Evidence Based Medicine on FHIR Implementation Guide
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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 1.0.0-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

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

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    <div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: Citation</b><a name="179625"> </a><a name="hc179625"> </a></p><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">ResourceCitation &quot;179625&quot; Version &quot;1&quot; Updated &quot;2023-11-26 22:35:21+0000&quot; </p></div><p><b>url</b>: <code>https://fevir.net/resources/Citation/179625</code></p><p><b>identifier</b>: FEvIR Object Identifier/179625, <code>https://pubmed.ncbi.nlm.nih.gov</code>/22502942</p><p><b>version</b>: 1.0.0-ballot</p><p><b>title</b>: 22502942 Addition of radiotherapy to long-term androgen deprivation in locally advanced prostate cancer: an open randomised phase 3 trial.</p><p><b>status</b>: active</p><p><b>date</b>: 2024-05-16 12:17:54+0000</p><p><b>publisher</b>: HL7 International / Clinical Decision Support</p><p><b>contact</b>: HL7 International / Clinical Decision Support: <a href="http://www.hl7.org/Special/committees/dss">http://www.hl7.org/Special/committees/dss</a></p><p><b>description</b>: This Citation Resource is referenced in an example for the EBMonFHIR Implementation Guide.</p><h3>UseContexts</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style="display: none">*</td><td>FEvIR Platform Use (Details: Citation Classification Type code fevir-platform-use = 'FEvIR Platform Use', stated as 'FEvIR Platform Use')</td><td>Medline Base <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-citation-artifact-classifier.html">Citation Artifact Classifier</a>#medline-base)</span></td></tr></table><p><b>jurisdiction</b>: World <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (m49.htm#001)</span></p><p><b>copyright</b>: https://creativecommons.org/licenses/by-nc-sa/4.0/</p><p><b>approvalDate</b>: 2012-12-07</p><p><b>lastReviewDate</b>: 2022-03-10</p><p><b>author</b>: Computable Publishing®: MEDLINE-to-FEvIR Converter: </p><blockquote><p><b>classification</b></p><p><b>type</b>: Citation Source <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-citation-classification-type.html">Citation Classification Type</a>#citation-source)</span></p><p><b>classifier</b>: MEDLINE <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p></blockquote><blockquote><p><b>classification</b></p><p><b>type</b>: MEDLINE Citation Owner <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-citation-classification-type.html">Citation Classification Type</a>#medline-owner)</span></p><p><b>classifier</b>: National Library of Medicine, Index Section <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (elements_descriptions.html#owner_value#NLM)</span></p></blockquote><p><b>currentState</b>: Medline Citation Status of Medline <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-citation-status-type.html">Citation Status Type</a>#medline-medline)</span>, PubMed PublicationStatus of ppublish <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-citation-status-type.html">Citation Status Type</a>#pubmed-publication-status-ppublish)</span></p><blockquote><p><b>statusDate</b></p><p><b>activity</b>: PubMed Pubstatus of Received <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-citation-status-type.html">Citation Status Type</a>#pubmed-pubstatus-received)</span></p><p><b>period</b>: ?? --&gt; 2012-02-03</p></blockquote><blockquote><p><b>statusDate</b></p><p><b>activity</b>: PubMed Pubstatus of Accepted <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-citation-status-type.html">Citation Status Type</a>#pubmed-pubstatus-accepted)</span></p><p><b>period</b>: ?? --&gt; 2012-03-23</p></blockquote><blockquote><p><b>statusDate</b></p><p><b>activity</b>: PubMed Pubstatus of Entrez <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-citation-status-type.html">Citation Status Type</a>#pubmed-pubstatus-entrez)</span></p><p><b>period</b>: ?? --&gt; 2012-04-17 06:00:00+0000</p></blockquote><blockquote><p><b>statusDate</b></p><p><b>activity</b>: PubMed Pubstatus of Pubmed <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-citation-status-type.html">Citation Status Type</a>#pubmed-pubstatus-pubmed)</span></p><p><b>period</b>: ?? --&gt; 2012-04-17 06:00:00+0000</p></blockquote><blockquote><p><b>statusDate</b></p><p><b>activity</b>: PubMed Pubstatus of Medline <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-citation-status-type.html">Citation Status