981-5986
    • Smith, T.J.1    Hillner, B.E.2
  • 11
    • 79951981575 scopus 로고    scopus 로고
    • Reporting of serious adverse drug reactions of targeted anticancer agents in pivotal phase III clinical trials
    • Seruga B, Sterling L, Wang L, Tannock IF Reporting of serious adverse drug reactions of targeted anticancer agents in pivotal phase III clinical trials. J Clin Oncol 2011, 29:174-185.
    • (2011) J Clin Oncol , vol.29 , pp. 174-185
    • Seruga, B.1    Sterling, L.2    Wang, L.3    Tannock, I.F.4
  • 12
    • 84865165918 scopus 로고    scopus 로고
    • The price we pay for progress: a meta-analysis of harms of newly approved anticancer drugs
    • Niraula S, Seruga B, Ocana A, et al. The price we pay for progress: a meta-analysis of harms of newly approved anticancer drugs. J Clin Oncol 2012, 30:3012-3019.
    • (2012) J Clin Oncol , vol.30 , pp. 3012-3019
    • Niraula, S.1    Seruga, B.2    Ocana, A.3
  • 13
    • 84927617823 scopus 로고    scopus 로고
    • Endpoints in clinical trials: what do our patients consider important? A survey of the Ovarian Cancer National Alliance (OCNA)
    • Coleman R, Alvarez R, Herzog T Endpoints in clinical trials: what do our patients consider important? A survey of the Ovarian Cancer National Alliance (OCNA). Gynecol Oncol 2013, 130:e13.
    • (2013) Gynecol Oncol , vol.130 , pp. e13
    • Coleman, R.1    Alvarez, R.2    Herzog, T.3
  • 14
    • 84927600462 scopus 로고    scopus 로고
    • Relative influence of factors determining a woman's preference for treatment options in ovarian cancer
    • Havrilesky LJ, Alvarez Secord A, Ehrisman JA, et al. Relative influence of factors determining a woman's preference for treatment options in ovarian cancer. Proc Am Soc Clin Oncol 2014, 32(suppl). abstr 5544.
    • (2014) Proc Am Soc Clin Oncol , vol.32
    • Havrilesky, L.J.1    Alvarez Secord, A.2    Ehrisman, J.A.3
  • 15
    • 84872138291 scopus 로고    scopus 로고
    • What research ethics should learn from genomics and society research: lessons from the ELSI Congress of 2011
    • Henderson GE, Juengst ET, King NM, Kuczynski K, Michie M What research ethics should learn from genomics and society research: lessons from the ELSI Congress of 2011. J Law Med Ethics 2012, 40:1008-1024.
    • (2012) J Law Med Ethics , vol.40 , pp. 1008-1024
    • Henderson, G.E.1    Juengst, E.T.2    King, N.M.3    Kuczynski, K.4    Michie, M.5
  • 16
    • 37349096424 scopus 로고    scopus 로고
    • Quality of life and/or symptom control in randomized clinical trials for patients with advanced cancer
    • Joly F, Vardy J, Pintilie M, Tannock IF Quality of life and/or symptom control in randomized clinical trials for patients with advanced cancer. Annal Oncol 2007, 18:1935-1942.
    • (2007) Annal Oncol , vol.18 , pp. 1935-1942
    • Joly, F.1    Vardy, J.2    Pintilie, M.3    Tannock, I.F.4
  • 17
    • 27744551640 scopus 로고    scopus 로고
    • 2004 consensus statements on the management of ovarian cancer: final document of the 3rd International Gynecologic Cancer Intergroup Ovarian Cancer Consensus Conference (GCIG OCCC 2004)
    • du Bois A, Quinn M, Thigpen T, et al. 2004 consensus statements on the management of ovarian cancer: final document of the 3rd International Gynecologic Cancer Intergroup Ovarian Cancer Consensus Conference (GCIG OCCC 2004). Ann Oncol 2005, 16(suppl):viii7-viii12.
    • (2005) Ann Oncol , vol.16 , pp. 87-812
    • Du Bois, A.1    Quinn, M.2    Thigpen, T.3
  • 18
    • 33644820903 scopus 로고    scopus 로고
    • Long-term corticosteroid replacement and bone mineral density in adult women with classical congenital adrenal hyperplasia
    • King JA, Wisniewski AB, Bankowski BJ, Carson KA, Zacur HA, Migeon CJ Long-term corticosteroid replacement and bone mineral density in adult women with classical congenital adrenal hyperplasia. J Clin Endocrinol Metab 2006, 91:865-869.
    • (2006) J Clin Endocrinol Metab , vol.91 , pp. 865-869
    • King, J.A.1    Wisniewski, A.B.2    Bankowski, B.J.3    Carson, K.A.4    Zacur, H.A.5    Migeon, C.J.6
  • 19
    • 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, 45:228-247.
    • (2009) Eur J Cancer , vol.45 , pp. 228-247
    • Eisenhauer, E.A.1    Therasse, P.2    Bogaerts, J.3
  • 20
    • 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, 92:205-216.
    • (2000) J Natl Cancer Inst , vol.92 , pp. 205-216
    • Therasse, P.1    Arbuck, S.G.2    Eisenhauer, E.A.3
  • 21
    • 79960259603 scopus 로고    scopus 로고
    • Patterns of reporting health-related quality of life outcomes in randomized clinical trials: implications for clinicians and quality of life researchers
    • Brundage M, Bass B, Davidson J, et al. Patterns of reporting health-related quality of life outcomes in randomized clinical trials: implications for clinicians and quality of life researchers. Qual Life Res 2011, 20:653-664.
