Generated Narrative: Citation 179623 version: 21; Last updated: 2025-10-13 12:34:35+0000; Language: en Profile: JournalArticleCitation ArtifactPublicationStatus: Active url: https://fevir.net/resources/Citation/179623 identifier: FEvIR Object Identifier/179623, https://pubmed.ncbi.nlm.nih.gov/23452809 title: 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. 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: 2013-04-22 lastReviewDate: 2021-10-21 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: ?? --> 2012-11-21 statusDate activity: PubMed Pubstatus of Revised period: ?? --> 2012-12-14 statusDate activity: PubMed Pubstatus of Accepted period: ?? --> 2012-12-18 statusDate activity: PubMed Pubstatus of Entrez period: ?? --> 2013-03-05 06:00:00+0000 statusDate activity: PubMed Pubstatus of Pubmed period: ?? --> 2013-03-05 06:00:00+0000 statusDate activity: PubMed Pubstatus of Medline period: ?? --> 2013-04-23 06:00:00+0000 citedArtifact identifier: https://pubmed.ncbi.nlm.nih.gov/23452809, https://doi.org/10.1016/j.urology.2012.12.025, pii/S0090-4295(12)01569-5 Titles - Type Text * Primary title Long-term follow-up of a phase II trial of chemotherapy plus hormone therapy for biochemical relapse after definitive local therapy for prostate cancer. Abstracts - Type Text Copyright * Primary human use OBJECTIVE: To evaluate long-term follow-up of a phase II trial of chemohormonal therapy in 62 men with prostate cancer biochemical relapse (BR). 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) <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 <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. CONCLUSION: 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. Copyright © 2013 Elsevier Inc. All rights reserved. RelatesTos - Type Classifier Citation Target[x] * Has Comment In Comment J Urol. 2013 Sep;190(3):880. doi: 10.1016/j.juro.2013.05.105. https://pubmed.ncbi.nlm.nih.gov/23931194/ publicationForm publishedIn type: Periodical identifier: Electronic ISSN Type/1527-9995, ISOAbbreviation/Urology, ISSN Linking/0090-4295, Medline Title Abbreviation/Urology, NLM Unique ID/0366151 title: Urology publisherLocation: United States citedMedium: Internet volume: 81 issue: 3 articleDate: 2013-03 pageString: 611-6 webLocation classifier: Abstract url: https://pubmed.ncbi.nlm.nih.gov/23452809/ webLocation classifier: DOI Based url: https://doi.org/10.1016/j.urology.2012.12.025 classification type: Publishing Model classifier: Print classification type: Chemical classifier: Androgen Antagonists, Anilides, Antineoplastic Agents, Antineoplastic Agents, Hormonal, Nitriles, Taxoids, Tosyl Compounds, Goserelin, Docetaxel, Estramustine, bicalutamide classification type: MeSH heading artifactAssessment: ArtifactAssessment: artifact[x] = this resource classification type: Publication type classifier: Clinical Trial, Phase II, Journal Article, Research Support, Non-U.S. Gov't 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: Nakabayashi M forenameInitials: M affiliation: Division of Medical Oncology, Department of Medicine, Lank Center for Genitourinary Oncology, Boston, MA 02215, USA. entry contributor: Xie W forenameInitials: W entry contributor: Buckle G forenameInitials: G entry contributor: Bubley G forenameInitials: G entry contributor: Ernstoff MS forenameInitials: MS entry contributor: Walsh W forenameInitials: W entry contributor: Morganstern DE forenameInitials: DE entry contributor: Kantoff PW forenameInitials: PW entry contributor: Taplin ME forenameInitials: ME Generated Narrative: Practitioner #contributor0 name: Mari Nakabayashi Generated Narrative: Practitioner #contributor1 name: Wanling Xie Generated Narrative: Practitioner #contributor2 name: Geoffrey Buckle Generated Narrative: Practitioner #contributor3 name: Glenn Bubley Generated Narrative: Practitioner #contributor4 name: Marc S Ernstoff Generated Narrative: Practitioner #contributor5 name: William Walsh Generated Narrative: Practitioner #contributor6 name: Daniel E Morganstern Generated Narrative: Practitioner #contributor7 name: Philip W Kantoff Generated Narrative: Practitioner #contributor8 name: Mary-Ellen Taplin Generated Narrative: ArtifactAssessment #meshHeading0 artifact: 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. content type: components (if present) include qualifier codings classifier: Aged freeToShare: true Components - Type Classifier * qualifier is not a major topic content type: components (if present) include qualifier codings classifier: Androgen Antagonists freeToShare: true component type: qualifier classifier: is not a major topic component type: qualifier classifier: therapeutic use Components - Type Classifier * is Major topic Yes content type: components (if present) include qualifier codings classifier: Anilides freeToShare: true component type: qualifier classifier: is not a major topic component type: qualifier classifier: therapeutic use Components - Type Classifier * is Major topic Yes content type: components (if present) include qualifier codings classifier: Antineoplastic Agents freeToShare: true component type: qualifier classifier: is not a major topic component type: qualifier classifier: administration & dosage Components - Type Classifier * is Major topic Yes content type: components (if present) include qualifier codings classifier: Antineoplastic Agents, Hormonal freeToShare: true component type: qualifier classifier: is not a major topic component type: qualifier classifier: administration & dosage Components - Type Classifier * is Major topic No content type: components (if present) include qualifier codings classifier: Antineoplastic Combined Chemotherapy Protocols freeToShare: true component type: qualifier classifier: is not a major topic component type: qualifier classifier: therapeutic use Components - Type Classifier * is Major topic Yes content type: components (if present) include qualifier codings classifier: Docetaxel freeToShare: true Components - Type Classifier * qualifier is not a major topic content type: components (if present) include qualifier codings classifier: Drug Therapy, Combination freeToShare: true Components - Type Classifier * qualifier is not a major topic content type: components (if present) include qualifier codings classifier: Estramustine freeToShare: true component type: qualifier classifier: is not a major topic component type: qualifier classifier: administration & dosage Components - Type Classifier * is Major topic Yes content type: components (if present) include qualifier codings classifier: Follow-Up Studies freeToShare: true Components - Type Classifier * qualifier is not a major topic content type: components (if present) include qualifier codings classifier: Goserelin freeToShare: true component type: qualifier classifier: is not a major topic component type: qualifier classifier: administration & dosage Components - Type Classifier * is Major topic Yes content type: components (if present) include qualifier codings classifier: Humans freeToShare: true Components - Type Classifier * qualifier is not a major topic content type: components (if present) include qualifier codings classifier: Male freeToShare: true Components - Type Classifier * qualifier is not a major topic content type: components (if present) include qualifier codings classifier: Middle Aged freeToShare: true Components - Type Classifier * qualifier is not a major topic content type: components (if present) include qualifier codings classifier: Neoplasm Recurrence, Local freeToShare: true component type: qualifier classifier: is not a major topic component type: qualifier classifier: drug therapy Components - Type Classifier * is Major topic Yes content type: components (if present) include qualifier codings classifier: Nitriles freeToShare: true component type: qualifier classifier: is not a major topic component type: qualifier classifier: therapeutic use Components - Type Classifier * is Major topic Yes content type: components (if present) include qualifier codings classifier: Prostatic Neoplasms freeToShare: true component type: qualifier classifier: is not a major topic component type: qualifier classifier: drug therapy Components - Type Classifier * is Major topic Yes content type: components (if present) include qualifier codings classifier: Retrospective Studies freeToShare: true Components - Type Classifier * qualifier is not a major topic content type: components (if present) include qualifier codings classifier: Taxoids freeToShare: true component type: qualifier classifier: is not a major topic component type: qualifier classifier: administration & dosage Components - Type Classifier * is Major topic Yes content type: components (if present) include qualifier codings classifier: Time Factors freeToShare: true Components - Type Classifier * qualifier is not a major topic content type: components (if present) include qualifier codings classifier: Tosyl Compounds freeToShare: true component type: qualifier classifier: is not a major topic component type: qualifier classifier: therapeutic use Components - Type Classifier * is Major topic Yes content type: components (if present) include qualifier codings classifier: Treatment Outcome freeToShare: true Components - Type Classifier * qualifier is not a major topic
components (if present) include qualifier codings
Antineoplastic Combined Chemotherapy Protocols
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.
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
Long-term follow-up of a phase II trial of chemotherapy plus hormone therapy for biochemical relapse after definitive local therapy for prostate cancer.
**OBJECTIVE:** To evaluate long-term follow-up of a phase II trial of chemohormonal therapy in 62 men with prostate cancer biochemical relapse (BR). **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) <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 <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. **CONCLUSION:** 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.
Copyright © 2013 Elsevier Inc. All rights reserved.
Classifier added by Computable Publishing LLC
Division of Medical Oncology, Department of Medicine, Lank Center for Genitourinary Oncology, Boston, MA 02215, USA.