메뉴 건너뛰기




Volumn 26, Issue 3, 2015, Pages 485-496

Evaluating surrogacy metrics and investigating approval decisions of progression-free survival (PFS) in metastatic renal cell cancer: A systematic review

Author keywords

Metastatic renal cell; Progression free survival; Surrogate marker; Surrogate threshold effect; Targeted therapy

Indexed keywords

AE 941; ALPHA INTERFERON; AXITINIB; BEVACIZUMAB; CAPECITABINE; CARNITINE; DEHYDRODIDEMNIN B; EVEROLIMUS; FLUOROURACIL; GAMMA INTERFERON; HISTAMINE; INTERFERON; INTERLEUKIN 2; MEDROXYPROGESTERONE ACETATE; N ACETYLSARCOSYLGLYCYLVALYL DEXTRO ALLOISOLEUCYLTHREONYLNORVALYLISOLEUCYLARGINYLPROLINE ETHYLAMIDE; PAZOPANIB; PLACEBO; RETINOIC ACID; SORAFENIB; SUNITINIB; TAMOXIFEN; TEMSIROLIMUS; VINBLASTINE; ANTINEOPLASTIC AGENT; BIOLOGICAL MARKER; CARBANILAMIDE DERIVATIVE; QUINOLINE DERIVATIVE; TIVOZANIB;

EID: 84939796768     PISSN: 09237534     EISSN: 15698041     Source Type: Journal    
DOI: 10.1093/annonc/mdu267     Document Type: Review
Times cited : (17)

References (82)
  • 1
    • 7144255510 scopus 로고    scopus 로고
    • Interferon gamma-1b compared with placebo in metastatic renal-cell carcinoma
    • Gleave ME, Elhilali M, Fradet Y et al. Interferon gamma-1b compared with placebo in metastatic renal-cell carcinoma. Canadian Urologic Oncology Group. N Engl J Med 1998; 338(18): 1265-1271.
    • (1998) N Engl J Med , vol.338 , Issue.18 , pp. 1265-1271
    • Gleave, M.E.1    Elhilali, M.2    Fradet, Y.3
  • 2
    • 33846260566 scopus 로고    scopus 로고
    • Sorafenib for the treatment of advanced renal cell carcinoma
    • Kane RC, Farrell AT, Saber H et al. Sorafenib for the treatment of advanced renal cell carcinoma. Clin Cancer Res 2006; 12(24): 7271-7278.
    • (2006) Clin Cancer Res , vol.12 , Issue.24 , pp. 7271-7278
    • Kane, R.C.1    Farrell, A.T.2    Saber, H.3
  • 3
    • 33947423448 scopus 로고    scopus 로고
    • Approval summary: sunitinib for the treatment of imatinib refractory or intolerant gastrointestinal stromal tumors and advanced renal cell carcinoma
    • Goodman VL, Rock EP, Dagher R et al. Approval summary: sunitinib for the treatment of imatinib refractory or intolerant gastrointestinal stromal tumors and advanced renal cell carcinoma. Clin Cancer Res 2007; 13(5): 1367-1373.
    • (2007) Clin Cancer Res , vol.13 , Issue.5 , pp. 1367-1373
    • Goodman, V.L.1    Rock, E.P.2    Dagher, R.3
  • 4
    • 80455140297 scopus 로고    scopus 로고
    • The European Medicines Agency review of pazopanib for the treatment of advanced renal cell carcinoma: summary of the scientific assessment of the committee for medicinal products for human use
    • Nieto M, Borregaard J, Ersboll J et al. The European Medicines Agency review of pazopanib for the treatment of advanced renal cell carcinoma: summary of the scientific assessment of the committee for medicinal products for human use. Clin Cancer Res 2011; 17(21): 6608-6614.
    • (2011) Clin Cancer Res , vol.17 , Issue.21 , pp. 6608-6614
    • Nieto, M.1    Borregaard, J.2    Ersboll, J.3
  • 5
    • 84941703895 scopus 로고    scopus 로고
    • (21 January 2013, date last accessed)
    • FDA. Axitinib. http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm289439.htm (21 January 2013, date last accessed).
  • 6
    • 77951729433 scopus 로고    scopus 로고
    • FDA approval summary: temsirolimus as treatment for advanced renal cell carcinoma
    • Kwitkowski VE, Prowell TM, Ibrahim A et al. FDA approval summary: temsirolimus as treatment for advanced renal cell carcinoma. Oncologist 2010; 15(4): 428-435.
    • (2010) Oncologist , vol.15 , Issue.4 , pp. 428-435
    • Kwitkowski, V.E.1    Prowell, T.M.2    Ibrahim, A.3
  • 7
    • 84941703896 scopus 로고    scopus 로고
    • (21 January 2013, date last accessed)
    • FDA. Everolimus 2010. http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedical ProductsandTobacco/CDER/ucm127799.htm (21 January 2013, date last accessed).
    • (2010)
  • 8
    • 75649152090 scopus 로고    scopus 로고
    • FDA drug approval summary: bevacizumab plus interferon for advanced renal cell carcinoma
    • Summers J, Cohen MH, Keegan P, Pazdur R. FDA drug approval summary: bevacizumab plus interferon for advanced renal cell carcinoma. Oncologist 2010; 15(1): 104-111.
