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 179617</b></p><a name="179617"> </a><a name="hc179617"> </a><a name="179617-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: 2024-07-18 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-179617.html">Citation 25301760 Survival with Newly Diagnosed Metastatic Prostate Cancer in the "Docetaxel Era": Data from 917 Patients in the Control Arm of the STAMPEDE Trial (MRC PR08, CRUK/06/019).</a></p><p><b>identifier</b>: FEvIR Object Identifier/179617, <code>https://pubmed.ncbi.nlm.nih.gov</code>/25301760, <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:2.16.840.1.113883.4.642.40.44.15.49</p><p><b>version</b>: 2.0.0-ballot</p><p><b>title</b>: 25301760 Survival with Newly Diagnosed Metastatic Prostate Cancer in the "Docetaxel Era": Data from 917 Patients in the Control Arm of the STAMPEDE Trial (MRC PR08, CRUK/06/019).</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>
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</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> Prostate cancer (PCa) is the second most common disease among men worldwide. It is important to know survival outcomes and prognostic factors for this disease. Recruitment for the largest therapeutic randomised controlled trial in PCa--the Systemic Therapy in Advancing or Metastatic Prostate Cancer: Evaluation of Drug Efficacy: A Multi-Stage Multi-Arm Randomised Controlled Trial (STAMPEDE)--includes men with newly diagnosed metastatic PCa who are commencing long-term androgen deprivation therapy (ADT); the control arm provides valuable data for a prospective cohort.
<strong>OBJECTIVE:</strong> Describe survival outcomes, along with current treatment standards and factors associated with prognosis, to inform future trial design in this patient group.
<strong>DESIGN, SETTING, AND PARTICIPANTS:</strong> STAMPEDE trial control arm comprising men newly diagnosed with M1 disease who were recruited between October 2005 and January 2014.
<strong>OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS:</strong> Overall survival (OS) and failure-free survival (FFS) were reported by primary disease characteristics using Kaplan-Meier methods. Hazard ratios and 95% confidence intervals (CIs) were derived from multivariate Cox models.
<strong>RESULTS AND LIMITATIONS:</strong> A cohort of 917 men with newly diagnosed M1 disease was recruited to the control arm in the specified interval. Median follow-up was 20 mo. Median age at randomisation was 66 yr (interquartile range [IQR]: 61-71), and median prostate-specific antigen level was 112 ng/ml (IQR: 34-373). Most men (n=574; 62%) had bone-only metastases, whereas 237 (26%) had both bone and soft tissue metastases; soft tissue metastasis was found mainly in distant lymph nodes. There were 238 deaths, 202 (85%) from PCa. Median FFS was 11 mo; 2-yr FFS was 29% (95% CI, 25-33). Median OS was 42 mo; 2-yr OS was 72% (95% CI, 68-76). Survival time was influenced by performance status, age, Gleason score, and metastases distribution. Median survival after FFS event was 22 mo. Trial eligibility criteria meant men were younger and fitter than general PCa population.
<strong>CONCLUSIONS:</strong> Survival remains disappointing in men presenting with M1 disease who are started on only long-term ADT, despite active treatments being available at first failure of ADT. Importantly, men with M1 disease now spend the majority of their remaining life in a state of castration-resistant relapse.
