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Volumn 33, Issue 1, 2015, Pages 36-41

Resampling the N9741 trial to compare tumor dynamic versus conventional end points in randomized phase II trials

Author keywords

[No Author keywords available]

Indexed keywords

FLUOROURACIL; FOLINIC ACID; IRINOTECAN; OXALIPLATIN; ANTINEOPLASTIC AGENT; CAMPTOTHECIN; PLATINUM COMPLEX;

EID: 84920612560     PISSN: 0732183X     EISSN: 15277755     Source Type: Journal    
DOI: 10.1200/JCO.2014.57.2826     Document Type: Article
Times cited : (14)

References (32)
  • 1
    • 84883173865 scopus 로고    scopus 로고
    • Clinical approval success rates for investigational cancer drugs
    • DiMasi JA, Reichert JM, Feldman L, et al.: Clinical approval success rates for investigational cancer drugs. Clin Pharmacol Ther 94:329-335, 2013
    • (2013) Clin Pharmacol Ther , vol.94 , pp. 329-335
    • DiMasi, J.A.1    Reichert, J.M.2    Feldman, L.3
  • 2
    • 77951639219 scopus 로고    scopus 로고
    • Comparison of error rates in single-arm versus randomized phase II cancer clinical trials
    • Tang H, Foster NR, Grothey A, et al.: Comparison of error rates in single-arm versus randomized phase II cancer clinical trials. J Clin Oncol 28:1936-1941, 2010
    • (2010) J Clin Oncol , vol.28 , pp. 1936-1941
    • Tang, H.1    Foster, N.R.2    Grothey, A.3
  • 3
    • 79960746726 scopus 로고    scopus 로고
    • Randomized phase II trials: A long-term investment with promising returns
    • Sharma MR, Stadler WM, Ratain MJ: Randomized phase II trials: A long-term investment with promising returns. J Natl Cancer Inst 103:1093-1100, 2011
    • (2011) J Natl Cancer Inst , vol.103 , pp. 1093-1100
    • Sharma, M.R.1    Stadler, W.M.2    Ratain, M.J.3
  • 4
    • 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 16:1764-1769, 2010
    • (2010) Clin Cancer Res , vol.16 , pp. 1764-1769
    • Seymour, L.1    Ivy, S.P.2    Sargent, D.3
  • 5
    • 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 45:228-247, 2009
    • (2009) Eur J Cancer , vol.45 , pp. 228-247
    • Eisenhauer, E.A.1    Therasse, P.2    Bogaerts, J.3
  • 6
    • 36849078044 scopus 로고    scopus 로고
    • Progression-free survival is a surrogate for survival in advanced colorectal cancer
    • Buyse M, Burzykowski T, Carroll K., et al.: Progression-free survival is a surrogate for survival in advanced colorectal cancer. J Clin Oncol 25:5218-5224, 2007
    • (2007) J Clin Oncol , vol.25 , pp. 5218-5224
    • Buyse, M.1    Burzykowski, T.2    Carroll, K.3
  • 7
    • 35649022759 scopus 로고    scopus 로고
    • Surrogate end points for median overall survival in meta-static colorectal cancer: Literature-based analysis from 39 randomized controlled trials of first-line chemotherapy
    • Tang PA, Bentzen SM, Chen E.X., et al.: Surrogate end points for median overall survival in meta-static colorectal cancer: Literature-based analysis from 39 randomized controlled trials of first-line chemotherapy. J Clin Oncol 25:4562-4568, 2007
    • (2007) J Clin Oncol , vol.25 , pp. 4562-4568
    • Tang, P.A.1    Bentzen, S.M.2    Chen, E.X.3
  • 8
    • 42949145995 scopus 로고    scopus 로고
    • Evaluation of tumor response, disease control, progression-free survival, and time to progression as potential surrogate end points in metastatic breast cancer
    • Burzykowski T, Buyse M, Piccart-Gebhart MJ, et al.: Evaluation of tumor response, disease control, progression-free survival, and time to progression as potential surrogate end points in metastatic breast cancer. J Clin Oncol 26:1987-1992, 2008