    • (2011) Qual Life Res , vol.20 , pp. 653-664
    • Brundage, M.1    Bass, B.2    Davidson, J.3
  • 22
    • 84876590938 scopus 로고    scopus 로고
    • The use and reporting of patient-reported outcomes in phase III breast cancer trials
    • Brim RL, Pearson SD The use and reporting of patient-reported outcomes in phase III breast cancer trials. Clin Trials 2013, 10:243-249.
    • (2013) Clin Trials , vol.10 , pp. 243-249
    • Brim, R.L.1    Pearson, S.D.2
  • 23
    • 81055141061 scopus 로고    scopus 로고
    • Reporting quality of life in clinical trials: a CONSORT extension
    • Calvert M, Blazeby J, Revicki D, Moher D, Brundage M Reporting quality of life in clinical trials: a CONSORT extension. Lancet 2011, 378:1684-1685.
    • (2011) Lancet , vol.378 , pp. 1684-1685
    • Calvert, M.1    Blazeby, J.2    Revicki, D.3    Moher, D.4    Brundage, M.5
  • 24
    • 84888265677 scopus 로고    scopus 로고
    • Patient-reported outcomes in ovarian cancer clinical trials
    • Friedlander ML, King MT Patient-reported outcomes in ovarian cancer clinical trials. Annals Oncol 2013, 24(suppl):x64-x68.
    • (2013) Annals Oncol , vol.24 , pp. x64-x68
    • Friedlander, M.L.1    King, M.T.2
  • 25
    • 84874371892 scopus 로고    scopus 로고
    • Reporting of patient-reported outcomes in randomized trials: the CONSORT PRO extension
    • Calvert M, Blazeby J, Altman DG, et al. Reporting of patient-reported outcomes in randomized trials: the CONSORT PRO extension. JAMA 2013, 309:814-822.
    • (2013) JAMA , vol.309 , pp. 814-822
    • Calvert, M.1    Blazeby, J.2    Altman, D.G.3
  • 26
    • 84887556152 scopus 로고    scopus 로고
    • Chemotherapy-induced neuropathy and its association with quality of life among 2-to 11-year colorectal cancer survivors: results from the population-based PROFILES registry
    • Mols F, Beijers T, Lemmens V, van den Hurk CJ, Vreugdenhil G, van de Poll-Franse LV Chemotherapy-induced neuropathy and its association with quality of life among 2-to 11-year colorectal cancer survivors: results from the population-based PROFILES registry. J Clin Oncol 2013, 31:2699-2707.
    • (2013) J Clin Oncol , vol.31 , pp. 2699-2707
    • Mols, F.1    Beijers, T.2    Lemmens, V.3    Van Den Hurk, C.J.4    Vreugdenhil, G.5    Van De Poll-Franse, L.V.6
  • 28
    • 84898013440 scopus 로고    scopus 로고
    • 18F-fluorodeoxyglucose positron-emission tomography on molecular targeted therapy and cytotoxic chemotherapy for clinical outcome prediction
    • 18F-fluorodeoxyglucose positron-emission tomography on molecular targeted therapy and cytotoxic chemotherapy for clinical outcome prediction. Clin Lung Cancer 2014, 15:182-187.
    • (2014) Clin Lung Cancer , vol.15 , pp. 182-187
    • Kanazu, M.1    Maruyama, K.2    Ando, M.3
  • 29
    • 84870735307 scopus 로고    scopus 로고
    • 18F]fluorodeoxyglucose positron emission tomography response evaluation in patients with high-tumor burden follicular lymphoma treated with immunochemotherapy: a prospective study from the Groupe d'Etudes des Lymphomes de l'Adulte and GOELAMS
    • 18F]fluorodeoxyglucose positron emission tomography response evaluation in patients with high-tumor burden follicular lymphoma treated with immunochemotherapy: a prospective study from the Groupe d'Etudes des Lymphomes de l'Adulte and GOELAMS. J Clin Oncol 2012, 30:4317-4322.
    • (2012) J Clin Oncol , vol.30 , pp. 4317-4322
    • Dupuis, J.1    Berriolo-Riedinger, A.2    Julian, A.3
  • 30
    • 77951645269 scopus 로고    scopus 로고
    • Lymph node staging by positron emission tomography in cervical cancer: relationship to prognosis
    • Kidd EA, Siegel BA, Dehdashti F, et al. Lymph node staging by positron emission tomography in cervical cancer: relationship to prognosis. J Clin Oncol 2010, 28:2108-2113.
    • (2010) J Clin Oncol , vol.28 , pp. 2108-2113
    • Kidd, E.A.1    Siegel, B.A.2    Dehdashti, F.3
  • 31
    • 34249085905 scopus 로고    scopus 로고
    • Correlation of computed tomography and positron emission tomography in patients with metastatic gastrointestinal stromal tumor treated at a single institution with imatinib mesylate: proposal of new computed tomography response criteria
    • Choi H, Charnsangavej C, Faria SC, et al. Correlation of computed tomography and positron emission tomography in patients with metastatic gastrointestinal stromal tumor treated at a single institution with imatinib mesylate: proposal of new computed tomography response criteria. J Clin Oncol 2007, 25:1753-1759.
