메뉴 건너뛰기




Volumn 13, Issue 2, 2016, Pages 169-179

Identifying treatment effect heterogeneity in clinical trials using subpopulations of events: STEPP

Author keywords

Biomarker; breast cancer; competing risk; interaction; overview; permutation based inference; personalized medicine; precision medicine; survival analysis

Indexed keywords

KI 67 ANTIGEN; LETROZOLE; TAMOXIFEN; ANTINEOPLASTIC AGENT; ANTINEOPLASTIC HORMONE AGONISTS AND ANTAGONISTS; NITRILE; TRIAZOLE DERIVATIVE; TUMOR MARKER;

EID: 84960449984     PISSN: 17407745     EISSN: 17407753     Source Type: Journal    
DOI: 10.1177/1740774515609106     Document Type: Article
Times cited : (22)

References (30)
  • 1
    • 36348939350 scopus 로고    scopus 로고
    • Statistics in medicine - Reporting of subgroup analyses in clinical trials
    • Wang R, Lagakos SW, Ware JH, et al. Statistics in medicine-reporting of subgroup analyses in clinical trials. N Eng J Med 2007; 357: 2189-2194.
    • (2007) N Eng J Med , vol.357 , pp. 2189-2194
    • Wang, R.1    Lagakos, S.W.2    Ware, J.H.3
  • 2
    • 77955382172 scopus 로고    scopus 로고
    • Assessing and reporting heterogeneity in treatment effects in clinical trials: A proposal
    • Kent DM, Rothwell PM, Ioannidis JPA, et al. Assessing and reporting heterogeneity in treatment effects in clinical trials: a proposal. Trials 2011; 11: 1-11.
    • (2011) Trials , vol.11 , pp. 1-11
    • Kent, D.M.1    Rothwell, P.M.2    Ioannidis, J.P.A.3
  • 3
    • 31344435149 scopus 로고    scopus 로고
    • Dichotomizing continuous predictors in multiple regression: A bad idea
    • Royston P, Altman D, Sauerbrei W,. Dichotomizing continuous predictors in multiple regression: a bad idea. Stat Med 2006; 25: 127-141.
    • (2006) Stat Med , vol.25 , pp. 127-141
    • Royston, P.1    Altman, D.2    Sauerbrei, W.3
  • 4
    • 78649960550 scopus 로고    scopus 로고
    • Statistical considerations in evaluating pharmacogenomics-based clinical effect for confirmatory trials
    • Wang SJ, O'Neil RT, Hung HJ,. Statistical considerations in evaluating pharmacogenomics-based clinical effect for confirmatory trials. Clin Trials 2010; 7: 525-536.
    • (2010) Clin Trials , vol.7 , pp. 525-536
    • Wang, S.J.1    O'Neil, R.T.2    Hung, H.J.3
  • 5
    • 33645895554 scopus 로고    scopus 로고
    • The challenge of subgroup analyses - Reporting without distorting
    • Lagakos SW,. The challenge of subgroup analyses-reporting without distorting. N Engl J Med 2006; 354: 1667-1669.
    • (2006) N Engl J Med , vol.354 , pp. 1667-1669
    • Lagakos, S.W.1
  • 6
    • 43249093045 scopus 로고    scopus 로고
    • More on subgroup analysis in clinical trials
    • Pocock S,. More on subgroup analysis in clinical trials. N Eng J Med 2008; 358: 2076-2077.
    • (2008) N Eng J Med , vol.358 , pp. 2076-2077
    • Pocock, S.1
  • 7
    • 0034668136 scopus 로고    scopus 로고
    • A graphical method to assess treatment-covariate interactions using the Cox model on subsets of the data
    • Bonetti M, Gelber RD,. A graphical method to assess treatment-covariate interactions using the Cox model on subsets of the data. Stat Med 2000; 19: 2595-2609.
    • (2000) Stat Med , vol.19 , pp. 2595-2609
    • Bonetti, M.1    Gelber, R.D.2
  • 8
    • 20044377408 scopus 로고    scopus 로고
    • Patterns of treatment effects in subsets of patients in clinical trials
    • Bonetti M, Gelber R,. Patterns of treatment effects in subsets of patients in clinical trials. Biostatistics 2004; 5: 465-481.
    • (2004) Biostatistics , vol.5 , pp. 465-481
    • Bonetti, M.1    Gelber, R.2
  • 9
