Metastasis-free survival is a strong Surrogate of overall survival in localized prostate cancer

Wanling Xie, Meredith M. Regan, Marc Buyse, Susan Halabi, Philip W. Kantoff, Oliver Sartor, Howard Soule, Noel W. Clarke, Laurence Collette, James J. Dignam, Karim Fizazi, Wendy R. Paruleker, Howard M. Sandler, Matthew R. Sydes, Bertrand Tombal, Scott G. Williams, Christopher J. Sweeney, Ove Andren, John Armstrong, Donald Berry & 39 others Michel Bolla, Joseph Chin, Simon Chowdhury, Noel Clarke, Matthew Cooperberg, Jim Denham, James Dignam, Savino Mauro Di Stasi, Mario Eisenberger, Boris Freidlin, Silke Gillessen, Martin Gleave, Muriel Habibian, Nicholas James, Jonathan Jarow, Nancy Keating, Gary Keloff, Laurence Klotz, Himu Lukka, Malcolm Mason, Andrea Miyahira, Nicolas Mottet, Mari Nakabayashi, Wendy R. Parulekar, Meredith Regan, Howard Sandler, Peter Scardino, Howard Scher, Richard Simon, Jonathan Simons, Eric Small, Matthew Sydes, Catherine Tangen, Ian Thompson, Anders Widmark, Thomas Wiegel, Manfred Wirth, Eric Yeoh, Almudena Zapatero

Research output: Contribution to journalArticle

Abstract

Purpose: Adjuvant therapy for intermediate-risk and high-risk localized prostate cancer decreases the number of deaths from this disease. Surrogates for overall survival (OS) could expedite the evaluation of new adjuvant therapies. Methods: By June 2013, 102 completed or ongoing randomized trials were identified and individual patient data were collected from 28 trials with 28,905 patients. Disease-free survival (DFS) and metastasisfree survival (MFS) were determined for 21,140 patients from 24 trials and 12,712 patients from 19 trials, respectively. We evaluated the surrogacy of DFS and MFS for OS by using a two-stage metaanalytic validation model by determining the correlation of an intermediate clinical end point with OS and the correlation of treatment effects on both the intermediate clinical end point and OS. Results: Trials enrolled patients from 1987 to 2011. After a median follow-up of 10 years, 45% of 21,140 men and 45% of 12,712 men experienced a DFS and MFS event, respectively. For DFS and MFS, 61% and 90% of the patients, respectively, were from radiation trials, and 63% and 66%, respectively, had high-risk disease. At the patient level, Kendall's π correlation with OS was 0.85 and 0.91 for DFS and MFS, respectively. At the trial level, R2 was 0.86 (95% CI, 0.78 to 0.90) and 0.83 (95% CI, 0.71 to 0.88) from weighted linear regression of 8-year OS rates versus 5-year DFS and MFS rates, respectively. Treatment effects-measured by log hazard ratios-for the surrogates and OS were well correlated (R2, 0.73 [95% CI, 0.53 to 0.82] for DFS and 0.92 [95% CI, 0.81 to 0.95] for MFS). Conclusion: MFS is a strong surrogate for OS for localized prostate cancer that is associated with a significant risk of death from prostate cancer.

Original languageEnglish (US)
Pages (from-to)3097-3104
Number of pages8
JournalJournal of Clinical Oncology
Volume35
Issue number27
DOIs
StatePublished - Sep 20 2017

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Prostatic Neoplasms
Neoplasm Metastasis
Survival
Disease-Free Survival
Survival Rate
Therapeutics
Linear Models
Radiation

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

Cite this

Xie, W., Regan, M. M., Buyse, M., Halabi, S., Kantoff, P. W., Sartor, O., ... Zapatero, A. (2017). Metastasis-free survival is a strong Surrogate of overall survival in localized prostate cancer. Journal of Clinical Oncology, 35(27), 3097-3104. https://doi.org/10.1200/JCO.2017.73.9987