    • (2008) J Clin Oncol , vol.26 , pp. 1987-1992
    • Burzykowski, T.1    Buyse, M.2    Piccart-Gebhart, M.J.3
  • 9
    • 84890617204 scopus 로고    scopus 로고
    • Progression-free survival as a surrogate endpoint of overall survival in patients with metastatic renal cell carcinoma
    • Halabi S, Rini B, Escudier B., et al.: Progression-free survival as a surrogate endpoint of overall survival in patients with metastatic renal cell carcinoma. Cancer 120:52-60, 2014
    • (2014) Cancer , vol.120 , pp. 52-60
    • Halabi, S.1    Rini, B.2    Escudier, B.3
  • 10
    • 84877648468 scopus 로고    scopus 로고
    • Prediction of survival benefits from progression-free survival benefits in advanced non-small-cell lung cancer: Evidence from a meta-analysis of 2334 patients from 5 randomised trials
    • [epub ahead of print on March 13, 2013]
    • Laporte S, Squifflet P, Baroux N., et al.: Prediction of survival benefits from progression-free survival benefits in advanced non-small-cell lung cancer: Evidence from a meta-analysis of 2334 patients from 5 randomised trials. BMJ Open [epub ahead of print on March 13, 2013]
    • BMJ Open
    • Laporte, S.1    Squifflet, P.2    Baroux, N.3
  • 11
    • 0019760378 scopus 로고
    • An alternative model for the evaluation of antitumor activity
    • Lavin PT: An alternative model for the evaluation of antitumor activity. Cancer Clin Trials 4:451-457, 1981
    • (1981) Cancer Clin Trials , vol.4 , pp. 451-457
    • Lavin, P.T.1
  • 12
    • 35148821353 scopus 로고    scopus 로고
    • Design of phase II cancer trials using a continuous endpoint of change in tumor size: Application to a study of sorafenib and erlotinib in non small-cell lung cancer
    • Karrison TG, Maitland ML, Stadler W.M., et al.: Design of phase II cancer trials using a continuous endpoint of change in tumor size: Application to a study of sorafenib and erlotinib in non small-cell lung cancer. J Natl Cancer Inst 99:1455-1461, 2007
    • (2007) J Natl Cancer Inst , vol.99 , pp. 1455-1461
    • Karrison, T.G.1    Maitland, M.L.2    Stadler, W.M.3
  • 13
    • 84879083853 scopus 로고    scopus 로고
    • Designing exploratory cancer trials using change in tumour size as primary endpoint
    • Jaki T, André V, Su TL, et al.: Designing exploratory cancer trials using change in tumour size as primary endpoint. Stat Med 32:2544-2554, 2013
    • (2013) Stat Med , vol.32 , pp. 2544-2554
    • Jaki, T.1    André, V.2    Su, T.L.3
  • 14
    • 84864047388 scopus 로고    scopus 로고
    • Change in tumor size by RECIST correlates linearly with overall survival in phase I oncology studies
    • Jain RK, Lee JJ, Ng C, et al.: Change in tumor size by RECIST correlates linearly with overall survival in phase I oncology studies. J Clin Oncol 30:2684-2690, 2012
    • (2012) J Clin Oncol , vol.30 , pp. 2684-2690
    • Jain, R.K.1    Lee, J.J.2    Ng, C.3
  • 15
    • 70249134646 scopus 로고    scopus 로고
    • Model-based prediction of phase III overall survival in colorectal cancer on the basis of phase II tumor dynamics
    • Claret L, Girard P, Hoff P.M., et al.: Model-based prediction of phase III overall survival in colorectal cancer on the basis of phase II tumor dynamics. J Clin Oncol 27:4103-4108, 2009
    • (2009) J Clin Oncol , vol.27 , pp. 4103-4108
    • Claret, L.1    Girard, P.2    Hoff, P.M.3
  • 16
    • 67651171223 scopus 로고    scopus 로고
