FHIR IG analytics| Package | hl7.fhir.uv.ebm |
| Resource Type | Citation |
| Id | Citation-179631.json |
| FHIR Version | R6 |
No resources found
No resources found
Note: links and images are rebased to the (stated) source
Generated Narrative: Citation 179631
version: 21; Last updated: 2025-10-13 12:34:35+0000
Profile: JournalArticleCitation
ArtifactPublicationStatus: Active
identifier: FEvIR Object Identifier/179631, https://pubmed.ncbi.nlm.nih.gov/19029421, Uniform Resource Identifier (URI)/urn:oid:2.16.840.1.113883.4.642.40.44.15.44
version: 1.0.0-ballot3
title: 19029421 Phase III trial of androgen ablation with or without three cycles of systemic chemotherapy for advanced prostate cancer.
status: Active
date: 2026-02-10 14:00:26+0000
author: Computable Publishing®: MEDLINE-to-FEvIR Converter:
publisher: HL7 International / Clinical Decision Support
contact: HL7 International / Clinical Decision Support: http://www.hl7.org/Special/committees/dss
description:
This Citation Resource is referenced in an example for the EBMonFHIR Implementation Guide.
| Code | Value[x] |
| Citation Classification Type: fevir-platform-use (FEvIR Platform Use) | Medline Base |
jurisdiction: World
copyright:
https://creativecommons.org/licenses/by-nc-sa/4.0/
approvalDate: 2009-01-13
lastReviewDate: 2023-02-02
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https://pubmed.ncbi.nlm.nih.gov/19029421,https://www.ncbi.nlm.nih.gov/pmc//PMC3864402,https://doi.org/10.1200/JCO.2007.15.9830, pii/JCO.2007.15.9830Titles
Type Text Primary title Phase III trial of androgen ablation with or without three cycles of systemic chemotherapy for advanced prostate cancer.
Abstracts
Type Text Primary human use PURPOSE: We conducted a phase III trial in patients with previously untreated metastatic prostate cancer to test the hypothesis that three 8-week cycles of ketoconazole and doxorubicin alternating with vinblastine and estramustine, given in addition to standard androgen deprivation, would delay the appearance of castrate-resistant disease. PATIENTS AND METHODS: Eligible patients had metastatic prostate cancer threatening enough to justify sustained androgen ablation and were fit enough for chemotherapy. The primary end point was time to castrate-resistant progression as shown by increasing prostate-specific antigen, new radiographic lesions, worsening cancer-related symptoms, or receipt of any other systemic therapy. RESULTS: Three hundred six patients were registered; 286 are reported. Median time to progression was 24 months (95% CI, 18 to 39 months) in the standard therapy arm, and 35 months (95% CI, 26 to 44 months) in the chemohormonal group (P = .39). At median follow-up of 6.4 years, overall survival was 5.4 years (95% CI, 4.7 to 7.8 years) in the standard therapy arm versus 6.1 years (95% CI, 5.1 to 10.1 years; P = .41). Prostate-specific antigen kinetics at the time of androgen ablation and the nadir after hormone treatment were strongly correlated with survival. Chemotherapy significantly increased the burden of therapy, with 51% of patients experiencing an adverse event of grade 3 or worse, especially thromboembolic events. CONCLUSION: There is no role for ketoconazole and doxorubicin alternating with vinblastine and estramustine before emergence of a castrate-resistant phenotype.
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classifier: Journal Article
citation:
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classifier: Journal Article
citation:
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citation:
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identifier: Electronic ISSN Type/1527-7755, ISOAbbreviation/J Clin Oncol, ISSN Linking/0732-183X, Medline Title Abbreviation/J Clin Oncol, NLM Unique ID/8309333
title: Journal of clinical oncology : official journal of the American Society of Clinical Oncology
publisherLocation: United States
citedMedium: Internet
volume: 26
issue: 36
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affiliation: Department of Genitourinary Medical Oncology, University of Texas MD Anderson Cancer Center, 1155 Pressler, CPB7.3462, Houston, TX 77030, USA. rmillika@mdanderson.org
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"text": "**PURPOSE:** We conducted a phase III trial in patients with previously untreated metastatic prostate cancer to test the hypothesis that three 8-week cycles of ketoconazole and doxorubicin alternating with vinblastine and estramustine, given in addition to standard androgen deprivation, would delay the appearance of castrate-resistant disease.\n**PATIENTS AND METHODS:** Eligible patients had metastatic prostate cancer threatening enough to justify sustained androgen ablation and were fit enough for chemotherapy. The primary end point was time to castrate-resistant progression as shown by increasing prostate-specific antigen, new radiographic lesions, worsening cancer-related symptoms, or receipt of any other systemic therapy.\n**RESULTS:** Three hundred six patients were registered; 286 are reported. Median time to progression was 24 months (95% CI, 18 to 39 months) in the standard therapy arm, and 35 months (95% CI, 26 to 44 months) in the chemohormonal group (P = .39). At median follow-up of 6.4 years, overall survival was 5.4 years (95% CI, 4.7 to 7.8 years) in the standard therapy arm versus 6.1 years (95% CI, 5.1 to 10.1 years; P = .41). Prostate-specific antigen kinetics at the time of androgen ablation and the nadir after hormone treatment were strongly correlated with survival. Chemotherapy significantly increased the burden of therapy, with 51% of patients experiencing an adverse event of grade 3 or worse, especially thromboembolic events.\n**CONCLUSION:** There is no role for ketoconazole and doxorubicin alternating with vinblastine and estramustine before emergence of a castrate-resistant phenotype."
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