    • (2007) J Clin Oncol , vol.25 , pp. 1753-1759
    • Choi, H.1    Charnsangavej, C.2    Faria, S.C.3
  • 32
    • 33947496614 scopus 로고    scopus 로고
    • Revised response criteria for malignant lymphoma
    • Cheson BD, Pfistner B, Juweid ME, et al. Revised response criteria for malignant lymphoma. J Clin Oncol 2007, 25:579-586.
    • (2007) J Clin Oncol , vol.25 , pp. 579-586
    • Cheson, B.D.1    Pfistner, B.2    Juweid, M.E.3
  • 33
    • 70350141199 scopus 로고    scopus 로고
    • Tumor shrinkage and objective response rates: gold standard for oncology efficacy screening trials, or an outdated end point?
    • Bradbury P, Seymour L Tumor shrinkage and objective response rates: gold standard for oncology efficacy screening trials, or an outdated end point?. Cancer J 2009, 15:354-360.
    • (2009) Cancer J , vol.15 , pp. 354-360
    • Bradbury, P.1    Seymour, L.2
  • 34
    • 1842509872 scopus 로고    scopus 로고
    • 18fluoro-deoxy-D-glucose positron emission tomography is a reliable predictor for viable tumor in postchemotherapy seminoma: an update of the prospective multicentric SEMPET trial
    • 18fluoro-deoxy-D-glucose positron emission tomography is a reliable predictor for viable tumor in postchemotherapy seminoma: an update of the prospective multicentric SEMPET trial. J Clin Oncol 2004, 22:1034-1039.
    • (2004) J Clin Oncol , vol.22 , pp. 1034-1039
    • De Santis, M.1    Becherer, A.2    Bokemeyer, C.3
  • 35
    • 66849095262 scopus 로고    scopus 로고
    • 18F]fluorodeoxyglucose positron emission tomography correlates with Akt pathway activity but is not predictive of clinical outcome during mTOR inhibitor therapy
    • 18F]fluorodeoxyglucose positron emission tomography correlates with Akt pathway activity but is not predictive of clinical outcome during mTOR inhibitor therapy. J Clin Oncol 2009, 27:2697-2704.
    • (2009) J Clin Oncol , vol.27 , pp. 2697-2704
    • Ma, W.W.1    Jacene, H.2    Song, D.3
  • 36
    • 0034793679 scopus 로고    scopus 로고
    • Sequential tumor biopsies in early phase clinical trials of anticancer agents for pharmacodynamic evaluation
    • Dowlati A, Haaga J, Remick SC, et al. Sequential tumor biopsies in early phase clinical trials of anticancer agents for pharmacodynamic evaluation. Clin Cancer Res 2001, 7:2971-2976.
    • (2001) Clin Cancer Res , vol.7 , pp. 2971-2976
    • Dowlati, A.1    Haaga, J.2    Remick, S.C.3
  • 37
    • 84864029167 scopus 로고    scopus 로고
    • Cracking open window of opportunity trials
    • Kalinsky K, Hershman DL Cracking open window of opportunity trials. J Clin Oncol 2012, 30:2573-2575.
    • (2012) J Clin Oncol , vol.30 , pp. 2573-2575
    • Kalinsky, K.1    Hershman, D.L.2
  • 38
    • 84864075329 scopus 로고    scopus 로고
    • Dual effect of metformin on breast cancer proliferation in a randomized presurgical trial
    • Bonanni B, Puntoni M, Cazzaniga M, et al. Dual effect of metformin on breast cancer proliferation in a randomized presurgical trial. J Clin Oncol 2012, 30:2593-2600.
    • (2012) J Clin Oncol , vol.30 , pp. 2593-2600
    • Bonanni, B.1    Puntoni, M.2    Cazzaniga, M.3
  • 39
    • 79960975329 scopus 로고    scopus 로고
    • Window-of-opportunity trials to evaluate clinical activity of new molecular entities in oncology
    • Glimelius B, Lahn M Window-of-opportunity trials to evaluate clinical activity of new molecular entities in oncology. Ann Oncol 2011, 22:1717-1725.
    • (2011) Ann Oncol , vol.22 , pp. 1717-1725
    • Glimelius, B.1    Lahn, M.2
  • 41
    • 84859765844 scopus 로고    scopus 로고
    • Dynamic reprogramming of the kinome in response to targeted MEK inhibition in triple-negative breast cancer
    • Duncan JS, Whittle MC, Nakamura K, et al. Dynamic reprogramming of the kinome in response to targeted MEK inhibition in triple-negative breast cancer. Cell 2012, 149:307-321.
    • (2012) Cell , vol.149 , pp. 307-321
    • Duncan, J.S.1    Whittle, M.C.2    Nakamura, K.3
  • 42
    • 0024520844 scopus 로고
    • Surrogate endpoints in clinical trials: definition and operational criteria
    • Prentice RL Surrogate endpoints in clinical trials: definition and operational criteria. Stat Med 1989, 8:431-440.
    • (1989) Stat Med , vol.8 , pp. 431-440
    • Prentice, R.L.1
  • 43
    • 0014119674 scopus 로고
    • Government regulations and the use of drugs
    • Hafkenschiel JH Government regulations and the use of drugs. Calif Med 1967, 107:159-163.