<strong>PATIENT SUMMARY:</strong> Results from this control arm cohort found survival is relatively short and highly influenced by patient age, fitness, and where prostate cancer has spread in the body.</p>
</div></td><td><div><p>Copyright © 2014 The Authors. Published by Elsevier B.V. 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>Eur Urol. 2015 Jun;67(6):1039-1041. doi: 10.1016/j.eururo.2014.12.004</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/25544634/">https://pubmed.ncbi.nlm.nih.gov/25544634/</a></td></tr></table><p><b>resourceReference</b>: Identifier: <code>https://pubmed.ncbi.nlm.nih.gov</code>/25544634</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. 2016 Feb;195(2):350. doi: 10.1016/j.juro.2015.10.165</p>
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true</p><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a href="#hc179617/contributor0">James ND</a></p><p><b>forenameInitials</b>: ND</p><p><b>affiliation</b>: University of Warwick, Coventry, UK. Electronic address: N.D.James@warwick.ac.uk.</p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a href="#hc179617/contributor1">Spears MR</a></p><p><b>forenameInitials</b>: MR</p><p><b>affiliation</b>: Medical Research Council Clinical Trials Unit at University College London, London, UK.</p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a href="#hc179617/contributor2">Clarke NW</a></p><p><b>forenameInitials</b>: NW</p><p><b>affiliation</b>: Department of Urology, The Christie NHS Foundation Trust, Manchester, UK.</p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a href="#hc179617/contributor3">Dearnaley DP</a></p><p><b>forenameInitials</b>: DP</p><p><b>affiliation</b>: Institute of Cancer Research, London, UK; The Royal Marsden NHS Foundation Trust, London and Sutton, UK.</p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a href="#hc179617/contributor4">De Bono JS</a></p><p><b>forenameInitials</b>: JS</p><p><b>affiliation</b>: Institute of Cancer Research, London, UK; The Royal Marsden NHS Foundation Trust, London and Sutton, UK.</p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a href="#hc179617/contributor5">Gale J</a></p><p><b>forenameInitials</b>: J</p><p><b>affiliation</b>: Queen Alexandra Hospital, Portsmouth, UK.</p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a href="#hc179617/contributor6">Hetherington J</a></p><p><b>forenameInitials</b>: J</p><p><b>affiliation</b>: Hull & East Yorkshire Hospitals NHS Trust, Hull, UK.</p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a href="#hc179617/contributor7">Hoskin PJ</a></p><p><b>forenameInitials</b>: PJ</p><p><b>affiliation</b>: Mount Vernon Hospital, Northwood, Middlesex, UK.</p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a href="#hc179617/contributor8">Jones RJ</a></p><p><b>forenameInitials</b>: RJ</p><p><b>affiliation</b>: University of Glasgow, Beatson West of Scotland Cancer Centre, Glasgow, UK.</p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a href="#hc179617/contributor9">Laing R</a></p><p><b>forenameInitials</b>: R</p><p><b>affiliation</b>: Royal Surrey County Hospital, Guildford, UK.</p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a href="#hc179617/contributor10">Lester JF</a></p><p><b>forenameInitials</b>: JF</p><p><b>affiliation</b>: Velindre Hospital, Cardiff, UK.</p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a href="#hc179617/contributor11">McLaren D</a></p><p><b>forenameInitials</b>: D</p><p><b>affiliation</b>: Western General Hospital, Edinburgh, UK.</p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a href="#hc179617/contributor12">Parker CC</a></p><p><b>forenameInitials</b>: CC</p><p><b>affiliation</b>: Institute of Cancer Research, London, UK; The Royal Marsden NHS Foundation Trust, London and Sutton, UK.</p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a href="#hc179617/contributor13">Parmar MKB</a></p><p><b>forenameInitials</b>: MKB</p><p><b>affiliation</b>: Medical Research Council Clinical Trials Unit at University College London, London, UK.</p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a href="#hc179617/contributor14">Ritchie AWS</a></p><p><b>forenameInitials</b>: AWS</p><p><b>affiliation</b>: Medical Research Council Clinical Trials Unit at University College London, London, UK.</p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a href="#hc179617/contributor15">Russell JM</a></p><p><b>forenameInitials</b>: JM</p><p><b>affiliation</b>: Institute of Cancer Sciences, University of Glasgow, Glasgow, UK.</p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a href="#hc179617/contributor16">Strebel RT</a></p><p><b>forenameInitials</b>: RT</p><p><b>affiliation</b>: Kantonsspital Graübunden, Chur, Switzerland.</p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a href="#hc179617/contributor17">Thalmann GN</a></p><p><b>forenameInitials</b>: GN</p><p><b>affiliation</b>: Department of Urology, University Hospital, Bern, Switzerland.</p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a href="#hc179617/contributor18">Mason MD</a></p><p><b>forenameInitials</b>: MD</p><p><b>affiliation</b>: Velindre Hospital, Cardiff, UK.