Evidence Based Medicine on FHIR Implementation Guide
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This page is part of the Evidence Based Medicine on FHIR Implementation Guide (v1.0.0-ballot2: STU1 Ballot 2) based on FHIR (HL7® FHIR® Standard) v6.0.0. No current official version has been published yet. For a full list of available versions, see the Directory of published versions

: 26028518 Androgen deprivation therapy plus docetaxel and estramustine versus androgen deprivation therapy alone for high-risk localised prostate cancer (GETUG 12): a phase 3 randomised controlled trial. - XML Representation

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    <div xmlns="http://www.w3.org/1999/xhtml"><p class="res-header-id"><b>Generated Narrative: Citation 179621</b></p><a name="179621"> </a><a name="hc179621"> </a><a name="179621-en-US"> </a><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">version: 9; Last updated: 2025-03-27 12:32:11+0000</p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-journal-article-citation.html">JournalArticleCitation</a></p></div><p><b>url</b>: <a href="Citation-179621.html">Citation 26028518 Androgen deprivation therapy plus docetaxel and estramustine versus androgen deprivation therapy alone for high-risk localised prostate cancer (GETUG 12): a phase 3 randomised controlled trial.</a></p><p><b>identifier</b>: FEvIR Object Identifier/https://fevir.net/FOI/179621, <code>https://pubmed.ncbi.nlm.nih.gov</code>/26028518, <a href="http://terminology.hl7.org/6.2.0/NamingSystem-uri.html" title="As defined by RFC 3986 (http://www.ietf.org/rfc/rfc3986.txt)(with many schemes defined in many RFCs). For OIDs and UUIDs, use the URN form (urn:oid:(note: lowercase) and urn:uuid:). See http://www.ietf.org/rfc/rfc3001.txt and http://www.ietf.org/rfc/rfc4122.txt 

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Note that this OID is created to aid with interconversion between CDA and FHIR - FHIR uses urn:ietf:rfc:3986 as equivalent to this OID. URIs as identifiers appear more commonly in FHIR.

This OID may also be used in CD.codeSystem.">Uniform Resource Identifier (URI)</a>/urn:oid:2.16.840.1.113883.4.642.40.44.15.7</p><p><b>version</b>: 1.0.0-ballot2</p><p><b>title</b>: 26028518 Androgen deprivation therapy plus docetaxel and estramustine versus androgen deprivation therapy alone for high-risk localised prostate cancer (GETUG 12): a phase 3 randomised controlled trial.</p><p><b>status</b>: Active</p><p><b>date</b>: 2025-03-28 17:11:38+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>: </p><div><p>This Citation Resource is referenced in an example for the EBMonFHIR Implementation Guide.</p>
</div><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><a href="http://hl7.org/fhir/R5/codesystem-citation-classification-type.html#citation-classification-type-fevir-platform-use">Citation Classification Type fevir-platform-use</a>: FEvIR Platform Use</td><td><span title="Codes:{http://hl7.org/fhir/citation-artifact-classifier medline-base}">Medline Base</span></td></tr></table><p><b>jurisdiction</b>: <span title="Codes:{http://unstats.un.org/unsd/methods/m49/m49.htm 001}">World</span></p><p><b>copyright</b>: </p><div><p>https://creativecommons.org/licenses/by-nc-sa/4.0/</p>
</div><p><b>approvalDate</b>: 2015-09-28</p><p><b>lastReviewDate</b>: 2024-08-05</p><p><b>author</b>: Computable Publishing®: MEDLINE-to-FEvIR Converter: </p><blockquote><p><b>classification</b></p><p><b>type</b>: <span title="Codes:{http://hl7.org/fhir/citation-classification-type citation-source}">Citation Source</span></p><p><b>classifier</b>: <span title="Codes:">MEDLINE</span></p></blockquote><blockquote><p><b>classification</b></p><p><b>type</b>: <span title="Codes:{http://hl7.org/fhir/citation-classification-type medline-owner}">MEDLINE Citation Owner</span></p><p><b>classifier</b>: <span title="Codes:{https://www.nlm.nih.gov/bsd/licensee/elements_descriptions.html#owner_value NLM}">National Library of Medicine, Index Section</span></p></blockquote><p><b>currentState</b>: <span title="Codes:{http://hl7.org/fhir/citation-status-type medline-medline}">Medline Citation Status of Medline</span>, <span title="Codes:{http://hl7.org/fhir/citation-status-type pubmed-publication-status-ppublish}">PubMed PublicationStatus of ppublish</span></p><blockquote><p><b>statusDate</b></p><p><b>activity</b>: <span title="Codes:{http://hl7.org/fhir/citation-status-type pubmed-pubstatus-received}">PubMed Pubstatus of Received</span></p><p><b>period</b>: ?? --&gt; 2015-04-15</p></blockquote><blockquote><p><b>statusDate</b></p><p><b>activity</b>: <span title="Codes:{http://hl7.org/fhir/citation-status-type pubmed-pubstatus-revised}">PubMed