    • (1967) Calif Med , vol.107 , pp. 159-163
    • Hafkenschiel, J.H.1
  • 44
    • 51449097507 scopus 로고    scopus 로고
    • STAMPEDE: systemic therapy for advancing or metastatic prostate cancer-a multi-arm multi-stage randomised controlled trial
    • James ND, Sydes MR, Clarke NW, et al. STAMPEDE: systemic therapy for advancing or metastatic prostate cancer-a multi-arm multi-stage randomised controlled trial. Clin Oncol 2008, 20:577-581.
    • (2008) Clin Oncol , vol.20 , pp. 577-581
    • James, N.D.1    Sydes, M.R.2    Clarke, N.W.3
  • 45
    • 84894477310 scopus 로고    scopus 로고
    • Evaluating many treatments and biomarkers in oncology: a new design
    • Kaplan R, Maughan T, Crook A, et al. Evaluating many treatments and biomarkers in oncology: a new design. J Clin Oncol 2013, 31:4562-4568.
    • (2013) J Clin Oncol , vol.31 , pp. 4562-4568
    • Kaplan, R.1    Maughan, T.2    Crook, A.3
  • 46
    • 51749123391 scopus 로고    scopus 로고
    • Speeding up the evaluation of new agents in cancer
    • Parmar MK, Barthel FM, Sydes M, et al. Speeding up the evaluation of new agents in cancer. J Natl Cancer Inst 2008, 100:1204-1214.
    • (2008) J Natl Cancer Inst , vol.100 , pp. 1204-1214
    • Parmar, M.K.1    Barthel, F.M.2    Sydes, M.3
  • 47
    • 84866145248 scopus 로고    scopus 로고
    • Flexible trial design in practice - stopping arms for lack-of-benefit and adding research arms mid-trial in STAMPEDE: a multi-arm multi-stage randomized controlled trial
    • Sydes MR, Parmar MK, Mason MD, et al. Flexible trial design in practice - stopping arms for lack-of-benefit and adding research arms mid-trial in STAMPEDE: a multi-arm multi-stage randomized controlled trial. Trials 2012, 13:168.
    • (2012) Trials , vol.13 , pp. 168
    • Sydes, M.R.1    Parmar, M.K.2    Mason, M.D.3
  • 48
    • 84955341007 scopus 로고    scopus 로고
    • Combining enzalutamide with abiraterone, prednisone, and androgen deprivation therapy in the STAMPEDE trial
    • published online June 27.
    • Attard G, Sydes MR, Mason MD, et al. Combining enzalutamide with abiraterone, prednisone, and androgen deprivation therapy in the STAMPEDE trial. Eur Urol 2014, published online June 27. 10.1016/j.eururo.2014.05.038.
    • (2014) Eur Urol
    • Attard, G.1    Sydes, M.R.2    Mason, M.D.3
  • 50
    • 84876096711 scopus 로고    scopus 로고
    • Fool's gold, lost treasures, and the randomized clinical trial
    • Stewart DJ, Kurzrock R Fool's gold, lost treasures, and the randomized clinical trial. BMC Cancer 2013, 13:193.
    • (2013) BMC Cancer , vol.13 , pp. 193
    • Stewart, D.J.1    Kurzrock, R.2
  • 51
    • 77956401725 scopus 로고    scopus 로고
    • Equipoise lost: ethics, costs, and the regulation of cancer clinical research
    • Stewart DJ, Whitney SN, Kurzrock R Equipoise lost: ethics, costs, and the regulation of cancer clinical research. J Clin Oncol 2010, 28:2925-2935.
    • (2010) J Clin Oncol , vol.28 , pp. 2925-2935
    • Stewart, D.J.1    Whitney, S.N.2    Kurzrock, R.3
  • 52
    • 84880991913 scopus 로고    scopus 로고
    • 'Basket studies' will hold intricate data for cancer drug approvals
    • Willyard C 'Basket studies' will hold intricate data for cancer drug approvals. Nat Med 2013, 19:655.
    • (2013) Nat Med , vol.19 , pp. 655
    • Willyard, C.1
  • 53
    • 84867333656 scopus 로고    scopus 로고
    • Genome sequencing identifies a basis for everolimus sensitivity
    • Iyer G, Hanrahan AJ, Milowsky MI, et al. Genome sequencing identifies a basis for everolimus sensitivity. Science 2012, 338:221.
    • (2012) Science , vol.338 , pp. 221
    • Iyer, G.1    Hanrahan, A.J.2    Milowsky, M.I.3
  • 54
    • 84884403681 scopus 로고    scopus 로고
    • Princess Margaret Cancer Centre (PMCC) integrated molecular profiling in advanced cancers trial (IMPACT) using genotyping and targeted next-generation sequencing (NGS)
    • Bedard P, Oza A, Tsao MS, et al. Princess Margaret Cancer Centre (PMCC) integrated molecular profiling in advanced cancers trial (IMPACT) using genotyping and targeted next-generation sequencing (NGS). Proc Am Soc Clin Oncol 2013, 31(suppl). abstr 11002.
    • (2013) Proc Am Soc Clin Oncol , vol.31
    • Bedard, P.1    Oza, A.2    Tsao, M.S.3
  • 55
    • 84869223443 scopus 로고    scopus 로고
    • Personalized medicine in a phase I clinical trials program: the MD Anderson Cancer Center initiative
    • 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 2012, 18:6373-6383.
