Evidence Based Medicine on FHIR Implementation Guide
1.0.0-ballot - ballot
Evidence Based Medicine on FHIR Implementation Guide
1.0.0-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 1.0.0-ballot built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/ebm/ and changes regularly. See the Directory of published versions
| Active as of 2024-05-16 |
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<div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: Citation</b><a name="179615"> </a><a name="hc179615"> </a></p><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">ResourceCitation "179615" Version "1" Updated "2023-11-26 18:53:59+0000" </p></div><p><b>url</b>: <code>https://fevir.net/resources/Citation/179615</code></p><p><b>identifier</b>: FEvIR Object Identifier/179615, <code>https://pubmed.ncbi.nlm.nih.gov</code>/23306100</p><p><b>version</b>: 1.0.0-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>: 2024-05-16 12:17:54+0000</p><p><b>publisher</b>: HL7 International / Clinical Decision Support</p><p><b>contact</b>: HL7 International / Clinical Decision Support: <a href="http://www.hl7.org/Special/committees/dss">http://www.hl7.org/Special/committees/dss</a></p><p><b>description</b>: This Citation Resource is referenced in an example for the EBMonFHIR Implementation Guide.</p><h3>UseContexts</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Code</b></td><td><b>Value[x]</b></td></tr><tr><td style="display: none">*</td><td>FEvIR Platform Use (Details: Citation Classification Type code fevir-platform-use = 'FEvIR Platform Use', stated as 'FEvIR Platform Use')</td><td>Medline Base <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-citation-artifact-classifier.html">Citation Artifact Classifier</a>#medline-base)</span></td></tr></table><p><b>jurisdiction</b>: World <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (m49.htm#001)</span></p><p><b>copyright</b>: https://creativecommons.org/licenses/by-nc-sa/4.0/</p><p><b>approvalDate</b>: 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>: Citation Source <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-citation-classification-type.html">Citation Classification Type</a>#citation-source)</span></p><p><b>classifier</b>: MEDLINE <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p></blockquote><blockquote><p><b>classification</b></p><p><b>type</b>: MEDLINE Citation Owner <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-citation-classification-type.html">Citation Classification Type</a>#medline-owner)</span></p><p><b>classifier</b>: National Library of Medicine, Index Section <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (elements_descriptions.html#owner_value#NLM)</span></p></blockquote><p><b>currentState</b>: Medline Citation Status of Medline <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-citation-status-type.html">Citation Status Type</a>#medline-medline)</span>, PubMed PublicationStatus of ppublish <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-citation-status-type.html">Citation Status Type</a>#pubmed-publication-status-ppublish)</span></p><blockquote><p><b>statusDate</b></p><p><b>activity</b>: PubMed Pubstatus of Entrez <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-citation-status-type.html">Citation Status Type</a>#pubmed-pubstatus-entrez)</span></p><p><b>period</b>: ?? --> 2013-01-12 06:00:00+0000</p></blockquote><blockquote><p><b>statusDate</b></p><p><b>activity</b>: PubMed Pubstatus of Pubmed <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-citation-status-type.html">Citation Status Type</a>#pubmed-pubstatus-pubmed)</span></p><p><b>period</b>: ?? --> 2013-01-12 06:00:00+0000</p></blockquote><blockquote><p><b>statusDate</b></p><p><b>activity</b>: PubMed Pubstatus of Medline <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-citation-status-type.html">Citation Status Type</a>#pubmed-pubstatus-medline)</span></p><p><b>period</b>: ?? --> 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>Primary title <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-title-type.html">Title Type</a>#primary)</span></td><td>English <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.5.0/CodeSystem-v3-ietf3066.html">Tags for the Identification of Languages</a>#en)</span></td><td>Androgen-deprivation therapy alone or with docetaxel in non-castrate metastatic prostate cancer (GETUG-AFU 15): a randomised, open-label, phase 3 trial.</td></tr></table><h3>Abstracts</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Text</b></td><td><b>Copyright</b></td></tr><tr><td style="display: none">*</td><td>**BACKGROUND:** 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.