Pubstatus of Revised</span></p><p><b>period</b>: ?? --&gt; 2015-05-06</p></blockquote><blockquote><p><b>statusDate</b></p><p><b>activity</b>: <span title="Codes:{http://hl7.org/fhir/citation-status-type pubmed-pubstatus-accepted}">PubMed Pubstatus of Accepted</span></p><p><b>period</b>: ?? --&gt; 2015-05-08</p></blockquote><blockquote><p><b>statusDate</b></p><p><b>activity</b>: <span title="Codes:{http://hl7.org/fhir/citation-status-type pubmed-pubstatus-entrez}">PubMed Pubstatus of Entrez</span></p><p><b>period</b>: ?? --&gt; 2015-06-02 06:00:00+0000</p></blockquote><blockquote><p><b>statusDate</b></p><p><b>activity</b>: <span title="Codes:{http://hl7.org/fhir/citation-status-type pubmed-pubstatus-pubmed}">PubMed Pubstatus of Pubmed</span></p><p><b>period</b>: ?? --&gt; 2015-06-02 06:00:00+0000</p></blockquote><blockquote><p><b>statusDate</b></p><p><b>activity</b>: <span title="Codes:{http://hl7.org/fhir/citation-status-type pubmed-pubstatus-medline}">PubMed Pubstatus of Medline</span></p><p><b>period</b>: ?? --&gt; 2015-09-29 06:00:00+0000</p></blockquote><blockquote><p><b>citedArtifact</b></p><p><b>identifier</b>: <code>https://pubmed.ncbi.nlm.nih.gov</code>/26028518, <code>https://doi.org</code>/10.1016/S1470-2045(15)00011-X, pii/S1470-2045(15)00011-X</p><p><b>relatedIdentifier</b>: <code>https://clinicaltrials.gov</code>/NCT00055731</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><span title="Codes:{http://hl7.org/fhir/title-type primary}">Primary title</span></td><td><span title="Codes:{urn:ietf:bcp:47 en}">English</span></td><td><div><p>Androgen deprivation therapy plus docetaxel and estramustine versus androgen deprivation therapy alone for high-risk localised prostate cancer (GETUG 12): a phase 3 randomised controlled trial.</p>
</div></td></tr></table><h3>Abstracts</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td><td><b>Text</b></td><td><b>Copyright</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:{http://hl7.org/fhir/cited-artifact-abstract-type primary-human-use}">Primary human use</span></td><td><div><p><strong>BACKGROUND:</strong> Early risk-stratified chemotherapy is a standard treatment for breast, colorectal, and lung cancers, but not for high-risk localised prostate cancer. Combined docetaxel and estramustine improves survival in patients with castration-resistant prostate cancer. We assessed the effects of combined docetaxel and estramustine on relapse in patients with high-risk localised prostate cancer.
<strong>METHODS:</strong> We did this randomised phase 3 trial at 26 hospitals in France. We enrolled patients with treatment-naive prostate cancer and at least one risk factor (ie, stage T3-T4 disease, Gleason score of ≥8, prostate-specific antigen concentration &gt;20 ng/mL, or pathological node-positive). All patients underwent a staging pelvic lymph node dissection. Patients were randomly assigned (1:1) to either androgen deprivation therapy (ADT; goserelin 10·8 mg every 3 months for 3 years) plus four cycles of docetaxel on day 2 at a dose of 70 mg/m(2) and estramustine 10 mg/kg per day on days 1-5, every 3 weeks, or ADT only. The randomisation was done centrally by computer, stratified by risk factor. Local treatment was administered at 3 months. Neither patients nor investigators were masked to treatment allocation. The primary endpoint was relapse-free survival in the intention-to-treat population. Follow-up for other endpoints is ongoing. This study is registered with ClinicalTrials.gov, number NCT00055731.
<strong>FINDINGS:</strong> We randomly assigned 207 patients to the ADT plus docetaxel and estramustine group and 206 to the ADT only group. Median follow-up was 8·8 years (IQR 8·1-9·7). 88 (43%) of 207 patients in the ADT plus docetaxel and estramustine group had an event (relapse or death) versus 111 (54%) of 206 in the ADT only group. 8-year relapse-free survival was 62% (95% CI 55-69) in the ADT plus docetaxel and estramustine group versus 50% (44-57) in the ADT only group (adjusted hazard ratio [HR] 0·71, 95% CI 0·54-0·94, p=0·017). Of patients who were treated with radiotherapy and had data available, 31 (21%) of 151 in the ADT plus docetaxel and estramustine group versus 26 (18%) of 143 in the ADT only group reported a grade 2 or higher long-term side-effect (p=0·61). We recorded no excess second cancers (26 [13%] of 207 vs 22 [11%] of 206; p=0·57), and there were no treatment-related deaths.
<strong>INTERPRETATION:</strong> Docetaxel-based chemotherapy improves relapse-free survival in patients with high-risk localised prostate cancer. Longer follow-up is needed to assess whether this benefit translates into improved metastasis-free survival and overall survival.
