Generated Narrative: Citation 179615 version: 18; Last updated: 2025-10-13 12:34:35+0000; Language: en Profile: JournalArticleCitation ArtifactPublicationStatus: Active url: https://fevir.net/resources/Citation/179615 identifier: FEvIR Object Identifier/179615, https://pubmed.ncbi.nlm.nih.gov/23306100 title: 23306100 Androgen-deprivation therapy alone or with docetaxel in non-castrate metastatic prostate cancer (GETUG-AFU 15): a randomised, open-label, phase 3 trial. 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: 2013-03-25 lastReviewDate: 2022-12-08 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 Entrez period: ?? --> 2013-01-12 06:00:00+0000 statusDate activity: PubMed Pubstatus of Pubmed period: ?? --> 2013-01-12 06:00:00+0000 statusDate activity: PubMed Pubstatus of Medline period: ?? --> 2013-03-26 06:00:00+0000 citedArtifact identifier: https://pubmed.ncbi.nlm.nih.gov/23306100, https://doi.org/10.1016/S1470-2045(12)70560-0, pii/S1470-2045(12)70560-0 relatedIdentifier: https://clinicaltrials.gov/NCT00104715 Titles - Type Text * Primary title Androgen-deprivation therapy alone or with docetaxel in non-castrate metastatic prostate cancer (GETUG-AFU 15): a randomised, open-label, phase 3 trial. Abstracts - Type Text Copyright * Primary human use BACKGROUND: Early chemotherapy might improve the overall outcomes of patients with metastatic non-castrate (ie, hormone-sensitive) prostate cancer. We investigated the effects of the addition of docetaxel to androgen-deprivation therapy (ADT) for patients with metastatic non-castrate prostate cancer. METHODS: In this randomised, open-label, phase 3 study, we enrolled patients in 29 centres in France and one in Belgium. Eligible patients were older than 18 years and had histologically confirmed adenocarcinoma of the prostate and radiologically proven metastatic disease; a Karnofsky score of at least 70%; a life expectancy of at least 3 months; and adequate hepatic, haematological, and renal function. They were randomly assigned to receive to ADT (orchiectomy or luteinising hormone-releasing hormone agonists, alone or combined with non-steroidal antiandrogens) alone or in combination with docetaxel (75 mg/m(2) intravenously on the first day of each 21-day cycle; up to nine cycles). Patients were randomised in a 1:1 ratio, with dynamic minimisation to minimise imbalances in previous systemic treatment with ADT, chemotherapy for local disease or isolated rising concentration of serum prostate-specific antigen, and Glass risk groups. Patients, physicians, and data analysts were not masked to treatment allocation. The primary endpoint was overall survival. Efficacy analyses were done by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT00104715. FINDINGS: Between Oct 18, 2004, and Dec 31, 2008, 192 patients were randomly allocated to receive ADT plus docetaxel and 193 to receive ADT alone. Median follow-up was 50 months (IQR 39-63). Median overall survival was 58·9 months (95% CI 50·8-69·1) in the group given ADT plus docetaxel and 54·2 months (42·2-not reached) in that given ADT alone (hazard ratio 1·01, 95% CI 0·75-1·36). 72 serious adverse events were reported in the group given ADT plus docetaxel, of which the most frequent were neutropenia (40 [21%]), febrile neutropenia (six [3%]), abnormal liver function tests (three [2%]), and neutropenia with infection (two [1%]). Four treatment-related deaths occurred in the ADT plus docetaxel group (two of which were neutropenia-related), after which the data monitoring committee recommended treatment with granulocyte colony-stimulating factor. After this recommendation, no further treatment-related deaths occurred. No serious adverse events were reported in the ADT alone group. INTERPRETATION: Docetaxel should not be used as part of first-line treatment for patients with non-castrate metastatic prostate cancer. FUNDING: French Health Ministry and Institut National du Cancer (PHRC), Sanofi-Aventis, AstraZeneca, and Amgen. Copyright © 2013 Elsevier Ltd. All rights reserved. relatesTo type: Has Comment In classifier: Comment citation: Lancet Oncol. 2013 Feb;14(2):104-5. doi: 10.1016/S1470-2045(12)70591-0. target: https://pubmed.ncbi.nlm.nih.gov/23306099/ relatesTo type: Has Comment In classifier: Comment citation: Nat Rev Urol. 2013 Mar;10(3):123. doi: 10.1038/nrurol.2013.12. target: https://pubmed.ncbi.nlm.nih.gov/23358518/ relatesTo type: Has Comment In classifier: Comment citation: J Urol. 2013 Dec;190(6):2094. doi: 10.1016/j.juro.2013.08.104. target: https://pubmed.ncbi.nlm.nih.gov/24209521/ relatesTo type: Has Comment In classifier: Comment citation: Urol Oncol. 