</td><td>Copyright © 2013 Elsevier Ltd. All rights reserved.</td></tr></table><blockquote><p><b>relatesTo</b></p><p><b>type</b>: comment-in</p><p><b>classifier</b>: Comment <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (#D016420)</span></p><p><b>citation</b>: Lancet Oncol. 2013 Feb;14(2):104-5</p><h3>Documents</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Url</b></td></tr><tr><td style="display: none">*</td><td><a href="https://pubmed.ncbi.nlm.nih.gov/23306099/">https://pubmed.ncbi.nlm.nih.gov/23306099/</a></td></tr></table><p><b>resourceReference</b>: <span><code>https://pubmed.ncbi.nlm.nih.gov</code>/23306099</span></p></blockquote><blockquote><p><b>relatesTo</b></p><p><b>type</b>: comment-in</p><p><b>classifier</b>: Comment <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (#D016420)</span></p><p><b>citation</b>: Nat Rev Urol. 2013 Mar;10(3):123</p><h3>Documents</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Url</b></td></tr><tr><td style="display: none">*</td><td><a href="https://pubmed.ncbi.nlm.nih.gov/23358518/">https://pubmed.ncbi.nlm.nih.gov/23358518/</a></td></tr></table><p><b>resourceReference</b>: <span><code>https://pubmed.ncbi.nlm.nih.gov</code>/23358518</span></p></blockquote><blockquote><p><b>relatesTo</b></p><p><b>type</b>: comment-in</p><p><b>classifier</b>: Comment <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (#D016420)</span></p><p><b>citation</b>: J Urol. 2013 Dec;190(6):2094</p><h3>Documents</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Url</b></td></tr><tr><td style="display: none">*</td><td><a href="https://pubmed.ncbi.nlm.nih.gov/24209521/">https://pubmed.ncbi.nlm.nih.gov/24209521/</a></td></tr></table><p><b>resourceReference</b>: <span><code>https://pubmed.ncbi.nlm.nih.gov</code>/24209521</span></p></blockquote><blockquote><p><b>relatesTo</b></p><p><b>type</b>: comment-in</p><p><b>classifier</b>: Comment <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (#D016420)</span></p><p><b>citation</b>: Urol Oncol. 2013 Nov;31(8):1845</p><h3>Documents</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Url</b></td></tr><tr><td style="display: none">*</td><td><a href="https://pubmed.ncbi.nlm.nih.gov/24210084/">https://pubmed.ncbi.nlm.nih.gov/24210084/</a></td></tr></table><p><b>resourceReference</b>: <span><code>https://pubmed.ncbi.nlm.nih.gov</code>/24210084</span></p></blockquote><blockquote><p><b>relatesTo</b></p><p><b>type</b>: comment-in</p><p><b>classifier</b>: Comment <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (#D016420)</span></p><p><b>citation</b>: Actas Urol Esp. 2017 Jul - Aug;41(6):347-351</p><h3>Documents</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Url</b></td></tr><tr><td style="display: none">*</td><td><a href="https://pubmed.ncbi.nlm.nih.gov/28214037/">https://pubmed.ncbi.nlm.nih.gov/28214037/</a></td></tr></table><p><b>resourceReference</b>: <span><code>https://pubmed.ncbi.nlm.nih.gov</code>/28214037</span></p></blockquote><blockquote><p><b>publicationForm</b></p><h3>PublishedIns</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td><td><b>Identifier</b></td><td><b>Title</b></td><td><b>PublisherLocation</b></td></tr><tr><td style="display: none">*</td><td>Periodical <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-published-in-type.html">Published In Type</a>#D020492)</span></td><td>Electronic ISSN Type/1474-5488, ISOAbbreviation/Lancet Oncol, ISSN Linking/1470-2045, Medline Title Abbreviation/Lancet Oncol, NLM Unique ID/100957246</td><td>The Lancet. 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heading")</span></p><p><b>classifier</b>: Docetaxel <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (#D000077143)</span></p><p><b>freeToShare</b>: true</p><h3>Components</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td><td><b>Classifier</b></td></tr><tr><td style="display: none">*</td><td>qualifier <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td><td>is not a major topic <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td></tr></table></blockquote><blockquote><p><b>content</b></p><p><b>informationType</b>: classifier</p><p><b>type</b>: components (if present) include qualifier codings <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-cited-artifact-classification-type.html">Cited Artifact Classification Type</a>#mesh-heading "MeSH heading")</span></p><p><b>classifier</b>: Humans <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (#D006801)</span></p><p><b>freeToShare</b>: true</p><h3>Components</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td><td><b>Classifier</b></td></tr><tr><td style="display: none">*</td><td>qualifier <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td><td>is not a major topic <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td></tr></table></blockquote><blockquote><p><b>content</b></p><p><b>informationType</b>: classifier</p><p><b>type</b>: components (if present) include qualifier codings <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-cited-artifact-classification-type.html">Cited Artifact Classification Type</a>#mesh-heading "MeSH heading")</span></p><p><b>classifier</b>: Male <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (#D008297)</span></p><p><b>freeToShare</b>: true</p><h3>Components</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td><td><b>Classifier</b></td></tr><tr><td style="display: none">*</td><td>qualifier <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td><td>is not a major topic <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td></tr></table></blockquote><blockquote><p><b>content</b></p><p><b>informationType</b>: classifier</p><p><b>type</b>: components (if present) include qualifier codings <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-cited-artifact-classification-type.html">Cited Artifact Classification Type</a>#mesh-heading "MeSH heading")</span></p><p><b>classifier</b>: Middle Aged <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (#D008875)</span></p><p><b>freeToShare</b>: true</p><h3>Components</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td><td><b>Classifier</b></td></tr><tr><td style="display: none">*</td><td>qualifier <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td><td>is not a major topic <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td></tr></table></blockquote><blockquote><p><b>content</b></p><p><b>informationType</b>: classifier</p><p><b>type</b>: components (if present) include qualifier codings <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-cited-artifact-classification-type.html">Cited Artifact Classification Type</a>#mesh-heading "MeSH heading")</span></p><p><b>classifier</b>: Orchiectomy <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (#D009919)</span></p><p><b>freeToShare</b>: true</p><h3>Components</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Type</b></td><td><b>Classifier</b></td></tr><tr><td style="display: none">*</td><td>qualifier <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td><td>is not a major topic <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></td></tr></table></blockquote><blockquote><p><b>content</b></p><p><b>informationType</b>: classifier</p><p><b>type</b>: components (if present) include qualifier codings <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-cited-artifact-classification-type.html">Cited Artifact Classification Type</a>#mesh-heading "MeSH heading")</span></p><p><b>classifier</b>: Prostatic Neoplasms <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (#D011471)</span></p><p><b>freeToShare</b>: true</p><blockquote><p><b>component</b></p><p><b>type</b>: qualifier <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>classifier</b>: is not a major topic <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p></blockquote><blockquote><p><b>component</b></p><p><b>type</b>: qualifier <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>classifier</b>: drug therapy <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (#Q000188)</span></p><blockquote><p><b>component</b></p></blockquote></blockquote><blockquote><p><b>component</b></p><p><b>type</b>: qualifier <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>classifier</b>: mortality <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (#Q000401)</span></p><blockquote><p><b>component</b></p></blockquote></blockquote></blockquote><blockquote><p><b>content</b></p><p><b>informationType</b>: classifier</p><p><b>type</b>: components (if present) include qualifier codings <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-cited-artifact-classification-type.html">Cited Artifact Classification Type</a>#mesh-heading "MeSH heading")</span></p><p><b>classifier</b>: Taxoids <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (#D043823)</span></p><p><b>freeToShare</b>: true</p><blockquote><p><b>component</b></p><p><b>type</b>: qualifier <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>classifier</b>: is not a major topic <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p></blockquote><blockquote><p><b>component</b></p><p><b>type</b>: qualifier <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>classifier</b>: administration & dosage <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (#Q000008)</span></p><blockquote><p><b>component</b></p></blockquote></blockquote><blockquote><p><b>component</b></p><p><b>type</b>: qualifier <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p><p><b>classifier</b>: therapeutic use <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (#Q000627)</span></p><blockquote><p><b>component</b></p></blockquote></blockquote></blockquote></blockquote></blockquote><blockquote><p><b>classification</b></p><p><b>type</b>: Publication Type <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-cited-artifact-classification-type.html">Cited Artifact Classification Type</a>#publication-type)</span></p><p><b>classifier</b>: Clinical Trial, Phase III <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (#D017428)</span>, Journal Article <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (#D016428)</span>, Randomized Controlled Trial <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (#D016449)</span>, Research Support, Non-U.S. Gov't <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (#D013485)</span></p></blockquote><blockquote><p><b>classification</b></p><p><b>type</b>: Knowledge Artifact Type <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-cited-artifact-classification-type.html">Cited Artifact Classification Type</a>#knowledge-artifact-type)</span></p><p><b>classifier</b>: Journal Article <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-citation-artifact-classifier.html">Citation Artifact Classifier</a>#D016428)</span></p><p><b>artifactAssessment</b>: <span>: Classifier added by Computable Publishing LLC</span></p></blockquote><blockquote><p><b>classification</b></p><p><b>type</b>: Citation Subset <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://hl7.org/fhir/R5/codesystem-cited-artifact-classification-type.html">Cited Artifact Classification Type</a>#citation-subset)</span></p><p><b>classifier</b>: IM <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (elements_descriptions.html#citationsubset#IM)</span></p></blockquote><blockquote><p><b>contributorship</b></p><p><b>complete</b>: true</p><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a name="hcauthor0"> </a></p><blockquote><p/><p><a name="author0"> </a></p><p><a name="hcauthor0"> </a></p><p><b>name</b>: Gwenaelle Gravis </p></blockquote><p><b>forenameInitials</b>: G</p><p><b>affiliation</b>: <span>: Medical Oncology and Biostatistics, Institut Paoli-Calmettes, Marseille, France. gravisg@ipc.unicancer.fr</span></p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a name="hcauthor1"> </a></p><blockquote><p/><p><a name="author1"> </a></p><p><a name="hcauthor1"> </a></p><p><b>name</b>: Karim Fizazi </p></blockquote><p><b>forenameInitials</b>: K</p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a name="hcauthor2"> </a></p><blockquote><p/><p><a name="author2"> </a></p><p><a name="hcauthor2"> </a></p><p><b>name</b>: Florence Joly </p></blockquote><p><b>forenameInitials</b>: F</p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a name="hcauthor3"> </a></p><blockquote><p/><p><a name="author3"> </a></p><p><a name="hcauthor3"> </a></p><p><b>name</b>: Stéphane Oudard </p></blockquote><p><b>forenameInitials</b>: S</p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a name="hcauthor4"> </a></p><blockquote><p/><p><a name="author4"> </a></p><p><a name="hcauthor4"> </a></p><p><b>name</b>: Franck Priou </p></blockquote><p><b>forenameInitials</b>: F</p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a name="hcauthor5"> </a></p><blockquote><p/><p><a name="author5"> </a></p><p><a name="hcauthor5"> </a></p><p><b>name</b>: Benjamin Esterni </p></blockquote><p><b>forenameInitials</b>: B</p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a name="hcauthor6"> </a></p><blockquote><p/><p><a name="author6"> </a></p><p><a name="hcauthor6"> </a></p><p><b>name</b>: Igor Latorzeff </p></blockquote><p><b>forenameInitials</b>: I</p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a name="hcauthor7"> </a></p><blockquote><p/><p><a name="author7"> </a></p><p><a name="hcauthor7"> </a></p><p><b>name</b>: Remy Delva </p></blockquote><p><b>forenameInitials</b>: R</p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a name="hcauthor8"> </a></p><blockquote><p/><p><a name="author8"> </a></p><p><a name="hcauthor8"> </a></p><p><b>name</b>: Ivan Krakowski </p></blockquote><p><b>forenameInitials</b>: I</p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a name="hcauthor9"> </a></p><blockquote><p/><p><a name="author9"> </a></p><p><a name="hcauthor9"> </a></p><p><b>name</b>: Brigitte Laguerre </p></blockquote><p><b>forenameInitials</b>: B</p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a name="hcauthor10"> </a></p><blockquote><p/><p><a name="author10"> </a></p><p><a name="hcauthor10"> </a></p><p><b>name</b>: Fréderic Rolland </p></blockquote><p><b>forenameInitials</b>: F</p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a name="hcauthor11"> </a></p><blockquote><p/><p><a name="author11"> </a></p><p><a name="hcauthor11"> </a></p><p><b>name</b>: Christine Théodore </p></blockquote><p><b>forenameInitials</b>: C</p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a name="hcauthor12"> </a></p><blockquote><p/><p><a name="author12"> </a></p><p><a name="hcauthor12"> </a></p><p><b>name</b>: Gael Deplanque </p></blockquote><p><b>forenameInitials</b>: G</p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a name="hcauthor13"> </a></p><blockquote><p/><p><a name="author13"> </a></p><p><a name="hcauthor13"> </a></p><p><b>name</b>: Jean Marc Ferrero </p></blockquote><p><b>forenameInitials</b>: JM</p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a name="hcauthor14"> </a></p><blockquote><p/><p><a name="author14"> </a></p><p><a name="hcauthor14"> </a></p><p><b>name</b>: Damien Pouessel </p></blockquote><p><b>forenameInitials</b>: D</p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a name="hcauthor15"> </a></p><blockquote><p/><p><a name="author15"> </a></p><p><a name="hcauthor15"> </a></p><p><b>name</b>: Loïc Mourey </p></blockquote><p><b>forenameInitials</b>: L</p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a name="hcauthor16"> </a></p><blockquote><p/><p><a name="author16"> </a></p><p><a name="hcauthor16"> </a></p><p><b>name</b>: Philippe Beuzeboc </p></blockquote><p><b>forenameInitials</b>: P</p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a name="hcauthor17"> </a></p><blockquote><p/><p><a name="author17"> </a></p><p><a name="hcauthor17"> </a></p><p><b>name</b>: Sylvie Zanetta </p></blockquote><p><b>forenameInitials</b>: S</p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a name="hcauthor18"> </a></p><blockquote><p/><p><a name="author18"> </a></p><p><a name="hcauthor18"> </a></p><p><b>name</b>: Muriel Habibian </p></blockquote><p><b>forenameInitials</b>: M</p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a name="hcauthor19"> </a></p><blockquote><p/><p><a name="author19"> </a></p><p><a name="hcauthor19"> </a></p><p><b>name</b>: Jean François Berdah </p></blockquote><p><b>forenameInitials</b>: JF</p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a name="hcauthor20"> </a></p><blockquote><p/><p><a name="author20"> </a></p><p><a name="hcauthor20"> </a></p><p><b>name</b>: Jerome Dauba </p></blockquote><p><b>forenameInitials</b>: J</p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a name="hcauthor21"> </a></p><blockquote><p/><p><a name="author21"> </a></p><p><a name="hcauthor21"> </a></p><p><b>name</b>: Marjorie Baciuchka </p></blockquote><p><b>forenameInitials</b>: M</p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a name="hcauthor22"> </a></p><blockquote><p/><p><a name="author22"> </a></p><p><a name="hcauthor22"> </a></p><p><b>name</b>: Christian Platini </p></blockquote><p><b>forenameInitials</b>: C</p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a name="hcauthor23"> </a></p><blockquote><p/><p><a name="author23"> </a></p><p><a name="hcauthor23"> </a></p><p><b>name</b>: Claude Linassier </p></blockquote><p><b>forenameInitials</b>: C</p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a name="hcauthor24"> </a></p><blockquote><p/><p><a name="author24"> </a></p><p><a name="hcauthor24"> </a></p><p><b>name</b>: Jean Luc Labourey </p></blockquote><p><b>forenameInitials</b>: JL</p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a name="hcauthor25"> </a></p><blockquote><p/><p><a name="author25"> </a></p><p><a name="hcauthor25"> </a></p><p><b>name</b>: Jean Pascal Machiels </p></blockquote><p><b>forenameInitials</b>: JP</p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a name="hcauthor26"> </a></p><blockquote><p/><p><a name="author26"> </a></p><p><a name="hcauthor26"> </a></p><p><b>name</b>: Claude El Kouri </p></blockquote><p><b>forenameInitials</b>: C</p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a name="hcauthor27"> </a></p><blockquote><p/><p><a name="author27"> </a></p><p><a