Metastasis-free survival is a strong Surrogate of overall survival in localized prostate cancer. / Xie, Wanling; Regan, Meredith M.; Buyse, Marc; Halabi, Susan; Kantoff, Philip W.; Sartor, Oliver; Soule, Howard; Clarke, Noel W.; Collette, Laurence; Dignam, James J.; Fizazi, Karim; Paruleker, Wendy R.; Sandler, Howard M.; Sydes, Matthew R.; Tombal, Bertrand; Williams, Scott G.; Sweeney, Christopher J.; Andren, Ove; Armstrong, John; Berry, Donald; Bolla, Michel; Chin, Joseph; Chowdhury, Simon; Clarke, Noel; Cooperberg, Matthew; Denham, Jim; Dignam, James; Di Stasi, Savino Mauro; Eisenberger, Mario; Freidlin, Boris; Gillessen, Silke; Gleave, Martin; Habibian, Muriel; James, Nicholas; Jarow, Jonathan; Keating, Nancy; Keloff, Gary; Klotz, Laurence; Lukka, Himu; Mason, Malcolm; Miyahira, Andrea; Mottet, Nicolas; Nakabayashi, Mari; Parulekar, Wendy R.; Regan, Meredith; Sandler, Howard; Scardino, Peter; Scher, Howard; Simon, Richard; Simons, Jonathan; Small, Eric; Sydes, Matthew; Tangen, Catherine; Thompson, Ian; Widmark, Anders; Wiegel, Thomas; Wirth, Manfred; Yeoh, Eric; Zapatero, Almudena.

In: Journal of Clinical Oncology, Vol. 35, No. 27, 20.09.2017, p. 3097-3104.

