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 2024-11-21 |
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<div xmlns="http://www.w3.org/1999/xhtml"><p class="res-header-id"><b>Generated Narrative: Citation 179615</b></p><a name="179615"> </a><a name="hc179615"> </a><a name="179615-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: 7; Last updated: 2024-07-18 18:00:06+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-179615.html">Citation 23306100 Androgen-deprivation therapy alone or with docetaxel in non-castrate metastatic prostate cancer (GETUG-AFU 15): a randomised, open-label, phase 3 trial.</a></p><p><b>identifier</b>: FEvIR Object Identifier/179615, <code>https://pubmed.ncbi.nlm.nih.gov</code>/23306100, <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
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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:2.16.840.1.113883.4.642.40.44.15.6</p><p><b>version</b>: 2.0.0-ballot</p><p><b>title</b>: 23306100 Androgen-deprivation therapy alone or with docetaxel in non-castrate metastatic prostate cancer (GETUG-AFU 15): a randomised, open-label, phase 3 trial.</p><p><b>status</b>: Active</p><p><b>date</b>: 2024-11-21 14:09:14+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>: 2013-03-25</p><p><b>lastReviewDate</b>: 2022-12-08</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-entrez}">PubMed Pubstatus of Entrez</span></p><p><b>period</b>: ?? --> 2013-01-12 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>: ?? --> 2013-01-12 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>: ?? --> 2013-03-26 06:00:00+0000</p></blockquote><blockquote><p><b>citedArtifact</b></p><p><b>identifier</b>: <code>https://pubmed.ncbi.nlm.nih.gov</code>/23306100, <code>https://doi.org</code>/10.1016/S1470-2045(12)70560-0, pii/S1470-2045(12)70560-0</p><p><b>relatedIdentifier</b>: <code>https://clinicaltrials.gov</code>/NCT00104715</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 alone or with docetaxel in non-castrate metastatic prostate cancer (GETUG-AFU 15): a randomised, open-label, phase 3 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 chemotherapy might improve the overall outcomes of patients with metastatic non-castrate (ie, hormone-sensitive) prostate cancer. We investigated the effects of the addition of docetaxel to androgen-deprivation therapy (ADT) for patients with metastatic non-castrate prostate cancer.
<strong>METHODS:</strong> In this randomised, open-label, phase 3 study, we enrolled patients in 29 centres in France and one in Belgium. Eligible patients were older than 18 years and had histologically confirmed adenocarcinoma of the prostate and radiologically proven metastatic disease; a Karnofsky score of at least 70%; a life expectancy of at least 3 months; and adequate hepatic, haematological, and renal function. They were randomly assigned to receive to ADT (orchiectomy or luteinising hormone-releasing hormone agonists, alone or combined with non-steroidal antiandrogens) alone or in combination with docetaxel (75 mg/m(2) intravenously on the first day of each 21-day cycle; up to nine cycles). Patients were randomised in a 1:1 ratio, with dynamic minimisation to minimise imbalances in previous systemic treatment with ADT, chemotherapy for local disease or isolated rising concentration of serum prostate-specific antigen, and Glass risk groups. Patients, physicians, and data analysts were not masked to treatment allocation. The primary endpoint was overall survival. Efficacy analyses were done by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT00104715.
<strong>FINDINGS:</strong> Between Oct 18, 2004, and Dec 31, 2008, 192 patients were randomly allocated to receive ADT plus docetaxel and 193 to receive ADT alone. Median follow-up was 50 months (IQR 39-63). Median overall survival was 58·9 months (95% CI 50·8-69·1) in the group given ADT plus docetaxel and 54·2 months (42·2-not reached) in that given ADT alone (hazard ratio 1·01, 95% CI 0·75-1·36). 72 serious adverse events were reported in the group given ADT plus docetaxel, of which the most frequent were neutropenia (40 [21%]), febrile neutropenia (six [3%]), abnormal liver function tests (three [2%]), and neutropenia with infection (two [1%]). Four treatment-related deaths occurred in the ADT plus docetaxel group (two of which were neutropenia-related), after which the data monitoring committee recommended treatment with granulocyte colony-stimulating factor. After this recommendation, no further treatment-related deaths occurred. No serious adverse events were reported in the ADT alone group.
<strong>INTERPRETATION:</strong> Docetaxel should not be used as part of first-line treatment for patients with non-castrate metastatic prostate cancer.