</p></blockquote><blockquote><p><b>entry</b></p><p><b>contributor</b>: <a href="#hc179617/contributor19">Sydes MR</a></p><p><b>forenameInitials</b>: MR</p><p><b>affiliation</b>: Medical Research Council Clinical Trials Unit at University College London, London, UK.</p></blockquote></blockquote></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: ArtifactAssessment #keywords0</b></p><a name="179617/keywords0"> </a><a name="hc179617/keywords0"> </a><a name="179617/keywords0-en-US"> </a><p><b>artifact</b>: <a href="#hc179617">Citation 25301760 Survival with Newly Diagnosed Metastatic Prostate Cancer in the "Docetaxel Era": Data from 917 Patients in the Control Arm of the STAMPEDE Trial (MRC PR08, CRUK/06/019).</a></p><blockquote><p><b>content</b></p><p><b>classifier</b>: <span title="Codes:">Control arm cohort</span></p></blockquote><blockquote><p><b>content</b></p><p><b>classifier</b>: <span title="Codes:">Hormone-naïve</span></p></blockquote><blockquote><p><b>content</b></p><p><b>classifier</b>: <span title="Codes:">Metastatic</span></p></blockquote><blockquote><p><b>content</b></p><p><b>classifier</b>: <span title="Codes:">Natural history</span></p></blockquote><blockquote><p><b>content</b></p><p><b>classifier</b>: <span title="Codes:">Prognostic factors</span></p></blockquote><blockquote><p><b>content</b></p><p><b>classifier</b>: <span title="Codes:">Prospective data</span></p></blockquote><blockquote><p><b>content</b></p><p><b>classifier</b>: <span title="Codes:">Prostate cancer</span></p></blockquote><blockquote><p><b>content</b></p><p><b>classifier</b>: <span title="Codes:">Survival</span></p></blockquote><blockquote><p><b>content</b></p><p><b>classifier</b>: <span title="Codes:">Time to progression</span></p></blockquote></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Practitioner #contributor0</b></p><a name="179617/contributor0"> </a><a name="hc179617/contributor0"> </a><a name="179617/contributor0-en-US"> </a><p><b>name</b>: Nicholas David James </p></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Practitioner #contributor1</b></p><a name="179617/contributor1"> </a><a name="hc179617/contributor1"> </a><a name="179617/contributor1-en-US"> </a><p><b>name</b>: Melissa R Spears </p></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Practitioner #contributor2</b></p><a name="179617/contributor2"> </a><a name="hc179617/contributor2"> </a><a name="179617/contributor2-en-US"> </a><p><b>name</b>: Noel W Clarke </p></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Practitioner #contributor3</b></p><a name="179617/contributor3"> </a><a name="hc179617/contributor3"> </a><a name="179617/contributor3-en-US"> </a><p><b>name</b>: David P Dearnaley </p></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Practitioner #contributor4</b></p><a name="179617/contributor4"> </a><a name="hc179617/contributor4"> </a><a name="179617/contributor4-en-US"> </a><p><b>name</b>: Johann S De Bono </p></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Practitioner #contributor5</b></p><a name="179617/contributor5"> </a><a name="hc179617/contributor5"> </a><a name="179617/contributor5-en-US"> </a><p><b>name</b>: Joanna Gale </p></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Practitioner #contributor6</b></p><a name="179617/contributor6"> </a><a name="hc179617/contributor6"> </a><a name="179617/contributor6-en-US"> </a><p><b>name</b>: John Hetherington </p></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Practitioner #contributor7</b></p><a name="179617/contributor7"> </a><a name="hc179617/contributor7"> </a><a name="179617/contributor7-en-US"> </a><p><b>name</b>: Peter J Hoskin </p></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Practitioner #contributor8</b></p><a name="179617/contributor8"> </a><a name="hc179617/contributor8"> </a><a name="179617/contributor8-en-US"> </a><p><b>name</b>: Robert J Jones </p></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Practitioner #contributor9</b></p><a name="179617/contributor9"> </a><a name="hc179617/contributor9"> </a><a name="179617/contributor9-en-US"> </a><p><b>name</b>: Robert Laing </p></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Practitioner #contributor10</b></p><a name="179617/contributor10"> </a><a name="hc179617/contributor10"> </a><a name="179617/contributor10-en-US"> </a><p><b>name</b>: Jason F Lester </p></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Practitioner #contributor11</b></p><a name="179617/contributor11"> </a><a name="hc179617/contributor11"> </a><a name="179617/contributor11-en-US"> </a><p><b>name</b>: Duncan McLaren </p></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Practitioner #contributor12</b></p><a name="179617/contributor12"> </a><a name="hc179617/contributor12"> </a><a name="179617/contributor12-en-US"> </a><p><b>name</b>: Christopher C Parker </p></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Practitioner #contributor13</b></p><a name="179617/contributor13"> </a><a name="hc179617/contributor13"> </a><a name="179617/contributor13-en-US"> </a><p><b>name</b>: Mahesh K B Parmar </p></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Practitioner #contributor14</b></p><a name="179617/contributor14"> </a><a name="hc179617/contributor14"> </a><a name="179617/contributor14-en-US"> </a><p><b>name</b>: Alastair W S Ritchie </p></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Practitioner #contributor15</b></p><a name="179617/contributor15"> </a><a name="hc179617/contributor15"> </a><a name="179617/contributor15-en-US"> </a><p><b>name</b>: J Martin Russell </p></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Practitioner #contributor16</b></p><a name="179617/contributor16"> </a><a name="hc179617/contributor16"> </a><a name="179617/contributor16-en-US"> </a><p><b>name</b>: Räto T Strebel </p></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Practitioner #contributor17</b></p><a name="179617/contributor17"> </a><a name="hc179617/contributor17"> </a><a name="179617/contributor17-en-US"> </a><p><b>name</b>: George N Thalmann </p></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Practitioner #contributor18</b></p><a name="179617/contributor18"> </a><a name="hc179617/contributor18"> </a><a name="179617/contributor18-en-US"> </a><p><b>name</b>: Malcolm D Mason </p></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: Practitioner #contributor19</b></p><a name="179617/contributor19"> </a><a name="hc179617/contributor19"> </a><a name="179617/contributor19-en-US"> </a><p><b>name</b>: Matthew R Sydes </p></blockquote><hr/><blockquote><p class="res-header-id"><b>Generated Narrative: ArtifactAssessment #meshHeading0</b></p><a name="179617/meshHeading0"> </a><a name="hc179617/meshHeading0"> </a><a name="179617/meshHeading0-en-US"> </a><p><b>artifact</b>: <a href="#hc179617">Citation 25301760 Survival with Newly Diagnosed Metastatic Prostate Cancer in the "Docetaxel Era": Data from 917 Patients in the Control Arm of the STAMPEDE Trial (MRC PR08, CRUK/06/019).</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/ D000328}">Adult</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/ D000367}">Age Factors</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/ 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/ D000369}">Aged, 80 and over</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 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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>: 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value="**BACKGROUND:** Prostate cancer (PCa) is the second most common disease among men worldwide. It is important to know survival outcomes and prognostic factors for this disease. Recruitment for the largest therapeutic randomised controlled trial in PCa--the Systemic Therapy in Advancing or Metastatic Prostate Cancer: Evaluation of Drug Efficacy: A Multi-Stage Multi-Arm Randomised Controlled Trial (STAMPEDE)--includes men with newly diagnosed metastatic PCa who are commencing long-term androgen deprivation therapy (ADT); the control arm provides valuable data for a prospective cohort.
**OBJECTIVE:** Describe survival outcomes, along with current treatment standards and factors associated with prognosis, to inform future trial design in this patient group.
**DESIGN, SETTING, AND PARTICIPANTS:** STAMPEDE trial control arm comprising men newly diagnosed with M1 disease who were recruited between October 2005 and January 2014.
**OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS:** Overall survival (OS) and failure-free survival (FFS) were reported by primary disease characteristics using Kaplan-Meier methods. Hazard ratios and 95% confidence intervals (CIs) were derived from multivariate Cox models.
**RESULTS AND LIMITATIONS:** A cohort of 917 men with newly diagnosed M1 disease was recruited to the control arm in the specified interval. Median follow-up was 20 mo. Median age at randomisation was 66 yr (interquartile range [IQR]: 61-71), and median prostate-specific antigen level was 112 ng/ml (IQR: 34-373). Most men (n=574; 62%) had bone-only metastases, whereas 237 (26%) had both bone and soft tissue metastases; soft tissue metastasis was found mainly in distant lymph nodes. There were 238 deaths, 202 (85%) from PCa. Median FFS was 11 mo; 2-yr FFS was 29% (95% CI, 25-33). Median OS was 42 mo; 2-yr OS was 72% (95% CI, 68-76). Survival time was influenced by performance status, age, Gleason score, and metastases distribution. Median survival after FFS event was 22 mo. Trial eligibility criteria meant men were younger and fitter than general PCa population.
**CONCLUSIONS:** Survival remains disappointing in men presenting with M1 disease who are started on only long-term ADT, despite active treatments being available at first failure of ADT. Importantly, men with M1 disease now spend the majority of their remaining life in a state of castration-resistant relapse.
**PATIENT SUMMARY:** Results from this control arm cohort found survival is relatively short and highly influenced by patient age, fitness, and where prostate cancer has spread in the body."/>
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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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