    • (2012) Clin Cancer Res , vol.18 , pp. 6373-6383
    • Tsimberidou, A.M.1    Iskander, N.G.2    Hong, D.S.3
  • 58
    • 84863012433 scopus 로고    scopus 로고
    • Antitumor activity of BRAF inhibitor vemurafenib in preclinical models of BRAF-mutant colorectal cancer
    • Yang H, Higgins B, Kolinsky K, et al. Antitumor activity of BRAF inhibitor vemurafenib in preclinical models of BRAF-mutant colorectal cancer. Cancer Res 2012, 72:779-789.
    • (2012) Cancer Res , vol.72 , pp. 779-789
    • Yang, H.1    Higgins, B.2    Kolinsky, K.3
  • 59
    • 84863230465 scopus 로고    scopus 로고
    • Unresponsiveness of colon cancer to BRAF(V600E) inhibition through feedback activation of EGFR
    • Prahallad A, Sun C, Huang S, et al. Unresponsiveness of colon cancer to BRAF(V600E) inhibition through feedback activation of EGFR. Nature 2012, 483:100-103.
    • (2012) Nature , vol.483 , pp. 100-103
    • Prahallad, A.1    Sun, C.2    Huang, S.3
  • 60
    • 79959795786 scopus 로고    scopus 로고
    • Improved survival with vemurafenib in melanoma with BRAF V600E mutation
    • Chapman PB, Hauschild A, Robert C, et al. Improved survival with vemurafenib in melanoma with BRAF V600E mutation. N Engl J Med 2011, 364:2507-2516.
    • (2011) N Engl J Med , vol.364 , pp. 2507-2516
    • Chapman, P.B.1    Hauschild, A.2    Robert, C.3
  • 61
    • 0036467826 scopus 로고    scopus 로고
    • Efficacy and safety of trastuzumab as a single agent in first-line treatment of HER2-overexpressing metastatic breast cancer
    • Vogel CL, Cobleigh MA, Tripathy D, et al. Efficacy and safety of trastuzumab as a single agent in first-line treatment of HER2-overexpressing metastatic breast cancer. J Clin Oncol 2002, 20:719-726.
    • (2002) J Clin Oncol , vol.20 , pp. 719-726
    • Vogel, C.L.1    Cobleigh, M.A.2    Tripathy, D.3
  • 62
    • 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, 363:809-819.
    • (2010) N Engl J Med , vol.363 , pp. 809-819
    • Flaherty, K.T.1    Puzanov, I.2    Kim, K.B.3
  • 63
    • 80051780280 scopus 로고    scopus 로고
    • Initial phase II results with crizotinib in advanced ALK-positive non-small cell lung cancer (NSCLC): PROFILE 1005
    • Crinò LK, Kim D, Riely GJ, et al. Initial phase II results with crizotinib in advanced ALK-positive non-small cell lung cancer (NSCLC): PROFILE 1005. Proc Am Soc Clin Oncol 2011, 29(suppl). abstr 7514.
    • (2011) Proc Am Soc Clin Oncol , vol.29
    • Crinò, L.K.1    Kim, D.2    Riely, G.J.3
  • 65
    • 1242297574 scopus 로고    scopus 로고
    • Optimal therapy of advanced ovarian cancer: carboplatin and paclitaxel versus cisplatin and paclitaxel (GOG158) and an update on GOG0182-ICON5
    • Bookman MA, Greer BE, Ozols RF Optimal therapy of advanced ovarian cancer: carboplatin and paclitaxel versus cisplatin and paclitaxel (GOG158) and an update on GOG0182-ICON5. Int J Gynecol Cancer 2003, 13(suppl):149-155.
    • (2003) Int J Gynecol Cancer , vol.13 , pp. 149-155
    • Bookman, M.A.1    Greer, B.E.2    Ozols, R.F.3
  • 66
    • 34447255724 scopus 로고    scopus 로고
    • Different strategies of sequential and combination chemotherapy for patients with poor prognosis advanced colorectal cancer (MRC FOCUS): a randomised controlled trial
    • Seymour MT, Maughan TS, Ledermann JA, et al. Different strategies of sequential and combination chemotherapy for patients with poor prognosis advanced colorectal cancer (MRC FOCUS): a randomised controlled trial. Lancet 2007, 370:143-152.
    • (2007) Lancet , vol.370 , pp. 143-152
    • Seymour, M.T.1    Maughan, T.S.2    Ledermann, J.A.3
  • 67
    • 84876278596 scopus 로고    scopus 로고
    • Prostate radiotherapy for men with metastatic disease: a new comparison in the systemic therapy in advancing or metastatic prostate cancer: evaluation of drug efficacy (STAMPEDE) trial
    • Parker CC, Sydes MR, Mason MD, et al. Prostate radiotherapy for men with metastatic disease: a new comparison in the systemic therapy in advancing or metastatic prostate cancer: evaluation of drug efficacy (STAMPEDE) trial. BJU Int 2013, 111:697-699.
    • (2013) BJU Int , vol.111 , pp. 697-699
    • Parker, C.C.1    Sydes, M.R.2    Mason, M.D.3
  • 69
    • 84861094901 scopus 로고    scopus 로고
    • Novel clinical trial designs for the development of new antiretroviral agents
    • Mani N, Murray J, Gulick RM, et al. Novel clinical trial designs for the development of new antiretroviral agents. Aids 2012, 26:899-907.
