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Packagehl7.fhir.uv.ebm
Resource TypeCitation
IdCitation-179631.json
FHIR VersionR6

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Narrative

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Generated Narrative: Citation 179631

version: 21; Last updated: 2025-10-13 12:34:35+0000

Profile: JournalArticleCitation

ArtifactPublicationStatus: Active

url: Citation 19029421 Phase III trial of androgen ablation with or without three cycles of systemic chemotherapy for advanced prostate cancer.

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.

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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.

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https://creativecommons.org/licenses/by-nc-sa/4.0/

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lastReviewDate: 2023-02-02

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citedArtifact

identifier: 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.2007.15.9830

Titles

-TypeText
*Primary title

Phase III trial of androgen ablation with or without three cycles of systemic chemotherapy for advanced prostate cancer.

Abstracts

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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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relatesTo

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classifier: Journal Article

citation:

Smith DC, Esper P, Strawderman M, et al: Phase II trial of oral estramustine, oral etoposide, and intravenous paclitaxel in hormone-refractory prostate cancer. J Clin Oncol 17:1664-1671, 1999

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Kelly WK, Curley T, Slovin S, et al: Paclitaxel, estramustine phosphate, and carboplatin in patients with advanced prostate cancer. J Clin Oncol 19:44-53, 2001

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Millikan RE, Thall PF, Lee SJ, et al: Randomized multicenter phase II trial of two multicomponent regimens in androgen independent prostate cancer. J Clin Oncol 21:878-883, 2003

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citation:

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Osborne CK, Blumenstein B, Crawford ED, et al: Combined versus sequential chemo-endocrine therapy in advanced prostate cancer: Final results of a randomized Southwest Oncology Group study. J Clin Oncol 8:1675-1682, 1990

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citation:

Pummer K, Lehnert M, Stettner H, et al: Randomized comparison of total androgen blockade alone versus combined with weekly epirubicin in advanced prostate cancer. Eur Urol 32:81-85, 1997. (suppl)

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classifier: Journal Article

citation:

Janknegt RA, Boon TA, van de Beek C, et al: Combined hormono/chemotherapy as primary treatment for metastatic prostate cancer: A randomized, multicenter study of orchiectomy alone versus orchiectomy plus estramustine phosphate. Urology 49:411-420, 1997

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citation:

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classifier: Journal Article

citation:

Boel K, Van Poppel H, Goethuys H, et al: Mitomycin C for metastatic prostate cancer: Final analysis of a randomized trial. Anticancer Res 19:2157-2161, 1999

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classifier: Journal Article

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Kuriyama M, Takanhashi Y, Sahashi M, et al: Prospective and randomized comparison of combined androgen blockade versus combination with oral UFT as an initial treatment for prostate cancer. Jpn J Clin Oncol 31:18-24, 2001

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type: Cites

classifier: Journal Article

citation:

Noguchi M, Noda Shinshi, Yoshida M, et al: Chemohormonal therapy as primary treatment for metastatic prostate cancer: A randomized study of estramustine phosphate plus luteinizing hormone-releasing hormone agonist versus flutamide plus luteinizing hormone-releasing hormone agonist. Int J Urol 11:103-109, 2004

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citation:

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publicationForm

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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

articleDate: 2008-12-20

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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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