<strong>FUNDING:</strong> Ligue Contre le Cancer, Sanofi-Aventis, AstraZeneca, Institut National du Cancer.</p>
</div></td><td><div><p>Copyright © 2015 Elsevier Ltd. All rights reserved.</p>
</div></td></tr></table><blockquote><p><b>relatesTo</b></p><p><b>TargetUri</b>: <a href="https://pubmed.ncbi.nlm.nih.gov/26028517/">https://pubmed.ncbi.nlm.nih.gov/26028517/</a></p><p><b>type</b>: comment-in</p><p><b>classifier</b>: <span title="Codes:{https://www.nlm.nih.gov/mesh D016420}">Comment</span></p><p><b>citation</b>: </p><div><p>Lancet Oncol. 2015 Jul;16(7):741-2. doi: 10.1016/S1470-2045(15)00012-1.</p>
</div></blockquote><blockquote><p><b>relatesTo</b></p><p><b>TargetUri</b>: <a href="https://pubmed.ncbi.nlm.nih.gov/26077993/">https://pubmed.ncbi.nlm.nih.gov/26077993/</a></p><p><b>type</b>: comment-in</p><p><b>classifier</b>: <span title="Codes:{https://www.nlm.nih.gov/mesh D016420}">Comment</span></p><p><b>citation</b>: </p><div><p>Nat Rev Urol. 2015 Jul;12(7):358. doi: 10.1038/nrurol.2015.146.</p>
</div></blockquote><blockquote><p><b>relatesTo</b></p><p><b>TargetUri</b>: <a href="https://pubmed.ncbi.nlm.nih.gov/26545569/">https://pubmed.ncbi.nlm.nih.gov/26545569/</a></p><p><b>type</b>: comment-in</p><p><b>classifier</b>: <span title="Codes:{https://www.nlm.nih.gov/mesh D016420}">Comment</span></p><p><b>citation</b>: </p><div><p>Eur Urol. 2015 Dec;68(6):1098-9. doi: 10.1016/j.eururo.2015.08.047.</p>
</div></blockquote><blockquote><p><b>relatesTo</b></p><p><b>TargetUri</b>: <a href="https://pubmed.ncbi.nlm.nih.gov/26552950/">https://pubmed.ncbi.nlm.nih.gov/26552950/</a></p><p><b>type</b>: comment-in</p><p><b>classifier</b>: <span title="Codes:{https://www.nlm.nih.gov/mesh D016420}">Comment</span></p><p><b>citation</b>: </p><div><p>Nat Rev Clin Oncol. 2015 Dec;12(12):687-8. doi: 10.1038/nrclinonc.2015.192.</p>
</div></blockquote><blockquote><p><b>publicationForm</b></p><blockquote><p><b>publishedIn</b></p><p><b>type</b>: <span title="Codes:{http://hl7.org/fhir/published-in-type D020492}">Periodical</span></p><p><b>identifier</b>: Electronic ISSN Type/1474-5488, ISOAbbreviation/Lancet Oncol, ISSN Linking/1470-2045, Medline Title Abbreviation/Lancet Oncol, NLM Unique ID/100957246</p><p><b>title</b>: The Lancet. Oncology</p><p><b>publisherLocation</b>: England</p></blockquote><p><b>citedMedium</b>: <span title="Codes:{http://hl7.org/fhir/cited-medium internet}">Internet</span></p><p><b>volume</b>: 16</p><p><b>issue</b>: 7</p><p><b>articleDate</b>: 2015-07</p><p><b>publicationDateText</b>: 2015-Jul</p><p><b>pageString</b>: 787-94</p></blockquote><blockquote><p><b>publicationForm</b></p><p><b>citedMedium</b>: <span title="Codes:{http://hl7.org/fhir/cited-medium internet-without-issue}">Internet without issue</span></p><p><b>articleDate</b>: 2015-05-28</p></blockquote><blockquote><p><b>webLocation</b></p><p><b>classifier</b>: <span title="Codes:{http://hl7.org/fhir/artifact-url-classifier abstract}">Abstract</span></p><p><b>url</b>: <a href="https://pubmed.ncbi.nlm.nih.gov/26028518/">https://pubmed.ncbi.nlm.nih.gov/26028518/</a></p></blockquote><blockquote><p><b>webLocation</b></p><p><b>classifier</b>: <span title="Codes:{http://hl7.org/fhir/artifact-url-classifier doi-based}">DOI Based</span></p><p><b>url</b>: <a href="https://doi.org/10.1016/S1470-2045(15)00011-X">https://doi.org/10.1016/S1470-2045(15)00011-X</a></p></blockquote><blockquote><p><b>classification</b></p><p><b>type</b>: <span title="Codes:{http://hl7.org/fhir/cited-artifact-classification-type publishing-model}">Publishing Model</span></p><p><b>classifier</b>: <span title="Codes:{http://hl7.org/fhir/citation-artifact-classifier Print-Electronic}">Print Electronic</span></p></blockquote><blockquote><p><b>classification</b></p><p><b>type</b>: <span title="Codes:{http://hl7.org/fhir/cited-artifact-classification-type chemical}">Chemical</span></p><p><b>classifier</b>: <span title="Codes:{https://www.nlm.nih.gov/mesh D000726}">Androgen Antagonists</span>, <span title="Codes:{https://www.nlm.nih.gov/mesh D043823}">Taxoids</span>, <span title="Codes:{https://www.cas.org/support/documentation/chemical-substances 15H5577CQD}, {https://www.nlm.nih.gov/mesh D000077143}">Docetaxel</span>, <span title="Codes:{https://www.cas.org/support/documentation/chemical-substances 35LT29625A}, {https://www.nlm.nih.gov/mesh D004961}">Estramustine</span>, <span title="Codes:{https://www.cas.org/support/documentation/chemical-substances EC 3.4.21.77}, {https://www.nlm.nih.gov/mesh D017430}">Prostate-Specific Antigen</span></p></blockquote><blockquote><p><b>classification</b></p><p><b>type</b>: <span title="Codes:{http://hl7.org/fhir/cited-artifact-classification-type mesh-heading}">MeSH heading</span></p><p><b>artifactAssessment</b>: <a href="#hc179621/meshHeading0">ArtifactAssessment: artifact[x] = this resource</a></p></blockquote><blockquote><p><b>classification</b></p><p><b>type</b>: <span title="Codes:{http://hl7.org/fhir/cited-artifact-classification-type publication-type}">Publication type</span></p><p><b>classifier</b>: <span title="Codes:{https://www.nlm.nih.gov/mesh D017428}">Clinical Trial, Phase III</span>, <span title="Codes:{https://www.nlm.nih.gov/mesh D003160}">Comparative Study</span>, <span title="Codes:{https://www.nlm.nih.gov/mesh D016428}">Journal Article</span>, <span title="Codes:{https://www.nlm.nih.gov/mesh D016448}">Multicenter Study</span>, <span title="Codes:{https://www.nlm.nih.gov/mesh D016449}">Randomized Controlled Trial</span>, <span title="Codes:{https://www.nlm.nih.gov/mesh D013485}">Research Support, Non-U.S. Gov't</span></p></blockquote><blockquote><p><b>classification</b></p><p><b>type</b>: <span title="Codes:{http://hl7.org/fhir/cited-artifact-classification-type knowledge-artifact-type}">Knowledge Artifact Type</span></p><p><b>classifier</b>: <span title="Codes:{http://hl7.org/fhir/citation-artifact-classifier D016428}">Journal Article</span></p><p><b>artifactAssessment</b>: Classifier added by Computable Publishing LLC</p></blockquote><blockquote><p><b>classification</b></p><p><b>type</b>: <span title="Codes:{http://hl7.org/fhir/cited-artifact-classification-type citation-subset}">Citation subset</span></p><p><b>classifier</b>: <span title="Codes:{https://www.nlm.nih.gov/bsd/licensee/elements_descriptions.html#citationsubset IM}">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 href="#hc179621/contributor0">Fizazi K</a></p><p><b>forenameInitials</b>: K</p><p><b>affiliation</b>: Institut Gustave Roussy, Villejuif, France. Electronic address: karim.fizazi@gustaveroussy.fr.</p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a href="#hc179621/contributor1">Faivre L</a></p><p><b>forenameInitials</b>: L</p><p><b>affiliation</b>: Institut Gustave Roussy, Villejuif, France.</p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a href="#hc179621/contributor2">Lesaunier F</a></p><p><b>forenameInitials</b>: F</p><p><b>affiliation</b>: Centre François Baclesse, Caen, France.</p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a href="#hc179621/contributor3">Delva R</a></p><p><b>forenameInitials</b>: R</p><p><b>affiliation</b>: Institut de Cancérologie de l'Ouest, Angers, France.</p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a href="#hc179621/contributor4">Gravis G</a></p><p><b>forenameInitials</b>: G</p><p><b>affiliation</b>: Institut Paoli Calmettes, Marseille, France.</p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a href="#hc179621/contributor5">Rolland F</a></p><p><b>forenameInitials</b>: F</p><p><b>affiliation</b>: Institut de Cancérologie de l'Ouest, Nantes, France.</p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a href="#hc179621/contributor6">Priou F</a></p><p><b>forenameInitials</b>: F</p><p><b>affiliation</b>: Centre Hospitalier Départemental, La Roche-sur-Yon, France.</p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a href="#hc179621/contributor7">Ferrero JM</a></p><p><b>forenameInitials</b>: JM</p><p><b>affiliation</b>: Centre Antoine Lacassagne, Nice, France.</p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a href="#hc179621/contributor8">Houede N</a></p><p><b>forenameInitials</b>: N</p><p><b>affiliation</b>: Centre Hospitalier de Nimes, Nimes, France.</p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a href="#hc179621/contributor9">Mourey L</a></p><p><b>forenameInitials</b>: L</p><p><b>affiliation</b>: Institut Claudius Regaud, Toulouse, France.</p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a href="#hc179621/contributor10">Theodore C</a></p><p><b>forenameInitials</b>: C</p><p><b>affiliation</b>: Hôpital Foch, Paris, France.</p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a href="#hc179621/contributor11">Krakowski I</a></p><p><b>forenameInitials</b>: I</p><p><b>affiliation</b>: Centre Alexis Vautrin, Nancy, France.</p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a href="#hc179621/contributor12">Berdah JF</a></p><p><b>forenameInitials</b>: JF</p><p><b>affiliation</b>: Clinique Sainte-Marguerite, Hyères, France.</p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a href="#hc179621/contributor13">Baciuchka M</a></p><p><b>forenameInitials</b>: M</p><p><b>affiliation</b>: Centre Hospitalier La Timone, Marseille, France.</p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a href="#hc179621/contributor14">Laguerre B</a></p><p><b>forenameInitials</b>: B</p><p><b>affiliation</b>: Centre Eugène Marquis, Rennes, France.</p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a href="#hc179621/contributor15">Fléchon A</a></p><p><b>forenameInitials</b>: A</p><p><b>affiliation</b>: Centre Léon Bérard, Lyon, France.</p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a href="#hc179621/contributor16">Ravaud A</a></p><p><b>forenameInitials</b>: A</p><p><b>affiliation</b>: Hôpital Saint-André, Bordeaux, France.