2013 Nov;31(8):1845. doi: 10.1016/j.urolonc.2013.08.011. target: https://pubmed.ncbi.nlm.nih.gov/24210084/ relatesTo type: Has Comment In classifier: Comment citation: Actas Urol Esp. 2017 Jul - Aug;41(6):347-351. doi: 10.1016/j.acuro.2016.11.008. target: https://pubmed.ncbi.nlm.nih.gov/28214037/ publicationForm publishedIn type: Periodical identifier: Electronic ISSN Type/1474-5488, ISOAbbreviation/Lancet Oncol, ISSN Linking/1470-2045, Medline Title Abbreviation/Lancet Oncol, NLM Unique ID/100957246 title: The Lancet. Oncology publisherLocation: England citedMedium: Internet volume: 14 issue: 2 articleDate: 2013-02 pageString: 149-58 publicationForm citedMedium: Internet without issue articleDate: 2013-01-08 webLocation classifier: Abstract url: https://pubmed.ncbi.nlm.nih.gov/23306100/ webLocation classifier: DOI Based url: https://doi.org/10.1016/S1470-2045(12)70560-0 classification type: Publishing Model classifier: Print Electronic classification type: Chemical classifier: Androgen Antagonists, Taxoids, Docetaxel classification type: MeSH heading artifactAssessment: ArtifactAssessment: artifact[x] = this resource classification type: Publication type classifier: Clinical Trial, Phase III, Journal Article, Randomized Controlled Trial, 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: Gravis G forenameInitials: G affiliation: Medical Oncology and Biostatistics, Institut Paoli-Calmettes, Marseille, France. gravisg@ipc.unicancer.fr entry contributor: Fizazi K forenameInitials: K entry contributor: Joly F forenameInitials: F entry contributor: Oudard S forenameInitials: S entry contributor: Priou F forenameInitials: F entry contributor: Esterni B forenameInitials: B entry contributor: Latorzeff I forenameInitials: I entry contributor: Delva R forenameInitials: R entry contributor: Krakowski I forenameInitials: I entry contributor: Laguerre B forenameInitials: B entry contributor: Rolland F forenameInitials: F entry contributor: Théodore C forenameInitials: C entry contributor: Deplanque G forenameInitials: G entry contributor: Ferrero JM forenameInitials: JM entry contributor: Pouessel D forenameInitials: D entry contributor: Mourey L forenameInitials: L entry contributor: Beuzeboc P forenameInitials: P entry contributor: Zanetta S forenameInitials: S 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name: Stéphane Oudard Generated Narrative: Practitioner #contributor4 name: Franck Priou Generated Narrative: Practitioner #contributor5 name: Benjamin Esterni Generated Narrative: Practitioner #contributor6 name: Igor Latorzeff Generated Narrative: Practitioner #contributor7 name: Remy Delva Generated Narrative: Practitioner #contributor8 name: Ivan Krakowski Generated Narrative: Practitioner #contributor9 name: Brigitte Laguerre Generated Narrative: Practitioner #contributor10 name: Fréderic Rolland Generated Narrative: Practitioner #contributor11 name: Christine Théodore Generated Narrative: Practitioner #contributor12 name: Gael Deplanque Generated Narrative: Practitioner #contributor13 name: Jean Marc Ferrero Generated Narrative: Practitioner #contributor14 name: Damien Pouessel Generated Narrative: Practitioner #contributor15 name: Loïc Mourey Generated Narrative: Practitioner #contributor16 name: Philippe Beuzeboc Generated Narrative: Practitioner #contributor17 name: Sylvie 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Guilhem Bousquet Generated Narrative: Practitioner #contributor32 name: Michel Soulie Generated Narrative: ArtifactAssessment #meshHeading0 artifact: Citation 23306100 Androgen-deprivation therapy alone or with docetaxel in non-castrate metastatic prostate cancer (GETUG-AFU 15): a randomised, open-label, phase 3 trial. 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: administration & dosage Components - Type Classifier * is Major topic No component type: qualifier classifier: therapeutic use Components - Type Classifier * is Major topic Yes content type: components (if present) include qualifier codings classifier: Antineoplastic Combined Chemotherapy Protocols 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23306100 Androgen-deprivation therapy alone or with docetaxel in non-castrate metastatic prostate cancer (GETUG-AFU 15): a randomised, open-label, phase 3 trial.
