Evidence Based Medicine on FHIR Implementation Guide
2.0.0-ballot - ballot
Evidence Based Medicine on FHIR Implementation Guide
2.0.0-ballot - 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
| Active as of 2024-12-19 |
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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: 8; Last updated: 2024-11-22 19:27:42+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/6.1.0/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
This oid is used as an identifier II.root to indicate the the extension is an absolute URI (technically, an IRI). Typically, this is used for OIDs and GUIDs. Note that when this OID is used with OIDs and GUIDs, the II.extension should start with urn:oid or urn:uuid:
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>: 2.0.0-ballot</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>: 2024-12-19 14:29:51+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>: ?? --> 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>: ?? --> 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>: ?? --> 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>: ?? --> 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>: ?? --> 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>: ?? --> 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>Text</b></td><td><b>Copyright</b></td></tr><tr><td style="display: none">*</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 >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>type</b>: comment-in</p><p><b>classifier</b>: <span title="Codes:{https://meshb.nlm.nih.gov/ 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><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/26028517/">https://pubmed.ncbi.nlm.nih.gov/26028517/</a></td></tr></table><p><b>resourceReference</b>: Identifier: <code>https://pubmed.ncbi.nlm.nih.gov</code>/26028517</p></blockquote><blockquote><p><b>relatesTo</b></p><p><b>type</b>: comment-in</p><p><b>classifier</b>: <span title="Codes:{https://meshb.nlm.nih.gov/ 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><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/26077993/">https://pubmed.ncbi.nlm.nih.gov/26077993/</a></td></tr></table><p><b>resourceReference</b>: Identifier: <code>https://pubmed.ncbi.nlm.nih.gov</code>/26077993</p></blockquote><blockquote><p><b>relatesTo</b></p><p><b>type</b>: comment-in</p><p><b>classifier</b>: <span title="Codes:{https://meshb.nlm.nih.gov/ 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><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/26545569/">https://pubmed.ncbi.nlm.nih.gov/26545569/</a></td></tr></table><p><b>resourceReference</b>: Identifier: <code>https://pubmed.ncbi.nlm.nih.gov</code>/26545569</p></blockquote><blockquote><p><b>relatesTo</b></p><p><b>type</b>: comment-in</p><p><b>classifier</b>: <span title="Codes:{https://meshb.nlm.nih.gov/ 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><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/26552950/">https://pubmed.ncbi.nlm.nih.gov/26552950/</a></td></tr></table><p><b>resourceReference</b>: Identifier: <code>https://pubmed.ncbi.nlm.nih.gov</code>/26552950</p></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>language</b>: <span title="Codes:{urn:ietf:bcp:47 en}">English</span></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://meshb.nlm.nih.gov/ D000726}">Androgen Antagonists</span>, <span title="Codes:{https://meshb.nlm.nih.gov/ D043823}">Taxoids</span>, <span title="Codes:{https://www.cas.org/support/documentation/chemical-substances 15H5577CQD}, {https://meshb.nlm.nih.gov/ D000077143}">Docetaxel</span>, <span title="Codes:{https://www.cas.org/support/documentation/chemical-substances 35LT29625A}, {https://meshb.nlm.nih.gov/ D004961}">Estramustine</span>, <span title="Codes:{https://www.cas.org/support/documentation/chemical-substances EC 3.4.21.77}, {https://meshb.nlm.nih.gov/ 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://meshb.nlm.nih.gov/ D017428}">Clinical Trial, Phase III</span>, <span title="Codes:{https://meshb.nlm.nih.gov/ D003160}">Comparative Study</span>, <span title="Codes:{https://meshb.nlm.nih.gov/ D016428}">Journal Article</span>, <span title="Codes:{https://meshb.nlm.nih.gov/ D016448}">Multicenter Study</span>, <span title="Codes:{https://meshb.nlm.nih.gov/ D016449}">Randomized Controlled Trial</span>, <span title="Codes:{https://meshb.nlm.nih.gov/ 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://meshb.nlm.nih.gov/ 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://meshb.nlm.nih.gov/ 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://meshb.nlm.nih.gov/ 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:{https://ncithesaurus.nci.nih.gov/ncitbrowser 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://meshb.nlm.nih.gov/ 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://meshb.nlm.nih.gov/ 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:{https://ncithesaurus.nci.nih.gov/ncitbrowser 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://meshb.nlm.nih.gov/ 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://meshb.nlm.nih.gov/ 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://meshb.nlm.nih.gov/ 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://meshb.nlm.nih.gov/ 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://meshb.nlm.nih.gov/ 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://meshb.nlm.nih.gov/ Q000008}">administration & 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:{https://ncithesaurus.nci.nih.gov/ncitbrowser 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://meshb.nlm.nih.gov/ 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 &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."/>
<copyright value="Copyright © 2015 Elsevier Ltd. All rights reserved."/>
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IG © 2024+ HL7 International / Clinical Decision Support. Package hl7.fhir.uv.ebm#2.0.0-ballot based on FHIR 6.0.0-ballot2. Generated 2024-12-19
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