    • 65649108011 scopus 로고    scopus 로고
    • A small sample study of the STEPP approach to assessing treatment-covariate interactions in survival data
    • Bonetti M, Zahrieh D, Cole BF, et al. A small sample study of the STEPP approach to assessing treatment-covariate interactions in survival data. Stat Med 2009; 28: 1255-1268.
    • (2009) Stat Med , vol.28 , pp. 1255-1268
    • Bonetti, M.1    Zahrieh, D.2    Cole, B.F.3
  • 10
    • 79951613307 scopus 로고    scopus 로고
    • Evaluation of treatment-effect heterogeneity using biomarkers measured on a continuous scale: Subpopulation treatment effect pattern plot
    • Lazar AA, Cole BF, Bonetti M, et al. Evaluation of treatment-effect heterogeneity using biomarkers measured on a continuous scale: subpopulation treatment effect pattern plot. J Clin Oncol 2010; 28: 4539-4544.
    • (2010) J Clin Oncol , vol.28 , pp. 4539-4544
    • Lazar, A.A.1    Cole, B.F.2    Bonetti, M.3
  • 11
    • 0036431372 scopus 로고    scopus 로고
    • Issues related to subgroup analysis in clinical trials
    • Cui I, Hung HM, Wang SJ, et al. Issues related to subgroup analysis in clinical trials. J Biopharm Stat 2002; 12: 347-358.
    • (2002) J Biopharm Stat , vol.12 , pp. 347-358
    • Cui, I.1    Hung, H.M.2    Wang, S.J.3
  • 12
    • 0000336139 scopus 로고
    • Regression models and life tables
    • with discussion
    • Cox DR,. Regression models and life tables (with discussion). J R Stat Soc Series B Stat Methodol 1972; 34: 187-220.
    • (1972) J R Stat Soc Series B Stat Methodol , vol.34 , pp. 187-220
    • Cox, D.R.1
  • 13
    • 29544433211 scopus 로고    scopus 로고
    • A comparison of letrozole and tamoxifen in postmenopausal women with early breast cancer
    • The Breast International Group (BIG) 1-98 Collaborative Group, Thürlimann B, Keshaviah A, et al. A comparison of letrozole and tamoxifen in postmenopausal women with early breast cancer. N Engl J Med 2005; 353: 2747-2757.
    • (2005) N Engl J Med , vol.353 , pp. 2747-2757
    • Thürlimann, B.1    Keshaviah, A.2
  • 14
    • 33947510501 scopus 로고    scopus 로고
    • Five years of letrozole compared with tamoxifen as initial adjuvant therapy for postmenopausal women with endocrine-responsive early breast cancer: Update of study BIG 1-98
    • Coates AS, Keshaviah A, Thürlimann B, et al. Five years of letrozole compared with tamoxifen as initial adjuvant therapy for postmenopausal women with endocrine-responsive early breast cancer: update of study BIG 1-98. J Clin Oncol 2007; 25: 486-492.
    • (2007) J Clin Oncol , vol.25 , pp. 486-492
    • Coates, A.S.1    Keshaviah, A.2    Thürlimann, B.3
  • 15
    • 0033180397 scopus 로고    scopus 로고
    • The utility of mitotic index, oestrogen receptor and Ki-67 measurements in the creation of novel prognostic indices for node-negative breast cancer
    • Clahsen PC, van de Velde CJ, Duval C, et al. The utility of mitotic index, oestrogen receptor and Ki-67 measurements in the creation of novel prognostic indices for node-negative breast cancer. Eur J Surg Oncol 1999; 25: 356-363.
    • (1999) Eur J Surg Oncol , vol.25 , pp. 356-363
    • Clahsen, P.C.1    Van De Velde, C.J.2    Duval, C.3
  • 16
    • 33645735920 scopus 로고    scopus 로고
    • Proliferation, steroid receptors and clinical/pathological response in breast cancer treated with letrozole
    • Miller WR, White S, Dixon JM, et al. Proliferation, steroid receptors and clinical/pathological response in breast cancer treated with letrozole. Br J Cancer 2006; 94: 1051-1056.
    • (2006) Br J Cancer , vol.94 , pp. 1051-1056