Research output: Contribution to journalArticle

Xie, W, Regan, MM, Buyse, M, Halabi, S, Kantoff, PW, Sartor, O, Soule, H, Clarke, NW, Collette, L, Dignam, JJ, Fizazi, K, Paruleker, WR, Sandler, HM, Sydes, MR, Tombal, B, Williams, SG, Sweeney, CJ, Andren, O, Armstrong, J, Berry, D, Bolla, M, Chin, J, Chowdhury, S, Clarke, N, Cooperberg, M, Denham, J, Dignam, J, Di Stasi, SM, Eisenberger, M, Freidlin, B, Gillessen, S, Gleave, M, Habibian, M, James, N, Jarow, J, Keating, N, Keloff, G, Klotz, L, Lukka, H, Mason, M, Miyahira, A, Mottet, N, Nakabayashi, M, Parulekar, WR, Regan, M, Sandler, H, Scardino, P, Scher, H, Simon, R, Simons, J, Small, E, Sydes, M, Tangen, C, Thompson, I, Widmark, A, Wiegel, T, Wirth, M, Yeoh, E & Zapatero, A 2017, 'Metastasis-free survival is a strong Surrogate of overall survival in localized prostate cancer', Journal of Clinical Oncology, vol. 35, no. 27, pp. 3097-3104. https://doi.org/10.1200/JCO.2017.73.9987
Xie, Wanling ; Regan, Meredith M. ; Buyse, Marc ; Halabi, Susan ; Kantoff, Philip W. ; Sartor, Oliver ; Soule, Howard ; Clarke, Noel W. ; Collette, Laurence ; Dignam, James J. ; Fizazi, Karim ; Paruleker, Wendy R. ; Sandler, Howard M. ; Sydes, Matthew R. ; Tombal, Bertrand ; Williams, Scott G. ; Sweeney, Christopher J. ; Andren, Ove ; Armstrong, John ; Berry, Donald ; Bolla, Michel ; Chin, Joseph ; Chowdhury, Simon ; Clarke, Noel ; Cooperberg, Matthew ; Denham, Jim ; Dignam, James ; Di Stasi, Savino Mauro ; Eisenberger, Mario ; Freidlin, Boris ; Gillessen, Silke ; Gleave, Martin ; Habibian, Muriel ; James, Nicholas ; Jarow, Jonathan ; Keating, Nancy ; Keloff, Gary ; Klotz, Laurence ; Lukka, Himu ; Mason, Malcolm ; Miyahira, Andrea ; Mottet, Nicolas ; Nakabayashi, Mari ; Parulekar, Wendy R. ; Regan, Meredith ; Sandler, Howard ; Scardino, Peter ; Scher, Howard ; Simon, Richard ; Simons, Jonathan ; Small, Eric ; Sydes, Matthew ; Tangen, Catherine ; Thompson, Ian ; Widmark, Anders ; Wiegel, Thomas ; Wirth, Manfred ; Yeoh, Eric ; Zapatero, Almudena. / Metastasis-free survival is a strong Surrogate of overall survival in localized prostate cancer. In: Journal of Clinical Oncology. 2017 ; Vol. 35, No. 27. pp. 3097-3104.
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abstract = "Purpose: Adjuvant therapy for intermediate-risk and high-risk localized prostate cancer decreases the number of deaths from this disease. Surrogates for overall survival (OS) could expedite the evaluation of new adjuvant therapies. Methods: By June 2013, 102 completed or ongoing randomized trials were identified and individual patient data were collected from 28 trials with 28,905 patients. Disease-free survival (DFS) and metastasisfree survival (MFS) were determined for 21,140 patients from 24 trials and 12,712 patients from 19 trials, respectively. We evaluated the surrogacy of DFS and MFS for OS by using a two-stage metaanalytic validation model by determining the correlation of an intermediate clinical end point with OS and the correlation of treatment effects on both the intermediate clinical end point and OS. Results: Trials enrolled patients from 1987 to 2011. After a median follow-up of 10 years, 45{\%} of 21,140 men and 45{\%} of 12,712 men experienced a DFS and MFS event, respectively. For DFS and MFS, 61{\%} and 90{\%} of the patients, respectively, were from radiation trials, and 63{\%} and 66{\%}, respectively, had high-risk disease. At the patient level, Kendall's π correlation with OS was 0.85 and 0.91 for DFS and MFS, respectively. At the trial level, R2 was 0.86 (95{\%} CI, 0.78 to 0.90) and 0.83 (95{\%} CI, 0.71 to 0.88) from weighted linear regression of 8-year OS rates versus 5-year DFS and MFS rates, respectively. Treatment effects-measured by log hazard ratios-for the surrogates and OS were well correlated (R2, 0.73 [95{\%} CI, 0.53 to 0.82] for DFS and 0.92 [95{\%} CI, 0.81 to 0.95] for MFS). Conclusion: MFS is a strong surrogate for OS for localized prostate cancer that is associated with a significant risk of death from prostate cancer.",
author = "Wanling Xie and Regan, {Meredith M.} and Marc Buyse and Susan Halabi and Kantoff, {Philip W.} and Oliver Sartor and Howard Soule and Clarke, {Noel W.} and Laurence Collette and Dignam, {James J.} and Karim Fizazi and Paruleker, {Wendy R.} and Sandler, {Howard M.} and Sydes, {Matthew R.} and Bertrand Tombal and Williams, {Scott G.} and Sweeney, {Christopher J.} and Ove Andren and John Armstrong and Donald Berry and Michel Bolla and Joseph Chin and Simon Chowdhury and Noel Clarke and Matthew Cooperberg and Jim Denham and James Dignam and {Di Stasi}, {Savino Mauro} and Mario Eisenberger and Boris Freidlin and Silke Gillessen and Martin Gleave and Muriel Habibian and Nicholas James and Jonathan Jarow and Nancy Keating and Gary Keloff and Laurence Klotz and Himu Lukka and Malcolm Mason and Andrea Miyahira and Nicolas Mottet and Mari Nakabayashi and Parulekar, {Wendy R.} and Meredith Regan and Howard Sandler and Peter Scardino and Howard Scher and Richard Simon and Jonathan Simons and Eric Small and Matthew Sydes and Catherine Tangen and Ian Thompson and Anders Widmark and Thomas Wiegel and Manfred Wirth and Eric Yeoh and Almudena Zapatero",
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TY - JOUR

T1 - Metastasis-free survival is a strong Surrogate of overall survival in localized prostate cancer

AU - Xie, Wanling

AU - Regan, Meredith M.

AU - Buyse, Marc

AU - Halabi, Susan

AU - Kantoff, Philip W.

AU - Sartor, Oliver

AU - Soule, Howard

AU - Clarke, Noel W.

AU - Collette, Laurence

AU - Dignam, James J.

AU - Fizazi, Karim

AU - Paruleker, Wendy R.

AU - Sandler, Howard M.

AU - Sydes, Matthew R.

AU - Tombal, Bertrand

AU - Williams, Scott G.

AU - Sweeney, Christopher J.

AU - Andren, Ove

AU - Armstrong, John

AU - Berry, Donald

AU - Bolla, Michel

AU - Chin, Joseph

AU - Chowdhury, Simon

AU - Clarke, Noel

AU - Cooperberg, Matthew

AU - Denham, Jim

AU - Dignam, James

AU - Di Stasi, Savino Mauro

AU - Eisenberger, Mario

AU - Freidlin, Boris

AU - Gillessen, Silke

AU - Gleave, Martin

AU - Habibian, Muriel

AU - James, Nicholas

AU - Jarow, Jonathan

AU - Keating, Nancy

AU - Keloff, Gary

AU - Klotz, Laurence

AU - Lukka, Himu

AU - Mason, Malcolm

AU - Miyahira, Andrea

AU - Mottet, Nicolas

AU - Nakabayashi, Mari

AU - Parulekar, Wendy R.