    • (2010) Oncologist , vol.15 , Issue.1 , pp. 104-111
    • Summers, J.1    Cohen, M.H.2    Keegan, P.3    Pazdur, R.4
  • 9
    • 84941703897 scopus 로고    scopus 로고
    • Ovarian Cancer Endpoints Workshop April 26, 2006 MEETING SUMMARY (21 January 2013, date last accessed)
    • U.S. Food and Drug Administration & ASCO, Co-sponsored by the American Association for Cancer Research. Ovarian Cancer Endpoints Workshop April 26, 2006 MEETING SUMMARY. http://www.fda.gov/downloads/AboutFDA/CentersOffices/CDER/ucm120657.pdf (21 January 2013, date last accessed).
    • Co-sponsored by the American Association for Cancer Research
  • 10
    • 35649022759 scopus 로고    scopus 로고
    • Surrogate end points for median overall survival in metastatic colorectal cancer: literature-based analysis from 39 randomized controlled trials of first-line chemotherapy
    • Tang PA, Bentzen SM, Chen EX, Siu LL. Surrogate end points for median overall survival in metastatic colorectal cancer: literature-based analysis from 39 randomized controlled trials of first-line chemotherapy. J Clin Oncol 2007; 25(29): 4562-4568.
    • (2007) J Clin Oncol , vol.25 , Issue.29 , pp. 4562-4568
    • Tang, P.A.1    Bentzen, S.M.2    Chen, E.X.3    Siu, L.L.4
  • 11
    • 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 2007; 25(33): 5218-5224.
    • (2007) J Clin Oncol , vol.25 , Issue.33 , pp. 5218-5224
    • Buyse, M.1    Burzykowski, T.2    Carroll, K.3
  • 12
    • 34548289390 scopus 로고    scopus 로고
    • FDA drug approval summary: panitumumab (Vectibix)
    • Giusti RM, Shastri KA, Cohen MH et al. FDA drug approval summary: panitumumab (Vectibix). Oncologist 2007; 12(5): 577-583.
    • (2007) Oncologist , vol.12 , Issue.5 , pp. 577-583
    • Giusti, R.M.1    Shastri, K.A.2    Cohen, M.H.3
  • 13
    • 77649244511 scopus 로고    scopus 로고
    • Review of oncology and hematology drug product approvals at the US Food and Drug Administration between July 2005 and December 2007
    • Sridhara R, Johnson JR, Justice R et al. Review of oncology and hematology drug product approvals at the US Food and Drug Administration between July 2005 and December 2007. J Natl Cancer Inst 2010; 102(4): 230-243.
    • (2010) J Natl Cancer Inst , vol.102 , Issue.4 , pp. 230-243
    • Sridhara, R.1    Johnson, J.R.2    Justice, R.3
  • 14
    • 77954629858 scopus 로고    scopus 로고
    • The role of the U.S. Food and Drug Administration review process: clinical trial endpoints in oncology
    • McKee AE, Farrell AT, Pazdur R, Woodcock J. The role of the U.S. Food and Drug Administration review process: clinical trial endpoints in oncology. Oncologist 2010; 15(Suppl 1): 13-18.
    • (2010) Oncologist , vol.15 , pp. 13-18
    • McKee, A.E.1    Farrell, A.T.2    Pazdur, R.3    Woodcock, J.4
  • 15
    • 80255138220 scopus 로고    scopus 로고
    • Targeted therapy for advanced renal cell cancer (RCC): a Cochrane systematic review of published randomised trials
    • Coppin C, Kollmannsberger C, Le L et al. Targeted therapy for advanced renal cell cancer (RCC): a Cochrane systematic review of published randomised trials. BJU Int 2011; 108(10): 1556-1563.
    • (2011) BJU Int , vol.108 , Issue.10 , pp. 1556-1563
    • Coppin, C.1    Kollmannsberger, C.2    Le, L.3
  • 18
    • 0030777744 scopus 로고    scopus 로고
    • Meta-analysis for the evaluation of potential surrogate markers
    • Daniels MJ, Hughes MD. Meta-analysis for the evaluation of potential surrogate markers. Stat Med 1997; 16(17): 1965-1982.
    • (1997) Stat Med , vol.16 , Issue.17 , pp. 1965-1982
    • Daniels, M.J.1    Hughes, M.D.2
  • 19
    • 48049115014 scopus 로고    scopus 로고
    • The Biomarker-Surrogacy Evaluation Schema: a review of the biomarker-surrogate literature and a proposal for a criterion-based, quantitative, multidimensional hierarchical levels of evidence schema for evaluating the status of biomarkers as surrogate endpoints
    • Lassere MN. The Biomarker-Surrogacy Evaluation Schema: a review of the biomarker-surrogate literature and a proposal for a criterion-based, quantitative, multidimensional hierarchical levels of evidence schema for evaluating the status of biomarkers as surrogate endpoints. Stat Methods Med Res 2008; 17(3): 303-340.
    • (2008) Stat Methods Med Res , vol.17 , Issue.3 , pp. 303-340
    • Lassere, M.N.1
  • 20
    • 84857976303 scopus 로고    scopus 로고
    • Is blood pressure reduction a valid surrogate endpoint for stroke prevention?. An analysis incorporating a systematic review of randomised controlled trials, a by-trial weighted errors-in-variables regression, the surrogate threshold effect (STE) and the Biomarker-Surrogacy (BioSurrogate) Evaluation Schema (BSES)
    • Lassere MN, Johnson KR, Schiff M, Rees D. Is blood pressure reduction a valid surrogate endpoint for stroke prevention? An analysis incorporating a systematic review of randomised controlled trials, a by-trial weighted errors-in-variables regression, the surrogate threshold effect (STE) and the Biomarker-Surrogacy (BioSurrogate) Evaluation Schema (BSES). BMC Med Res Methodol 2012; 12: 27.