</p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a href="#hc179621/contributor17">Cojean-Zelek I</a></p><p><b>forenameInitials</b>: I</p><p><b>affiliation</b>: Groupe Hospitalier Diaconesses Croix Saint-Simon, Paris, France.</p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a href="#hc179621/contributor18">Oudard S</a></p><p><b>forenameInitials</b>: S</p><p><b>affiliation</b>: Hôpital Européen Georges Pompidou, Paris, France.</p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a href="#hc179621/contributor19">Labourey JL</a></p><p><b>forenameInitials</b>: JL</p><p><b>affiliation</b>: CHU Dupuytren, Limoges, France.</p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a href="#hc179621/contributor20">Chinet-Charrot P</a></p><p><b>forenameInitials</b>: P</p><p><b>affiliation</b>: Centre Henri Becquerel, Rouen, France.</p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a href="#hc179621/contributor21">Legouffe E</a></p><p><b>forenameInitials</b>: E</p><p><b>affiliation</b>: Centre Médical Oncogard, Nimes, France.</p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a href="#hc179621/contributor22">Lagrange JL</a></p><p><b>forenameInitials</b>: JL</p><p><b>affiliation</b>: Hôpital Henri-Mondor, Créteil, France.</p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a href="#hc179621/contributor23">Linassier C</a></p><p><b>forenameInitials</b>: C</p><p><b>affiliation</b>: Hôpital Bretonneau, Tours, France.</p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a href="#hc179621/contributor24">Deplanque G</a></p><p><b>forenameInitials</b>: G</p><p><b>affiliation</b>: Hôpital Saint-Joseph, Paris, France.</p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a href="#hc179621/contributor25">Beuzeboc P</a></p><p><b>forenameInitials</b>: P</p><p><b>affiliation</b>: Institut Curie, Paris, France.</p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a href="#hc179621/contributor26">Davin JL</a></p><p><b>forenameInitials</b>: JL</p><p><b>affiliation</b>: Clinique Sainte-Catherine, Avignon, France.</p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a href="#hc179621/contributor27">Martin AL</a></p><p><b>forenameInitials</b>: AL</p><p><b>affiliation</b>: Unicancer, Paris, France.</p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a href="#hc179621/contributor28">Habibian M</a></p><p><b>forenameInitials</b>: M</p><p><b>affiliation</b>: Unicancer, Paris, France.</p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a href="#hc179621/contributor29">Laplanche A</a></p><p><b>forenameInitials</b>: A</p><p><b>affiliation</b>: Institut Gustave Roussy, Villejuif, France.</p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a href="#hc179621/contributor30">Culine S</a></p><p><b>forenameInitials</b>: S</p><p><b>affiliation</b>: Hôpital Saint-Louis, Paris, France.</p></blockquote></blockquote></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Practitioner #contributor0</b></p><a name="179621/contributor0"> </a><a name="hc179621/contributor0"> </a><a name="179621/contributor0-en-US"> </a><p><b>name</b>: Karim Fizazi </p></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Practitioner #contributor1</b></p><a name="179621/contributor1"> </a><a name="hc179621/contributor1"> </a><a name="179621/contributor1-en-US"> </a><p><b>name</b>: Laura Faivre </p></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Practitioner #contributor2</b></p><a name="179621/contributor2"> </a><a name="hc179621/contributor2"> </a><a name="179621/contributor2-en-US"> </a><p><b>name</b>: François Lesaunier </p></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Practitioner #contributor3</b></p><a name="179621/contributor3"> </a><a name="hc179621/contributor3"> </a><a name="179621/contributor3-en-US"> </a><p><b>name</b>: Remy Delva </p></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Practitioner #contributor4</b></p><a name="179621/contributor4"> </a><a name="hc179621/contributor4"> </a><a name="179621/contributor4-en-US"> </a><p><b>name</b>: Gwenaëlle Gravis </p></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Practitioner #contributor5</b></p><a name="179621/contributor5"> </a><a name="hc179621/contributor5"> </a><a name="179621/contributor5-en-US"> </a><p><b>name</b>: Frédéric Rolland </p></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Practitioner #contributor6</b></p><a name="179621/contributor6"> </a><a name="hc179621/contributor6"> </a><a name="179621/contributor6-en-US"> </a><p><b>name</b>: Frank Priou </p></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Practitioner #contributor7</b></p><a name="179621/contributor7"> </a><a name="hc179621/contributor7"> </a><a name="179621/contributor7-en-US"> </a><p><b>name</b>: Jean-Marc Ferrero </p></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Practitioner #contributor8</b></p><a name="179621/contributor8"> </a><a