Justin R Gregg1, John W Davis2, Chad Reichard2, Xuemei Wang3, Mary Achim2, Brian F Chapin2, Louis Pisters2, Curtis Pettaway2, John F Ward2, Seungtaek Choi4, Quynh-Nhu Nguyen4, Deborah Kuban4, Richard Babaian2, Patricia Troncoso5, Lydia T Madsen6, Christopher Logothetis7, Jeri Kim8. 1. Department of Urology, The University of Texas MD Anderson Cancer Center, Houston, TX. Electronic address: jrgregg@mdanderson.org. 2. Department of Urology, The University of Texas MD Anderson Cancer Center, Houston, TX. 3. Department of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, TX. 4. Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX. 5. Department of Pathology, The University of Texas MD Anderson Cancer Center, Houston, TX. 6. Department of Acute and Continuing Care, University of Texas Health Cizik School of Nursing, Houston, TX. 7. Department of Genitourinary Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX. 8. Department of Genitourinary Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX; Affiliation change since completion of this work: Merck & Co., Inc., Kenilworth, NJ.
Abstract
OBJECTIVE: To report biopsy-related and oncologic outcomes in a large prospective active surveillance cohort that was initiated in the premagnetic resonance imaging era and to additionally identify clinical factors associated with disease reclassification in order to inform future studies designed to improve enrollment and follow-up on active surveillance. METHODS: Patients were prospectively enrolled at a single institution from 2006 to 2014 and followed until 2016. Men with Gleason 6 or 7 disease were eligible, and those with >6 months follow-up were included in the analysis. Patients were risk stratified based on clinical/pathologic criteria, including based on a combination of baseline and confirmatory biopsy tumor characteristics. Reclassification-free survival, based on tumor volume increase or Gleason score increase, was analyzed using multivariable Cox proportional hazards models. RESULTS: Of 825 enrolled patients, 682 met inclusion criteria. Median follow-up was 40 months (range 6.6-126.8). Disease was reclassified in 249 (36.5%), and 157 (23.0%) underwent treatment. A single positive core with a negative confirmatory biopsy was significantly associated with time to reclassification (median not met vs 43 months, log rank test P <.001). Composite tumor length, defined as the combined tumor length between baseline and confirmatory biopsies, was associated with shorter Gleason upgrade-free survival (hazard ratio 1.24, 95% confidence interval 1.11-1.40, P <.001) in multivariable analysis. CONCLUSION: Baseline stratification using clinical factors including tumor length may refine risk stratification and offer the foundation on which new systems that incorporate modalities such as magnetic resonance imaging may be based.
OBJECTIVE: To report biopsy-related and oncologic outcomes in a large prospective active surveillance cohort that was initiated in the premagnetic resonance imaging era and to additionally identify clinical factors associated with disease reclassification in order to inform future studies designed to improve enrollment and follow-up on active surveillance. METHODS: Patients were prospectively enrolled at a single institution from 2006 to 2014 and followed until 2016. Men with Gleason 6 or 7 disease were eligible, and those with >6 months follow-up were included in the analysis. Patients were risk stratified based on clinical/pathologic criteria, including based on a combination of baseline and confirmatory biopsy tumor characteristics. Reclassification-free survival, based on tumor volume increase or Gleason score increase, was analyzed using multivariable Cox proportional hazards models. RESULTS: Of 825 enrolled patients, 682 met inclusion criteria. Median follow-up was 40 months (range 6.6-126.8). Disease was reclassified in 249 (36.5%), and 157 (23.0%) underwent treatment. A single positive core with a negative confirmatory biopsy was significantly associated with time to reclassification (median not met vs 43 months, log rank test P <.001). Composite tumor length, defined as the combined tumor length between baseline and confirmatory biopsies, was associated with shorter Gleason upgrade-free survival (hazard ratio 1.24, 95% confidence interval 1.11-1.40, P <.001) in multivariable analysis. CONCLUSION: Baseline stratification using clinical factors including tumor length may refine risk stratification and offer the foundation on which new systems that incorporate modalities such as magnetic resonance imaging may be based.
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