    • (2012) BMC Med Res Methodol , vol.12 , pp. 27
    • Lassere, M.N.1    Johnson, K.R.2    Schiff, M.3    Rees, D.4
  • 21
    • 0023925278 scopus 로고
    • Does chemotherapy improve survival in advanced breast cancer? A statistical overview
    • A'Hern RP, Ebbs SR, Baum MB. Does chemotherapy improve survival in advanced breast cancer? A statistical overview. Br J Cancer 1988; 57(6): 615-618.
    • (1988) Br J Cancer , vol.57 , Issue.6 , pp. 615-618
    • A'Hern, R.P.1    Ebbs, S.R.2    Baum, M.B.3
  • 22
    • 68549101842 scopus 로고    scopus 로고
    • The PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate healthcare interventions: explanation and elaboration
    • Liberati A, Altman DG, Tetzlaff J et al. The PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate healthcare interventions: explanation and elaboration. Br J Med 2009; 339: b2700-b.
    • (2009) Br J Med , vol.339
    • Liberati, A.1    Altman, D.G.2    Tetzlaff, J.3
  • 25
    • 0031674558 scopus 로고    scopus 로고
    • Interleukin-2, interferon-alpha and interleukin-2 plus interferon-alpha in renal cell carcinoma. A randomized phase II trial
    • Boccardo F, Rubagotti A, Canobbio L et al. Interleukin-2, interferon-alpha and interleukin-2 plus interferon-alpha in renal cell carcinoma. A randomized phase II trial. Tumori 1998; 84(5): 534-539.
    • (1998) Tumori , vol.84 , Issue.5 , pp. 534-539
    • Boccardo, F.1    Rubagotti, A.2    Canobbio, L.3
  • 26
    • 7144227930 scopus 로고    scopus 로고
    • Recombinant human interleukin-2, recombinant human interferon alfa-2a, or both in metastatic renal-cell carcinoma. Groupe Francais D'immunotherapie
    • Negrier S, Escudier B, Lasset C et al. Recombinant human interleukin-2, recombinant human interferon alfa-2a, or both in metastatic renal-cell carcinoma. Groupe Francais D'immunotherapie. N Engl J Med 1998; 338(18): 1272-1278.
    • (1998) N Engl J Med , vol.338 , Issue.18 , pp. 1272-1278
    • Negrier, S.1    Escudier, B.2    Lasset, C.3
  • 27
    • 0033514050 scopus 로고    scopus 로고
    • Interferon-alpha and survival in metastatic renal carcinoma: early results of a randomised controlled trial. Medical Research Council Renal Cancer Collaborators
    • Collaborators MRCRC. Interferon-alpha and survival in metastatic renal carcinoma: early results of a randomised controlled trial. Medical Research Council Renal Cancer Collaborators. Lancet 1999; 353(9146): 14-17.
    • (1999) Lancet , vol.353 , Issue.9146 , pp. 14-17
  • 28
    • 2442737061 scopus 로고    scopus 로고
    • Prospective randomized trial of interferon alfa-2a plus vinblastine versus vinblastine alone in patients with advanced renal cell cancer
    • Pyrhonen S, Salminen E, Ruutu M et al. Prospective randomized trial of interferon alfa-2a plus vinblastine versus vinblastine alone in patients with advanced renal cell cancer. J Clin Oncol 1999; 17(9): 2859-2867.
    • (1999) J Clin Oncol , vol.17 , Issue.9 , pp. 2859-2867
    • Pyrhonen, S.1    Salminen, E.2    Ruutu, M.3
  • 29
    • 0033902999 scopus 로고    scopus 로고
    • Phase III trial of interferon alfa-2a with or without 13-cis-retinoic acid for patients with advanced renal cell carcinoma
    • Motzer RJ, Murphy BA, Bacik J et al. Phase III trial of interferon alfa-2a with or without 13-cis-retinoic acid for patients with advanced renal cell carcinoma. J Clin Oncol 2000; 18(16): 2972-2980.
    • (2000) J Clin Oncol , vol.18 , Issue.16 , pp. 2972-2980
    • Motzer, R.J.1    Murphy, B.A.2    Bacik, J.3
  • 30
    • 0034671326 scopus 로고    scopus 로고
    • Treatment of patients with metastatic renal carcinoma with a combination of subcutaneous interleukin-2 and interferon alfa with or without fluorouracil. Groupe Francais D'immunotherapie, Federation Nationale des Centres de Lutte Contre le Cancer
    • Negrier S, Caty A, Lesimple T et al. Treatment of patients with metastatic renal carcinoma with a combination of subcutaneous interleukin-2 and interferon alfa with or without fluorouracil. Groupe Francais D'immunotherapie, Federation Nationale des Centres de Lutte Contre le Cancer. J Clin Oncol 2000; 18(24): 4009-4015.
    • (2000) J Clin Oncol , vol.18 , Issue.24 , pp. 4009-4015
    • Negrier, S.1    Caty, A.2    Lesimple, T.3
  • 31
    • 0035914255 scopus 로고    scopus 로고
    • Il-2 in combination with IFN-alpha and 5-FU versus tamoxifen in metastatic renal cell carcinoma: long-term results of a controlled randomized clinical trial
    • Atzpodien J, Kirchner H, Illiger HJ et al. Il-2 in combination with IFN-alpha and 5-FU versus tamoxifen in metastatic renal cell carcinoma: long-term results of a controlled randomized clinical trial. Br J Cancer 2001; 85(8): 1130-1136.
