Radiographic Progression-Free Survival As a Response Biomarker in Metastatic Castration-Resistant Prostate Cancer: COU-AA-302 Results

被引：112

作者：

Morris, Michael J. ^{[1
,2
]}

Molina, Arturo ^{[3
]}

Small, Eric J. ^{[4
]}

de Bono, Johann S. ^{[5
,6
]}

Logothetis, Christopher J. ^{[7
]}

Fizazi, Karim ^{[8
]}

de Souza, Paul ^{[9
]}

Kantoff, Philip W. ^{[10
]}

Higano, Celestia S. ^{[11
]}

Li, Jinhui ^{[12
]}

Thian Kheoh ^{[3
]}

Larson, Steven M. ^{[1
,2
]}

Matheny, Shannon L. ^{[3
]}

Naini, Vahid ^{[3
]}

Burzykowski, Tomasz ^{[13
]}

Griffin, Thomas W. ^{[3
]}

Scher, Howard I. ^{[1
,2
]}

Ryan, Charles J. ^{[4
]}

机构：

[1] Mem Sloan Kettering Canc Ctr, New York, NY 10065 USA

[2] Weill Cornell Med Coll, New York, NY USA

[3] Janssen Res & Dev, Los Angeles, CA USA

[4] Univ Calif San Francisco, Helen Diller Family Comprehens Canc Ctr, San Francisco, CA 94143 USA

[5] Inst Canc Res, Sutton, Surrey, England

[6] Royal Marsden Hosp, Sutton, Surrey, England

[7] Univ Texas MD Anderson Canc Ctr, Houston, TX 77030 USA

[8] Univ Paris 11, Inst Gustave Roussy, Villejuif, France

[9] Univ Western Sydney, Sch Med, Ingham Inst, Liverpool, Merseyside, England

[10] Harvard Univ, Sch Med, Dana Farber Canc Inst, Boston, MA 02115 USA

[11] Univ Washington, Seattle, WA 98195 USA

[12] Janssen Res & Dev, Raritan, NJ USA

[13] Int Inst Drug Dev, Louvain La Neuve, Belgium

来源：

JOURNAL OF CLINICAL ONCOLOGY | 2015年 / 33卷 / 12期

关键词：

ABIRATERONE ACETATE; CLINICAL-TRIALS; END-POINTS; PREDNISONE; MEN;

D O I：

10.1200/JCO.2014.55.3875

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

Purpose Progression-free survival (PFS) in metastatic castration-resistant prostate cancer (mCRPC) trials has been inconsistently defined and poorly associated with overall survival (OS). A reproducible quantitative definition of radiographic PFS (rPFS) was tested for association with a coprimary end point of OS in a randomized trial of abiraterone in patients with mCRPC. Patients and Methods rPFS was defined as two new lesions on an 8-week bone scan plus two additional lesions on a confirmatory scan, two new confirmed lesions on any scan 12 weeks after random assignment, and/or progression in nodes or viscera on cross-sectional imaging, or death. rPFS was assessed by independent review at 15% of deaths and by investigator review at 15% and 40% of deaths. rPFS and OS association was evaluated by Spearman's correlation. Results A total of 1,088 patients were randomly assigned to abiraterone plus prednisone or prednisone alone. At first interim analysis, the hazard ratio (HR) by independent review was 0.43 (95% CI, 0.35 to 0.52; P < .001; abiraterone plus prednisone: median rPFS, not estimable; prednisone: median rPFS, 8.3 months). Similar HRs were obtained by investigator review at the first two interim analyses (HR, 0.49; 95% CI, 0.41 to 0.60; P < .001 and HR, 0.53; 95% CI, 0.45 to 0.62; P < .001, respectively), validating the imaging data assay used. Spearman's correlation coefficient between rPFS and OS was 0.72. Conclusion rPFS was highly consistent and highly associated with OS, providing initial prospective evidence on further developing rPFS as an intermediate end point in mCRPC trials. (C) 2015 by American Society of Clinical Oncology

引用

页码：1356 / +

页数：9

共 26 条

[11] Sipuleucel-T Immunotherapy for Castration-Resistant Prostate Cancer. [J].

