메뉴 건너뛰기




Volumn 15, Issue 5, 2009, Pages 386-394

Progression-free survival: Gaining on overall survival as a gold standard and acceleratingdrug development

Author keywords

Efficacy; Measurement; Overall survival; Progression free survival; Surrogate

Indexed keywords

ALTRETAMINE; AMIFOSTINE; ANASTROZOLE; ANTHRACYCLINE; ANTINEOPLASTIC AGENT; ARSENIC TRIOXIDE; BEXAROTENE; BLEOMYCIN; BUSULFAN; CAPECITABINE; CARBOPLATIN; CARMUSTINE; CISPLATIN; CLADRIBINE; DOCETAXEL; DOXORUBICIN; EPIRUBICIN; EXEMESTANE; FLUDARABINE; FLUOROURACIL; FOLINIC ACID; FULVESTRANT; GEMCITABINE; IMATINIB; IRINOTECAN; OXALIPLATIN; PLACEBO; RAZOXANE; SUNITINIB; UNINDEXED DRUG;

EID: 70350141192     PISSN: 15289117     EISSN: 1540336X     Source Type: Journal    
DOI: 10.1097/PPO.0b013e3181b9c5ec     Document Type: Review
Times cited : (45)

References (37)
  • 1
    • 47749118439 scopus 로고    scopus 로고
    • Endpoints for assessing drug activity in clinical trials
    • Pazdur R. Endpoints for assessing drug activity in clinical trials. Oncologist. 2008;13(suppl 2):19-21.
    • (2008) Oncologist , vol.13 , Issue.SUPPL. 2 , pp. 19-21
    • Pazdur, R.1
  • 2
    • 34548043509 scopus 로고    scopus 로고
    • More clinical cancer treatments judged by progression-free rather than overall survival
    • Beckman M. More clinical cancer treatments judged by progression-free rather than overall survival. J Natl Cancer Inst. 2007;99:1068-1069.
    • (2007) J Natl Cancer Inst , vol.99 , pp. 1068-1069
    • Beckman, M.1
  • 3
    • 70350153936 scopus 로고    scopus 로고
    • Guidance for industry: Clinical trial endpoints for the approval of cancer drugs and biologics
    • US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER)
    • US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER). Guidance for industry: clinical trial endpoints for the approval of cancer drugs and biologics. Biotechnol Law Rep. 2007;26:375-386.
    • (2007) Biotechnol Law Rep , vol.26 , pp. 375-386
  • 4
    • 34250370236 scopus 로고    scopus 로고
    • European Medicines Agency. Committee for Medicinal Products for Human Use. December. Document CPMP/EWP/205/95/Rev.3/Corr. Available at: Accessed September 22, 2009
    • European Medicines Agency. Committee for Medicinal Products for Human Use. Guideline on the evaluation of anticancer medicinal products in man. December 2005. Document CPMP/EWP/205/95/Rev.3/Corr. Available at: http://www.tga.gov.au/docs/pdf/euguide/ewp/020509enrev3.pdf. Accessed September 22, 2009.
    • (2005) Guideline on the Evaluation of Anticancer Medicinal Products in Man
  • 5
    • 35348925113 scopus 로고    scopus 로고
    • Clinical trial endpoints in ovarian cancer: Report of an FDA/ASCO/AACR public workshop
    • Bast RC, Thigpen JT, Arbuck SG, et al. Clinical trial endpoints in ovarian cancer: report of an FDA/ASCO/AACR public workshop. Gynecol Oncol. 2007;107:173-176.
    • (2007) Gynecol Oncol , vol.107 , pp. 173-176
    • Bast, R.C.1    Thigpen, J.T.2    Arbuck, S.G.3
  • 6
    • 34548187711 scopus 로고    scopus 로고
    • The impact of new chemotherapeutic and hormone agents on survival in a population-based cohort of women with metastatic breast cancer
    • Chia SK, Speers CH, D'yachkova Y, et al. The impact of new chemotherapeutic and hormone agents on survival in a population-based cohort of women with metastatic breast cancer. Cancer. 2007;110:973-979.
    • (2007) Cancer , vol.110 , pp. 973-979
    • Chia, S.K.1    Speers, C.H.2    D'Yachkova, Y.3
  • 7
    • 2142703727 scopus 로고    scopus 로고
    • Survival of patients with advanced colorectal cancer improves with the availability of fluorouracilleucovorin, irinotecan, and oxaliplatin in the course of treatment