    • (2001) Br J Cancer , vol.85 , Issue.8 , pp. 1130-1136
    • Atzpodien, J.1    Kirchner, H.2    Illiger, H.J.3
  • 32
    • 0141636459 scopus 로고    scopus 로고
    • Stratification by risk factors predicts survival on the active treatment arm in a randomized phase II study of interferon-gamma plus/minus interferon-alpha in advanced renal cell carcinoma
    • Dutcher JP, Fine JP, Krigel RL et al. Stratification by risk factors predicts survival on the active treatment arm in a randomized phase II study of interferon-gamma plus/minus interferon-alpha in advanced renal cell carcinoma. Med Oncol 2003; 20(3): 271-281.
    • (2003) Med Oncol , vol.20 , Issue.3 , pp. 271-281
    • Dutcher, J.P.1    Fine, J.P.2    Krigel, R.L.3
  • 33
    • 0042343801 scopus 로고    scopus 로고
    • A randomized trial of bevacizumab, an antivascular endothelial growth factor antibody, for metastatic renal cancer
    • Yang JC, Haworth L, Sherry RM et al. A randomized trial of bevacizumab, an antivascular endothelial growth factor antibody, for metastatic renal cancer. N Engl J Med 2003; 349(5): 427-434.
    • (2003) N Engl J Med , vol.349 , Issue.5 , pp. 427-434
    • Yang, J.C.1    Haworth, L.2    Sherry, R.M.3
  • 34
    • 2142695181 scopus 로고    scopus 로고
    • Interleukin-2-and interferon alfa-2a-based immunochemotherapy in advanced renal cell carcinoma: a prospectively randomized trial of the German cooperative renal carcinoma chemoimmunotherapy group
    • Atzpodien J, Kirchner H, Jonas U et al. Interleukin-2-and interferon alfa-2a-based immunochemotherapy in advanced renal cell carcinoma: a prospectively randomized trial of the German cooperative renal carcinoma chemoimmunotherapy group. J Clin Oncol 2004; 22(7): 1188-1194.
    • (2004) J Clin Oncol , vol.22 , Issue.7 , pp. 1188-1194
    • Atzpodien, J.1    Kirchner, H.2    Jonas, U.3
  • 35
    • 23044461230 scopus 로고    scopus 로고
    • Randomized phase II/III trial of interferon alfa-2a with and without 13-cis-retinoic acid in patients with progressive metastatic renal cell carcinoma: the European Organisation for Research and Treatment of Cancer Genito-urinary Tract Cancer Group (EORTC 30951)
    • Aass N, De Mulder PH, Mickisch GH et al. Randomized phase II/III trial of interferon alfa-2a with and without 13-cis-retinoic acid in patients with progressive metastatic renal cell carcinoma: the European Organisation for Research and Treatment of Cancer Genito-urinary Tract Cancer Group (EORTC 30951). J Clin Oncol 2005; 23(18): 4172-4178.
    • (2005) J Clin Oncol , vol.23 , Issue.18 , pp. 4172-4178
    • Aass, N.1    De Mulder, P.H.2    Mickisch, G.H.3
  • 36
    • 27144501804 scopus 로고    scopus 로고
    • Two randomised phase II trials of subcutaneous interleukin-2 and histamine dihydrochloride in patients with metastatic renal cell carcinoma
    • Donskov F, Middleton M, Fode K et al. Two randomised phase II trials of subcutaneous interleukin-2 and histamine dihydrochloride in patients with metastatic renal cell carcinoma. Br J Cancer 2005; 93(7): 757-762.
    • (2005) Br J Cancer , vol.93 , Issue.7 , pp. 757-762
    • Donskov, F.1    Middleton, M.2    Fode, K.3
  • 37
    • 16644401873 scopus 로고    scopus 로고
    • Randomized phase III trial of high-dose interleukin-2 versus subcutaneous interleukin-2 and interferon in patients with metastatic renal cell carcinoma
    • McDermott DF, Regan MM, Clark JI et al. Randomized phase III trial of high-dose interleukin-2 versus subcutaneous interleukin-2 and interferon in patients with metastatic renal cell carcinoma. J Clin Oncol 2005; 23(1): 133-141.
    • (2005) J Clin Oncol , vol.23 , Issue.1 , pp. 133-141
    • McDermott, D.F.1    Regan, M.M.2    Clark, J.I.3
  • 38
    • 33747153299 scopus 로고    scopus 로고
    • Interleukin-2/interferon-alpha2a/13-retinoic acid-based chemoimmunotherapy in advanced renal cell carcinoma: results of a prospectively randomised trial of the German Cooperative Renal Carcinoma Chemoimmunotherapy group (DGCIN)
    • Atzpodien J, Kirchner H, Rebmann U et al. Interleukin-2/interferon-alpha2a/13-retinoic acid-based chemoimmunotherapy in advanced renal cell carcinoma: results of a prospectively randomised trial of the German Cooperative Renal Carcinoma Chemoimmunotherapy group (DGCIN). Br J Cancer 2006; 95(4): 463-469.
    • (2006) Br J Cancer , vol.95 , Issue.4 , pp. 463-469
    • Atzpodien, J.1    Kirchner, H.2    Rebmann, U.3
  • 39
    • 33750532947 scopus 로고    scopus 로고
    • Improved tolerability and quality of life with maintained efficacy using twice-daily low-dose interferon-alpha-2b: results of a randomized phase II trial of low-dose versus intermediate-dose interferon-alpha-2b in patients with metastatic renal cell carcinoma
    • Tannir NM, Cohen L, Wang X et al. Improved tolerability and quality of life with maintained efficacy using twice-daily low-dose interferon-alpha-2b: results of a randomized phase II trial of low-dose versus intermediate-dose interferon-alpha-2b in patients with metastatic renal cell carcinoma. Cancer 2006; 107(9): 2254-2261.
