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      Effect of Androgen Deprivation on Long-term Outcomes of Intermediate-Risk Prostate Cancer Stratified as Favorable or Unfavorable : A Secondary Analysis of the RTOG 9408 Randomized Clinical Trial

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          Abstract

          This secondary analysis of a randomized clinical trial examines the effect of androgen deprivation therapy (ADT) during radiotherapy in patients who were classified as having either favorable intermediate-risk or unfavorable intermediate-risk prostate cancer.

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          A new risk classification system for therapeutic decision making with intermediate-risk prostate cancer patients undergoing dose-escalated external-beam radiation therapy.

          The management of intermediate-risk prostate cancer (PCa) is controversial, in part due to the heterogeneous nature of patients falling within this classification. We propose a new risk stratification system for intermediate-risk PCa to aid in prognosis and therapeutic decision making. Between 1992 and 2007, 1024 patients with National Comprehensive Cancer Network intermediate-risk PCa and complete biopsy information were treated with definitive external-beam radiation therapy (EBRT) utilizing doses ≥ 81 Gy. Unfavorable intermediate-risk (UIR) PCa was defined as any intermediate-risk patient with a primary Gleason pattern of 4, percentage of positive biopsy cores (PPBC) ≥ 50%, or multiple intermediate-risk factors (IRFs; cT2b-c, prostate-specific antigen [PSA] 10-20, or Gleason score 7). All patients received EBRT with ≥ 81 Gy with or without neoadjuvant and concurrent androgen-deprivation therapy (ADT). Univariate and multivariate analyses were performed using a Cox proportional hazards model for PSA recurrence-free survival (PSA-RFS) and distant metastasis (DM). PCa-specific mortality (PCSM) was analyzed using a competing-risk method. Median follow-up was 71 mo. Primary Gleason pattern 4 (hazard ratio [HR]: 3.26; p<0.0001), PPBC ≥ 50% (HR: 2.72; p=0.0007), and multiple IRFs (HR: 2.20; p=0.008) all were significant predictors of increased DM in multivariate analyses. Primary Gleason pattern 4 (HR: 5.23; p<0.0001) and PPBC ≥ 50% (HR: 4.08; p=0.002) but not multiple IRFs (HR: 1.74; p=0.21) independently predicted for increased PCSM. Patients with UIR disease had inferior PSA-RFS (HR: 2.37; p<0.0001), DM (HR: 4.34; p=0.0003), and PCSM (HR: 7.39; p=0.007) compared with those with favorable intermediate-risk disease, despite being more likely to receive neoadjuvant ADT. Short follow-up and retrospective study design are the primary limitations. Intermediate-risk PCa is a heterogeneous collection of diseases that can be separated into favorable and unfavorable subsets. These groups likely will benefit from divergent therapeutic paradigms. Copyright © 2013 European Association of Urology. Published by Elsevier B.V. All rights reserved.
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            The likelihood of death from prostate cancer in men with favorable or unfavorable intermediate-risk disease.

            Recently, men with intermediate-risk prostate cancer (PC) were classified into favorable and unfavorable categories; however, whether the risk of PC-specific mortality (PCSM) among men with high-risk PC versus unfavorable intermediate-risk PC is increased is unknown. In a prospective, randomized trial conducted between 1995 and 2001, 206 men with intermediate-risk or high-risk PC were randomized to receive 70 Gy with or without 6 months of androgen-suppression therapy (AST). The subgroup of 197 patients with information available on the percentage of positive biopsies formed the cohort. Fine and Gray regression analysis was used to assess whether men with high-risk PC versus unfavorable intermediate-risk PC had an increased risk of PCSM. After a median follow-up of 14.3 years, there were 127 deaths (64.5%), including 22 deaths (17.3%) from PC. There were no PC deaths in the favorable intermediate-risk group. There was an increase in the risk of PCSM among men with high-risk PC versus unfavorable intermediate-risk PC, but the difference was not significant (adjusted hazard ratio, 1.59; 95% confidence interval, 0.66-3.83; P = .30) after adjusting for age, randomized treatment arm, and comorbidity. The lack of PC deaths among men with favorable intermediate-risk PC suggests that adding AST may not reduce their risk of PCSM; whereas many men with unfavorable intermediate-risk PC are at risk for harboring occult PC with Gleason scores from 8 to 10 and, if proven, would benefit from long-term AST. Multiparametric magnetic resonance imaging and targeted biopsy of suspicious lesions should be considered to identify PC with Gleason scores from 8 to 10 in these men. © 2014 American Cancer Society.
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              Androgen deprivation therapy and the risk of death from prostate cancer among men with favorable or unfavorable intermediate-risk disease.

              Radiotherapy (RT), short-course androgen deprivation therapy (ADT), and brachytherapy in various combinations are treatment options for patients with intermediate-risk prostate cancer (PC), but the question of which combination if any is necessary to minimize PC-specific mortality (PCSM) risk in patients with favorable or unfavorable intermediate-risk PC is unknown. The authors assessed PCSM risk after commonly used treatments.
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                Author and article information

                Journal
                JAMA Netw Open
                JAMA Netw Open
                JAMA Netw Open
                JAMA Network Open
                American Medical Association
                2574-3805
                9 September 2020
                September 2020
                9 September 2020
                : 3
                : 9
                Affiliations
                [1 ]Department of Radiation Oncology, Cedars-Sinai Medical Center, Los Angeles, California
                [2 ]Department of Radiation Oncology, University of Michigan, Ann Arbor
                [3 ]NRG Oncology Statistics and Data Management Center, Philadelphia, Pennsylvania
                Author notes
                Article Information
                Accepted for Publication:
                Published:10.1001/jamanetworkopen.2020.15083
                Open Access: CC-BY License JAMA Network Open
                Corresponding Author: Zachary S. Zumsteg, MD, Department of Radiation Oncology, Cedars-Sinai Medical Center, 8700 Beverly Blvd, Room AC1004, Los Angeles, CA 90048 ( zachary.zumsteg@ 123456cshs.org ).
                Author Contributions:
                Concept and design:
                Acquisition, analysis, or interpretation of data:
                Drafting of the manuscript:
                Critical revision of the manuscript for important intellectual content:
                Statistical analysis:
                Administrative, technical, or material support:
                Supervision:
                Conflict of Interest Disclosures:
                Funding/Support:
                Role of the Funder/Sponsor:
                Data Sharing Statement: Supplement 3
                Additional Contributions:
                Article
                zld200106
                10.1001/jamanetworkopen.2020.15083
                7489808
                Copyright 2020 Zumsteg ZS et al. JAMA Network Open.

                This is an open access article distributed under the terms of the CC-BY License.

                Categories
                Research
                Research Letter
                Online Only
                Oncology

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