메뉴 건너뛰기




Volumn 93, Issue 1, 2015, Pages 50-59

Progression-free survival as primary endpoint in randomized clinical trials of targeted agents for advanced renal cell carcinoma. Correlation with overall survival, benchmarking and power analysis

Author keywords

Correlation; Overall survival; Progression free survival; Renal cell carcinoma

Indexed keywords

ALPHA INTERFERON; ALPHA2A INTERFERON; AXITINIB; BEVACIZUMAB; FLUOROURACIL; GAMMA1B INTERFERON; INTERFERON; INTERLEUKIN 2; ISOTRETINOIN; PAZOPANIB; PLACEBO; RECOMBINANT ALPHA2C INTERFERON; RECOMBINANT GAMMA INTERFERON; SORAFENIB; SUNITINIB; TEMSIROLIMUS; TIVOZANIB; ANTINEOPLASTIC AGENT;

EID: 84915752188     PISSN: 10408428     EISSN: 18790461     Source Type: Journal    
DOI: 10.1016/j.critrevonc.2014.08.001     Document Type: Review
Times cited : (13)

References (34)
  • 1
    • 84879449360 scopus 로고    scopus 로고
    • Optimal management of metastatic renal cell carcinoma: current status
    • Escudier B., Albiges L., Sonpavde G. Optimal management of metastatic renal cell carcinoma: current status. Drugs 2013, 73(5):427-438.
    • (2013) Drugs , vol.73 , Issue.5 , pp. 427-438
    • Escudier, B.1    Albiges, L.2    Sonpavde, G.3
  • 2
    • 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
  • 3
    • 84861972784 scopus 로고    scopus 로고
    • Post-study therapy as a source of confounding in survival analysis of first-line studies in patients with advanced non-small-cell lung cancer
    • Zietemann V.D., Schuster T., Duell T.H. Post-study therapy as a source of confounding in survival analysis of first-line studies in patients with advanced non-small-cell lung cancer. J Thorac Dis 2011, 3(2):88-98.
    • (2011) J Thorac Dis , vol.3 , Issue.2 , pp. 88-98
    • Zietemann, V.D.1    Schuster, T.2    Duell, T.H.3
  • 4
    • 71549143528 scopus 로고    scopus 로고
    • Detecting an overall survival benefit that is derived from progression-free survival
    • Broglio K.R., Berry D.A. Detecting an overall survival benefit that is derived from progression-free survival. J Natl Cancer Inst 2009, 101(23):1642-1649.
    • (2009) J Natl Cancer Inst , vol.101 , Issue.23 , pp. 1642-1649
    • Broglio, K.R.1    Berry, D.A.2
  • 5
    • 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 M.J., 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 2008, 26(12):1987-1992.
    • (2008) J Clin Oncol , vol.26 , Issue.12 , pp. 1987-1992
    • Burzykowski, T.1    Buyse, M.2    Piccart-Gebhart, M.J.3
  • 6
    • 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-S10.
    • (2011) Curr Oncol , vol.18 , pp. S5-S10
    • Gill, S.1    Berry, S.2    Biagi, J.3
  • 7
    • 67649965349 scopus 로고    scopus 로고
    • Progression-free survival as a predictor of overall survival in men with castrate-resistant prostate cancer
    • Halabi S., Vogelzang N.J., Ou S.S., Owzar K., Archer L., Small E.J. Progression-free survival as a predictor of overall survival in men with castrate-resistant prostate cancer. J Clin Oncol 2009, 27(17):2766-2771.
    • (2009) J Clin Oncol , vol.27 , Issue.17 , pp. 2766-2771
    • Halabi, S.1    Vogelzang, N.J.2    Ou, S.S.3    Owzar, K.4    Archer, L.5    Small, E.J.6
  • 8
    • 80053238941 scopus 로고    scopus 로고
    • Delivering affordable cancer care in high-income countries
    • Sullivan R., Peppercorn J., Sikora K., et al. Delivering affordable cancer care in high-income countries. Lancet Oncol 2011, 12(10):933-980.
    • (2011) Lancet Oncol , vol.12 , Issue.10 , pp. 933-980
    • Sullivan, R.1    Peppercorn, J.2    Sikora, K.3
  • 9
    • 33846148701 scopus 로고    scopus 로고
    • Sorafenib in advanced clear-cell renal-cell carcinoma
    • Escudier B., Eisen T., Stadler W.M., et al. Sorafenib in advanced clear-cell renal-cell carcinoma. N Engl J Med 2007, 356(2):125-134.
    • (2007) N Engl J Med , vol.356 , Issue.2 , pp. 125-134
    • Escudier, B.1    Eisen, T.2    Stadler, W.M.3
  • 10
    • 77949890945 scopus 로고    scopus 로고
    • Pazopanib in locally advanced or metastatic renal cell carcinoma: results of a randomized phase III trial
    • Sternberg C.N., Davis I.D., 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(6):1061-1068.
    • (2010) J Clin Oncol , vol.28 , Issue.6 , pp. 1061-1068
    • Sternberg, C.N.1    Davis, I.D.2    Mardiak, J.3
  • 11
    • 82755183572 scopus 로고    scopus 로고
    • Comparative effectiveness of axitinib versus sorafenib in advanced renal cell carcinoma (AXIS): a randomised phase 3 trial