Kantoff, Philip W. ;

Higano, Celestia S. ;

Shore, Neal D. ;

Berger, E. Roy ;

Small, Eric J. ;

Penson, David F. ;

Redfern, Charles H. ;

Ferrari, Anna C. ;

Dreicer, Robert ;

Sims, Robert B. ;

Xu, Yi ;

Frohlich, Mark W. ;

Schellhammer, Paul F. ;

Ahmed, T. ;

Amin, A. ;

Arseneau, J. ;

Barth, N. ;

Bernstein, G. ;

Bracken, B. ;

Burch, P. ;

Caggiano, V. ;

Chin, J. ;

Chodak, G. ;

Chu, F. ;

Corman, J. ;

Curti, B. ;

Dawson, N. ;

Deeken, J. F. ;

Dubernet, T. ;

Fishman, M. ;

Flanigan, R. ;

Gailani, F. ;

Garbo, L. ;

Gardner, T. ;

Gelmann, E. ;

George, D. ;

Godfrey, T. ;

Gomella, L. ;

Guerra, M. ;

Hall, S. ;

Hanson, J. ;

Israeli, R. ;

Jancis, E. ;

Jewett, M. A. S. ;

Kassabian, V. ;

Katz, J. ;

Klotz, L. ;

Koeneman, K. ;

Koh, H. ;

Kratzke, R. .

NEW ENGLAND JOURNAL OF MEDICINE, 2010, 363 (05) :411-422

[12] Abiraterone Acetate in Combination with Prednisone for the Treatment of Patients with Metastatic Castration-Resistant Prostate Cancer: US Food and Drug Administration Drug Approval Summary [J].

Kluetz, Paul G. ;

Ning, Yang-Min ;

Maher, V. Ellen ;

Zhang, Lijun ;

Tang, Shenghui ;

Ghosh, Debasis ;

Aziz, Robeena ;

Palmby, Todd ;

Pfuma, Elimika ;

Zirkelbach, Jeanne Fourie ;

Mehrotra, Nitin ;

Tilley, Amy ;

Sridhara, Rajeshwari ;

Ibrahim, Amna ;

Justice, Robert ;

Pazdur, Richard .

CLINICAL CANCER RESEARCH, 2013, 19 (24) :6650-6656

[13] Alpha Emitter Radium-223 and Survival in Metastatic Prostate Cancer [J].

Parker, C. ;

Nilsson, S. ;

Heinrich, D. ;

Helle, S. I. ;

O'Sullivan, J. M. ;

Fossa, S. D. ;

Chodacki, A. ;

Wiechno, P. ;

Logue, J. ;

Seke, M. ;

Widmark, A. ;

Johannessen, D. C. ;

Hoskin, P. ;

Bottomley, D. ;

James, N. D. ;

Solberg, A. ;

Syndikus, I. ;

Kliment, J. ;

Wedel, S. ;

Boehmer, S. ;

Dall'Oglio, M. ;

Franzen, L. ;

Coleman, R. ;

Vogelzang, N. J. ;

O'Bryan-Tear, C. G. ;

Staudacher, K. ;

Garcia-Vargas, J. ;

Shan, M. ;

Bruland, O. S. ;

Sartor, O. .

NEW ENGLAND JOURNAL OF MEDICINE, 2013, 369 (03) :213-223

[14] Abiraterone in Metastatic Prostate Cancer without Previous Chemotherapy [J].

