Generated Narrative: PublicationRecord 179629 version: 23; Last updated: 2025-10-13 12:34:35+0000 Profile: JournalArticleCitation ArtifactPublicationStatus: Active url: https://fevir.net/resources/PublicationRecord/179629 identifier: FEvIR Object Identifier/179629, https://pubmed.ncbi.nlm.nih.gov/23604530 title: 23604530 A phase II trial of androgen deprivation therapy (ADT) plus chemotherapy as initial treatment for local failures or advanced prostate cancer. status: Active author: Computable Publishing®: MEDLINE-to-FEvIR Converter: publisher: Computable Publishing LLC contact: support@computablepublishing.com description: This Citation Resource is referenced in an example for the EBMonFHIR Implementation Guide. UseContexts - Code Value[x] * Citation Classification Type: fevir-platform-use (FEvIR Platform Use) Medline Base copyright: https://creativecommons.org/licenses/by-nc-sa/4.0/ approvalDate: 2013-08-01 lastReviewDate: 2021-11-22 classification type: Citation Source classifier: MEDLINE classification type: MEDLINE Citation Owner classifier: National Library of Medicine, Index Section currentState: Medline Citation Status of Medline, PubMed PublicationStatus of ppublish statusDate activity: PubMed Pubstatus of Received period: ?? --> 2013-02-14 statusDate activity: PubMed Pubstatus of Accepted period: ?? --> 2013-04-08 statusDate activity: PubMed Pubstatus of Entrez period: ?? --> 2013-04-23 06:00:00+0000 statusDate activity: PubMed Pubstatus of Pubmed period: ?? --> 2013-04-23 06:00:00+0000 statusDate activity: PubMed Pubstatus of Medline period: ?? --> 2013-08-02 06:00:00+0000 citedArtifact identifier: https://pubmed.ncbi.nlm.nih.gov/23604530, https://doi.org/10.1007/s00280-013-2163-4 Titles - Type Language Text * Primary title English A phase II trial of androgen deprivation therapy (ADT) plus chemotherapy as initial treatment for local failures or advanced prostate cancer. Abstracts - Type Text * Primary human use PURPOSE: Long-term hormonal ablation in prostate cancer is associated with decreased overall health and quality of life. Few reports emphasized the role of chemotherapy in the management of early stage prostate cancer. This study analyzed the safety and efficacy of androgen deprivation therapy (ADT) plus chemotherapy as initial treatment for patients identified as local failures or not eligible for prostatectomy or radiation therapy due to advanced disease presentation. METHODS: Enrolled patients received ADT in the form of leuprolide every 12 weeks for 24 months with bicalutamide initiating after the completion of chemotherapy. Chemotherapy consisted of ketoconazole and doxorubicin for weeks 1, 3, and 5 and estramustine and docetaxel and for weeks 2, 4 and 6. During weeks 7 and 8, no treatment was received. RESULTS: Forty-six patients were enrolled, and forty-five patients were evaluable. Median progression-free survival (PFS) was 23.4 months. Median overall survival (OS) was 53.7 months. Out of 45 patients with measurable disease, 22 patients had an objective response: 9 patients achieved a complete response; 2 patients achieved a partial response; 10 patients achieved stable disease. Frequent grade 3 adverse events included elevated ALT (17 %), hypokalemia (13 %), and hypophosphatemia (13 %). Grade 4 adverse events were rare and included low bicarbonate (2 %), hypokalemia (2 %), leukocytopenia (2 %), and neutropenia (2 %). CONCLUSIONS: The treatment demonstrated clinical benefit in all patient subsets with minimal reversible treatment-related adverse events. Subgroup analysis suggests that having prior local therapy resulted in greater PFS and OS. publicationForm publishedIn type: Periodical identifier: Electronic ISSN Type/1432-0843, ISOAbbreviation/Cancer Chemother Pharmacol, ISSN Linking/0344-5704, Medline Title Abbreviation/Cancer Chemother Pharmacol, NLM Unique ID/7806519 title: Cancer chemotherapy and pharmacology publisherLocation: Germany citedMedium: Internet volume: 71 issue: 6 articleDate: 2013-06 pageString: 1629-34 publicationForm citedMedium: Internet without issue articleDate: 2013-04-21 webLocation classifier: Abstract url: https://pubmed.ncbi.nlm.nih.gov/23604530/ webLocation classifier: DOI Based url: https://doi.org/10.1007/s00280-013-2163-4 classification type: Publishing