<strong>FUNDING:</strong> French Health Ministry and Institut National du Cancer (PHRC), Sanofi-Aventis, AstraZeneca, and Amgen.</p>
</div></td><td><div><p>Copyright © 2013 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. 2013 Feb;14(2):104-5. doi: 10.1016/S1470-2045(12)70591-0</p>
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</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/23358518/">https://pubmed.ncbi.nlm.nih.gov/23358518/</a></td></tr></table><p><b>resourceReference</b>: Identifier: <code>https://pubmed.ncbi.nlm.nih.gov</code>/23358518</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>J Urol. 2013 Dec;190(6):2094. doi: 10.1016/j.juro.2013.08.104</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/24209521/">https://pubmed.ncbi.nlm.nih.gov/24209521/</a></td></tr></table><p><b>resourceReference</b>: Identifier: <code>https://pubmed.ncbi.nlm.nih.gov</code>/24209521</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>Urol Oncol. 2013 Nov;31(8):1845. doi: 10.1016/j.urolonc.2013.08.011</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/24210084/">https://pubmed.ncbi.nlm.nih.gov/24210084/</a></td></tr></table><p><b>resourceReference</b>: Identifier: <code>https://pubmed.ncbi.nlm.nih.gov</code>/24210084</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>Actas Urol Esp. 2017 Jul - Aug;41(6):347-351. doi: 10.1016/j.acuro.2016.11.008</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/28214037/">https://pubmed.ncbi.nlm.nih.gov/28214037/</a></td></tr></table><p><b>resourceReference</b>: Identifier: <code>https://pubmed.ncbi.nlm.nih.gov</code>/28214037</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. 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href="#hc179615/contributor26">El Kouri C</a></p><p><b>forenameInitials</b>: C</p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a href="#hc179615/contributor27">Ravaud A</a></p><p><b>forenameInitials</b>: A</p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a href="#hc179615/contributor28">Suc E</a></p><p><b>forenameInitials</b>: E</p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a href="#hc179615/contributor29">Eymard JC</a></p><p><b>forenameInitials</b>: JC</p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a href="#hc179615/contributor30">Hasbini A</a></p><p><b>forenameInitials</b>: A</p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a href="#hc179615/contributor31">Bousquet G</a></p><p><b>forenameInitials</b>: G</p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a href="#hc179615/contributor32">Soulie M</a></p><p><b>forenameInitials</b>: M</p></blockquote></blockquote></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Practitioner #contributor0</b></p><a name="179615/contributor0"> </a><a name="hc179615/contributor0"> </a><a name="179615/contributor0-en-US"> </a><p><b>name</b>: Gwenaelle Gravis </p></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Practitioner #contributor1</b></p><a name="179615/contributor1"> </a><a name="hc179615/contributor1"> </a><a name="179615/contributor1-en-US"> </a><p><b>name</b>: Karim Fizazi </p></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Practitioner #contributor2</b></p><a name="179615/contributor2"> </a><a name="hc179615/contributor2"> </a><a name="179615/contributor2-en-US"> </a><p><b>name</b>: Florence Joly </p></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Practitioner #contributor3</b></p><a name="179615/contributor3"> </a><a name="hc179615/contributor3"> </a><a name="179615/contributor3-en-US"> </a><p><b>name</b>: Stéphane Oudard </p></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Practitioner #contributor4</b></p><a name="179615/contributor4"> </a><a name="hc179615/contributor4"> </a><a name="179615/contributor4-en-US"> </a><p><b>name</b>: Franck Priou </p></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Practitioner #contributor5</b></p><a name="179615/contributor5"> </a><a name="hc179615/contributor5"> </a><a name="179615/contributor5-en-US"> </a><p><b>name</b>: Benjamin Esterni </p></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Practitioner #contributor6</b></p><a name="179615/contributor6"> </a><a name="hc179615/contributor6"> </a><a name="179615/contributor6-en-US"> </a><p><b>name</b>: Igor Latorzeff </p></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Practitioner #contributor7</b></p><a name="179615/contributor7"> </a><a name="hc179615/contributor7"> </a><a name="179615/contributor7-en-US"> </a><p><b>name</b>: Remy Delva </p></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Practitioner #contributor8</b></p><a name="179615/contributor8"> </a><a name="hc179615/contributor8"> </a><a name="179615/contributor8-en-US"> </a><p><b>name</b>: Ivan Krakowski </p></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Practitioner #contributor9</b></p><a name="179615/contributor9"> </a><a name="hc179615/contributor9"> </a><a name="179615/contributor9-en-US"> </a><p><b>name</b>: Brigitte Laguerre </p></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Practitioner #contributor10</b></p><a