Abstract

Simple SummaryThis is a safety and efficacy analysis from a very large dataset of patients affected by localized prostate cancer having received radiotherapy with or without concomitant androgen deprivation therapy in twelve academic and non-academic Italian Institutions. The aim of this retrospective "real life" study was to provide additional data on clinical presentation, diagnostic workup, radiation therapy management and toxicity as collected within the framework of POP III. Though the usual limitations for a retrospective analysis apply, it nevertheless may expand the current knowledge in this area showing the progress of radiation therapy techniques and clinical outcomes in the period between 2004 and 2011 after a significant period of follow up.Background and purpose: Two previous “Patterns Of Practice” surveys (POP I and POP II), including more than 4000 patients affected by prostate cancer treated with radical external beam radiotherapy (EBRT) between 1980 and 2003, established a “benchmark” Italian data source for prostate cancer radiotherapy. This report (POP III) updates the previous studies. Methods: Data on clinical management and outcome of 2525 prostate cancer patients treated by EBRT from 2004 to 2011 were collected and compared with POP II and, when feasible, also with POP I. This report provides data on clinical presentation, diagnostic workup, radiation therapy management, and toxicity as collected within the framework of POP III. Results: More than 50% of POP III patients were classified as low or intermediate risk using D’Amico risk categories as in POP II; 46% were classified as ISUP grade group 1. CT scan, bone scan, and endorectal ultrasound were less frequently prescribed. Dose-escalated radiotherapy (RT), intensity modulated radiotherapy (IMRT), image guided radiotherapy (IGRT), and hypofractionated RT were more frequently offered during the study period. Treatment was commonly well tolerated. Acute toxicity improved compared to the previous series; late toxicity was influenced by prescribed dose and treatment technique. Five-year overall survival, biochemical relapse free survival (BRFS), and disease specific survival were similar to those of the previous series (POP II). BRFS was better in intermediate- and high-risk patients treated with ≥ 76 Gy. Conclusions: This report highlights the improvements in radiotherapy planning and dose delivery among Italian Centers in the 2004–2011 period. Dose-escalated treatments resulted in better biochemical control with a reduction in acute toxicity and higher but acceptable late toxicity, as not yet comprehensively associated with IMRT/IGRT. CTV-PTV margins >8 mm were associated with increased toxicity, again suggesting that IGRT—allowing for tighter margins—would reduce toxicity for dose escalated RT. These conclusions confirm the data obtained from randomized controlled studies.

Highlights

  • Prostate Cancer (PCa) is the second most frequently diagnosed tumor in the male population worldwide [1]

  • More than 50% (1495, 59%) of patients presented with low or intermediate D’Amico risk disease, in line with the patterns of practice (POP) II (52%) cohort, while 1016 patients (40%) presented with high risk disease

  • > 20 ng/mL dropped from 32% (POP I) to 27% (POP II) to 15% (POP III)

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Summary

Introduction

Prostate Cancer (PCa) is the second most frequently diagnosed tumor in the male population worldwide [1]. The clinical impact of image-guided radiotherapy (IGRT) techniques has already been tested in randomized trials, highlighting an improved tumor control and decreased toxicity, resulting in a favorable therapeutic index [3,4]. Methods: Data on clinical management and outcome of 2525 prostate cancer patients treated by EBRT from 2004 to 2011 were collected and compared with POP II and, when feasible, with POP I. This report provides data on clinical presentation, diagnostic workup, radiation therapy management, and toxicity as collected within the framework of POP III. Acute toxicity improved compared to the previous series; late toxicity was influenced by prescribed dose and treatment technique. BRFS was better in intermediate- and high-risk patients treated with ≥ 76 Gy. Conclusions: This report highlights the improvements in radiotherapy planning and dose delivery among Italian

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