    • Grothey A, Sargent D, Goldberg RM, et al. Survival of patients with advanced colorectal cancer improves with the availability of fluorouracilleucovorin, irinotecan, and oxaliplatin in the course of treatment. J Clin Oncol. 2004;22:1209-1214.
    • (2004) J Clin Oncol , vol.22 , pp. 1209-1214
    • Grothey, A.1    Sargent, D.2    Goldberg, R.M.3
  • 8
    • 42949113031 scopus 로고    scopus 로고
    • Assessing the measure of a new drug: Is survival the only thing that matters?
    • Sargent DJ, Hayes DF. Assessing the measure of a new drug: is survival the only thing that matters? J Clin Oncol. 2008;26:1922-1923.
    • (2008) J Clin Oncol , vol.26 , pp. 1922-1923
    • Sargent, D.J.1    Hayes, D.F.2
  • 9
    • 68949188438 scopus 로고    scopus 로고
    • Novel statistical analysis of long-term survival to account for crossover in a phase III trial of sunitinib (SU) vs. placebo (PL) in advanced GIST after imatinib (IM) failure [abstract]
    • Demetri GD, Huan X, Garrett CR, et al. Novel statistical analysis of long-term survival to account for crossover in a phase III trial of sunitinib (SU) vs. placebo (PL) in advanced GIST after imatinib (IM) failure [abstract]. J Clin Oncol. 2008;26(15S):10524.
    • (2008) J Clin Oncol , vol.26 , Issue.15 SUPPL. , pp. 10524
    • Demetri, G.D.1    Huan, X.2    Garrett, C.R.3
  • 10
    • 0037986306 scopus 로고    scopus 로고
    • End points and United States Food and Drug Administration approval of oncology drugs
    • Johnson JR, Williams G, Pazdur R. End points and United States Food and Drug Administration approval of oncology drugs. J Clin Oncol. 2003;21: 1404-1411.
    • (2003) J Clin Oncol , vol.21 , pp. 1404-1411
    • Johnson, J.R.1    Williams, G.2    Pazdur, R.3
  • 11
    • 70350150945 scopus 로고    scopus 로고
    • EMEA experience with endpoints for oncology drug approval
    • December 16. Available at: Accessed June 3, 2009
    • Pignatti F. EMEA Experience with Endpoints for Oncology Drug Approval. EMEA/CHMP Biomarkers Workshop. December 16, 2005. Available at: http:// www.emea.europa.eu/pdfs/human/biomarkers/04PIGNATTI.pdf. Accessed June 3, 2009.
    • (2005) EMEA/CHMP Biomarkers Workshop
    • Pignatti, F.1
  • 12
    • 34047254691 scopus 로고    scopus 로고
    • When you look matters: The effect of assessment schedule on progression-free survival
    • Panageas KS, Ben-Porat L, Dickler NM, et al. When you look matters: the effect of assessment schedule on progression-free survival. J Natl Cancer Inst. 2007;99:428-432.
    • (2007) J Natl Cancer Inst , vol.99 , pp. 428-432
    • Panageas, K.S.1    Ben-Porat, L.2    Dickler, N.M.3
  • 13
    • 0034594628 scopus 로고    scopus 로고
    • New guidelines to evaluate the response to treatment in solid tumors
    • Therasse P, Arbuck SG, Eisenhauer EA, et al. New guidelines to evaluate the response to treatment in solid tumors. J Natl Cancer Inst. 2000;92:205-216.
    • (2000) J Natl Cancer Inst , vol.92 , pp. 205-216
    • Therasse, P.1    Arbuck, S.G.2    Eisenhauer, E.A.3
  • 14
    • 0003486931 scopus 로고
    • Geneva, Switzerland: World Health Organization Offset Publication No. 48
    • WHO Handbook for Reporting Results of Cancer Treatment. Geneva, Switzerland: World Health Organization Offset Publication No. 48;1979.
    • (1979) WHO Handbook for Reporting Results of Cancer Treatment
  • 15
    • 0030658087 scopus 로고    scopus 로고
    • Response rate accuracy in oncology trials: Reasons for interobserver variability
    • Thiesse P, Ollivier L, Di Stefano-Louineau D, et al. Response rate accuracy in oncology trials: reasons for interobserver variability. J Clin Oncol. 1997; 15:3507-3514.
    • (1997) J Clin Oncol , vol.15 , pp. 3507-3514