name="hcauthor27"> </a></p><p><b>name</b>: Alain Ravaud </p></blockquote><p><b>forenameInitials</b>: A</p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a name="hcauthor28"> </a></p><blockquote><p/><p><a name="author28"> </a></p><p><a name="hcauthor28"> </a></p><p><b>name</b>: Etienne Suc </p></blockquote><p><b>forenameInitials</b>: E</p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a name="hcauthor29"> </a></p><blockquote><p/><p><a name="author29"> </a></p><p><a name="hcauthor29"> </a></p><p><b>name</b>: Jean Christophe Eymard </p></blockquote><p><b>forenameInitials</b>: JC</p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a name="hcauthor30"> </a></p><blockquote><p/><p><a name="author30"> </a></p><p><a name="hcauthor30"> </a></p><p><b>name</b>: Ali Hasbini </p></blockquote><p><b>forenameInitials</b>: A</p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a name="hcauthor31"> </a></p><blockquote><p/><p><a name="author31"> </a></p><p><a name="hcauthor31"> </a></p><p><b>name</b>: Guilhem Bousquet </p></blockquote><p><b>forenameInitials</b>: G</p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a name="hcauthor32"> </a></p><blockquote><p/><p><a name="author32"> </a></p><p><a name="hcauthor32"> </a></p><p><b>name</b>: Michel Soulie </p></blockquote><p><b>forenameInitials</b>: M</p></blockquote></blockquote></blockquote><hr/><blockquote><p><b>Generated Narrative: Practitioner #author0</b><a name="author0"> </a><a name="hcauthor0"> </a></p><p><b>name</b>: Gwenaelle Gravis </p></blockquote><hr/><blockquote><p><b>Generated Narrative: Practitioner #author1</b><a name="author1"> </a><a name="hcauthor1"> </a></p><p><b>name</b>: Karim Fizazi </p></blockquote><hr/><blockquote><p><b>Generated Narrative: Practitioner #author2</b><a name="author2"> </a><a name="hcauthor2"> </a></p><p><b>name</b>: Florence Joly </p></blockquote><hr/><blockquote><p><b>Generated Narrative: Practitioner #author3</b><a name="author3"> </a><a name="hcauthor3"> </a></p><p><b>name</b>: Stéphane Oudard </p></blockquote><hr/><blockquote><p><b>Generated Narrative: Practitioner #author4</b><a name="author4"> </a><a name="hcauthor4"> </a></p><p><b>name</b>: Franck Priou </p></blockquote><hr/><blockquote><p><b>Generated Narrative: Practitioner #author5</b><a name="author5"> </a><a name="hcauthor5"> </a></p><p><b>name</b>: Benjamin Esterni </p></blockquote><hr/><blockquote><p><b>Generated Narrative: Practitioner #author6</b><a name="author6"> </a><a name="hcauthor6"> </a></p><p><b>name</b>: Igor Latorzeff </p></blockquote><hr/><blockquote><p><b>Generated Narrative: Practitioner #author7</b><a name="author7"> </a><a name="hcauthor7"> </a></p><p><b>name</b>: Remy Delva </p></blockquote><hr/><blockquote><p><b>Generated Narrative: Practitioner #author8</b><a name="author8"> </a><a name="hcauthor8"> </a></p><p><b>name</b>: Ivan Krakowski </p></blockquote><hr/><blockquote><p><b>Generated Narrative: Practitioner #author9</b><a name="author9"> </a><a name="hcauthor9"> </a></p><p><b>name</b>: Brigitte Laguerre </p></blockquote><hr/><blockquote><p><b>Generated Narrative: Practitioner #author10</b><a name="author10"> </a><a name="hcauthor10"> </a></p><p><b>name</b>: Fréderic Rolland </p></blockquote><hr/><blockquote><p><b>Generated Narrative: Practitioner #author11</b><a name="author11"> </a><a name="hcauthor11"> </a></p><p><b>name</b>: Christine Théodore </p></blockquote><hr/><blockquote><p><b>Generated Narrative: Practitioner #author12</b><a name="author12"> </a><a name="hcauthor12"> </a></p><p><b>name</b>: Gael Deplanque </p></blockquote><hr/><blockquote><p><b>Generated Narrative: Practitioner #author13</b><a name="author13"> </a><a name="hcauthor13"> </a></p><p><b>name</b>: Jean Marc Ferrero </p></blockquote><hr/><blockquote><p><b>Generated Narrative: Practitioner #author14</b><a name="author14"> </a><a name="hcauthor14"> </a></p><p><b>name</b>: Damien Pouessel </p></blockquote><hr/><blockquote><p><b>Generated Narrative: Practitioner #author15</b><a name="author15"> </a><a name="hcauthor15"> </a></p><p><b>name</b>: Loïc Mourey </p></blockquote><hr/><blockquote><p><b>Generated Narrative: Practitioner #author16</b><a name="author16"> </a><a name="hcauthor16"> </a></p><p><b>name</b>: Philippe Beuzeboc </p></blockquote><hr/><blockquote><p><b>Generated Narrative: 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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 © 2022+ HL7 International / Clinical Decision Support. Package hl7.fhir.uv.ebm#1.0.0-ballot based on FHIR 5.0.0. Generated 2024-05-16
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