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  • br Methods This population based cohort study used


    Methods: This population-based cohort study used Surveillance, Epidemiology, and End Results − Medicare data. Eligible patients were men aged 66 or older and diagnosed with high-risk prostate cancer between 1996 and 2003. Outcomes evaluated were 10-year overall mortality and prostate cancer-specific mortality, complications, health service use, and cost. We used Cox regression, Poisson regression, and Generalized Linear Model (GLM) log-link models to assess the outcomes.
    Principal conclusions: Our results also demonstrate long-term overall survival benefits for EBRT + BT § ADT, and greater bowel and ATPγS side effects over a decade, compared to RP. The RP group had advantage for long-term prostate-cancer specific mortality, compared to EBRT + ADT group. Thus, RP can provide superior cancer control with clear cost advantage for older men with high-risk disease. In terms of value proposition, our results support RP as preferred treatment option, compared to EBRT + ADT and EBRT + BT § ADT for high-risk prostate cancer patients. 2019 Elsevier Inc. All rights reserved.
    Keywords: High-risk prostate cancer; SEER-Medicare elderly; Comparative effectiveness; Radical prostatectomy; Radiation therapy; Androgen deprivation therapy
    1. Introduction
    Radical prostatectomy (RP), external bean radiation ther-apy (EBRT) with androgen deprivation therapy (ADT), and EBRT with brachytherapy (BT), with or without ADT, are
    E-mail address: [email protected] (R. Jayadevappa).
    competing treatment modalities for high-risk prostate cancer (PCa). Between 20% and 30% of PCa patients have high-risk disease [1,2]. Due to the supposed increased risk of can-cer recurrence and uncertain oncologic outcomes, surgical management was often excluded in high-risk individuals [3,4]. Since then, studies have shown comparable oncologic outcomes for RP relative to RT § ADT for high-risk disease [3,5]. Use of RP in aggressive disease patients has increased
    over the last decade, thereby confirming its role as a reason-able treatment option in selected patients [3,5−7].
    In the absence of prospective, randomized, comparative effectiveness studies of treatment modalities for high-risk PCa, observational studies can provide clinical and policy guidance [8]. Currently there is no consensus regarding opti-mal management strategy for high-risk PCa [8−11]. Guide-lines (NCCN, AUA, and EAU) recommend EBRT + ADT, EBRT + BT, with or without ADT; and RP, for treating high-risk disease. The retrospective series to date comparing out-comes of RP and RT treatment high-risk PCa demonstrated widely disparate results, with some reporting improved out-comes after RP [12,13], or after RT [14], and a few noting equivalent efficacy [15]. These studies involved different defi-nitions of high-risk PCa, evaluated disparate outcomes, and included smaller sample with short-term follow-up. Addition-ally, RP patients were younger and healthier than those receiv-ing RT; these differences may further obscure the ability of these studies to establish the impact of treatment modality on outcomes [16−20].
    A study using National Cancer Database reported that RP, and EBRT + BT § ADT, had comparable survival, and EBRT + ADT had lower survival [16]. Another multicenter study reported that for PCa patients with Gleason score between 9 and 10, EBRT + BT + ADT was associated with significantly better ATPγS PCa-specific mortality and longer time to distant metastasis compared with EBRT + ADT or RP [18]. While these results are important, comparative effectiveness of the treatment modalities related to complications, health service use, and cost over a long follow-up is unclear. The objective of our study was to analyze survival (overall and PCa-specific), health services use (emergency room [ER], inpatient and outpatient visits), complications, and cost between RP, EBRT + ADT, and EBRT + BT § ADT, among fee-for-service Medicare enrollees with high-risk PCa.