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. © 2017 by American Society of Clinical Oncology.

Xie, W., Regan, M., Buyse, M., Halabi, S., Kantoff, P., Sartor, O., et al. (2017). Metastasis-free survival is a strong Surrogate of overall survival in localized prostate cancer. JOURNAL OF CLINICAL ONCOLOGY, 35(27), 3097-3114 [10.1200/JCO.2017.73.9987].

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

Di Stasi, SM
Membro del Collaboration Group
;
2017-09-20

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. © 2017 by American Society of Clinical Oncology.
20-set-2017
Pubblicato
Rilevanza internazionale
Articolo
Esperti anonimi
Settore MED/24 - UROLOGIA
English
Con Impact Factor ISI
aged; androgen deprivation therapy; Article; cancer; localization cancer; radiotherapy; cancer surgery controlled study; correlational study; disease free survival; follow up high risk patient; human intermediate risk patient; major clinical study; male metastasis free survival; overall survival; patient coding priority; journal prostate cancer prostatectomy treatment; duration; bio assay meta analysis; metastasis multimodality; cancer therapy; pathology; Prostatic Neoplasms randomized controlled trial (topic); risk factor survival analysis
Xie, W., Regan, M., Buyse, M., Halabi, S., Kantoff, P., Sartor, O., et al. (2017). Metastasis-free survival is a strong Surrogate of overall survival in localized prostate cancer. JOURNAL OF CLINICAL ONCOLOGY, 35(27), 3097-3114 [10.1200/JCO.2017.73.9987].
Xie, W; Regan, M; Buyse, M; Halabi, S; Kantoff, P; Sartor, O; Soule, H; Clarke, N; Collette, L; Dignam, J; Fizazi, K; Paruleker, W; Sandler, H; Sydes, M; Tombal, B; Williams, S; Sweeney, C; Andren, O; Armstrong, J; Berry, D; Bolla, M; Chin, J; Chowdhury, S; Clarke, N; Cooperberg, M; Denham, J; Dignam, J; Di Stasi, S; 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, W; 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
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/2108/193187
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