    • Rini B.I., Escudier B., Tomczak, et al. Comparative effectiveness of axitinib versus sorafenib in advanced renal cell carcinoma (AXIS): a randomised phase 3 trial. Lancet 2011, 378:1931-1939.
    • (2011) Lancet , vol.378 , pp. 1931-1939
    • Rini, B.I.1    Escudier, B.T.2
  • 12
    • 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 D.Y., Xie W., Bjarnason G.A., 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
  • 13
    • 33846181370 scopus 로고    scopus 로고
    • Sunitinib versus interferon alfa in metastatic renal-cell carcinoma
    • Motzer R.J., Hutson T.E., Tomczak P., et al. Sunitinib versus interferon alfa in metastatic renal-cell carcinoma. N Engl J Med 2007, 356(2):115-124.
    • (2007) N Engl J Med , vol.356 , Issue.2 , pp. 115-124
    • Motzer, R.J.1    Hutson, T.E.2    Tomczak, P.3
  • 14
    • 56749161699 scopus 로고    scopus 로고
    • Bevacizumab plus interferon alfa compared with interferon alfa monotherapy in patients with metastatic renal cell carcinoma: CALGB 90206
    • Rini B.I., Halabi S., Rosenberg J.E., 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(33):5422-5428.
    • (2008) J Clin Oncol , vol.26 , Issue.33 , pp. 5422-5428
    • Rini, B.I.1    Halabi, S.2    Rosenberg, J.E.3
  • 15
    • 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(9605):2103-2111.
    • (2007) Lancet , vol.370 , Issue.9605 , pp. 2103-2111
    • Escudier, B.1    Pluzanska, A.2    Koralewski, P.3
  • 16
    • 84882781441 scopus 로고    scopus 로고
    • Pazopanib versus sunitinib in metastatic renal cell carcinoma
    • Motzer R.J., Hutson T.E., Cella D., et al. Pazopanib versus sunitinib in metastatic renal cell carcinoma. N Engl J Med 2013, 369:722-731.
    • (2013) N Engl J Med , vol.369 , pp. 722-731
    • Motzer, R.J.1    Hutson, T.E.2    Cella, D.3
  • 17
    • 84891713447 scopus 로고    scopus 로고
    • Tivozanib versus sorafenib as initial targeted therapy for patients with metastatic renal cell carcinoma: results from a phase III trial
    • Motzer R.J., Nosov D., Eisen T., et al. Tivozanib versus sorafenib as initial targeted therapy for patients with metastatic renal cell carcinoma: results from a phase III trial. J Clin Oncol 2013, 31(30):3791-3799.
    • (2013) J Clin Oncol , vol.31 , Issue.30 , pp. 3791-3799
    • Motzer, R.J.1    Nosov, D.2    Eisen, T.3
  • 18
    • 84899630091 scopus 로고    scopus 로고
    • Randomized phase III trial of temsirolimus and bevacizumab versus interferon alfa and bevacizumab in metastatic renal cell carcinoma: INTORACT trial
    • Rini B.I., Bellmunt J., Clancy J., et al. Randomized phase III trial of temsirolimus and bevacizumab versus interferon alfa and bevacizumab in metastatic renal cell carcinoma: INTORACT trial. J Clin Oncol 2014, 32(8):752-759.
    • (2014) J Clin Oncol , vol.32 , Issue.8 , pp. 752-759
    • Rini, B.I.1    Bellmunt, J.2    Clancy, J.3
  • 19
    • 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 P.H.M., Mickisch G.H.J., 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.M.2    Mickisch, G.H.J.3
  • 20
    • 0028798749 scopus 로고
    • EORTC (30885) randomised phase III study with recombinant interferon alpha and recombinant interferon alpha and gamma in patients with advanced renal cell carcinoma
    • De Mulder P.H.M., Oosterhof G.O.N., Bouffioux C., et al. EORTC (30885) randomised phase III study with recombinant interferon alpha and recombinant interferon alpha and gamma in patients with advanced renal cell carcinoma. Br J Cancer 1995, 71:371-375.
    • (1995) Br J Cancer , vol.71 , pp. 371-375
    • De Mulder, P.H.M.1    Oosterhof, G.O.N.2    Bouffioux, C.3
  • 21
    • 16644401873 scopus 로고    scopus 로고
    • Randomised phase III trial of high-dose interleukin-2 versus subcutaneous interleukin-2 and interferon in patients with metastatic renal cell carcinoma
    • Mc Dermott D.F., Regan M.M., Clark J.I., et al. Randomised 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
    • Mc Dermott, D.F.1    Regan, M.M.2    Clark, J.I.3
  • 22
    • 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 R.J., Murphy B.A., 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
  • 23
    • 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 M.E., Griffin C.L., 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
  • 24
    • 84863230396 scopus 로고    scopus 로고
