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Title: Impact of Ultrahigh Baseline PSA Levels on Biochemical and Clinical Outcomes in Two Radiation Therapy Oncology Group Prostate Clinical Trials

Journal Article · · International Journal of Radiation Oncology, Biology and Physics
 [1];  [2];  [3];  [4];  [5];  [6];  [7];  [8];  [9];  [10]
  1. Department of Oncology, University of Western Ontario, London, Ontario (Canada)
  2. Department of Statistics, Radiation Therapy Oncology Group, Philadelphia, Pennsylvania (United States)
  3. Department of Radiation Oncology, University of California San Francisco, San Francisco, California (United States)
  4. Department of Radiation Oncology, Medical College of Wisconsin, Milwaukee, Wisconsin (United States)
  5. Department of Surgical Oncology, University of Calgary, Calgary, Alberta (Canada)
  6. Department of Pathology, Indiana Pathology Institute, Indianapolis, Indiana (United States)
  7. Department of Radiation Oncology, Fox Chase Cancer Center, Philadelphia, Pennsylvania (United States)
  8. Department of Oncology, McGill University Health Centre, Montreal, Quebec (Canada)
  9. Department of Urology, NY University Langone Medical Center, New York, New York (United States)
  10. Department of Radiation Oncology, Cedars-Sinai Medical Center, Los Angeles, California (United States)

Purpose: To assess ultrahigh (UH; prostate-specific antigen [PSA]levels {>=}50 ng/ml) patient outcomes by comparison to other high-risk patient outcomes and to identify outcome predictors. Methods and Materials: Prostate cancer patients (PCP) from two Phase III Radiation Therapy Oncology Group clinical trials (studies 9202 and 9413) were divided into two groups: high-risk patients with and without UH baseline PSA levels. Predictive variables included age, Gleason score, clinical T stage, Karnofsky performance score, and treatment arm. Outcomes included overall survival (OS), distant metastasis (DM), and biochemical failure (BF). Unadjusted and adjusted hazard ratios (HRs) were calculated using either the Cox or Fine and Gray's regression model with associated 95% confidence intervals (CI) and p values. Results: There were 401 patients in the UH PSA group and 1,792 patients in the non-UH PSA PCP group of a total of 2,193 high-risk PCP. PCP with UH PSA were found to have inferior OS (HR, 1.19; 95% CI, 1.02-1.39, p = 0.02), DM (HR, 1.51; 95% CI, 1.19-1.92; p = 0.0006), and BF (HR, 1.50; 95% CI, 1.29-1.73; p < 0.0001) compared to other high-risk PCP. In the UH cohort, PSA level was found to be a significant factor for the risk of DM (HR, 1.01; 95% CI, 1.001-1.02) but not OS and BF. Gleason grades of 8 to 10 were found to consistently predict for poor OS, DM, and BF outcomes (with HR estimates ranging from 1.41-2.36) in both the high-risk cohort and the UH cohort multivariable analyses. Conclusions: UH PSA levels at diagnosis are related to detrimental changes in OS, DM, and BF. All three outcomes can be modeled by various combinations of all predictive variables tested.

OSTI ID:
21491751
Journal Information:
International Journal of Radiation Oncology, Biology and Physics, Vol. 80, Issue 2; Other Information: DOI: 10.1016/j.ijrobp.2010.02.034; PII: S0360-3016(10)00326-3; Copyright (c) 2011 Elsevier Science B.V., Amsterdam, The Netherlands, All rights reserved.; ISSN 0360-3016
Country of Publication:
United States
Language:
English