메뉴 건너뛰기




Volumn 18, Issue SUPPL. 2, 2011, Pages

Progression-free survival as a clinical trial endpoint in advanced renal cell carcinoma

(17)  Hotte, S J a   Bjarnason, G A b   Heng, D Y C c   Jewett, M A S d   Kapoor, A a   Kollmannsberger, C e   Maroun, J f   Mayhew, L A g   North, S h   Reaume, M N i   Ruether, J D c   Soulieres, D j   Venner, P M k   Winquist, E W l   Wood, L m   Yong, J H E m   Saad, F j  


Author keywords

Clinical trial endpoints; Kidney cancer; Overall survival; Progression free survival; Regulatory approval

Indexed keywords

ALPHA INTERFERON; BEVACIZUMAB; PLACEBO; SORAFENIB; SUNITINIB; TEMSIROLIMUS;

EID: 80053523278     PISSN: None     EISSN: 17187729     Source Type: Journal    
DOI: 10.3747/co.v18i0.941     Document Type: Article
Times cited : (35)

References (28)
  • 1
    • 56749161699 scopus 로고    scopus 로고
    • Bevacizumab plus interferon alfa compared with interferon alfa monotherapy in patients with metastatic renal cell carcinoma: Calgb 90206
    • Rini BI, Halabi S, Rosenberg JE, et al. Bevacizumab plus interferon alfa compared with interferon alfa monotherapy in patients with metastatic renal cell carcinoma: calgb 90206. J Clin Oncol 2008;26:5422-8.
    • (2008) J Clin Oncol , vol.26 , pp. 5422-5428
    • Rini, B.I.1    Halabi, S.2    Rosenberg, J.E.3
  • 2
    • 33846181370 scopus 로고    scopus 로고
    • Sunitinib versus interferon alfa in metastatic renal-cell carcinoma
    • Motzer RJ, Hutson TE, Tomczak P, et al. Sunitinib versus interferon alfa in metastatic renal-cell carcinoma. N Engl J Med 2007;356:115-24.
    • (2007) N Engl J Med , vol.356 , pp. 115-124
    • Motzer, R.J.1    Hutson, T.E.2    Tomczak, P.3
  • 3
    • 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;25:5218-24.
    • (2007) J Clin Oncol , vol.25 , pp. 5218-5224
    • Buyse, M.1    Burzykowski, T.2    Carroll, K.3
  • 4
    • 0034038518 scopus 로고    scopus 로고
    • Chemotherapy for renal cell carcinoma
    • Amato RJ. Chemotherapy for renal cell carcinoma. Semin Oncol 2000;27:177-86.
    • (2000) Semin Oncol , vol.27 , pp. 177-186
    • Amato, R.J.1
  • 5
    • 0036842215 scopus 로고    scopus 로고
    • Vascular permeability factor/vascular endothelial growth factor: A critical cytokine in tumor angiogenesis and a potential target for diagnosis and therapy
    • Dvorak HF. Vascular permeability factor/vascular endothelial growth factor: a critical cytokine in tumor angiogenesis and a potential target for diagnosis and therapy. J Clin Oncol 2002;20:4368-80.
    • (2002) J Clin Oncol , vol.20 , pp. 4368-4380
    • Dvorak, H.F.1
  • 6
    • 37349080670 scopus 로고    scopus 로고
    • Bevacizumab plus interferon alfa-2a for treatment of metastatic renal cell carcinoma: A randomised, double-blind phase iii trial
    • Escudier B, Pluzanska A, Koralewski P, et al. Bevacizumab plus interferon alfa-2a for treatment of metastatic renal cell carcinoma: a randomised, double-blind phase iii trial. Lancet 2007;370:2103-11.
    • (2007) Lancet , vol.370 , pp. 2103-2111
    • Escudier, B.1    Pluzanska, A.2    Koralewski, P.3
  • 7
    • 70349264943 scopus 로고    scopus 로고
    • Final results of the phase iii, randomized, double-blind avoren trial of first-line bevacizumab (bev) + interferon-a2a (ifn) in metastatic renal cell carcinoma (mrcc)
    • abstract 5020, Available online at, cited August 21, 2011
    • Escudier BJ, Bellmunt J, Negrier S, et al. Final results of the phase iii, randomized, double-blind avoren trial of first-line bevacizumab (bev) + interferon-a2a (ifn) in metastatic renal cell carcinoma (mrcc) [abstract 5020]. J Clin Oncol 2009;27:. [Available online at: /http://www.asco.org/ASCOv2/Meetings/Abstracts?&vmview=abst_detail_view&confID=65&abstractID=32687; cited August 21, 2011]
    • (2009) J Clin Oncol , vol.27
    • Escudier, B.J.1    Bellmunt, J.2    Negrier, S.3
  • 8
    • 70349283555 scopus 로고    scopus 로고
    • Bevacizumab plus interferon-alpha versus interferon-alpha monotherapy in patients with metastatic renal cell carcinoma: Results of overall survival for CALGB 90206
    • abstract LBA5019, Available online at, cited August 21, 2011
