Evidence Based Medicine on FHIR Implementation Guide
1.0.0-ballot2 - STU 1 ballot
Evidence Based Medicine on FHIR Implementation Guide
1.0.0-ballot2 - STU 1 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-ballot2 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
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<div xmlns="http://www.w3.org/1999/xhtml"><p class="res-header-id"><b>Generated Narrative: Citation 179623</b></p><a name="179623"> </a><a name="hc179623"> </a><a name="179623-en-US"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">version: 9; Last updated: 2025-03-27 12:29:04+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-179623.html">Citation 23452809 Long-term follow-up of a phase II trial of chemotherapy plus hormone therapy for biochemical relapse after definitive local therapy for prostate cancer.</a></p><p><b>identifier</b>: FEvIR Object Identifier/https://fevir.net/FOI/179623, <code>https://pubmed.ncbi.nlm.nih.gov</code>/23452809, <a href="http://terminology.hl7.org/6.2.0/NamingSystem-uri.html" title="As defined by RFC 3986 (http://www.ietf.org/rfc/rfc3986.txt)(with many schemes defined in many RFCs). For OIDs and UUIDs, use the URN form (urn:oid:(note: lowercase) and urn:uuid:). See http://www.ietf.org/rfc/rfc3001.txt and http://www.ietf.org/rfc/rfc4122.txt
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Note that this OID is created to aid with interconversion between CDA and FHIR - FHIR uses urn:ietf:rfc:3986 as equivalent to this OID. URIs as identifiers appear more commonly in FHIR.
This OID may also be used in CD.codeSystem.">Uniform Resource Identifier (URI)</a>/urn:oid:2.16.840.1.113883.4.642.40.44.15.39</p><p><b>version</b>: 1.0.0-ballot2</p><p><b>title</b>: 23452809 Long-term follow-up of a phase II trial of chemotherapy plus hormone therapy for biochemical relapse after definitive local therapy for prostate cancer.</p><p><b>status</b>: Active</p><p><b>date</b>: 2025-03-27 17:53:24+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>Type</b></td><td><b>Text</b></td><td><b>Copyright</b></td></tr><tr><td style="display: none">*</td><td><span title="Codes:{http://hl7.org/fhir/cited-artifact-abstract-type primary-human-use}">Primary human use</span></td><td><div><p><strong>OBJECTIVE:</strong> To evaluate long-term follow-up of a phase II trial of chemohormonal therapy in 62 men with prostate cancer biochemical relapse (BR).
<strong>METHODS:</strong> Treatment was 4 cycles of docetaxel (70 mg/m(2)) every 3 weeks and estramustine 280 mg three times a day (days 1-5) followed by 15 months of goserelin acetate/bicalutamide. The primary endpoint was the proportion with prostate-specific antigen (PSA) <0.1 with recovered testosterone 5 years after completion of therapy. Secondary endpoints included time to progression (TTP), time to reinitiate androgen deprivation therapy (ADT), the proportion with castration-resistant prostate cancer (CRPC), and overall survival (OS).
<strong>RESULTS:</strong> Median follow-up was 8.6 years (range 1.3-11.1 years). At 5 year follow-up, 7 patients (11%) had PSA <0.1 (5 undetectable); 8 (13%) had PSA >0.1 but without reinitiation of ADT (median PSA 0.37). Of the 15 (24%) men without reinitiation of ADT, and 14 have recovered testosterone to normal range. Median TTP for the complete cohort was 35.0 months (95% confidence interval [CI] 31.7-39.2). Baseline PSA <3.0 ng/dL, no prior ADT, and prostatectomy (vs radiation) were associated with longer TTP (P = .0001, P = .0055, and P = .0398, respectively). At the time of analysis, 42 men (68%) had restarted ADT, 23 men had CRPC (37%), and 11 (18%) had chemotherapy. Median time to reinitiation of ADT was 32.6 months (range 0-107.6 months). Median OS has not been reached; there were 15 deaths.
<strong>CONCLUSION:</strong> Chemotherapy plus ADT for BR resulted in durable (>5 years) complete responses (<0.1 ng/mL) in 7 men (11%). Twenty-four percent of men have not re-initiated ADT 5 years from completion of protocol therapy.</p>
</div></td><td><div><p>Copyright © 2013 Elsevier Inc. All rights reserved.</p>
</div></td></tr></table><h3>RelatesTos</h3><table class="grid"><tr><td style="display: none">-</td><td><b>Extension</b></td><td><b>Type</b></td><td><b>Classifier</b></td><td><b>Citation</b></td></tr><tr><td style="display: none">*</td><td/><td>comment-in</td><td><span title="Codes:{https://www.nlm.nih.gov/mesh D016420}">Comment</span></td><td><div><p>J Urol. 2013 Sep;190(3):880. doi: 10.1016/j.juro.2013.05.105.</p>
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**METHODS:** Treatment was 4 cycles of docetaxel (70 mg/m(2)) every 3 weeks and estramustine 280 mg three times a day (days 1-5) followed by 15 months of goserelin acetate/bicalutamide. The primary endpoint was the proportion with prostate-specific antigen (PSA) &lt;0.1 with recovered testosterone 5 years after completion of therapy. Secondary endpoints included time to progression (TTP), time to reinitiate androgen deprivation therapy (ADT), the proportion with castration-resistant prostate cancer (CRPC), and overall survival (OS).
**RESULTS:** Median follow-up was 8.6 years (range 1.3-11.1 years). At 5 year follow-up, 7 patients (11%) had PSA &lt;0.1 (5 undetectable); 8 (13%) had PSA &gt;0.1 but without reinitiation of ADT (median PSA 0.37). Of the 15 (24%) men without reinitiation of ADT, and 14 have recovered testosterone to normal range. Median TTP for the complete cohort was 35.0 months (95% confidence interval [CI] 31.7-39.2). Baseline PSA &lt;3.0 ng/dL, no prior ADT, and prostatectomy (vs radiation) were associated with longer TTP (P = .0001, P = .0055, and P = .0398, respectively). At the time of analysis, 42 men (68%) had restarted ADT, 23 men had CRPC (37%), and 11 (18%) had chemotherapy. Median time to reinitiation of ADT was 32.6 months (range 0-107.6 months). Median OS has not been reached; there were 15 deaths.
**CONCLUSION:** Chemotherapy plus ADT for BR resulted in durable (&gt;5 years) complete responses (&lt;0.1 ng/mL) in 7 men (11%). Twenty-four percent of men have not re-initiated ADT 5 years from completion of protocol therapy."/>
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IG © 2024+ HL7 International / Clinical Decision Support. Package hl7.fhir.uv.ebm#1.0.0-ballot2 based on FHIR 6.0.0-ballot2. Generated 2025-03-27
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