    • (2012) Aids , vol.26 , pp. 899-907
    • Mani, N.1    Murray, J.2    Gulick, R.M.3
  • 70
    • 12144287534 scopus 로고    scopus 로고
    • United States Food and Drug administration drug approval summary: gefitinib (ZD1839; Iressa) tablets
    • Cohen MH, Williams GA, Sridhara R, et al. United States Food and Drug administration drug approval summary: gefitinib (ZD1839; Iressa) tablets. Clin Cancer Res 2004, 10:1212-1218.
    • (2004) Clin Cancer Res , vol.10 , pp. 1212-1218
    • Cohen, M.H.1    Williams, G.A.2    Sridhara, R.3
  • 71
    • 0142055937 scopus 로고    scopus 로고
    • Efficacy of gefitinib, an inhibitor of the epidermal growth factor receptor tyrosine kinase, in symptomatic patients with non-small cell lung cancer: a randomized trial
    • Kris MG, Natale RB, Herbst RS, et al. Efficacy of gefitinib, an inhibitor of the epidermal growth factor receptor tyrosine kinase, in symptomatic patients with non-small cell lung cancer: a randomized trial. JAMA 2003, 290:2149-2158.
    • (2003) JAMA , vol.290 , pp. 2149-2158
    • Kris, M.G.1    Natale, R.B.2    Herbst, R.S.3
  • 72
    • 27544503230 scopus 로고    scopus 로고
    • Gefitinib plus best supportive care in previously treated patients with refractory advanced non-small-cell lung cancer: results from a randomised, placebo-controlled, multicentre study (Iressa Survival Evaluation in Lung Cancer)
    • Thatcher N, Chang A, Parikh P, et al. Gefitinib plus best supportive care in previously treated patients with refractory advanced non-small-cell lung cancer: results from a randomised, placebo-controlled, multicentre study (Iressa Survival Evaluation in Lung Cancer). Lancet 2005, 366:1527-1537.
    • (2005) Lancet , vol.366 , pp. 1527-1537
    • Thatcher, N.1    Chang, A.2    Parikh, P.3
  • 73
    • 33750962024 scopus 로고    scopus 로고
    • Molecular predictors of outcome with gefitinib in a phase III placebo-controlled study in advanced non-small-cell lung cancer
    • Hirsch FR, Varella-Garcia M, Bunn PA, et al. Molecular predictors of outcome with gefitinib in a phase III placebo-controlled study in advanced non-small-cell lung cancer. J Clin Oncol 2006, 24:5034-5042.
    • (2006) J Clin Oncol , vol.24 , pp. 5034-5042
    • Hirsch, F.R.1    Varella-Garcia, M.2    Bunn, P.A.3
  • 74
    • 0020673662 scopus 로고
    • A randomized comparison of melphalan versus melphalan plus hexamethylmelamine versus adriamycin plus cyclophosphamide in ovarian carcinoma
    • Omura GA, Morrow CP, Blessing JA, et al. A randomized comparison of melphalan versus melphalan plus hexamethylmelamine versus adriamycin plus cyclophosphamide in ovarian carcinoma. Cancer 1983, 51:783-789.
    • (1983) Cancer , vol.51 , pp. 783-789
    • Omura, G.A.1    Morrow, C.P.2    Blessing, J.A.3
  • 75
    • 0022591561 scopus 로고
    • A randomized trial of cyclophosphamide and doxorubicin with or without cisplatin in advanced ovarian carcinoma. A gynecologic oncology group study
    • Omura G, Blessing JA, Ehrlich CE, et al. A randomized trial of cyclophosphamide and doxorubicin with or without cisplatin in advanced ovarian carcinoma. A gynecologic oncology group study. Cancer 1986, 57:1725-1730.
    • (1986) Cancer , vol.57 , pp. 1725-1730
    • Omura, G.1    Blessing, J.A.2    Ehrlich, C.E.3
  • 76
    • 84855425106 scopus 로고    scopus 로고
    • Incorporation of bevacizumab in the primary treatment of ovarian cancer
    • Burger RA, Brady MF, Bookman MA, et al. Incorporation of bevacizumab in the primary treatment of ovarian cancer. N Engl J Med 2011, 365:2473-2483.
    • (2011) N Engl J Med , vol.365 , pp. 2473-2483
    • Burger, R.A.1    Brady, M.F.2    Bookman, M.A.3
  • 77
    • 84855466019 scopus 로고    scopus 로고
    • A phase 3 trial of bevacizumab in ovarian cancer
    • Perren TJ, Swart AM, Pfisterer J, et al. A phase 3 trial of bevacizumab in ovarian cancer. N Engl J Med 2011, 365:2484-2496.
    • (2011) N Engl J Med , vol.365 , pp. 2484-2496
    • Perren, T.J.1    Swart, A.M.2    Pfisterer, J.3
  • 78
    • 71549143528 scopus 로고    scopus 로고
    • Detecting an overall survival benefit that is derived from progression-free survival
    • Broglio KR, Berry DA Detecting an overall survival benefit that is derived from progression-free survival. J Natl Cancer Inst 2009, 101:1642-1649.
    • (2009) J Natl Cancer Inst , vol.101 , pp. 1642-1649
    • Broglio, K.R.1    Berry, D.A.2
  • 79
    • 82955237376 scopus 로고    scopus 로고
    • Age-specific trends of survival in metastatic breast cancer: 26 years longitudinal data from a population-based cancer registry in Stockholm, Sweden
    • Foukakis T, Fornander T, Lekberg T, Hellborg H, Adolfsson J, Bergh J Age-specific trends of survival in metastatic breast cancer: 26 years longitudinal data from a population-based cancer registry in Stockholm, Sweden. Breast Cancer Res Treat 2011, 130:553-560.