name="179615/contributor10"> </a><a name="hc179615/contributor10"> </a><a name="179615/contributor10-en-US"> </a><p><b>name</b>: Fréderic Rolland </p></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Practitioner #contributor11</b></p><a name="179615/contributor11"> </a><a name="hc179615/contributor11"> </a><a name="179615/contributor11-en-US"> </a><p><b>name</b>: Christine Théodore </p></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Practitioner #contributor12</b></p><a name="179615/contributor12"> </a><a name="hc179615/contributor12"> </a><a name="179615/contributor12-en-US"> </a><p><b>name</b>: Gael Deplanque </p></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Practitioner #contributor13</b></p><a name="179615/contributor13"> </a><a name="hc179615/contributor13"> </a><a name="179615/contributor13-en-US"> </a><p><b>name</b>: Jean Marc Ferrero </p></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Practitioner #contributor14</b></p><a name="179615/contributor14"> </a><a name="hc179615/contributor14"> </a><a name="179615/contributor14-en-US"> </a><p><b>name</b>: Damien Pouessel </p></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Practitioner #contributor15</b></p><a name="179615/contributor15"> </a><a name="hc179615/contributor15"> </a><a name="179615/contributor15-en-US"> </a><p><b>name</b>: Loïc Mourey </p></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Practitioner #contributor16</b></p><a name="179615/contributor16"> </a><a name="hc179615/contributor16"> </a><a name="179615/contributor16-en-US"> </a><p><b>name</b>: Philippe Beuzeboc </p></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Practitioner #contributor17</b></p><a name="179615/contributor17"> </a><a name="hc179615/contributor17"> </a><a name="179615/contributor17-en-US"> </a><p><b>name</b>: Sylvie Zanetta </p></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Practitioner #contributor18</b></p><a name="179615/contributor18"> </a><a name="hc179615/contributor18"> </a><a name="179615/contributor18-en-US"> </a><p><b>name</b>: Muriel Habibian </p></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Practitioner #contributor19</b></p><a name="179615/contributor19"> </a><a name="hc179615/contributor19"> </a><a name="179615/contributor19-en-US"> </a><p><b>name</b>: Jean François Berdah </p></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Practitioner #contributor20</b></p><a name="179615/contributor20"> </a><a name="hc179615/contributor20"> </a><a name="179615/contributor20-en-US"> </a><p><b>name</b>: Jerome Dauba </p></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Practitioner #contributor21</b></p><a name="179615/contributor21"> </a><a name="hc179615/contributor21"> </a><a name="179615/contributor21-en-US"> </a><p><b>name</b>: Marjorie Baciuchka </p></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Practitioner #contributor22</b></p><a name="179615/contributor22"> </a><a name="hc179615/contributor22"> </a><a name="179615/contributor22-en-US"> </a><p><b>name</b>: Christian Platini </p></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Practitioner #contributor23</b></p><a name="179615/contributor23"> </a><a name="hc179615/contributor23"> </a><a name="179615/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="179615/contributor24"> </a><a name="hc179615/contributor24"> </a><a name="179615/contributor24-en-US"> </a><p><b>name</b>: Jean Luc Labourey </p></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Practitioner #contributor25</b></p><a name="179615/contributor25"> </a><a name="hc179615/contributor25"> </a><a name="179615/contributor25-en-US"> </a><p><b>name</b>: Jean Pascal Machiels </p></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Practitioner #contributor26</b></p><a name="179615/contributor26"> </a><a name="hc179615/contributor26"> </a><a name="179615/contributor26-en-US"> </a><p><b>name</b>: Claude El Kouri </p></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Practitioner #contributor27</b></p><a name="179615/contributor27"> </a><a name="hc179615/contributor27"> </a><a name="179615/contributor27-en-US"> </a><p><b>name</b>: Alain Ravaud </p></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Practitioner #contributor28</b></p><a name="179615/contributor28"> </a><a name="hc179615/contributor28"> </a><a name="179615/contributor28-en-US"> </a><p><b>name</b>: Etienne Suc </p></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Practitioner #contributor29</b></p><a name="179615/contributor29"> </a><a name="hc179615/contributor29"> </a><a name="179615/contributor29-en-US"> </a><p><b>name</b>: Jean Christophe Eymard </p></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Practitioner #contributor30</b></p><a name="179615/contributor30"> </a><a name="hc179615/contributor30"> </a><a name="179615/contributor30-en-US"> </a><p><b>name</b>: Ali Hasbini </p></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Practitioner #contributor31</b></p><a name="179615/contributor31"> </a><a name="hc179615/contributor31"> </a><a name="179615/contributor31-en-US"> </a><p><b>name</b>: Guilhem Bousquet </p></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Practitioner #contributor32</b></p><a name="179615/contributor32"> </a><a name="hc179615/contributor32"> </a><a name="179615/contributor32-en-US"> </a><p><b>name</b>: Michel Soulie </p></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: ArtifactAssessment #meshHeading0</b></p><a name="179615/meshHeading0"> </a><a name="hc179615/meshHeading0"> </a><a name="179615/meshHeading0-en-US"> </a><p><b>artifact</b>: <a href="#hc179615">Citation 23306100 Androgen-deprivation therapy alone or with docetaxel in non-castrate metastatic prostate cancer (GETUG-AFU 15): a randomised, open-label, phase 3 trial.