Behfar Ehdaie1,2, Bing Ying Poon3, Daniel D Sjoberg3, Pedro Recabal4,5, Vincent Laudone4, Karim Touijer4, James Eastham4, Peter T Scardino4. 1. Urology Service, Sidney Kimmel Center for Prostate and Urologic Cancers, New York, NY, USA. ehdaieb@mskcc.org. 2. Department of Epidemiology and Biostatistics, Memorial Sloan-Kettering Cancer Center, New York, NY, USA. ehdaieb@mskcc.org. 3. Department of Epidemiology and Biostatistics, Memorial Sloan-Kettering Cancer Center, New York, NY, USA. 4. Urology Service, Sidney Kimmel Center for Prostate and Urologic Cancers, New York, NY, USA. 5. Urology Service, Fundacion Arturo Lopez Perez, Santiago, Chile.
Abstract
OBJECTIVE: To describe fluctuations in prostate-specific antigen (PSA) levels in men managed with active surveillance (AS) to determine if a single PSA increase is a consistent measure to use to trigger intervention. PATIENTS AND METHODS: We evaluated data on 541 patients undergoing AS between 1995 and 2011. PSA variation was described by studying the Kaplan-Meier probability of patients' PSA levels reaching 4 or 7 ng/mL, falling below those thresholds, and then rising to those thresholds again. We also examined PSA variation by calculating the Kaplan-Meier probability of a PSA change followed by an equal or greater change in the opposite direction. RESULTS: We analysed data on 541 patients undergoing AS with a median (interquartile range [IQR]) of 8 (6-12) PSA measurements and undergoing AS for a median (IQR) of 4 (2-6) years. The 5-year estimate of the probability of reaching a threshold PSA of 7 ng/mL was 40% (95% confidence interval [CI] 35-46%) and the 5-year estimate of subsequently falling below this threshold was 90% (95% CI 82-95%). The 5-year estimate of a PSA direction change was 95% (95% CI 93-97%) overall and 56% (95% CI 51-61%) for PSA direction changes of ≥1 ng/mL. CONCLUSIONS: We observed a high probability of variability in PSA levels for patients on AS. The probability of changes in PSA, defined by an increase to the specified thresholds or a rise >1 ng/mL within 6 months and subsequent decrease of equal or greater value on a subsequent measurement, increases over time; therefore, a single change in PSA level is not a reliable endpoint for patients on AS.
OBJECTIVE: To describe fluctuations in prostate-specific antigen (PSA) levels in men managed with active surveillance (AS) to determine if a single PSA increase is a consistent measure to use to trigger intervention. PATIENTS AND METHODS: We evaluated data on 541 patients undergoing AS between 1995 and 2011. PSA variation was described by studying the Kaplan-Meier probability of patients' PSA levels reaching 4 or 7 ng/mL, falling below those thresholds, and then rising to those thresholds again. We also examined PSA variation by calculating the Kaplan-Meier probability of a PSA change followed by an equal or greater change in the opposite direction. RESULTS: We analysed data on 541 patients undergoing AS with a median (interquartile range [IQR]) of 8 (6-12) PSA measurements and undergoing AS for a median (IQR) of 4 (2-6) years. The 5-year estimate of the probability of reaching a threshold PSA of 7 ng/mL was 40% (95% confidence interval [CI] 35-46%) and the 5-year estimate of subsequently falling below this threshold was 90% (95% CI 82-95%). The 5-year estimate of a PSA direction change was 95% (95% CI 93-97%) overall and 56% (95% CI 51-61%) for PSA direction changes of ≥1 ng/mL. CONCLUSIONS: We observed a high probability of variability in PSA levels for patients on AS. The probability of changes in PSA, defined by an increase to the specified thresholds or a rise >1 ng/mL within 6 months and subsequent decrease of equal or greater value on a subsequent measurement, increases over time; therefore, a single change in PSA level is not a reliable endpoint for patients on AS.
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