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
Androgen-deprivation therapy alone or with docetaxel in non-castrate metastatic prostate cancer (GETUG-AFU 15): a randomised, open-label, phase 3 trial.
**BACKGROUND:** Early chemotherapy might improve the overall outcomes of patients with metastatic non-castrate (ie, hormone-sensitive) prostate cancer. We investigated the effects of the addition of docetaxel to androgen-deprivation therapy (ADT) for patients with metastatic non-castrate prostate cancer. **METHODS:** In this randomised, open-label, phase 3 study, we enrolled patients in 29 centres in France and one in Belgium. Eligible patients were older than 18 years and had histologically confirmed adenocarcinoma of the prostate and radiologically proven metastatic disease; a Karnofsky score of at least 70%; a life expectancy of at least 3 months; and adequate hepatic, haematological, and renal function. They were randomly assigned to receive to ADT (orchiectomy or luteinising hormone-releasing hormone agonists, alone or combined with non-steroidal antiandrogens) alone or in combination with docetaxel (75 mg/m(2) intravenously on the first day of each 21-day cycle; up to nine cycles). Patients were randomised in a 1:1 ratio, with dynamic minimisation to minimise imbalances in previous systemic treatment with ADT, chemotherapy for local disease or isolated rising concentration of serum prostate-specific antigen, and Glass risk groups. Patients, physicians, and data analysts were not masked to treatment allocation. The primary endpoint was overall survival. Efficacy analyses were done by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT00104715. **FINDINGS:** Between Oct 18, 2004, and Dec 31, 2008, 192 patients were randomly allocated to receive ADT plus docetaxel and 193 to receive ADT alone. Median follow-up was 50 months (IQR 39-63). Median overall survival was 58·9 months (95% CI 50·8-69·1) in the group given ADT plus docetaxel and 54·2 months (42·2-not reached) in that given ADT alone (hazard ratio 1·01, 95% CI 0·75-1·36). 72 serious adverse events were reported in the group given ADT plus docetaxel, of which the most frequent were neutropenia (40 [21%]), febrile neutropenia (six [3%]), abnormal liver function tests (three [2%]), and neutropenia with infection (two [1%]). Four treatment-related deaths occurred in the ADT plus docetaxel group (two of which were neutropenia-related), after which the data monitoring committee recommended treatment with granulocyte colony-stimulating factor. After this recommendation, no further treatment-related deaths occurred. No serious adverse events were reported in the ADT alone group. **INTERPRETATION:** Docetaxel should not be used as part of first-line treatment for patients with non-castrate metastatic prostate cancer. **FUNDING:** French Health Ministry and Institut National du Cancer (PHRC), Sanofi-Aventis, AstraZeneca, and Amgen.
Copyright © 2013 Elsevier Ltd. All rights reserved.
Classifier added by Computable Publishing LLC
Medical Oncology and Biostatistics, Institut Paoli-Calmettes, Marseille, France. gravisg@ipc.unicancer.fr