    • (2011) Breast Cancer Res Treat , vol.130 , pp. 553-560
    • Foukakis, T.1    Fornander, T.2    Lekberg, T.3    Hellborg, H.4    Adolfsson, J.5    Bergh, J.6
  • 80
    • 84874725527 scopus 로고    scopus 로고
    • Survival in patients with metastatic recurrent breast cancer after adjuvant chemotherapy: little evidence of improvement over the past 30 years
    • Tevaarwerk AJ, Gray RJ, Schneider BP, et al. Survival in patients with metastatic recurrent breast cancer after adjuvant chemotherapy: little evidence of improvement over the past 30 years. Cancer 2013, 119:1140-1148.
    • (2013) Cancer , vol.119 , pp. 1140-1148
    • Tevaarwerk, A.J.1    Gray, R.J.2    Schneider, B.P.3
  • 81
    • 0035869407 scopus 로고    scopus 로고
    • Use of chemotherapy plus a monoclonal antibody against HER2 for metastatic breast cancer that overexpresses HER2
    • Slamon DJ, Leyland-Jones B, Shak S, et al. Use of chemotherapy plus a monoclonal antibody against HER2 for metastatic breast cancer that overexpresses HER2. N Engl J Med 2001, 344:783-792.
    • (2001) N Engl J Med , vol.344 , pp. 783-792
    • Slamon, D.J.1    Leyland-Jones, B.2    Shak, S.3
  • 82
    • 84887029479 scopus 로고    scopus 로고
    • First-line bevacizumab in combination with chemotherapy for HER2-negative metastatic breast cancer: pooled and subgroup analyses of data from 2447 patients
    • Miles DW, Dieras V, Cortes J, Duenne AA, Yi J, O'Shaughnessy J First-line bevacizumab in combination with chemotherapy for HER2-negative metastatic breast cancer: pooled and subgroup analyses of data from 2447 patients. Ann Oncol 2013, 24:2773-2780.
    • (2013) Ann Oncol , vol.24 , pp. 2773-2780
    • Miles, D.W.1    Dieras, V.2    Cortes, J.3    Duenne, A.A.4    Yi, J.5    O'Shaughnessy, J.6
  • 83
    • 79960241809 scopus 로고    scopus 로고
    • Changing end points in breast-cancer drug approval-the Avastin story
    • D'Agostino RB Changing end points in breast-cancer drug approval-the Avastin story. N Engl J Med 2011, 365:e2.
    • (2011) N Engl J Med , vol.365 , pp. e2
    • D'Agostino, R.B.1
  • 85
    • 0037151389 scopus 로고    scopus 로고
    • FDA evaluating oxaliplatin for advanced colorectal cancer treatment
    • Baldwin J FDA evaluating oxaliplatin for advanced colorectal cancer treatment. J Natl Cancer Inst 2002, 94:1191-1193.
    • (2002) J Natl Cancer Inst , vol.94 , pp. 1191-1193
    • Baldwin, J.1
  • 86
    • 0037531121 scopus 로고    scopus 로고
    • Superiority of oxaliplatin and fluorouracil-leucovorin compared with either therapy alone in patients with progressive colorectal cancer after irinotecan and fluorouracil-leucovorin: interim results of a phase III trial
    • Rothenberg ML, Oza AM, Bigelow RH, et al. Superiority of oxaliplatin and fluorouracil-leucovorin compared with either therapy alone in patients with progressive colorectal cancer after irinotecan and fluorouracil-leucovorin: interim results of a phase III trial. J Clin Oncol 2003, 21:2059-2069.
    • (2003) J Clin Oncol , vol.21 , pp. 2059-2069
    • Rothenberg, M.L.1    Oza, A.M.2    Bigelow, R.H.3
  • 87
    • 1842569206 scopus 로고    scopus 로고
    • A randomized controlled trial of fluorouracil plus leucovorin, irinotecan, and oxaliplatin combinations in patients with previously untreated metastatic colorectal cancer
    • Goldberg RM, Sargent DJ, Morton RF, et al. A randomized controlled trial of fluorouracil plus leucovorin, irinotecan, and oxaliplatin combinations in patients with previously untreated metastatic colorectal cancer. J Clin Oncol 2004, 22:23-30.
    • (2004) J Clin Oncol , vol.22 , pp. 23-30
    • Goldberg, R.M.1    Sargent, D.J.2    Morton, R.F.3
  • 88
    • 84861736119 scopus 로고    scopus 로고
    • OCEANS: a randomized, double-blind, placebo-controlled phase III trial of chemotherapy with or without bevacizumab in patients with platinum-sensitive recurrent epithelial ovarian, primary peritoneal, or fallopian tube cancer
    • Aghajanian C, Blank SV, Goff BA, et al. OCEANS: a randomized, double-blind, placebo-controlled phase III trial of chemotherapy with or without bevacizumab in patients with platinum-sensitive recurrent epithelial ovarian, primary peritoneal, or fallopian tube cancer. J Clin Oncol 2012, 30:2039-2045.