    • Miller, W.R.1    White, S.2    Dixon, J.M.3
  • 17
    • 57149103724 scopus 로고    scopus 로고
    • Prognostic and predictive value of centrally reviewed Ki-67 labeling index in postmenopausal women with endocrine-responsive breast cancer: Results from Breast International Group Trial 1-98 comparing adjuvant tamoxifen with letrozole
    • Viale G, Giobbie-Hurder A, Regan MM, et al. Prognostic and predictive value of centrally reviewed Ki-67 labeling index in postmenopausal women with endocrine-responsive breast cancer: results from Breast International Group Trial 1-98 comparing adjuvant tamoxifen with letrozole. J Clin Oncol 2008; 26: 5569-5575.
    • (2008) J Clin Oncol , vol.26 , pp. 5569-5575
    • Viale, G.1    Giobbie-Hurder, A.2    Regan, M.M.3
  • 19
    • 33845382806 scopus 로고
    • Nonparametric estimation from incomplete observations
    • Kaplan EL, Meier P,. Nonparametric estimation from incomplete observations. J Am Stat Assoc 1958; 53: 457-481.
    • (1958) J Am Stat Assoc , vol.53 , pp. 457-481
    • Kaplan, E.L.1    Meier, P.2
  • 21
    • 0017365573 scopus 로고
    • Design and analysis of randomized clinical trials requiring prolonged observation of each patient
    • Peto R, Pike MC, Armitage P, et al. Design and analysis of randomized clinical trials requiring prolonged observation of each patient. Br J Cancer 1977; 35: 1-39.
    • (1977) Br J Cancer , vol.35 , pp. 1-39
    • Peto, R.1    Pike, M.C.2    Armitage, P.3
  • 22
    • 0000336139 scopus 로고
    • Regression models and life tables
    • with discussion
    • Cox DR,. Regression models and life tables (with discussion). J R Stat Soc Series B Stat Methodol 1972; 34: 187-220.
    • (1972) J R Stat Soc Series B Stat Methodol , vol.34 , pp. 187-220
    • Cox, D.R.1
  • 23
    • 1542532754 scopus 로고    scopus 로고
    • A proportional hazards model for the subdistribution of a competing risk
    • Fine JP, Gray RJ,. A proportional hazards model for the subdistribution of a competing risk. J Am Stat Assoc 1999; 94: 496-509.
    • (1999) J Am Stat Assoc , vol.94 , pp. 496-509
    • Fine, J.P.1    Gray, R.J.2
  • 24
    • 0035970127 scopus 로고    scopus 로고
    • Detecting treatment-by-centre interactions in multi-centre clinical trials
    • Potthoff RF, Peterson BL, George SL,. Detecting treatment-by-centre interactions in multi-centre clinical trials. Stat Med 2001; 30: 193-213.
    • (2001) Stat Med , vol.30 , pp. 193-213
    • Potthoff, R.F.1    Peterson, B.L.2    George, S.L.3
  • 25
    • 43249093045 scopus 로고    scopus 로고
    • More on subgroup analysis in clinical trials
    • Pocock S,. More on subgroup analysis in clinical trials. N Engl J Med 2008; 358: 2076.
    • (2008) N Engl J Med , vol.358 , pp. 2076
    • Pocock, S.1
  • 28
    • 4344621625 scopus 로고    scopus 로고
    • A new approach to modeling interactions between treatment and continuous covariates in clinical trials by using fractional polynomials
    • Royston P, Sauerbrei W,. A new approach to modeling interactions between treatment and continuous covariates in clinical trials by using fractional polynomials. Stat Med 2004; 19: 2509-2525.
    • (2004) Stat Med , vol.19 , pp. 2509-2525
    • Royston, P.1    Sauerbrei, W.2
  • 30
    • 0037108041 scopus 로고    scopus 로고
    • Bayesian subset analysis: Application to studying treatment-by-gender interactions
    • Simon R,. Bayesian subset analysis: application to studying treatment-by-gender interactions. Stat Med 2002; 21: 2909-2916.
    • (2002) Stat Med , vol.21 , pp. 2909-2916
    • Simon, R.1


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.