name="hc179621/contributor8"> </a><a name="179621/contributor8-en-US"> </a><p><b>name</b>: Nadine Houede </p></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Practitioner #contributor9</b></p><a name="179621/contributor9"> </a><a name="hc179621/contributor9"> </a><a name="179621/contributor9-en-US"> </a><p><b>name</b>: Loïc Mourey </p></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Practitioner #contributor10</b></p><a name="179621/contributor10"> </a><a name="hc179621/contributor10"> </a><a name="179621/contributor10-en-US"> </a><p><b>name</b>: Christine Theodore </p></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Practitioner #contributor11</b></p><a name="179621/contributor11"> </a><a name="hc179621/contributor11"> </a><a name="179621/contributor11-en-US"> </a><p><b>name</b>: Ivan Krakowski </p></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Practitioner #contributor12</b></p><a name="179621/contributor12"> </a><a name="hc179621/contributor12"> </a><a name="179621/contributor12-en-US"> </a><p><b>name</b>: Jean-François Berdah </p></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Practitioner #contributor13</b></p><a name="179621/contributor13"> </a><a name="hc179621/contributor13"> </a><a name="179621/contributor13-en-US"> </a><p><b>name</b>: Marjorie Baciuchka </p></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Practitioner #contributor14</b></p><a name="179621/contributor14"> </a><a name="hc179621/contributor14"> </a><a name="179621/contributor14-en-US"> </a><p><b>name</b>: Brigitte Laguerre </p></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Practitioner #contributor15</b></p><a name="179621/contributor15"> </a><a name="hc179621/contributor15"> </a><a name="179621/contributor15-en-US"> </a><p><b>name</b>: Aude Fléchon </p></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Practitioner #contributor16</b></p><a name="179621/contributor16"> </a><a name="hc179621/contributor16"> </a><a name="179621/contributor16-en-US"> </a><p><b>name</b>: Alain Ravaud </p></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Practitioner #contributor17</b></p><a name="179621/contributor17"> </a><a name="hc179621/contributor17"> </a><a name="179621/contributor17-en-US"> </a><p><b>name</b>: Isabelle Cojean-Zelek </p></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Practitioner #contributor18</b></p><a name="179621/contributor18"> </a><a name="hc179621/contributor18"> </a><a name="179621/contributor18-en-US"> </a><p><b>name</b>: Stéphane Oudard </p></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Practitioner #contributor19</b></p><a name="179621/contributor19"> </a><a name="hc179621/contributor19"> </a><a name="179621/contributor19-en-US"> </a><p><b>name</b>: Jean-Luc Labourey </p></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Practitioner #contributor20</b></p><a name="179621/contributor20"> </a><a name="hc179621/contributor20"> </a><a name="179621/contributor20-en-US"> </a><p><b>name</b>: Paule Chinet-Charrot </p></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Practitioner #contributor21</b></p><a name="179621/contributor21"> </a><a name="hc179621/contributor21"> </a><a name="179621/contributor21-en-US"> </a><p><b>name</b>: Eric Legouffe </p></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Practitioner #contributor22</b></p><a name="179621/contributor22"> </a><a name="hc179621/contributor22"> </a><a name="179621/contributor22-en-US"> </a><p><b>name</b>: Jean-Léon Lagrange </p></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Practitioner #contributor23</b></p><a name="179621/contributor23"> </a><a name="hc179621/contributor23"> </a><a name="179621/contributor23-en-US"> </a><p><b>name</b>: Claude Linassier </p></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Practitioner #contributor24</b></p><a name="179621/contributor24"> </a><a name="hc179621/contributor24"> </a><a name="179621/contributor24-en-US"> </a><p><b>name</b>: Gaël Deplanque </p></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Practitioner #contributor25</b></p><a name="179621/contributor25"> </a><a name="hc179621/contributor25"> </a><a name="179621/contributor25-en-US"> </a><p><b>name</b>: Philippe Beuzeboc </p></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Practitioner #contributor26</b></p><a name="179621/contributor26"> </a><a name="hc179621/contributor26"> </a><a name="179621/contributor26-en-US"> </a><p><b>name</b>: Jean-Louis Davin </p></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Practitioner #contributor27</b></p><a name="179621/contributor27"> </a><a name="hc179621/contributor27"> </a><a name="179621/contributor27-en-US"> </a><p><b>name</b>: Anne-Laure Martin </p></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Practitioner #contributor28</b></p><a name="179621/contributor28"> </a><a name="hc179621/contributor28"> </a><a