Type</a>#pubmed-pubstatus-medline)</span></p><p><b>period</b>: ?? --&gt; 2012-12-12 06:00:00+0000</p></blockquote><blockquote><p><b>citedArtifact</b></p><p><b>identifier</b>: <code>https://pubmed.ncbi.nlm.nih.gov</code>/22502942, <code>https://doi.org</code>/10.1016/j.eururo.2012.03.053, pii/S0302-2838(12)00425-3</p><h3>Titles</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td><td><b>Language</b></td><td><b>Text</b></td></tr><tr><td style="display: none">*</td><td>Primary title <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-title-type.html">Title Type</a>#primary)</span></td><td>English <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.5.0/CodeSystem-v3-ietf3066.html">Tags for the Identification of Languages</a>#en)</span></td><td>Addition of radiotherapy to long-term androgen deprivation in locally advanced prostate cancer: an open randomised phase 3 trial.</td></tr></table><h3>Abstracts</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Text</b></td><td><b>Copyright</b></td></tr><tr><td style="display: none">*</td><td>**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&amp;lt;0.0001), and 64.7% versus 15.4%, respectively, for Phoenix (p&amp;lt;0.0011). Locoregional progression was reported in 9.8% of combined-therapy patients versus 29.2% with ADT alone (p&amp;lt;0.0001) and metastatic progression in 3.0% versus 10.8%, respectively (p&amp;lt;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.</td><td>Copyright © 2012 European Association of Urology. Published by Elsevier B.V. All rights reserved.</td></tr></table><blockquote><p><b>relatesTo</b></p><p><b>type</b>: comment-in</p><p><b>classifier</b>: Comment <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (#D016420)</span></p><p><b>citation</b>: Eur Urol. 2012 Aug;62(2):220-1; author reply 222-3</p><h3>Documents</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Url</b></td></tr><tr><td style="display: none">*</td><td><a href="https://pubmed.ncbi.nlm.nih.gov/22552217/">https://pubmed.ncbi.nlm.nih.gov/22552217/</a></td></tr></table><p><b>resourceReference</b>: <span><code>https://pubmed.ncbi.nlm.nih.gov</code>/22552217</span></p></blockquote><blockquote><p><b>publicationForm</b></p><h3>PublishedIns</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td><td><b>Identifier</b></td><td><b>Title</b></td><td><b>PublisherLocation</b></td></tr><tr><td style="display: none">*</td><td>Periodical <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-published-in-type.html">Published In Type</a>#D020492)</span></td><td>Electronic ISSN Type/1873-7560, ISOAbbreviation/Eur Urol, ISSN Linking/0302-2838, Medline Title Abbreviation/Eur Urol, NLM Unique ID/7512719</td><td>European urology</td><td>Switzerland</td></tr></table><p><b>citedMedium</b>: Internet <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-cited-medium.html">Cited Medium</a>#internet)</span></p><p><b>volume</b>: 62</p><p><b>issue</b>: 2</p><p><b>articleDate</b>: 2012-08</p><p><b>publicationDateText</b>: 2012-Aug</p><p><b>language</b>: English <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.5.0/CodeSystem-v3-ietf3066.html">Tags for the Identification of Languages</a>#en)</span></p><p><b>pageString</b>: 213-9</p></blockquote><blockquote><p><b>publicationForm</b></p><p><b>citedMedium</b>: Internet without issue <span style="background: LightGoldenRodYellow; 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margin: 4px; border: 1px solid khaki"> (#D018572)</span></p><p><b>freeToShare</b>: true</p><h3>Components</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td><td><b>Classifier</b></td></tr><tr><td style="display: none">*</td><td>qualifier <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td><td>is not a major topic <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td></tr></table></blockquote><blockquote><p><b>content</b></p><p><b>informationType</b>: classifier</p><p><b>type</b>: components (if present) include qualifier codings <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-cited-artifact-classification-type.html">Cited Artifact Classification Type</a>#mesh-heading &quot;MeSH heading&quot;)</span></p><p><b>classifier</b>: Drug Therapy, Combination <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (#D004359)</span></p><p><b>freeToShare</b>: true</p><h3>Components</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td><td><b>Classifier</b></td></tr><tr><td style="display: none">*</td><td>qualifier <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td><td>is not a major topic <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td></tr></table></blockquote><blockquote><p><b>content</b></p><p><b>informationType</b>: classifier</p><p><b>type</b>: components (if present) include qualifier codings <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-cited-artifact-classification-type.html">Cited Artifact Classification Type</a>#mesh-heading &quot;MeSH heading&quot;)</span></p><p><b>classifier</b>: Flutamide <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (#D005485)</span></p><p><b>freeToShare</b>: true</p><blockquote><p><b>component</b></p><p><b>type</b>: qualifier <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>classifier</b>: is not a major topic <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p></blockquote><blockquote><p><b>component</b></p><p><b>type</b>: qualifier <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>classifier</b>: therapeutic use <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (#Q000627)</span></p><blockquote><p><b>component</b></p></blockquote></blockquote></blockquote><blockquote><p><b>content</b></p><p><b>informationType</b>: classifier</p><p><b>type</b>: components (if present) include qualifier codings <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-cited-artifact-classification-type.html">Cited Artifact Classification Type</a>#mesh-heading &quot;MeSH heading&quot;)</span></p><p><b>classifier</b>: Humans <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (#D006801)</span></p><p><b>freeToShare</b>: true</p><h3>Components</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td><td><b>Classifier</b></td></tr><tr><td style="display: none">*</td><td>qualifier <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td><td>is not a major topic <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td></tr></table></blockquote><blockquote><p><b>content</b></p><p><b>informationType</b>: classifier</p><p><b>type</b>: components (if present) include qualifier codings <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-cited-artifact-classification-type.html">Cited Artifact Classification Type</a>#mesh-heading &quot;MeSH heading&quot;)</span></p><p><b>classifier</b>: Leuprolide <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (#D016729)</span></p><p><b>freeToShare</b>: true</p><blockquote><p><b>component</b></p><p><b>type</b>: qualifier <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>classifier</b>: is not a major topic <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p></blockquote><blockquote><p><b>component</b></p><p><b>type</b>: qualifier <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>classifier</b>: therapeutic use <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (#Q000627)</span></p><blockquote><p><b>component</b></p></blockquote></blockquote></blockquote><blockquote><p><b>content</b></p><p><b>informationType</b>: classifier</p><p><b>type</b>: components (if present) include qualifier codings <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-cited-artifact-classification-type.html">Cited Artifact Classification Type</a>#mesh-heading &quot;MeSH heading&quot;)</span></p><p><b>classifier</b>: Male <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (#D008297)</span></p><p><b>freeToShare</b>: true</p><h3>Components</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td><td><b>Classifier</b></td></tr><tr><td style="display: none">*</td><td>qualifier <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td><td>is not a major topic <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td></tr></table></blockquote><blockquote><p><b>content</b></p><p><b>informationType</b>: classifier</p><p><b>type</b>: components (if present) include qualifier codings <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-cited-artifact-classification-type.html">Cited Artifact Classification Type</a>#mesh-heading &quot;MeSH heading&quot;)</span></p><p><b>classifier</b>: Middle Aged <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (#D008875)</span></p><p><b>freeToShare</b>: true</p><h3>Components</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td><td><b>Classifier</b></td></tr><tr><td style="display: none">*</td><td>qualifier <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td><td>is not a major topic <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td></tr></table></blockquote><blockquote><p><b>content</b></p><p><b>informationType</b>: classifier</p><p><b>type</b>: components (if present) include qualifier codings <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-cited-artifact-classification-type.html">Cited Artifact Classification Type</a>#mesh-heading &quot;MeSH heading&quot;)</span></p><p><b>classifier</b>: Neoplasm Grading <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (#D060787)</span></p><p><b>freeToShare</b>: true</p><h3>Components</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td><td><b>Classifier</b></td></tr><tr><td style="display: none">*</td><td>qualifier <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td><td>is not a major topic <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td></tr></table></blockquote><blockquote><p><b>content</b></p><p><b>informationType</b>: classifier</p><p><b>type</b>: components (if present) include qualifier codings <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-cited-artifact-classification-type.html">Cited Artifact Classification Type</a>#mesh-heading &quot;MeSH heading&quot;)</span></p><p><b>classifier</b>: Prostate-Specific Antigen <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (#D017430)</span></p><p><b>freeToShare</b>: true</p><blockquote><p><b>component</b></p><p><b>type</b>: qualifier <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>classifier</b>: is not a major topic <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p></blockquote><blockquote><p><b>component</b></p><p><b>type</b>: qualifier <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>classifier</b>: blood <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (#Q000097)</span></p><blockquote><p><b>component</b></p></blockquote></blockquote></blockquote><blockquote><p><b>content</b></p><p><b>informationType</b>: classifier</p><p><b>type</b>: components (if present) include qualifier codings <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-cited-artifact-classification-type.html">Cited Artifact Classification Type</a>#mesh-heading &quot;MeSH heading&quot;)</span></p><p><b>classifier</b>: Prostatic Neoplasms <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (#D011471)</span></p><p><b>freeToShare</b>: true</p><blockquote><p><b>component</b></p><p><b>type</b>: qualifier <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>classifier</b>: is not a major topic <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p></blockquote><blockquote><p><b>component</b></p><p><b>type</b>: qualifier <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>classifier</b>: drug therapy <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (#Q000188)</span></p><blockquote><p><b>component</b></p></blockquote></blockquote><blockquote><p><b>component</b></p><p><b>type</b>: qualifier <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>classifier</b>: radiotherapy <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (#Q000532)</span></p><blockquote><p><b>component</b></p></blockquote></blockquote><blockquote><p><b>component</b></p><p><b>type</b>: qualifier <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>classifier</b>: therapy <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (#Q000628)</span></p><blockquote><p><b>component</b></p></blockquote></blockquote></blockquote></blockquote></blockquote><blockquote><p><b>classification</b></p><p><b>type</b>: Publication Type <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-cited-artifact-classification-type.html">Cited Artifact Classification Type</a>#publication-type)</span></p><p><b>classifier</b>: Clinical Trial, Phase III <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (#D017428)</span>, Journal Article <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (#D016428)</span>, Multicenter Study <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (#D016448)</span>, Randomized Controlled Trial <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (#D016449)</span>, Research Support, Non-U.S. Gov't <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (#D013485)</span></p></blockquote><blockquote><p><b>classification</b></p><p><b>type</b>: Knowledge Artifact Type <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-cited-artifact-classification-type.html">Cited Artifact Classification Type</a>#knowledge-artifact-type)</span></p><p><b>classifier</b>: Journal Article <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-citation-artifact-classifier.html">Citation Artifact Classifier</a>#D016428)</span></p><p><b>artifactAssessment</b>: <span>: Classifier added by Computable Publishing LLC</span></p></blockquote><blockquote><p><b>classification</b></p><p><b>type</b>: Citation Subset <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-cited-artifact-classification-type.html">Cited Artifact Classification Type</a>#citation-subset)</span></p><p><b>classifier</b>: IM <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (elements_descriptions.html#citationsubset#IM)</span></p></blockquote><blockquote><p><b>contributorship</b></p><p><b>complete</b>: true</p><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a name="hcauthor0"> </a></p><blockquote><p/><p><a name="author0"> </a></p><p><a name="hcauthor0"> </a></p><p><b>name</b>: Nicolas Mottet </p></blockquote><p><b>forenameInitials</b>: N</p><p><b>affiliation</b>: <span>: Department of Urology, University Hospital, St. Etienne, France. nicolas.mottet@wanadoo.fr</span></p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a name="hcauthor1"> </a></p><blockquote><p/><p><a name="author1"> </a></p><p><a name="hcauthor1"> </a></p><p><b>name</b>: Michel Peneau </p></blockquote><p><b>forenameInitials</b>: M</p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a name="hcauthor2"> </a></p><blockquote><p/><p><a name="author2"> </a></p><p><a name="hcauthor2"> </a></p><p><b>name</b>: Jean-Jacques Mazeron </p></blockquote><p><b>forenameInitials</b>: JJ</p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a name="hcauthor3"> </a></p><blockquote><p/><p><a name="author3"> </a></p><p><a name="hcauthor3"> </a></p><p><b>name</b>: Vincent Molinie </p></blockquote><p><b>forenameInitials</b>: V</p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a name="hcauthor4"> </a></p><blockquote><p/><p><a name="author4"> </a></p><p><a name="hcauthor4"> </a></p><p><b>name</b>: Pierre Richaud </p></blockquote><p><b>forenameInitials</b>: P</p></blockquote></blockquote></blockquote><hr/><blockquote><p><b>Generated Narrative: Practitioner #author0</b><a name="author0"> </a><a name="hcauthor0"> </a></p><p><b>name</b>: Nicolas Mottet </p></blockquote><hr/><blockquote><p><b>Generated Narrative: Practitioner #author1</b><a name="author1"> </a><a name="hcauthor1"> </a></p><p><b>name</b>: Michel Peneau </p></blockquote><hr/><blockquote><p><b>Generated Narrative: Practitioner #author2</b><a name="author2"> </a><a name="hcauthor2"> </a></p><p><b>name</b>: Jean-Jacques Mazeron </p></blockquote><hr/><blockquote><p><b>Generated Narrative: Practitioner #author3</b><a name="author3"> </a><a name="hcauthor3"> </a></p><p><b>name</b>: Vincent Molinie </p></blockquote><hr/><blockquote><p><b>Generated Narrative: Practitioner #author4</b><a name="author4"> </a><a name="hcauthor4"> </a></p><p><b>name</b>: Pierre Richaud </p></blockquote><hr/><blockquote><p><b>Generated Narrative: ArtifactAssessment #meshHeading0</b><a name="meshHeading0"> </a><a name="hcmeshHeading0"> </a></p><p><b>artifact</b>: <a href="#">#</a></p><blockquote><p><b>content</b></p><p><b>informationType</b>: classifier</p><p><b>type</b>: components (if present) include qualifier codings <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-cited-artifact-classification-type.html">Cited Artifact Classification Type</a>#mesh-heading &quot;MeSH heading&quot;)</span></p><p><b>classifier</b>: Adenocarcinoma <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (#D000230)</span></p><p><b>freeToShare</b>: true</p><blockquote><p><b>component</b></p><p><b>type</b>: qualifier <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>classifier</b>: is not a major topic <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p></blockquote><blockquote><p><b>component</b></p><p><b>type</b>: qualifier <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>classifier</b>: drug therapy <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (#Q000188)</span></p><blockquote><p><b>component</b></p></blockquote></blockquote><blockquote><p><b>component</b></p><p><b>type</b>: qualifier <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>classifier</b>: radiotherapy <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (#Q000532)</span></p><blockquote><p><b>component</b></p></blockquote></blockquote><blockquote><p><b>component</b></p><p><b>type</b>: qualifier <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>classifier</b>: therapy <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (#Q000628)</span></p><blockquote><p><b>component</b></p></blockquote></blockquote></blockquote><blockquote><p><b>content</b></p><p><b>informationType</b>: classifier</p><p><b>type</b>: components (if present) include qualifier codings <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-cited-artifact-classification-type.html">Cited Artifact Classification Type</a>#mesh-heading &quot;MeSH heading&quot;)</span></p><p><b>classifier</b>: Aged <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (#D000368)</span></p><p><b>freeToShare</b>: true</p><h3>Components</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td><td><b>Classifier</b></td></tr><tr><td style="display: none">*</td><td>qualifier <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td><td>is not a major topic <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td></tr></table></blockquote><blockquote><p><b>content</b></p><p><b>informationType</b>: classifier</p><p><b>type</b>: components (if present) include qualifier codings <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-cited-artifact-classification-type.html">Cited Artifact Classification Type</a>#mesh-heading &quot;MeSH heading&quot;)</span></p><p><b>classifier</b>: Androgen Antagonists <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (#D000726)</span></p><p><b>freeToShare</b>: true</p><blockquote><p><b>component</b></p><p><b>type</b>: qualifier <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>classifier</b>: is not a major topic <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p></blockquote><blockquote><p><b>component</b></p><p><b>type</b>: qualifier <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>classifier</b>: therapeutic use <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (#Q000627)</span></p><blockquote><p><b>component</b></p></blockquote></blockquote></blockquote><blockquote><p><b>content</b></p><p><b>informationType</b>: classifier</p><p><b>type</b>: components (if present) include qualifier codings <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-cited-artifact-classification-type.html">Cited Artifact Classification Type</a>#mesh-heading &quot;MeSH heading&quot;)</span></p><p><b>classifier</b>: Antineoplastic Agents, Hormonal <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (#D018931)</span></p><p><b>freeToShare</b>: true</p><blockquote><p><b>component</b></p><p><b>type</b>: qualifier <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>classifier</b>: is not a major topic <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p></blockquote><blockquote><p><b>component</b></p><p><b>type</b>: qualifier <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>classifier</b>: therapeutic use <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (#Q000627)</span></p><blockquote><p><b>component</b></p></blockquote></blockquote></blockquote><blockquote><p><b>content</b></p><p><b>informationType</b>: classifier</p><p><b>type</b>: components (if present) include qualifier codings <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-cited-artifact-classification-type.html">Cited Artifact Classification Type</a>#mesh-heading &quot;MeSH heading&quot;)</span></p><p><b>classifier</b>: Chemoradiotherapy <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (#D059248)</span></p><p><b>freeToShare</b>: true</p><h3>Components</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td><td><b>Classifier</b></td></tr><tr><td style="display: none">*</td><td>qualifier <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td><td>is not a major topic <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td></tr></table></blockquote><blockquote><p><b>content</b></p><p><b>informationType</b>: classifier</p><p><b>type</b>: components (if present) include qualifier codings <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-cited-artifact-classification-type.html">Cited Artifact Classification Type</a>#mesh-heading &quot;MeSH heading&quot;)</span></p><p><b>classifier</b>: Disease-Free Survival <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (#D018572)</span></p><p><b>freeToShare</b>: true</p><h3>Components</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td><td><b>Classifier</b></td></tr><tr><td style="display: none">*</td><td>qualifier <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td><td>is not a major topic <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td></tr></table></blockquote><blockquote><p><b>content</b></p><p><b>informationType</b>: classifier</p><p><b>type</b>: components (if present) include qualifier codings <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-cited-artifact-classification-type.html">Cited Artifact Classification Type</a>#mesh-heading &quot;MeSH heading&quot;)</span></p><p><b>classifier</b>: Drug Therapy, Combination <span style="background: LightGoldenRodYellow; 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**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&amp;lt;0.0001), and 64.7% versus 15.4%, respectively, for Phoenix (p&amp;lt;0.0011). Locoregional progression was reported in 9.8% of combined-therapy patients versus 29.2% with ADT alone (p&amp;lt;0.0001) and metastatic progression in 3.0% versus 10.8%, respectively (p&amp;lt;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."/>
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