    • (2006) Cancer , vol.107 , Issue.9 , pp. 2254-2261
    • Tannir, N.M.1    Cohen, L.2    Wang, X.3
  • 40
    • 36749060830 scopus 로고    scopus 로고
    • Phase 2 study of abt-510 in patients with previously untreated advanced renal cell carcinoma
    • Ebbinghaus S, Hussain M, Tannir N et al. Phase 2 study of abt-510 in patients with previously untreated advanced renal cell carcinoma. Clin Cancer Res 2007; 13(22 Pt 1): 6689-6695.
    • (2007) Clin Cancer Res , vol.13 , Issue.22 , pp. 6689-6695
    • Ebbinghaus, S.1    Hussain, M.2    Tannir, N.3
  • 41
    • 4644300560 scopus 로고    scopus 로고
    • Phase III trial of Neovastaat in metastatic renal cell carcinoma patients refractory to immunotherapy
    • Escudier B, Venner P, Bukowski R et al. Phase III trial of Neovastaat in metastatic renal cell carcinoma patients refractory to immunotherapy. J Clin Oncol 2003; 22 (suppl): abstract 844.
    • (2003) J Clin Oncol , vol.22
    • Escudier, B.1    Venner, P.2    Bukowski, R.3
  • 42
    • 34249779568 scopus 로고    scopus 로고
    • Temsirolimus, interferon alfa, or both for advanced renal-cell carcinoma
    • Hudes G, Carducci M, Tomczak P et al. Temsirolimus, interferon alfa, or both for advanced renal-cell carcinoma. N Engl J Med 2007; 356(22): 2271-2281.
    • (2007) N Engl J Med , vol.356 , Issue.22 , pp. 2271-2281
    • Hudes, G.1    Carducci, M.2    Tomczak, P.3
  • 43
    • 36448930484 scopus 로고    scopus 로고
    • Medroxyprogesterone, interferon alfa-2a, interleukin 2, or combination of both cytokines in patients with metastatic renal carcinoma of intermediate prognosis: results of a randomized controlled trial
    • Negrier S, Perol D, Ravaud A et al. Medroxyprogesterone, interferon alfa-2a, interleukin 2, or combination of both cytokines in patients with metastatic renal carcinoma of intermediate prognosis: results of a randomized controlled trial. Cancer 2007; 110(11): 2468-2477.
    • (2007) Cancer , vol.110 , Issue.11 , pp. 2468-2477
    • Negrier, S.1    Perol, D.2    Ravaud, A.3
  • 44
    • 53249097858 scopus 로고    scopus 로고
    • Randomized study of intravenous versus subcutaneous interleukin-2, and IFNalpha in patients with good prognosis metastatic renal cancer
    • Negrier S, Perol D, Ravaud A et al. Randomized study of intravenous versus subcutaneous interleukin-2, and IFNalpha in patients with good prognosis metastatic renal cancer. Clin Cancer Res 2008; 14(18): 5907-5912.
    • (2008) Clin Cancer Res , vol.14 , Issue.18 , pp. 5907-5912
    • Negrier, S.1    Perol, D.2    Ravaud, A.3
  • 45
    • 70249097380 scopus 로고    scopus 로고
    • Sorafenib for treatment of renal cell carcinoma: final efficacy and safety results of the phase III treatment approaches in renal cancer global evaluation trial
    • Escudier B, Eisen T, Stadler WM et al. Sorafenib for treatment of renal cell carcinoma: final efficacy and safety results of the phase III treatment approaches in renal cancer global evaluation trial. J Clin Oncol 2009; 27(20): 3312-3318.
    • (2009) J Clin Oncol , vol.27 , Issue.20 , pp. 3312-3318
    • Escudier, B.1    Eisen, T.2    Stadler, W.M.3
  • 46
    • 68949145218 scopus 로고    scopus 로고
    • Overall survival and updated results for sunitinib compared with interferon alfa in patients with metastatic renal cell carcinoma
    • Motzer RJ, Hutson TE, Tomczak P et al. Overall survival and updated results for sunitinib compared with interferon alfa in patients with metastatic renal cell carcinoma. J Clin Oncol 2009; 27(22): 3584-3590.
    • (2009) J Clin Oncol , vol.27 , Issue.22 , pp. 3584-3590
    • Motzer, R.J.1    Hutson, T.E.2    Tomczak, P.3
  • 47
    • 63049135328 scopus 로고    scopus 로고
    • Phase II randomized study of plitidepsin (aplidin), alone or in association with l-carnitine, in patients with unresectable advanced renal cell carcinoma
    • Schoffski P, Guillem V, Garcia M et al. Phase II randomized study of plitidepsin (aplidin), alone or in association with l-carnitine, in patients with unresectable advanced renal cell carcinoma. Mar Drugs 2009; 7(1): 57-70.
    • (2009) Mar Drugs , vol.7 , Issue.1 , pp. 57-70
    • Schoffski, P.1    Guillem, V.2    Garcia, M.3
  • 48
    • 77952300540 scopus 로고    scopus 로고
    • Phase III trial of bevacizumab plus interferon alfa-2a in patients with metastatic renal cell carcinoma (AVOREN): final analysis of overall survival
    • Escudier B, Bellmunt J, Negrier S et al. Phase III trial of bevacizumab plus interferon alfa-2a in patients with metastatic renal cell carcinoma (AVOREN): final analysis of overall survival. J Clin Oncol 2010; 28(13): 2144-2150.