    • Rini BI, Halabi S, Rosenberg J, et al. Bevacizumab plus interferon-alpha versus interferon-alpha monotherapy in patients with metastatic renal cell carcinoma: results of overall survival for CALGB 90206 [abstract LBA5019]. J Clin Oncol 2009;27:. [Available online at: http://www.asco.org/ASCOv2/Meetings/Abstracts?&vmview=abst_detail_view&confID=65&abstractID=30922; cited August 21, 2011]
    • (2009) J Clin Oncol , vol.27
    • Rini, B.I.1    Halabi, S.2    Rosenberg, J.3
  • 9
    • 0042343801 scopus 로고    scopus 로고
    • A randomized trial of bevacizumab, an anti-vascular endothelial growth factor antibody, for metastatic renal cell cancer
    • Yang JC, Haworth L, Sherry RM, et al. A randomized trial of bevacizumab, an anti-vascular endothelial growth factor antibody, for metastatic renal cell cancer. N Engl J Med 2003;349:427-34.
    • (2003) N Engl J Med , vol.349 , pp. 427-434
    • Yang, J.C.1    Haworth, L.2    Sherry, R.M.3
  • 10
    • 48649107474 scopus 로고    scopus 로고
    • Efficacy of everolimus in advanced renal cell carcinoma: A double-blind, randomised, placebo-controlled phase iii trial
    • Motzer RJ, Escudier B, Oudard S, et al. Efficacy of everolimus in advanced renal cell carcinoma: a double-blind, randomised, placebo-controlled phase iii trial. Lancet 2008;372:449-56.
    • (2008) Lancet , vol.372 , pp. 449-456
    • Motzer, R.J.1    Escudier, B.2    Oudard, S.3
  • 11
    • 77949890945 scopus 로고    scopus 로고
    • Pazopanib in locally advanced or metastatic renal cell carcinoma: Results of a randomized phase iii trial
    • Sternberg CN, Davis ID, Mardiak J, et al. Pazopanib in locally advanced or metastatic renal cell carcinoma: results of a randomized phase iii trial. J Clin Oncol 2010;28:1061-8.
    • (2010) J Clin Oncol , vol.28 , pp. 1061-1068
    • Sternberg, C.N.1    Davis, I.D.2    Mardiak, J.3
  • 12
    • 33846148701 scopus 로고    scopus 로고
    • Sorafenib in advanced clear-cell renal-cell carcinoma
    • Escudier B, Eisen T, Stadler WM, et al. Sorafenib in advanced clear-cell renal-cell carcinoma. N Engl J Med 2007;356:125-34.
    • (2007) N Engl J Med , vol.356 , pp. 125-134
    • Escudier, B.1    Eisen, T.2    Stadler, W.M.3
  • 13
    • 35548931472 scopus 로고    scopus 로고
    • Randomized phase ii trial of first-line treatment with sorafenib versus interferon in patients with advanced renal cell carcinoma: Final results
    • abstract 5025, Available online at, cited August 21, 2011
    • Szczylik C, Demkow T, Staehler M, et al. Randomized phase ii trial of first-line treatment with sorafenib versus interferon in patients with advanced renal cell carcinoma: final results [abstract 5025]. J Clin Oncol 2007;25:. [Available online at: http://www.asco.org/ASCOv2/Meetings/Abstracts?&vmview=abst_detail_view&confID=47&abstractID=34559; cited August 21, 2011]
    • (2007) J Clin Oncol , vol.25
    • Szczylik, C.1    Demkow, T.2    Staehler, M.3
  • 14
    • 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;356:2271-81.
    • (2007) N Engl J Med , vol.356 , pp. 2271-2281
    • Hudes, G.1    Carducci, M.2    Tomczak, P.3
  • 15
    • 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;8:431-40.
    • (1989) Stat Med , vol.8 , pp. 431-440
    • Prentice, R.L.1
  • 16
    • 80053554282 scopus 로고    scopus 로고
    • Health Canada. Record of Proceedings: February 26, Scientific Advisory Committee on Oncology Therapies (sacot) [Web page]. Ottawa, ON: Health Canada; 2009. [Available at, cited: August 21, 2011
    • Health Canada. Record of Proceedings: February 26, 2009, Scientific Advisory Committee on Oncology Therapies (sacot) [Web page]. Ottawa, ON: Health Canada; 2009. [Available at: http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/sci-com/onco/sacot_rop_ccsto_ai_2009-02-26-eng.php; cited: August 21, 2011]
    • (2009)
  • 17
    • 60849120120 scopus 로고    scopus 로고
    • A population-based study evaluating the impact of sunitinib on overall survival in the treatment of patients with metastatic renal cell cancer
    • Heng DY, Chi KN, Murray N, et al. A population-based study evaluating the impact of sunitinib on overall survival in the treatment of patients with metastatic renal cell cancer. Cancer 2009;115:776-83.
    • (2009) Cancer , vol.115 , pp. 776-783