    • Thiesse, P.1    Ollivier, L.2    Di Stefano-Louineau, D.3
  • 16
    • 57849139273 scopus 로고    scopus 로고
    • Lessons learned from independent central review
    • Ford R, Schwartz L, Dancey J, et al. Lessons learned from independent central review. Eur J Cancer. 2009;45:268-274.
    • (2009) Eur J Cancer , vol.45 , pp. 268-274
    • Ford, R.1    Schwartz, L.2    Dancey, J.3
  • 17
    • 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, Friedlin 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;26:3791-3796.
    • (2008) J Clin Oncol , vol.26 , pp. 3791-3796
    • Dodd, L.E.1    Korn, E.L.2    Friedlin, B.3
  • 18
    • 33750096548 scopus 로고    scopus 로고
    • General and statistical hierarchy of appropriate biologic endpoints
    • Sargent D. General and statistical hierarchy of appropriate biologic endpoints. Oncology (Williston Park). 2006;20:5-9.
    • (2006) Oncology (Williston Park) , vol.20 , pp. 5-9
    • Sargent, D.1
  • 19
    • 70350148819 scopus 로고    scopus 로고
    • US Food and Drug Administration American Society of Clinical Oncology American Association of Cancer Research. Available at: Accessed April 23, 2009
    • US Food and Drug Administration, American Society of Clinical Oncology, American Association of Cancer Research. Meeting Summary. Ovarian Cancer Endpoints Workshop. 2006. Available at: http://www.fda.gov/CDER/ drug/cancer-endpoints/ovarian-summary.pdf Accessed April 23, 2009.
    • (2006) Meeting Summary. Ovarian Cancer Endpoints Workshop
  • 20
    • 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, et al. 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;25:4562-4568.
    • (2007) J Clin Oncol , vol.25 , pp. 4562-4568
    • Tang, P.A.1    Bentzen, S.M.2    Chen, E.X.3
  • 21
    • 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: 5218-5224.
    • (2007) J Clin Oncol , vol.25 , pp. 5218-5224
    • Buyse, M.1    Burzykowski, T.2    Carroll, K.3
  • 22
    • 36849069358 scopus 로고    scopus 로고
    • Toward progression-free survival as a primary end point in advanced colorectal cancer
    • Yothers G. Toward progression-free survival as a primary end point in advanced colorectal cancer. J Clin Oncol. 2007;25:5153-5154.
    • (2007) J Clin Oncol , vol.25 , pp. 5153-5154
    • Yothers, G.1
  • 23
    • 53149130962 scopus 로고    scopus 로고
    • Progression-free survival as a surrogate end point in advanced breast cancer
    • Miksad RA, Zietemann V, Gothe R, et al. Progression-free survival as a surrogate end point in advanced breast cancer. Int J Technol Assess Health Care. 2008;24:371-383.
    • (2008) Int J Technol Assess Health Care , vol.24 , pp. 371-383
    • Miksad, R.A.1    Zietemann, V.2    Gothe, R.3
  • 24
    • 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. 2008;26:1987-1992.
    • (2008) J Clin Oncol , vol.26 , pp. 1987-1992
    • Burzykowski, T.1    Buyse, M.2    Piccart-Gebhart, M.J.3
  • 25
    • 60349128880 scopus 로고    scopus 로고
    • AVASTIN® (Bevacizumab) South San Francisco, CA: Genentech Inc.
    • AVASTIN® (Bevacizumab) Prescribing Information. South San Francisco, CA: Genentech, Inc.; 2008.
    • (2008) Prescribing Information
  • 26
    • 0032772880 scopus 로고    scopus 로고
    • Survival and prognostic factors of 670 patients with advanced renal cell carcinoma
    • Motzer RJ, Mazumdar M, Bacik J, et al. Survival and prognostic factors of 670 patients with advanced renal cell carcinoma. J Clin Oncol. 1999;17: 2530-2540.
    • (1999) J Clin Oncol , vol.17 , pp. 2530-2540
    • Motzer, R.J.1    Mazumdar, M.2    Bacik, J.3
  • 27
    • 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;356:125-134.
