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url: https://fevir.net/resources/PublicationRecord/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.

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publisher: Computable Publishing LLC

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approvalDate: 2013-03-25

lastReviewDate: 2022-12-08

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classifier: MEDLINE

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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: 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

-	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.

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

target: https://pubmed.ncbi.nlm.nih.gov/23306099/

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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.

target: https://pubmed.ncbi.nlm.nih.gov/24209521/

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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.

target: https://pubmed.ncbi.nlm.nih.gov/28214037/

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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

publicationDateText: 2013-Feb

pageString: 149-58

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url: https://pubmed.ncbi.nlm.nih.gov/23306100/

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url: https://doi.org/10.1016/S1470-2045(12)70560-0

classification

type: Publishing Model

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classification

type: Chemical

classifier: Androgen Antagonists, Taxoids, Docetaxel

classification

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artifactAssessment: ArtifactAssessment: artifact[x] = this resource

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classifier: Clinical Trial, Phase III, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't

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contributorship

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entry

contributor: Gravis G

forenameInitials: G

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

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contributor: Latorzeff I

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contributor: Delva R

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Generated Narrative: Practitioner #contributor0

Gwenaelle Gravis

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Generated Narrative: Practitioner #contributor1

Karim Fizazi

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Generated Narrative: Practitioner #contributor2

Florence Joly

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Generated Narrative: Practitioner #contributor3

Stéphane Oudard

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Generated Narrative: Practitioner #contributor4

Franck Priou

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Generated Narrative: Practitioner #contributor5

Benjamin Esterni

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Generated Narrative: Practitioner #contributor6

Igor Latorzeff

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Generated Narrative: Practitioner #contributor7

Remy Delva

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Generated Narrative: Practitioner #contributor8

Ivan Krakowski

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Generated Narrative: Practitioner #contributor9

Brigitte Laguerre

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Generated Narrative: Practitioner #contributor10

Fréderic Rolland

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Generated Narrative: Practitioner #contributor11

Christine Théodore

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Generated Narrative: Practitioner #contributor12

Gael Deplanque

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Generated Narrative: Practitioner #contributor13

Jean Marc Ferrero

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Generated Narrative: Practitioner #contributor14

Damien Pouessel

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Generated Narrative: Practitioner #contributor15

Loïc Mourey

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Generated Narrative: Practitioner #contributor16

Philippe Beuzeboc

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Generated Narrative: Practitioner #contributor17

Sylvie Zanetta

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Generated Narrative: Practitioner #contributor18

Muriel Habibian

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Generated Narrative: Practitioner #contributor19

Jean François Berdah

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Generated Narrative: Practitioner #contributor20

Jerome Dauba

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Generated Narrative: Practitioner #contributor21

Marjorie Baciuchka

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Generated Narrative: Practitioner #contributor22

Christian Platini

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Generated Narrative: Practitioner #contributor23

Claude Linassier

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Generated Narrative: Practitioner #contributor24

Jean Luc Labourey

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Generated Narrative: Practitioner #contributor25

Jean Pascal Machiels

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Generated Narrative: Practitioner #contributor26

Claude El Kouri

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Generated Narrative: Practitioner #contributor27

Alain Ravaud

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Generated Narrative: Practitioner #contributor28

Etienne Suc

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Generated Narrative: Practitioner #contributor29

Jean Christophe Eymard

---

Generated Narrative: Practitioner #contributor30

Ali Hasbini

---

Generated Narrative: Practitioner #contributor31

Guilhem Bousquet

---

Generated Narrative: Practitioner #contributor32

Michel Soulie

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Generated Narrative: ArtifactAssessment #meshHeading0

artifact: PublicationRecord 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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