    • Elucidation of relationship between tumor size and survival in non-small-cell lung cancer patients can aid early decision making in clinical drug development
    • Wang Y, Sung C, Dartois C., et al.: Elucidation of relationship between tumor size and survival in non-small-cell lung cancer patients can aid early decision making in clinical drug development. Clin Pharmacol Ther 86:167-174, 2009
    • (2009) Clin Pharmacol Ther , vol.86 , pp. 167-174
    • Wang, Y.1    Sung, C.2    Dartois, C.3
  • 17
    • 84887454644 scopus 로고    scopus 로고
    • Evaluation of tumor-size response metrics to predict overall survival in western and Chinese patients with first-line metastatic colorectal cancer
    • Claret L, Gupta M, Han K., et al.: Evaluation of tumor-size response metrics to predict overall survival in Western and Chinese patients with first-line metastatic colorectal cancer. J Clin Oncol 31:2110-2114, 2013
    • (2013) J Clin Oncol , vol.31 , pp. 2110-2114
    • Claret, L.1    Gupta, M.2    Han, K.3
  • 18
    • 84859828707 scopus 로고    scopus 로고
    • Resampling phase III data to assess phase II trial designs and endpoints
    • Sharma MR, Karrison TG, Jin Y, et al.: Resampling phase III data to assess phase II trial designs and endpoints. Clin Cancer Res 18:2309-2315, 2012
    • (2012) Clin Cancer Res , vol.18 , pp. 2309-2315
    • Sharma, M.R.1    Karrison, T.G.2    Jin, Y.3
  • 19
    • 1842569206 scopus 로고    scopus 로고
    • A randomized controlled trial of fluorouracil plus leuco-vorin, irinotecan, and oxaliplatin combinations in patients with previously untreated metastatic colo-rectal cancer
    • Goldberg RM, Sargent DJ, Morton R.F., et al.: A randomized controlled trial of fluorouracil plus leuco-vorin, irinotecan, and oxaliplatin combinations in patients with previously untreated metastatic colo-rectal cancer. J Clin Oncol 22:23-30, 2004
    • (2004) J Clin Oncol , vol.22 , pp. 23-30
    • Goldberg, R.M.1    Sargent, D.J.2    Morton, R.F.3
  • 20
    • 57449096129 scopus 로고    scopus 로고
    • Five-year data and prognostic factor analysis of oxaliplatin and irinotecan combinations for advanced colorectal cancer: N9741
    • Sanoff HK, Sargent DJ, Campbell M.E., et al.: Five-year data and prognostic factor analysis of oxaliplatin and irinotecan combinations for advanced colorectal cancer: N9741. J Clin Oncol 26:5721-5727, 2008
    • (2008) J Clin Oncol , vol.26 , pp. 5721-5727
    • Sanoff, H.K.1    Sargent, D.J.2    Campbell, M.E.3
  • 22
    • 73349093435 scopus 로고    scopus 로고
    • NCCTG study N9741: Leveraging learning from an NCI cooperative group phase III trial
    • Goldberg RM, Sargent DJ, Morton R.F., et al.: NCCTG study N9741: Leveraging learning from an NCI Cooperative Group phase III trial. Oncologist 14:970-978, 2009
    • (2009) Oncologist , vol.14 , pp. 970-978
    • Goldberg, R.M.1    Sargent, D.J.2    Morton, R.F.3
  • 23
    • 84859377987 scopus 로고    scopus 로고
    • Role of randomized phase III trials in an era of effective targeted therapies
    • Sharma MR, Schilsky RL: Role of randomized phase III trials in an era of effective targeted therapies. Nat Rev Clin Oncol 9:208-214, 2012
    • (2012) Nat Rev Clin Oncol , vol.9 , pp. 208-214
    • Sharma, M.R.1    Schilsky, R.L.2
  • 24
    • 84885431341 scopus 로고    scopus 로고
    • Using continuous data on tumour measurements to improve inference in phase II cancer studies
    • Wason JM, Seaman SR: Using continuous data on tumour measurements to improve inference in phase II cancer studies. Stat Med 32:4639-4650, 2013
