22502942 Addition of radiotherapy to long-term androgen deprivation in locally advanced prostate cancer: an open randomised phase 3 trial. - Evidence Based Medicine on FHIR Implementation Guide v2.0.0-ballot

Evidence Based Medicine on FHIR Implementation Guide, published by HL7 International / Clinical Decision Support. This guide is not an authorized publication; it is the continuous build for version 2.0.0-ballot built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/ebm/ and changes regularly. See the Directory of published versions

Example Citation: 22502942 Addition of radiotherapy to long-term androgen deprivation in locally advanced prostate cancer: an open randomised phase 3 trial.

Active as of 2024-11-21

Generated Narrative: Citation 179625

version: 7; Last updated: 2024-07-18 17:55:00+0000

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url: Citation 22502942 Addition of radiotherapy to long-term androgen deprivation in locally advanced prostate cancer: an open randomised phase 3 trial.

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version: 2.0.0-ballot

title: 22502942 Addition of radiotherapy to long-term androgen deprivation in locally advanced prostate cancer: an open randomised phase 3 trial.

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date: 2024-11-21 14:09:14+0000

publisher: HL7 International / Clinical Decision Support

contact: HL7 International / Clinical Decision Support: http://www.hl7.org/Special/committees/dss

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This Citation Resource is referenced in an example for the EBMonFHIR Implementation Guide.

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https://creativecommons.org/licenses/by-nc-sa/4.0/

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Addition of radiotherapy to long-term androgen deprivation in locally advanced prostate cancer: an open randomised phase 3 trial.

Abstracts
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*
BACKGROUND: Radiotherapy combined with androgen-deprivation therapy (ADT) is superior to radiotherapy alone in localised prostate cancer; however, data comparing ADT alone are somewhat limited. OBJECTIVE: To compare 3-yr ADT plus radiotherapy with ADT alone in locally advanced prostate cancer patients. DESIGN, SETTING, AND PARTICIPANTS: A multicentre randomised open controlled phase 3 trial in 264 histologically confirmed T3-4 or pT3N0M0 prostate cancer patients randomised from March 2000 to December 2003. INTERVENTION: ADT (11.25mg subcutaneous depot injection of leuprorelin every 3 mo for 3 yr) plus external-beam radiotherapy or ADT alone. Flutamide (750 g/d) was administered for 1 mo. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The primary objective was 5 yr progression-free survival (PFS) according to clinical or biologic criteria, using the American Society for Therapeutic Radiology and Oncology (ASTRO) and the newer (Phoenix) definition (nadir plus 2 ng/ml), by intention to treat. Secondary objectives included time to locoregional recurrence and distant metastases, and overall and disease-specific survival. Our Analyses: intent-to-treat analysis, multivariate analyses using a Cox model with a 5% threshold from univariate analysis, and Kaplan-Meier estimates. RESULTS AND LIMITATIONS: ADT alone was administered to 130 patients and combined therapy to 133. With a median follow-up of 67 mo, 5-yr PFS was 60.9% for combined therapy versus 8.5% with ADT alone (ASTRO; p<0.0001), and 64.7% versus 15.4%, respectively, for Phoenix (p<0.0011). Locoregional progression was reported in 9.8% of combined-therapy patients versus 29.2% with ADT alone (p<0.0001) and metastatic progression in 3.0% versus 10.8%, respectively (p<0.018). Overall survival was 71.4% with combined therapy versus 71.5% with ADT alone; disease-specific survival was 93.2% versus 86.2%. Limitations included the relatively small population and a relatively short follow-up period. CONCLUSIONS: Combined therapy strongly favoured improved PFS, locoregional control, and metastasis-free survival. Longer follow-up is needed to assess the potential survival impact.

Copyright © 2012 European Association of Urology. Published by Elsevier B.V. All rights reserved.

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citation:
Eur Urol. 2012 Aug;62(2):220-1; author reply 222-3. doi: 10.1016/j.eururo.2012.04.040

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identifier: Electronic ISSN Type/1873-7560, ISOAbbreviation/Eur Urol, ISSN Linking/0302-2838, Medline Title Abbreviation/Eur Urol, NLM Unique ID/7512719
title: European urology
publisherLocation: Switzerland
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volume: 62
issue: 2
articleDate: 2012-08
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