    • (2010) J Clin Oncol , vol.28 , Issue.13 , pp. 2144-2150
    • Escudier, B.1    Bellmunt, J.2    Negrier, S.3
  • 49
    • 76749116183 scopus 로고    scopus 로고
    • Interferon alfa-2a versus combination therapy with interferon alfa-2a, interleukin-2, and fluorouracil in patients with untreated metastatic renal cell carcinoma (MRC RE04/EORTC GU 30012): an open-label randomised trial
    • Gore ME, Griffin CL, Hancock B et al. Interferon alfa-2a versus combination therapy with interferon alfa-2a, interleukin-2, and fluorouracil in patients with untreated metastatic renal cell carcinoma (MRC RE04/EORTC GU 30012): an open-label randomised trial. Lancet 2010; 375(9715): 641-648.
    • (2010) Lancet , vol.375 , Issue.9715 , pp. 641-648
    • Gore, M.E.1    Griffin, C.L.2    Hancock, B.3
  • 50
    • 77956227464 scopus 로고    scopus 로고
    • Phase 3 trial of everolimus for metastatic renal cell carcinoma: final results and analysis of prognostic factors
    • Motzer RJ, Escudier B, Oudard S et al. Phase 3 trial of everolimus for metastatic renal cell carcinoma: final results and analysis of prognostic factors. Cancer 2010; 116(18): 4256-4265.
    • (2010) Cancer , vol.116 , Issue.18 , pp. 4256-4265
    • Motzer, R.J.1    Escudier, B.2    Oudard, S.3
  • 51
    • 77952318310 scopus 로고    scopus 로고
    • Phase III trial of bevacizumab plus interferon alfa versus interferon alfa monotherapy in patients with metastatic renal cell carcinoma: final results of CALGB 90206
    • Rini BI, Halabi S, Rosenberg JE et al. Phase III trial of bevacizumab plus interferon alfa versus interferon alfa monotherapy in patients with metastatic renal cell carcinoma: final results of CALGB 90206. J Clin Oncol 2010; 28(13): 2137-2143.
    • (2010) J Clin Oncol , vol.28 , Issue.13 , pp. 2137-2143
    • Rini, B.I.1    Halabi, S.2    Rosenberg, J.E.3
  • 52
    • 84863230396 scopus 로고    scopus 로고
    • Randomized study of autologous cytokine-induced killer cell immunotherapy in metastatic renal carcinoma
    • Liu L, Zhang W, Qi X et al. Randomized study of autologous cytokine-induced killer cell immunotherapy in metastatic renal carcinoma. Clin Cancer Res 2012; 18(6): 1751-1759.
    • (2012) Clin Cancer Res , vol.18 , Issue.6 , pp. 1751-1759
    • Liu, L.1    Zhang, W.2    Qi, X.3
  • 53
    • 84860355062 scopus 로고    scopus 로고
    • Randomized phase II trial of sunitinib on an intermittent versus continuous dosing schedule as first-line therapy for advanced renal cell carcinoma
    • Motzer RJ, Hutson TE, Olsen MR et al. Randomized phase II trial of sunitinib on an intermittent versus continuous dosing schedule as first-line therapy for advanced renal cell carcinoma. J Clin Oncol 2012; 30(12): 1371-1377.
    • (2012) J Clin Oncol , vol.30 , Issue.12 , pp. 1371-1377
    • Motzer, R.J.1    Hutson, T.E.2    Olsen, M.R.3
  • 54
    • 0034594628 scopus 로고    scopus 로고
    • New guidelines to evaluate the response to treatment in solid tumors
    • Therasse P, Arbuck S, Eisenhauer E 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.2    Eisenhauer, E.3
  • 55
    • 52649122745 scopus 로고    scopus 로고
    • Use of progression-free survival as a surrogate marker in oncology trials: some regulatory issues
    • Chakravarty A, Sridhara R. Use of progression-free survival as a surrogate marker in oncology trials: some regulatory issues. Stat Methods Med Res 2008; 17(5): 515-518.
    • (2008) Stat Methods Med Res , vol.17 , Issue.5 , pp. 515-518
    • Chakravarty, A.1    Sridhara, R.2
  • 56
    • 33846440150 scopus 로고    scopus 로고
    • Food and Drug Administration drug approval summary: sunitinib malate for the treatment of gastrointestinal stromal tumor and advanced renal cell carcinoma
    • Rock EP, Goodman V, Jiang JX et al. Food and Drug Administration drug approval summary: sunitinib malate for the treatment of gastrointestinal stromal tumor and advanced renal cell carcinoma. Oncologist 2007; 12(1): 107-113.
    • (2007) Oncologist , vol.12 , Issue.1 , pp. 107-113
    • Rock, E.P.1    Goodman, V.2    Jiang, J.X.3
  • 57
    • 0030268577 scopus 로고    scopus 로고
    • Surrogate endpoints in clinical trials: are we being misled?
    • Fleming T, DeMets D. Surrogate endpoints in clinical trials: are we being misled? Ann Int Med 1996; 125: 605-613.
    • (1996) Ann Int Med , vol.125 , pp. 605-613
    • Fleming, T.1    DeMets, D.2
  • 58
    • 84890617204 scopus 로고    scopus 로고
    • Progression-free survival as a surrogate endpoint of overall survival in patiens with metastatic renal cell carcinoma
    • Halabi S, Rini B, Escudier B et al. Progression-free survival as a surrogate endpoint of overall survival in patiens with metastatic renal cell carcinoma. Cancer 2014; 120: 52.
    • (2014) Cancer , vol.120 , pp. 52
    • Halabi, S.1    Rini, B.2    Escudier, B.3
  • 59
    • 84890772195 scopus 로고    scopus 로고
    • Editorial: progression-free survival: does a correlation with survival justify its role as a surrogate clinical endpoint?