Ryan, Charles J. ;

Smith, Matthew R. ;

de Bono, Johann S. ;

Molina, Arturo ;

Logothetis, Christopher J. ;

de Souza, Paul ;

Fizazi, Karim ;

Mainwaring, Paul ;

Piulats, Josep M. ;

Ng, Siobhan ;

Carles, Joan ;

Mulders, Peter F. A. ;

Basch, Ethan ;

Small, Eric J. ;

Saad, Fred ;

Schrijvers, Dirk ;

Van Poppel, Hendrik ;

Mukherjee, Som D. ;

Suttmann, Henrik ;

Gerritsen, Winald R. ;

Flaig, Thomas W. ;

George, Daniel J. ;

Yu, Evan Y. ;

Efstathiou, Eleni ;

Pantuck, Allan ;

Winquist, Eric ;

Higano, Celestia S. ;

Taplin, Mary-Ellen ;

Park, Youn ;

Kheoh, Thian ;

Griffin, Thomas ;

Scher, Howard I. ;

Rathkopf, Dana E. .

NEW ENGLAND JOURNAL OF MEDICINE, 2013, 368 (02) :138-148

[15] Phase II Study of Abiraterone Acetate in Chemotherapy-Naive Metastatic Castration-Resistant Prostate Cancer Displaying Bone Flare Discordant with Serologic Response [J].

Ryan, Charles J. ;

Shah, Shreya ;

Efstathiou, Eleni ;

Smith, Matthew R. ;

Taplin, Mary-Ellen ;

Bubley, Glenn J. ;

Logothetis, Christopher J. ;

Thian Kheoh ;

Kilian, Christine ;

Haqq, Christopher M. ;

Molina, Arturo ;

Small, Eric J. .

CLINICAL CANCER RESEARCH, 2011, 17 (14) :4854-4861

[16] Prostate cancer clinical trial end points: "RECIST"ing a step backwards [J].

Scher, HI ;

Morris, MJ ;

Kelly, WK ;

Schwartz, LH ;

Heller, G .

CLINICAL CANCER RESEARCH, 2005, 11 (14) :5223-5232

[17]

Scher HI, 2013, J CLIN ONCOL S15S, V31, p321s

[18] Design and end points of clinical trials for patients with progressive prostate cancer and castrate levels of testosterone: Recommendations of the prostate cancer clinical trials working group [J].

Scher, Howard I. ;

Halabi, Susan ;

Tannock, Ian ;

Morris, Michael ;

Sternberg, Cora N. ;

Carducci, Michael A. ;

Eisenberger, Mario A. ;

Higano, Celestia ;

Bubley, Glenn J. ;

Dreicer, Robert ;

Petrylak, Daniel ;

Kantoff, Philip ;

Basch, Ethan ;

Kelly, William Kevin ;

Figg, William D. ;

Small, Eric J. ;

Beer, Tomasz M. ;

Wilding, George ;

Martin, Alison ;

Hussain, Maha .

JOURNAL OF CLINICAL ONCOLOGY, 2008, 26 (07) :1148-1159

[19] The association between measures of progression and survival in castrate-metastatic prostate cancer [J].

Scher, Howard I. ;

Warren, Mary ;

Heller, Glenn .

CLINICAL CANCER RESEARCH, 2007, 13 (05) :1488-1492

[20] Increased Survival with Enzalutamide in Prostate Cancer after Chemotherapy [J].

Scher, Howard I. ;

Fizazi, Karim ;

Saad, Fred ;

Taplin, Mary-Ellen ;

Sternberg, Cora N. ;

Miller, Kurt ;

de Wit, Ronald ;

Mulders, Peter ;

Chi, Kim N. ;

Shore, Neal D. ;

Armstrong, Andrew J. ;

Flaig, Thomas W. ;

Flechon, Aude ;

Mainwaring, Paul ;

Fleming, Mark ;

Hainsworth, John D. ;

Hirmand, Mohammad ;

Selby, Bryan ;

Seely, Lynn ;

de Bono, Johann S. .

NEW ENGLAND JOURNAL OF MEDICINE, 2012, 367 (13) :1187-1197

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