</a></p><blockquote><p><b>content</b></p><p><b>informationType</b>: Classifier</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>informationType</b>: Classifier</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/ 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><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>informationType</b>: Classifier</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>informationType</b>: Classifier</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>informationType</b>: Classifier</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>informationType</b>: Classifier</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/ D006801}">Humans</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>informationType</b>: Classifier</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/ D008297}">Male</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>informationType</b>: Classifier</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/ D008875}">Middle 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>informationType</b>: Classifier</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/ D009919}">Orchiectomy</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>informationType</b>: Classifier</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/ D011471}">Prostatic Neoplasms</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/ Q000188}">drug therapy</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 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value="**BACKGROUND:** Early chemotherapy might improve the overall outcomes of patients with metastatic non-castrate (ie, hormone-sensitive) prostate cancer. We investigated the effects of the addition of docetaxel to androgen-deprivation therapy (ADT) for patients with metastatic non-castrate prostate cancer.
**METHODS:** In this randomised, open-label, phase 3 study, we enrolled patients in 29 centres in France and one in Belgium. Eligible patients were older than 18 years and had histologically confirmed adenocarcinoma of the prostate and radiologically proven metastatic disease; a Karnofsky score of at least 70%; a life expectancy of at least 3 months; and adequate hepatic, haematological, and renal function. They were randomly assigned to receive to ADT (orchiectomy or luteinising hormone-releasing hormone agonists, alone or combined with non-steroidal antiandrogens) alone or in combination with docetaxel (75 mg/m(2) intravenously on the first day of each 21-day cycle; up to nine cycles). Patients were randomised in a 1:1 ratio, with dynamic minimisation to minimise imbalances in previous systemic treatment with ADT, chemotherapy for local disease or isolated rising concentration of serum prostate-specific antigen, and Glass risk groups. Patients, physicians, and data analysts were not masked to treatment allocation. The primary endpoint was overall survival. Efficacy analyses were done by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT00104715.
**FINDINGS:** Between Oct 18, 2004, and Dec 31, 2008, 192 patients were randomly allocated to receive ADT plus docetaxel and 193 to receive ADT alone. Median follow-up was 50 months (IQR 39-63). Median overall survival was 58·9 months (95% CI 50·8-69·1) in the group given ADT plus docetaxel and 54·2 months (42·2-not reached) in that given ADT alone (hazard ratio 1·01, 95% CI 0·75-1·36). 72 serious adverse events were reported in the group given ADT plus docetaxel, of which the most frequent were neutropenia (40 [21%]), febrile neutropenia (six [3%]), abnormal liver function tests (three [2%]), and neutropenia with infection (two [1%]). Four treatment-related deaths occurred in the ADT plus docetaxel group (two of which were neutropenia-related), after which the data monitoring committee recommended treatment with granulocyte colony-stimulating factor. After this recommendation, no further treatment-related deaths occurred. No serious adverse events were reported in the ADT alone group.
**INTERPRETATION:** Docetaxel should not be used as part of first-line treatment for patients with non-castrate metastatic prostate cancer.
**FUNDING:** French Health Ministry and Institut National du Cancer (PHRC), Sanofi-Aventis, AstraZeneca, and Amgen."/>
<copyright value="Copyright © 2013 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 2024-11-21
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