Model classifier: Print Electronic classification type: Chemical classifier: Androgen Antagonists, Anilides, Antineoplastic Agents, Hormonal, Nitriles, Tosyl Compounds, bicalutamide, KLK3 protein, human, Kallikreins, Prostate-Specific Antigen, Leuprolide classification type: MeSH heading artifactAssessment: ArtifactAssessment: artifact[x] = this resource classification type: Publication type classifier: Clinical Trial, Phase II, Journal Article classification type: Knowledge Artifact Type classifier: Journal Article artifactAssessment: Classifier added by Computable Publishing LLC classification type: Citation subset classifier: IM contributorship complete: true entry contributor: Amato R forenameInitials: R affiliation: Division of Oncology, Department of Internal Medicine, University of Texas Health Science Center at Houston (Medical School)/Memorial Hermann Cancer Center, 6410 Fannin St., Suite 830, Houston, TX 77030, USA. robert.amato@uth.tmc.edu entry contributor: Stepankiw M forenameInitials: M entry contributor: Gonzales P forenameInitials: P Generated Narrative: Practitioner #contributor0 name: Robert Amato Generated Narrative: Practitioner #contributor1 name: Mika Stepankiw Generated Narrative: Practitioner #contributor2 name: Patricia Gonzales Generated Narrative: ArtifactAssessment #meshHeading0 artifact: PublicationRecord 23604530 A phase II trial of androgen deprivation therapy (ADT) plus chemotherapy as initial treatment for local failures or advanced prostate cancer. content type: components (if present) include qualifier codings classifier: Adenocarcinoma freeToShare: true component type: qualifier classifier: is not a major topic component type: qualifier classifier: drug therapy Components - 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Antineoplastic Combined Chemotherapy Protocols
23604530 A phase II trial of androgen deprivation therapy (ADT) plus chemotherapy as initial treatment for local failures or advanced prostate cancer.
Computable Publishing®: MEDLINE-to-FEvIR Converter
This Citation Resource is referenced in an example for the EBMonFHIR Implementation Guide.
National Library of Medicine, Index Section
A phase II trial of androgen deprivation therapy (ADT) plus chemotherapy as initial treatment for local failures or advanced prostate cancer.
**PURPOSE:** Long-term hormonal ablation in prostate cancer is associated with decreased overall health and quality of life. Few reports emphasized the role of chemotherapy in the management of early stage prostate cancer. This study analyzed the safety and efficacy of androgen deprivation therapy (ADT) plus chemotherapy as initial treatment for patients identified as local failures or not eligible for prostatectomy or radiation therapy due to advanced disease presentation. **METHODS:** Enrolled patients received ADT in the form of leuprolide every 12 weeks for 24 months with bicalutamide initiating after the completion of chemotherapy. Chemotherapy consisted of ketoconazole and doxorubicin for weeks 1, 3, and 5 and estramustine and docetaxel and for weeks 2, 4 and 6. During weeks 7 and 8, no treatment was received. **RESULTS:** Forty-six patients were enrolled, and forty-five patients were evaluable. Median progression-free survival (PFS) was 23.4 months. Median overall survival (OS) was 53.7 months. Out of 45 patients with measurable disease, 22 patients had an objective response: 9 patients achieved a complete response; 2 patients achieved a partial response; 10 patients achieved stable disease. Frequent grade 3 adverse events included elevated ALT (17 %), hypokalemia (13 %), and hypophosphatemia (13 %). Grade 4 adverse events were rare and included low bicarbonate (2 %), hypokalemia (2 %), leukocytopenia (2 %), and neutropenia (2 %). **CONCLUSIONS:** The treatment demonstrated clinical benefit in all patient subsets with minimal reversible treatment-related adverse events. Subgroup analysis suggests that having prior local therapy resulted in greater PFS and OS.
Classifier added by Computable Publishing LLC
Division of Oncology, Department of Internal Medicine, University of Texas Health Science Center at Houston (Medical School)/Memorial Hermann Cancer Center, 6410 Fannin St., Suite 830, Houston, TX 77030, USA. robert.amato@uth.tmc.edu