    • (2007) N Engl J Med , vol.356 , pp. 125-134
    • Escudier, B.1    Eisen, T.2    Stadler, W.M.3
  • 28
    • 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 Eng J Med. 2007;356:115-124.
    • (2007) N Eng J Med , vol.356 , pp. 115-124
    • Motzer, R.J.1    Hutson, T.E.2    Tomczak, P.3
  • 29
    • 37349080670 scopus 로고    scopus 로고
    • Bevacizumab plus interferon alfa-2a for treatment of metastatic renal cell carcinoma: A randomized, 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 randomized, double-blind phase III trial. Lancet. 2007;370:2103-2111.
    • (2007) Lancet , vol.370 , pp. 2103-2111
    • Escudier, B.1    Pluzanska, A.2    Koralewski, P.3
  • 30
    • 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 Eng J Med. 2007;356:2271-2281.
    • (2007) N Eng J Med , vol.356 , pp. 2271-2281
    • Hudes, G.1    Carducci, M.2    Tomczak, P.3
  • 31
    • 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;372:449-456.
    • (2008) Lancet , vol.372 , pp. 449-456
    • Motzer, R.J.1    Escudier, B.2    Oudard, S.3
  • 32
    • 77955625913 scopus 로고    scopus 로고
    • Updated data from a phase III randomized trial of everolimus (RAD001) versus PBO in metastatic renal cell carcinoma (mRCC)
    • Abstract 278
    • Kay A, Motzer R, Escudier B, et al. Updated data from a phase III randomized trial of everolimus (RAD001) versus PBO in metastatic renal cell carcinoma (mRCC). ASCO 2009 Genitourinary Cancers Symposium. Abstract 278.
    • ASCO 2009 Genitourinary Cancers Symposium
    • Kay, A.1    Motzer, R.2    Escudier, B.3
  • 33
    • 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;12:7271-7278.
    • (2006) Clin Cancer Res , vol.12 , pp. 7271-7278
    • Kane, R.C.1    Farrell, A.T.2    Saber, H.3
  • 34
    • 48649094719 scopus 로고    scopus 로고
    • Overall survival with sunitinib versus interferon (IFN)-alfa as first-line treatment of metastatic renal cell carcinoma (mRCC)
    • (May 20 suppl): Abstract 5024 and Oral Presentation. Available at: Accessed June 3, 2009
    • Figlin RA, Hutson TE, Tomczak P, et al. Overall survival with sunitinib versus interferon (IFN)-alfa as first-line treatment of metastatic renal cell carcinoma (mRCC). J Clin Oncol. 2008;26(May 20 suppl): Abstract 5024 and Oral Presentation. Available at: http://www.asco.org/ASCOv2/MultiMedia/Virtual- Meeting?& vmview-vm-session-presentations-view&confID-55&sessionID- 363. Accessed June 3, 2009.
    • (2008) J Clin Oncol , vol.26
    • Figlin, R.A.1    Hutson, T.E.2    Tomczak, P.3
  • 35
    • 48649087700 scopus 로고    scopus 로고
    • Progression-free survival as endpoint in metastatic RCC?
    • Knox JJ. Progression-free survival as endpoint in metastatic RCC? Lancet. 2008;372:427-429.
    • (2008) Lancet , vol.372 , pp. 427-429
    • Knox, J.J.1
  • 36
    • 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
    • Delea TE, Khuu A, Kay 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):Abstract 5105.
    • (2009) J Clin Oncol , vol.27 , Issue.15 SUPPL.
    • Delea, T.E.1    Khuu, A.2    Kay, A.3
  • 37
    • 33644834827 scopus 로고    scopus 로고
    • Disease-free survival versus overall survival as a primary end point for adjuvant colon cancer studies: Individual patient data from 20,989 patients on 18 randomized trials
    • Sargent DJ, Wieand HS, Haller DG, et al. Disease-free survival versus overall survival as a primary end point for adjuvant colon cancer studies: individual patient data from 20,989 patients on 18 randomized trials. J Clin Oncol. 2005;23:8664-8670.
    • (2005) J Clin Oncol , vol.23 , pp. 8664-8670
    • Sargent, D.J.1    Wieand, H.S.2    Haller, D.G.3


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.