name="179621/contributor28-en-US"> </a><p><b>name</b>: Muriel Habibian </p></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Practitioner #contributor29</b></p><a name="179621/contributor29"> </a><a name="hc179621/contributor29"> </a><a name="179621/contributor29-en-US"> </a><p><b>name</b>: Agnès Laplanche </p></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Practitioner #contributor30</b></p><a name="179621/contributor30"> </a><a name="hc179621/contributor30"> </a><a name="179621/contributor30-en-US"> </a><p><b>name</b>: Stéphane Culine </p></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: ArtifactAssessment #meshHeading0</b></p><a name="179621/meshHeading0"> </a><a name="hc179621/meshHeading0"> </a><a name="179621/meshHeading0-en-US"> </a><p><b>artifact</b>: <a href="#hc179621">Citation 26028518 Androgen deprivation therapy plus docetaxel and estramustine versus androgen deprivation therapy alone for high-risk localised prostate cancer (GETUG 12): a phase 3 randomised controlled trial.</a></p><blockquote><p><b>content</b></p><p><b>type</b>: <span title="Codes:{http://hl7.org/fhir/cited-artifact-classification-type mesh-heading}">components (if present) include qualifier codings</span></p><p><b>classifier</b>: <span title="Codes:{https://www.nlm.nih.gov/mesh D000368}">Aged</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><span title="Codes:">qualifier</span></td><td><span title="Codes:">is not a major topic</span></td></tr></table></blockquote><blockquote><p><b>content</b></p><p><b>type</b>: <span title="Codes:{http://hl7.org/fhir/cited-artifact-classification-type mesh-heading}">components (if present) include qualifier codings</span></p><p><b>classifier</b>: <span title="Codes:{https://www.nlm.nih.gov/mesh D000726}">Androgen Antagonists</span></p><p><b>freeToShare</b>: true</p><blockquote><p><b>component</b></p><p><b>type</b>: <span title="Codes:">qualifier</span></p><p><b>classifier</b>: <span title="Codes:">is not a major topic</span></p></blockquote><blockquote><p><b>component</b></p><p><b>type</b>: <span title="Codes:">qualifier</span></p><p><b>classifier</b>: <span title="Codes:{https://www.nlm.nih.gov/mesh Q000627}">therapeutic use</span></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><span title="Codes:">is Major topic</span></td><td><span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C49488}">Yes</span></td></tr></table></blockquote></blockquote><blockquote><p><b>content</b></p><p><b>type</b>: <span title="Codes:{http://hl7.org/fhir/cited-artifact-classification-type mesh-heading}">components (if present) include qualifier codings</span></p><p><b>classifier</b>: <span title="Codes:{https://www.nlm.nih.gov/mesh D000971}">Antineoplastic Combined Chemotherapy Protocols</span></p><p><b>freeToShare</b>: true</p><blockquote><p><b>component</b></p><p><b>type</b>: <span title="Codes:">qualifier</span></p><p><b>classifier</b>: <span title="Codes:">is not a major topic</span></p></blockquote><blockquote><p><b>component</b></p><p><b>type</b>: <span title="Codes:">qualifier</span></p><p><b>classifier</b>: <span title="Codes:{https://www.nlm.nih.gov/mesh Q000627}">therapeutic use</span></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><span title="Codes:">is Major topic</span></td><td><span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C49488}">Yes</span></td></tr></table></blockquote></blockquote><blockquote><p><b>content</b></p><p><b>type</b>: <span title="Codes:{http://hl7.org/fhir/cited-artifact-classification-type mesh-heading}">components (if present) include qualifier codings</span></p><p><b>classifier</b>: <span title="Codes:{https://www.nlm.nih.gov/mesh D018572}">Disease-Free Survival</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><span title="Codes:">qualifier</span></td><td><span title="Codes:">is not a major topic</span></td></tr></table></blockquote><blockquote><p><b>content</b></p><p><b>type</b>: <span title="Codes:{http://hl7.org/fhir/cited-artifact-classification-type mesh-heading}">components (if present) include qualifier codings</span></p><p><b>classifier</b>: <span title="Codes:{https://www.nlm.nih.gov/mesh D000077143}">Docetaxel</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><span title="Codes:">qualifier</span></td><td><span title="Codes:">is not a major topic</span></td></tr></table></blockquote><blockquote><p><b>content</b></p><p><b>type</b>: <span title="Codes:{http://hl7.org/fhir/cited-artifact-classification-type mesh-heading}">components (if present) include qualifier codings</span></p><p><b>classifier</b>: <span title="Codes:{https://www.nlm.nih.gov/mesh D004305}">Dose-Response Relationship, Drug</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><span title="Codes:">qualifier</span></td><td><span title="Codes:">is not a major topic</span></td></tr></table></blockquote><blockquote><p><b>content</b></p><p><b>type</b>: <span