    • Becker A, Eichelberg C, Sun M. Editorial: progression-free survival: does a correlation with survival justify its role as a surrogate clinical endpoint? Cancer 2014; 120: 7-10.
    • (2014) Cancer , vol.120 , pp. 7-10
    • Becker, A.1    Eichelberg, C.2    Sun, M.3
  • 60
    • 0024520844 scopus 로고
    • Surrogate endpoints in clinical trials: definitions and operational criteria
    • Prentice R. Surrogate endpoints in clinical trials: definitions and operational criteria. Stat Med 1989; 8: 431-440.
    • (1989) Stat Med , vol.8 , pp. 431-440
    • Prentice, R.1
  • 62
    • 0033603814 scopus 로고    scopus 로고
    • Are surrogate markers adequate to assess cardiovascular disease drugs?
    • Temple R. Are surrogate markers adequate to assess cardiovascular disease drugs? JAMA 1999; 282: 790-795.
    • (1999) JAMA , vol.282 , pp. 790-795
    • Temple, R.1
  • 63
    • 0033603794 scopus 로고    scopus 로고
    • Users' guides to the medical literature: XIX. Applying clinical trial results. A. How to use an article measuring the effect of an intervention on surrogate end points
    • Bucher H, Guyatt G, Cook D et al. Users' guides to the medical literature: XIX. Applying clinical trial results. A. How to use an article measuring the effect of an intervention on surrogate end points. Evidence-Based Medicine Working Group. JAMA 1999; 282: 771-778.
    • (1999) JAMA , vol.282 , pp. 771-778
    • Bucher, H.1    Guyatt, G.2    Cook, D.3
  • 64
    • 0034802767 scopus 로고    scopus 로고
    • Considerations in the evaluation of surrogate endpoints in clinical trials. Summary of a National Institutes of Health workshop
    • De Gruttola VG, Clax P, DeMets DL et al. Considerations in the evaluation of surrogate endpoints in clinical trials. Summary of a National Institutes of Health workshop. Control Clin Trials 2001; 22(5): 485-502.
    • (2001) Control Clin Trials , vol.22 , Issue.5 , pp. 485-502
    • De Gruttola, V.G.1    Clax, P.2    DeMets, D.L.3
  • 65
    • 33847628809 scopus 로고    scopus 로고
    • Definitions and validation criteria for biomarker and surrogate endpoints: development and testing of a quantitative hierarchical levels of evidence schema
    • Lassere M, Johnson K, Boers M et al. Definitions and validation criteria for biomarker and surrogate endpoints: development and testing of a quantitative hierarchical levels of evidence schema. J Rheumatol 2007; 34(3): 607-615.
    • (2007) J Rheumatol , vol.34 , Issue.3 , pp. 607-615
    • Lassere, M.1    Johnson, K.2    Boers, M.3
  • 66
    • 33747844588 scopus 로고    scopus 로고
    • Response rate or time to progression as predictors of survival in trials of metastatic colorectal cancer or non-small-cell lung cancer: a meta-analysis
    • Johnson K, Ringland C, Stokes B et al. Response rate or time to progression as predictors of survival in trials of metastatic colorectal cancer or non-small-cell lung cancer: a meta-analysis. Lancet Oncol 2006; 7(9): 741-746.
    • (2006) Lancet Oncol , vol.7 , Issue.9 , pp. 741-746
    • Johnson, K.1    Ringland, C.2    Stokes, B.3
  • 67
    • 70350165346 scopus 로고    scopus 로고
    • Association between treatment effects on disease progression DP) endpoints and overall survival (OS) in patients with metastatic renal cell carcinoma (mRCC)
    • Delea TE, Khuu A, Hay A et al. Association between treatment effects on disease progression DP) endpoints and overall survival (OS) in patients with metastatic renal cell carcinoma (mRCC). J Clin Oncol 2009; 27: 15s; (suppl); abstr 5105.
    • (2009) J Clin Oncol , vol.27 , pp. 15s
    • Delea, T.E.1    Khuu, A.2    Hay, A.3
  • 68
    • 79958790070 scopus 로고    scopus 로고
    • Progression-free survival as a predictor of overall survival in metastatic renal cell carcinoma treated with contemporary targeted therapy
    • Heng DY, Xie W, Bjarnason GA et al. Progression-free survival as a predictor of overall survival in metastatic renal cell carcinoma treated with contemporary targeted therapy. Cancer 2011; 117(12): 2637-2642.
    • (2011) Cancer , vol.117 , Issue.12 , pp. 2637-2642
    • Heng, D.Y.1    Xie, W.2    Bjarnason, G.A.3
  • 70
    • 0034729931 scopus 로고    scopus 로고
    • Relation between tumour response to firstline chemotherapy and survival in advanced colorectal cancer: a meta-analysis. Meta-Analysis Group in Cancer
    • Buyse M, Thirion P, Carlson RW et al. Relation between tumour response to firstline chemotherapy and survival in advanced colorectal cancer: a meta-analysis. Meta-Analysis Group in Cancer. Lancet 2000; 356(9227): 373e8.
    • (2000) Lancet , vol.356 , Issue.9227 , pp. 373-378
    • Buyse, M.1    Thirion, P.2    Carlson, R.W.3
  • 71
    • 58849099511 scopus 로고    scopus 로고
    • LDL-cholesterol differences predicted survival benefit in statin trials by the surrogate threshold effect (STE)
    • Johnson KR, Freemantle N, Anthony DM, Lassere MN. LDL-cholesterol differences predicted survival benefit in statin trials by the surrogate threshold effect (STE). J Clin Epidemiol 2009; 62(3): 328-336.