    • (2013) Stat Med , vol.32 , pp. 4639-4650
    • Wason, J.M.1    Seaman, S.R.2
  • 25
    • 80051725760 scopus 로고    scopus 로고
    • Variability of lung tumor measurements on repeat computed tomography scans taken within 15 minutes
    • Oxnard GR, Zhao B, Sima C.S., et al.: Variability of lung tumor measurements on repeat computed tomography scans taken within 15 minutes. J Clin Oncol 29:3114-3119, 2011
    • (2011) J Clin Oncol , vol.29 , pp. 3114-3119
    • Oxnard, G.R.1    Zhao, B.2    Sima, C.S.3
  • 26
    • 77956672580 scopus 로고    scopus 로고
    • A pilot study of volume measurement as a method of tumor response evaluation to aid biomarker development
    • Zhao B, Oxnard GR, Moskowitz C.S., et al.: A pilot study of volume measurement as a method of tumor response evaluation to aid biomarker development. Clin Cancer Res 16:4647-4653, 2010
    • (2010) Clin Cancer Res , vol.16 , pp. 4647-4653
    • Zhao, B.1    Oxnard, G.R.2    Moskowitz, C.S.3
  • 27
    • 84876922158 scopus 로고    scopus 로고
    • Exploring intra-and inter-reader variability in uni-dimensional, bi-dimensional, and volumetric measurements of solid tumors on CT scans reconstructed at different slice intervals
    • Zhao B, Tan Y, Bell D.J., et al.: Exploring intra-and inter-reader variability in uni-dimensional, bi-dimensional, and volumetric measurements of solid tumors on CT scans reconstructed at different slice intervals. Eur J Radiol 82:959-968, 2013
    • (2013) Eur J Radiol , vol.82 , pp. 959-968
    • Zhao, B.1    Tan, Y.2    Bell, D.J.3
  • 28
    • 84872577135 scopus 로고    scopus 로고
    • Tumor burden modeling versus progression-free survival for phase II decision making
    • Kaiser LD: Tumor burden modeling versus progression-free survival for phase II decision making. Clin Cancer Res 19:314-319, 2013
    • (2013) Clin Cancer Res , vol.19 , pp. 314-319
    • Kaiser, L.D.1
  • 29
    • 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 101:1642-1649, 2009
    • (2009) J Natl Cancer Inst , vol.101 , pp. 1642-1649
    • Broglio, K.R.1    Berry, D.A.2
  • 30
    • 80054122239 scopus 로고    scopus 로고
    • Comparison of continuous versus categorical tumor measurement-based metrics to predict overall survival in cancer treatment trials
    • An MW, Mandrekar SJ, Branda M.E., et al.: Comparison of continuous versus categorical tumor measurement-based metrics to predict overall survival in cancer treatment trials. Clin Cancer Res 17:6592-6599, 2011
    • (2011) Clin Cancer Res , vol.17 , pp. 6592-6599
    • An, M.W.1    Mandrekar, S.J.2    Branda, M.E.3
  • 31
    • 79959596337 scopus 로고    scopus 로고
    • Tumor status at 12 weeks predicts survival in advanced colorectal cancer: Findings from NCCTG N9741
    • Huen JM, Grothey A, Branda M.E., et al.: Tumor status at 12 weeks predicts survival in advanced colorectal cancer: Findings from NCCTG N9741. Oncologist 16:859-867, 2011
    • (2011) Oncologist , vol.16 , pp. 859-867
    • Huen, J.M.1    Grothey, A.2    Branda, M.E.3
  • 32
    • 84857407870 scopus 로고    scopus 로고
    • The ARCAD clinical trials program: An update and invitation
    • Sargent DJ, Buyse M, Matheson A., et al.: The ARCAD clinical trials program: An update and invitation. Oncologist 17:188-191, 2012
    • (2012) Oncologist , vol.17 , pp. 188-191
    • Sargent, D.J.1    Buyse, M.2    Matheson, A.3


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.