Generated Narrative: Citation 179615

url: 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.

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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

date: 2024-12-19 14:29:51+0000

publisher: HL7 International / Clinical Decision Support

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

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approvalDate: 2013-03-25

lastReviewDate: 2022-12-08

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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	Language	Text
*	Primary title	English	Androgen-deprivation therapy alone or with docetaxel in non-castrate metastatic prostate cancer (GETUG-AFU 15): a randomised, open-label, phase 3 trial.

Abstracts

-	Text	Copyright
*	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.

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Lancet Oncol. 2013 Feb;14(2):104-5. doi: 10.1016/S1470-2045(12)70591-0

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Nat Rev Urol. 2013 Mar;10(3):123. doi: 10.1038/nrurol.2013.12

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J Urol. 2013 Dec;190(6):2094. doi: 10.1016/j.juro.2013.08.104

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Urol Oncol. 2013 Nov;31(8):1845. doi: 10.1016/j.urolonc.2013.08.011

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Actas Urol Esp. 2017 Jul - Aug;41(6):347-351. doi: 10.1016/j.acuro.2016.11.008

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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

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classifier: Androgen Antagonists, Taxoids, Docetaxel

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affiliation: Medical Oncology and Biostatistics, Institut Paoli-Calmettes, Marseille, France. gravisg@ipc.unicancer.fr

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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.

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