    • (2009) J Clin Epidemiol , vol.62 , Issue.3 , pp. 328-336
    • Johnson, K.R.1    Freemantle, N.2    Anthony, D.M.3    Lassere, M.N.4
  • 72
    • 77952600681 scopus 로고    scopus 로고
    • Blinded independent central review of the progression-free survival endpoint
    • Amit O, Bushnell W, Dodd L et al. Blinded independent central review of the progression-free survival endpoint. Oncologist 2010; 15(5): 492-495.
    • (2010) Oncologist , vol.15 , Issue.5 , pp. 492-495
    • Amit, O.1    Bushnell, W.2    Dodd, L.3
  • 73
    • 49249111441 scopus 로고    scopus 로고
    • Blinded independent central review of progression-free survival in phase III clinical trials: important design element or unnecessary expense?
    • Dodd LE, Korn EL, Freidlin B et al. Blinded independent central review of progression-free survival in phase III clinical trials: important design element or unnecessary expense? J Clin Oncol 2008; 26(22): 3791-3796.
    • (2008) J Clin Oncol , vol.26 , Issue.22 , pp. 3791-3796
    • Dodd, L.E.1    Korn, E.L.2    Freidlin, B.3
  • 74
    • 34249929780 scopus 로고    scopus 로고
    • Proposal for the use of progression-free survival in unblinded randomized trials
    • Freidlin B, Korn EL, Hunsberger S et al. Proposal for the use of progression-free survival in unblinded randomized trials. J Clin Oncol 2007; 25(15): 2122-2126.
    • (2007) J Clin Oncol , vol.25 , Issue.15 , pp. 2122-2126
    • Freidlin, B.1    Korn, E.L.2    Hunsberger, S.3
  • 75
    • 80051550977 scopus 로고    scopus 로고
    • Research outcomes and recommendations for the assessment of progression in cancer clinical trials from a PhRMA working group
    • Stone AM, Bushnell W, Denne J et al. Research outcomes and recommendations for the assessment of progression in cancer clinical trials from a PhRMA working group. Eur J Cancer 2011; 47(12): 1763-1771.
    • (2011) Eur J Cancer , vol.47 , Issue.12 , pp. 1763-1771
    • Stone, A.M.1    Bushnell, W.2    Denne, J.3
  • 76
    • 84941703898 scopus 로고    scopus 로고
    • (20 January 2013, date last accessed)
    • FDA_axitinib_BriefingDoc_2011_NDA 202324_ucm282290.pdf; http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/OncologicDrugsAdvisoryCommittee/UCM282290.pdf (20 January 2013, date last accessed).
  • 77
    • 84941703899 scopus 로고    scopus 로고
    • MEETING (axitinib_transcript_FDA_2011_UCM288716.pdf) (20 January 2013, date last accessed)
    • RESEARCH FADACFDEA. ONCOLOGIC DRUGS ADVISORY COMMITTEE (ODAC) MEETING (axitinib_transcript_FDA_2011_UCM288716.pdf ) http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/OncologicDrugsAdvisoryCommittee/UCM288716.pdf (20 January 2013, date last accessed).
  • 78
    • 82755183572 scopus 로고    scopus 로고
    • Comparative effectiveness of axitinib versus sorafenib in advanced renal cell carcinoma (AXIS): a randomised phase 3 trial
    • Rini BI, Escudier B, Tomczak P et al. Comparative effectiveness of axitinib versus sorafenib in advanced renal cell carcinoma (AXIS): a randomised phase 3 trial. Lancet 2011; 378(9807): 1931-1939.
    • (2011) Lancet , vol.378 , Issue.9807 , pp. 1931-1939
    • Rini, B.I.1    Escudier, B.2    Tomczak, P.3
  • 79
    • 0001015983 scopus 로고
    • Correcting for non-compliance in randomized trials using rank preserving structural failure time models
    • Robins J, Tsiatis A. Correcting for non-compliance in randomized trials using rank preserving structural failure time models. Commun Stat Theory Methods 1991; 20: 2609-2631.
    • (1991) Commun Stat Theory Methods , vol.20 , pp. 2609-2631
    • Robins, J.1    Tsiatis, A.2
  • 80
    • 78651098651 scopus 로고    scopus 로고
    • Assessing methods for dealing with treatment switching in randomised controlled trials: a simulation study
    • Morden JP, Lambert PC, Latimer N et al. Assessing methods for dealing with treatment switching in randomised controlled trials: a simulation study. BMC Med Res Methodol 2011; 11: 4.
    • (2011) BMC Med Res Methodol , vol.11 , pp. 4
    • Morden, J.P.1    Lambert, P.C.2    Latimer, N.3
  • 81
    • 79959280313 scopus 로고    scopus 로고
    • Overall survival as the outcome for randomized clinical trials with effecitve subsequent therapies
    • Korn EL, Freidlin B, Abrams J. Overall survival as the outcome for randomized clinical trials with effecitve subsequent therapies. J Clin Oncol 2011; 29(17): 2439-2442.
    • (2011) J Clin Oncol , vol.29 , Issue.17 , pp. 2439-2442
    • Korn, E.L.1    Freidlin, B.2    Abrams, J.3
  • 82
    • 67649990278 scopus 로고    scopus 로고
    • Issues in using progression-free survival when evaluating oncology products
    • Fleming TR, Rothmann MD, Lu HL. Issues in using progression-free survival when evaluating oncology products. J Clin Oncol 2009; 27(17): 2874-2880.
    • (2009) J Clin Oncol , vol.27 , Issue.17 , pp. 2874-2880
    • Fleming, T.R.1    Rothmann, M.D.2    Lu, H.L.3


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.