Event-Free Survival, a Prostate-Specific Antigen-Based Composite End Point, Is Not a Surrogate for Overall Survival in Men With Localized Prostate Cancer Treated With Radiation.

Autor:	Xie W; Division of Biostatistics, Dana-Farber Cancer Institute, Boston, MA., Regan MM; Division of Biostatistics, Dana-Farber Cancer Institute, Boston, MA., Buyse M; International Drug Development Institute, Louvain la Neuve, Belgium., Halabi S; Department of Biostatistics and Bioinformatics, Duke University, Durham, NC., Kantoff PW; Department of Medicine, Memorial Sloan-Kettering Cancer Center, New York, NY., Sartor O; Departments of Medicine & Urology, Tulane University, New Orleans, LA., Soule H; Prostate Cancer Foundation, Santa Monica, CA., Berry D; Department of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, TX., Clarke N; Urological Oncology, The Christie NHS Foundation Trust, Manchester, United Kingdom., Collette L; European Organisation for Research and Treatment of Cancer Headquarters, Brussels, Belgium., D'Amico A; Department of Radiation Oncology, Brigham and Women's Hospital and Dana-Farber Cancer Institute, Boston, MA., Lourenco RA; Centre for Health Economics Research and Evaluation, University of Technology Sydney, Sydney, NSW, Australia., Dignam J; Department of Public Health Science, University of Chicago, Chicago, IL., Eisenberger M; Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University, Baltimore, MD., James N; University Hospitals Birmingham, Birmingham, United Kingdom., Fizazi K; Department of Cancer Medicine, Institut Gustave Roussy, Villejuif, France., Gillessen S; Division of Cancer Sciences, University of Manchester and The Christie, Manchester, United Kingdom., Loriot Y; Department of Cancer Medicine, Institut Gustave Roussy, Villejuif, France., Mottet N; Urology Oncology, University Jean Monnet, St Etienne, France., Parulekar W; Canadian Cancer Trials Group, Cancer Research Institute, Queen's University, Kingston, Ontario, Canada., Sandler H; Radiation Oncology, Cedars Sinai Medical Center, Los Angeles, CA., Spratt DE; University of Michigan, Ann Arbor, MI., Sydes MR; Medical Research Council Clinical Trials Unit, Institute of Clinical Trials and Methodology, University College London, London, United Kingdom., Tombal B; Institut de Recherche Clinique, Université Catholique de Louvain, Brussels, Belgium., Williams S; Radiation Oncology, Peter MacCallum Cancer Centre, Melbourne, Australia., Sweeney CJ; Lank Center for Genitourinary Oncology, Dana-Farber Cancer Institute, Boston, MA.
Jazyk:	angličtina
Zdroj:	Journal of clinical oncology : official journal of the American Society of Clinical Oncology [J Clin Oncol] 2020 Sep 10; Vol. 38 (26), pp. 3032-3041. Date of Electronic Publication: 2020 Jun 18.
DOI:	10.1200/JCO.19.03114
Abstrakt:	Purpose: Recently, we have shown that metastasis-free survival is a strong surrogate for overall survival (OS) in men with intermediate- and high-risk localized prostate cancer and can accelerate the evaluation of new (neo)adjuvant therapies. Event-free survival (EFS), an earlier prostate-specific antigen (PSA)-based composite end point, may further expedite trial completion. Methods: EFS was defined as the time from random assignment to the date of first evidence of disease recurrence, including biochemical failure, local or regional recurrence, distant metastasis, or death from any cause, or was censored at the date of last PSA assessment. Individual patient data from trials within the Intermediate Clinical Endpoints in Cancer of the Prostate-ICECaP-database with evaluable PSA and disease follow-up data were analyzed. We evaluated the surrogacy of EFS for OS using a 2-stage meta-analytic validation model by determining the correlation of EFS with OS (patient level) and the correlation of treatment effects (hazard ratios [HRs]) on both EFS and OS (trial level). A clinically relevant surrogacy was defined a priori as an R 2 ≥ 0.7. Results: Data for 10,350 patients were analyzed from 15 radiation therapy-based trials enrolled from 1987 to 2011 with a median follow-up of 10 years. At the patient level, the correlation of EFS with OS was 0.43 (95% CI, 0.42 to 0.44) as measured by Kendall's tau from a copula model. At the trial level, the R 2 was 0.35 (95% CI, 0.01 to 0.60) from the weighted linear regression of log(HR)-OS on log(HR)-EFS. Conclusion: EFS is a weak surrogate for OS and is not suitable for use as an intermediate clinical end point to substitute for OS to accelerate phase III (neo)adjuvant trials of prostate cancer therapies for primary radiation therapy-based trials.
Databáze:	MEDLINE
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