    • Heng, D.Y.1    Chi, K.N.2    Murray, N.3
  • 18
    • 70450159233 scopus 로고    scopus 로고
    • A population-based study examining the effect of tyrosine kinase inhibitors on survival in metastatic renal cell carcinoma in Alberta and the role of nephrectomy prior to treatment
    • Warren M, Venner PM, North S, et al. A population-based study examining the effect of tyrosine kinase inhibitors on survival in metastatic renal cell carcinoma in Alberta and the role of nephrectomy prior to treatment. Can Urol Assoc J 2009;3:281-9.
    • (2009) Can Urol Assoc J , vol.3 , pp. 281-289
    • Warren, M.1    Venner, P.M.2    North, S.3
  • 19
    • 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)
    • abstract 5105, Available online at, cited August 21, 2011
    • Delea TE, Khuu A, Kay A, Zheng J, Baladi JF. Association between treatment effects on disease progression (dp) endpoints and overall survival (os) in patients with metastatic renal cell carcinoma (mrcc) [abstract 5105]. J Clin Oncol 2009; 27: [Available online at: http://www.asco.org/ASCOv2/Meetings/Abstracts?&vmview=abst_detail_view&confID=65&abstract ID=35312; cited August 21, 2011]
    • (2009) J Clin Oncol , vol.27
    • Delea, T.E.1    Khuu, A.2    Kay, A.3    Zheng, J.4    Baladi, J.F.5
  • 20
    • 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 su0rvival in metastatic renal cell carcinoma treated with contemporary targeted therapy. Cancer 2011;117:2637-42.
    • (2011) Cancer , vol.117 , pp. 2637-2642
    • Heng, D.Y.1    Xie, W.2    Bjarnason, G.A.3
  • 21
    • 80053467288 scopus 로고    scopus 로고
    • Progression-free survival as a primary endpoint in clinical trials of metastatic colorectal cancer
    • Gill S, Berry S, Biagi J, et al. Progression-free survival as a primary endpoint in clinical trials of metastatic colorectal cancer. Curr Oncol 2011;18(suppl 2): S5-10.
    • (2011) Curr Oncol , vol.18 , Issue.SUPPL. 2
    • Gill, S.1    Berry, S.2    Biagi, J.3
  • 22
    • 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;25:4562-8.
    • (2007) J Clin Oncol , vol.25 , pp. 4562-4568
    • Tang, P.A.1    Bentzen, S.M.2    Chen, E.X.3    Siu, L.L.4
  • 23
    • 67649965349 scopus 로고    scopus 로고
    • Progression-free survival as a predictor of overall survival in men with castrate-resistant prostate cancer
    • Halabi S, Vogelzang NJ, Ou SS, Owzar K, Archer L, Small EJ. Progression-free survival as a predictor of overall survival in men with castrate-resistant prostate cancer. J Clin Oncol 2009;27:2766-71.
    • (2009) J Clin Oncol , vol.27 , pp. 2766-2771
    • Halabi, S.1    Vogelzang, N.J.2    Ou, S.S.3    Owzar, K.4    Archer, L.5    Small, E.J.6
  • 24
    • 42949145995 scopus 로고    scopus 로고
    • Evaluation of tumor response, disease control, progressionfree 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, progressionfree survival, and time to progression as potential surrogate end points in metastatic breast cancer. J Clin Oncol 2008;26:1987-92.
    • (2008) J Clin Oncol , vol.26 , pp. 1987-1992
    • Burzykowski, T.1    Buyse, M.2    Piccart-Gebhart, M.J.3
  • 25
    • 52649101507 scopus 로고    scopus 로고
    • Surrogate endpoints: Wishful thinking or reality
    • Burzykowski T. Surrogate endpoints: wishful thinking or reality. Stat Methods Med Res 2008;17:463-6.
    • (2008) Stat Methods Med Res , vol.17 , pp. 463-466
    • Burzykowski, T.1
  • 26
    • 78649904076 scopus 로고    scopus 로고
    • U.S. Department of Health and Human Services, Food and Drug Administration (fda). Guidance for Industry, Washington, DC: fda
    • U.S. Department of Health and Human Services, Food and Drug Administration (fda). Guidance for Industry: Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics. Washington, DC: fda; 2007.
    • (2007) Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics
  • 28
    • 0034922729 scopus 로고    scopus 로고
    • EQ-5D: A measure of health status from the EuroQol Group
    • Rabin R, de Charro F. EQ-5D: a measure of health status from the EuroQol Group. Ann Med 2001;33:337-43.
    • (2001) Ann Med , vol.33 , pp. 337-343
    • Rabin, R.1    de Charro, F.2


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.