title="Codes:{http://hl7.org/fhir/cited-artifact-classification-type mesh-heading}">components (if present) include qualifier codings</span></p><p><b>classifier</b>: <span title="Codes:{https://www.nlm.nih.gov/mesh D004334}">Drug Administration Schedule</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><span title="Codes:">qualifier</span></td><td><span title="Codes:">is not a major topic</span></td></tr></table></blockquote><blockquote><p><b>content</b></p><p><b>type</b>: <span title="Codes:{http://hl7.org/fhir/cited-artifact-classification-type mesh-heading}">components (if present) include qualifier codings</span></p><p><b>classifier</b>: <span title="Codes:{https://www.nlm.nih.gov/mesh D004961}">Estramustine</span></p><p><b>freeToShare</b>: true</p><blockquote><p><b>component</b></p><p><b>type</b>: <span title="Codes:">qualifier</span></p><p><b>classifier</b>: <span title="Codes:">is not a major topic</span></p></blockquote><blockquote><p><b>component</b></p><p><b>type</b>: <span title="Codes:">qualifier</span></p><p><b>classifier</b>: <span title="Codes:{https://www.nlm.nih.gov/mesh Q000008}">administration &amp; dosage</span></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><span title="Codes:">is Major topic</span></td><td><span title="Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C49487}">No</span></td></tr></table></blockquote></blockquote><blockquote><p><b>content</b></p><p><b>type</b>: <span title="Codes:{http://hl7.org/fhir/cited-artifact-classification-type mesh-heading}">components (if present) include qualifier codings</span></p><p><b>classifier</b>: <span title="Codes:{https://www.nlm.nih.gov/mesh D005500}">Follow-Up Studies</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><span title="Codes:">qualifier</span></td><td><span title="Codes:">is not a major topic</span></td></tr></table></blockquote><blockquote><p><b>content</b></p><p><b>type</b>: <span title="Codes:{http://hl7.org/fhir/cited-artifact-classification-type mesh-heading}">components (if present) include qualifier codings</span></p><p><b>classifier</b>: <span 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            value="**BACKGROUND:** Early risk-stratified chemotherapy is a standard treatment for breast, colorectal, and lung cancers, but not for high-risk localised prostate cancer. Combined docetaxel and estramustine improves survival in patients with castration-resistant prostate cancer. We assessed the effects of combined docetaxel and estramustine on relapse in patients with high-risk localised prostate cancer.
**METHODS:** We did this randomised phase 3 trial at 26 hospitals in France. We enrolled patients with treatment-naive prostate cancer and at least one risk factor (ie, stage T3-T4 disease, Gleason score of ≥8, prostate-specific antigen concentration &amp;gt;20 ng/mL, or pathological node-positive). All patients underwent a staging pelvic lymph node dissection. Patients were randomly assigned (1:1) to either androgen deprivation therapy (ADT; goserelin 10·8 mg every 3 months for 3 years) plus four cycles of docetaxel on day 2 at a dose of 70 mg/m(2) and estramustine 10 mg/kg per day on days 1-5, every 3 weeks, or ADT only. The randomisation was done centrally by computer, stratified by risk factor. Local treatment was administered at 3 months. Neither patients nor investigators were masked to treatment allocation. The primary endpoint was relapse-free survival in the intention-to-treat population. Follow-up for other endpoints is ongoing. This study is registered with ClinicalTrials.gov, number NCT00055731.
**FINDINGS:** We randomly assigned 207 patients to the ADT plus docetaxel and estramustine group and 206 to the ADT only group. Median follow-up was 8·8 years (IQR 8·1-9·7). 88 (43%) of 207 patients in the ADT plus docetaxel and estramustine group had an event (relapse or death) versus 111 (54%) of 206 in the ADT only group. 8-year relapse-free survival was 62% (95% CI 55-69) in the ADT plus docetaxel and estramustine group versus 50% (44-57) in the ADT only group (adjusted hazard ratio [HR] 0·71, 95% CI 0·54-0·94, p=0·017). Of patients who were treated with radiotherapy and had data available, 31 (21%) of 151 in the ADT plus docetaxel and estramustine group versus 26 (18%) of 143 in the ADT only group reported a grade 2 or higher long-term side-effect (p=0·61). We recorded no excess second cancers (26 [13%] of 207 vs 22 [11%] of 206; p=0·57), and there were no treatment-related deaths.
**INTERPRETATION:** Docetaxel-based chemotherapy improves relapse-free survival in patients with high-risk localised prostate cancer. Longer follow-up is needed to assess whether this benefit translates into improved metastasis-free survival and overall survival.
**FUNDING:** Ligue Contre le Cancer, Sanofi-Aventis, AstraZeneca, Institut National du Cancer."/>
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