    • Randomised study of autologous cytokine-induced killer cell immunotherapy in metastatic renal carcinoma
    • Liu L., Zhang W., Qi X., et al. Randomised 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
  • 25
    • 53249097858 scopus 로고    scopus 로고
    • Randomised study of intravenous versus subcutaneous interleukin-2 and IFNα in patients with good prognosis metastatic renal cancer
    • Negrier S., Perol D., Ravaud A., et al. Randomised study of intravenous versus subcutaneous interleukin-2 and IFNα in patients with good prognosis metastatic renal cancer. Clin Cancer Res 2008, 14:5907-5912.
    • (2008) Clin Cancer Res , vol.14 , pp. 5907-5912
    • Negrier, S.1    Perol, D.2    Ravaud, A.3
  • 26
    • 7144227930 scopus 로고    scopus 로고
    • Recombinant human interleukin-2, recombinant human interferon alfa-2a, or both in metastatic renal-cell carcinoma
    • Negrier S., Escudier B., Lasset C., et al. Recombinant human interleukin-2, recombinant human interferon alfa-2a, or both in metastatic renal-cell carcinoma. N Engl J Med 1998, 338:1272-1278.
    • (1998) N Engl J Med , vol.338 , pp. 1272-1278
    • Negrier, S.1    Escudier, B.2    Lasset, C.3
  • 27
    • 7144255510 scopus 로고    scopus 로고
    • Inteferon gamma-1b compared with placebo in metastatic renal-cell carcinoma
    • Gleave M.E., Elhilali M., Fradet Y., et al. Inteferon gamma-1b compared with placebo in metastatic renal-cell carcinoma. N Engl J Med 1998, 18:1265-1271.
    • (1998) N Engl J Med , vol.18 , pp. 1265-1271
    • Gleave, M.E.1    Elhilali, M.2    Fradet, Y.3
  • 28
    • 77956227464 scopus 로고    scopus 로고
    • Phase 3 trial of everolimus for metastatic renal cell carcinoma: final results and analysis of prognostic factors
    • Motzer R.J., 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
  • 29
    • 84899679988 scopus 로고    scopus 로고
    • Randomized phase III trial of temsirolimus versus sorafenib as second-line therapy after sunitinib in patients with metastatic renal cell carcinoma
    • Hutson T.E., Escudier B., Esteban E., et al. Randomized phase III trial of temsirolimus versus sorafenib as second-line therapy after sunitinib in patients with metastatic renal cell carcinoma. J Clin Oncol 2014, 32(8):760-777.
    • (2014) J Clin Oncol , vol.32 , Issue.8 , pp. 760-777
    • Hutson, T.E.1    Escudier, B.2    Esteban, E.3
  • 30
    • 42949113031 scopus 로고    scopus 로고
    • Assessing the measure of a new drug: is survival the only thing that matters?
    • Sargent D.J., Hayes D.F. Assessing the measure of a new drug: is survival the only thing that matters?. J Clin Oncol 2008, 26(12):1922-1923.
    • (2008) J Clin Oncol , vol.26 , Issue.12 , pp. 1922-1923
    • Sargent, D.J.1    Hayes, D.F.2
  • 31
    • 84866929052 scopus 로고    scopus 로고
    • Association between treatment effects on disease progression end points and overall survival in clinical studies of patients with metastatic renal cell carcinoma
    • Delea T.E., Khuu A., Heng D.Y., Haas T., Soulieres D. Association between treatment effects on disease progression end points and overall survival in clinical studies of patients with metastatic renal cell carcinoma. Br J Cancer 2012, 107(7):1059-1068.
    • (2012) Br J Cancer , vol.107 , Issue.7 , pp. 1059-1068
    • Delea, T.E.1    Khuu, A.2    Heng, D.Y.3    Haas, T.4    Soulieres, D.5
  • 32
    • 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 2014, 120(1):52-60.
    • (2014) Cancer , vol.120 , Issue.1 , pp. 52-60
    • Halabi, S.1    Rini, B.2    Escudier, B.3
  • 33
    • 84888132613 scopus 로고    scopus 로고
    • Axitinib versus sorafenib as first-line therapy in patients with metastatic renal-cell carcinoma: a randomised open-label phase 3 trial
    • Hutson T.E., Lesovoy V., Al-Shukri S., et al. Axitinib versus sorafenib as first-line therapy in patients with metastatic renal-cell carcinoma: a randomised open-label phase 3 trial. Lancet Oncol 2013, 14(13):1287-1294.
    • (2013) Lancet Oncol , vol.14 , Issue.13 , pp. 1287-1294
    • Hutson, T.E.1    Lesovoy, V.2    Al-Shukri, S.3
  • 34
    • 0024520844 scopus 로고
    • Surrogate endpoints in clinical trials: definition and operational criteria
    • Prentice R.L. Surrogate endpoints in clinical trials: definition and operational criteria. Stat Med 1989, 8(4):431-440.
    • (1989) Stat Med , vol.8 , Issue.4 , pp. 431-440
    • Prentice, R.L.1


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.