    • (2012) J Clin Oncol , vol.30 , pp. 2039-2045
    • Aghajanian, C.1    Blank, S.V.2    Goff, B.A.3
  • 89
    • 84907819828 scopus 로고    scopus 로고
    • accessed Jan 31
    • Novel new drugs 2013 summary US Food and Drug Administration, (accessed Jan 31, 2014). http://www.fda.gov/downloads/drugs/developmentapprovalprocess/druginnovation/ucm381803.pdf.
    • (2014) Novel new drugs 2013 summary
  • 90
    • 8944220720 scopus 로고    scopus 로고
    • Chemotherapy with mitoxantrone plus prednisone or prednisone alone for symptomatic hormone-resistant prostate cancer: a Canadian randomized trial with palliative end points
    • Tannock IF, Osoba D, Stockler MR, et al. Chemotherapy with mitoxantrone plus prednisone or prednisone alone for symptomatic hormone-resistant prostate cancer: a Canadian randomized trial with palliative end points. J Clin Oncol 1996, 14:1756-1764.
    • (1996) J Clin Oncol , vol.14 , pp. 1756-1764
    • Tannock, I.F.1    Osoba, D.2    Stockler, M.R.3
  • 91
    • 84876082159 scopus 로고    scopus 로고
    • Effect of ruxolitinib therapy on myelofibrosis-related symptoms and other patient-reported outcomes in COMFORT-I: a randomized, double-blind, placebo-controlled trial
    • Mesa RA, Gotlib J, Gupta V, et al. Effect of ruxolitinib therapy on myelofibrosis-related symptoms and other patient-reported outcomes in COMFORT-I: a randomized, double-blind, placebo-controlled trial. J Clin Oncol 2013, 31:1285-1292.
    • (2013) J Clin Oncol , vol.31 , pp. 1285-1292
    • Mesa, R.A.1    Gotlib, J.2    Gupta, V.3
  • 92
    • 84863393110 scopus 로고    scopus 로고
    • A double-blind, placebo-controlled trial of ruxolitinib for myelofibrosis
    • Verstovsek S, Mesa RA, Gotlib J, et al. A double-blind, placebo-controlled trial of ruxolitinib for myelofibrosis. N Engl J Med 2012, 366:799-807.
    • (2012) N Engl J Med , vol.366 , pp. 799-807
    • Verstovsek, S.1    Mesa, R.A.2    Gotlib, J.3
  • 93
    • 84893757599 scopus 로고    scopus 로고
    • Randomised controlled trials and population-based observational research: partners in the evolution of medical evidence
    • Booth CM, Tannock IF Randomised controlled trials and population-based observational research: partners in the evolution of medical evidence. Br J Cancer 2014, 110:551-555.
    • (2014) Br J Cancer , vol.110 , pp. 551-555
    • Booth, C.M.1    Tannock, I.F.2
  • 94
    • 84891518400 scopus 로고    scopus 로고
    • Evaluation of treatment benefit: randomized controlled trials and population-based observational research
    • Booth CM, Tannock IF Evaluation of treatment benefit: randomized controlled trials and population-based observational research. J Clin Oncol 2013, 31:3298-3299.
    • (2013) J Clin Oncol , vol.31 , pp. 3298-3299
    • Booth, C.M.1    Tannock, I.F.2
  • 95
    • 84898744858 scopus 로고    scopus 로고
    • Comparison of survival outcomes among cancer patients treated in and out of clinical trials
    • Unger JM, Barlow WE, Martin DP, et al. Comparison of survival outcomes among cancer patients treated in and out of clinical trials. J Natl Cancer Inst 2014, 106:dju002.
    • (2014) J Natl Cancer Inst , vol.106
    • Unger, J.M.1    Barlow, W.E.2    Martin, D.P.3
  • 96
    • 33646872630 scopus 로고    scopus 로고
    • Generalizability of cancer clinical trial results: prognostic differences between participants and nonparticipants
    • Elting LS, Cooksley C, Bekele BN, et al. Generalizability of cancer clinical trial results: prognostic differences between participants and nonparticipants. Cancer 2006, 106:2452-2458.
    • (2006) Cancer , vol.106 , pp. 2452-2458
    • Elting, L.S.1    Cooksley, C.2    Bekele, B.N.3
  • 97
    • 0942278952 scopus 로고    scopus 로고
    • Comparison of outcomes in cancer patients treated within and outside clinical trials: conceptual framework and structured review
    • Peppercorn JM, Weeks JC, Cook EF, Joffe S Comparison of outcomes in cancer patients treated within and outside clinical trials: conceptual framework and structured review. Lancet 2004, 363:263-270.
    • (2004) Lancet , vol.363 , pp. 263-270
    • Peppercorn, J.M.1    Weeks, J.C.2    Cook, E.F.3    Joffe, S.4
  • 99
    • 77951115122 scopus 로고    scopus 로고
    • International network of cancer genome projects
    • Hudson TJ, Anderson W, et al. International network of cancer genome projects. Nature 2010, 464:993-998. International Cancer Genome Consortium.
    • (2010) Nature , vol.464 , pp. 993-998
    • Hudson, T.J.1    Anderson, W.2
  • 100
    • 79959838081 scopus 로고    scopus 로고
    • Integrated genomic analyses of ovarian carcinoma
    • Integrated genomic analyses of ovarian carcinoma. Nature 2011, 474:609-615. Cancer Genome Atlas Research Network.
    • (2011) Nature , vol.474 , pp. 609-615


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.