Generated Narrative: Citation 179631

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/https://fevir.net/FOI/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-ballot2

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

status: Active

date: 2025-03-27 17:53:24+0000

publisher: HL7 International / Clinical Decision Support

contact: HL7 International / Clinical Decision Support: http://www.hl7.org/Special/committees/dss

description:

UseContexts

jurisdiction: World

copyright:

approvalDate: 2009-01-13

lastReviewDate: 2023-02-02

author: Computable Publishing®: MEDLINE-to-FEvIR Converter:

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type: MEDLINE Citation Owner

classifier: National Library of Medicine, Index Section

currentState: Medline Citation Status of Medline, PubMed PublicationStatus of ppublish

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period: ?? --> 2009-12-20

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

-	Type	Language	Text
*	Primary title	English	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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publicationForm

publishedIn

type: Periodical

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

publicationDateText: 2008-Dec-20

pageString: 5936-42

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citedMedium: Internet without issue

articleDate: 2008-11-24

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url: https://pubmed.ncbi.nlm.nih.gov/19029421/

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url: https://doi.org/10.1200/JCO.2007.15.9830

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type: Publishing Model

classifier: Print Electronic

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type: Chemical

classifier: Androgen Antagonists, Antibiotics, Antineoplastic, Antineoplastic Agents, Alkylating, Antineoplastic Agents, Phytogenic, Estramustine, Vinblastine, Doxorubicin, Ketoconazole

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artifactAssessment: ArtifactAssessment: artifact[x] = this resource

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contributor: Millikan RE

forenameInitials: RE

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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contributor: Wen S

forenameInitials: S

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contributor: Moomey B

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Generated Narrative: Practitioner #contributor0

name: Randall E Millikan

Generated Narrative: Practitioner #contributor1

name: Sijin Wen

Generated Narrative: Practitioner #contributor2

name: Lance C Pagliaro

Generated Narrative: Practitioner #contributor3

name: Melissa A Brown

Generated Narrative: Practitioner #contributor4

name: Brenda Moomey

Generated Narrative: Practitioner #contributor5

name: Kim-Anh Do

Generated Narrative: Practitioner #contributor6

name: Christopher J Logothetis

Generated Narrative: ArtifactAssessment #meshHeading0

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

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