AU - Regan, Meredith

AU - Sandler, Howard

AU - Scardino, Peter

AU - Scher, Howard

AU - Simon, Richard

AU - Simons, Jonathan

AU - Small, Eric

AU - Sydes, Matthew

AU - Tangen, Catherine

AU - Thompson, Ian

AU - Widmark, Anders

AU - Wiegel, Thomas

AU - Wirth, Manfred

AU - Yeoh, Eric

AU - Zapatero, Almudena

PY - 2017/9/20

Y1 - 2017/9/20

N2 - Purpose: Adjuvant therapy for intermediate-risk and high-risk localized prostate cancer decreases the number of deaths from this disease. Surrogates for overall survival (OS) could expedite the evaluation of new adjuvant therapies. Methods: By June 2013, 102 completed or ongoing randomized trials were identified and individual patient data were collected from 28 trials with 28,905 patients. Disease-free survival (DFS) and metastasisfree survival (MFS) were determined for 21,140 patients from 24 trials and 12,712 patients from 19 trials, respectively. We evaluated the surrogacy of DFS and MFS for OS by using a two-stage metaanalytic validation model by determining the correlation of an intermediate clinical end point with OS and the correlation of treatment effects on both the intermediate clinical end point and OS. Results: Trials enrolled patients from 1987 to 2011. After a median follow-up of 10 years, 45% of 21,140 men and 45% of 12,712 men experienced a DFS and MFS event, respectively. For DFS and MFS, 61% and 90% of the patients, respectively, were from radiation trials, and 63% and 66%, respectively, had high-risk disease. At the patient level, Kendall's π correlation with OS was 0.85 and 0.91 for DFS and MFS, respectively. At the trial level, R2 was 0.86 (95% CI, 0.78 to 0.90) and 0.83 (95% CI, 0.71 to 0.88) from weighted linear regression of 8-year OS rates versus 5-year DFS and MFS rates, respectively. Treatment effects-measured by log hazard ratios-for the surrogates and OS were well correlated (R2, 0.73 [95% CI, 0.53 to 0.82] for DFS and 0.92 [95% CI, 0.81 to 0.95] for MFS). Conclusion: MFS is a strong surrogate for OS for localized prostate cancer that is associated with a significant risk of death from prostate cancer.

AB - Purpose: Adjuvant therapy for intermediate-risk and high-risk localized prostate cancer decreases the number of deaths from this disease. Surrogates for overall survival (OS) could expedite the evaluation of new adjuvant therapies. Methods: By June 2013, 102 completed or ongoing randomized trials were identified and individual patient data were collected from 28 trials with 28,905 patients. Disease-free survival (DFS) and metastasisfree survival (MFS) were determined for 21,140 patients from 24 trials and 12,712 patients from 19 trials, respectively. We evaluated the surrogacy of DFS and MFS for OS by using a two-stage metaanalytic validation model by determining the correlation of an intermediate clinical end point with OS and the correlation of treatment effects on both the intermediate clinical end point and OS. Results: Trials enrolled patients from 1987 to 2011. After a median follow-up of 10 years, 45% of 21,140 men and 45% of 12,712 men experienced a DFS and MFS event, respectively. For DFS and MFS, 61% and 90% of the patients, respectively, were from radiation trials, and 63% and 66%, respectively, had high-risk disease. At the patient level, Kendall's π correlation with OS was 0.85 and 0.91 for DFS and MFS, respectively. At the trial level, R2 was 0.86 (95% CI, 0.78 to 0.90) and 0.83 (95% CI, 0.71 to 0.88) from weighted linear regression of 8-year OS rates versus 5-year DFS and MFS rates, respectively. Treatment effects-measured by log hazard ratios-for the surrogates and OS were well correlated (R2, 0.73 [95% CI, 0.53 to 0.82] for DFS and 0.92 [95% CI, 0.81 to 0.95] for MFS). Conclusion: MFS is a strong surrogate for OS for localized prostate cancer that is associated with a significant risk of death from prostate cancer.

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