Generated Narrative: Citation 179621

url: Citation 26028518 Androgen deprivation therapy plus docetaxel and estramustine versus androgen deprivation therapy alone for high-risk localised prostate cancer (GETUG 12): a phase 3 randomised controlled trial.

identifier: FEvIR Object Identifier/179621, https://pubmed.ncbi.nlm.nih.gov/26028518, Uniform Resource Identifier (URI)/urn:oid:2.16.840.1.113883.4.642.40.44.15.7

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title: 26028518 Androgen deprivation therapy plus docetaxel and estramustine versus androgen deprivation therapy alone for high-risk localised prostate cancer (GETUG 12): a phase 3 randomised controlled trial.

status: Active

date: 2024-11-21 14:09:14+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: 2015-09-28

lastReviewDate: 2022-03-30

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identifier: https://pubmed.ncbi.nlm.nih.gov/26028518, https://doi.org/10.1016/S1470-2045(15)00011-X, pii/S1470-2045(15)00011-X

relatedIdentifier: https://clinicaltrials.gov/NCT00055731

Titles

-	Type	Language	Text
*	Primary title	English	Androgen deprivation therapy plus docetaxel and estramustine versus androgen deprivation therapy alone for high-risk localised prostate cancer (GETUG 12): a phase 3 randomised controlled trial.

Abstracts

-	Text	Copyright
*	BACKGROUND: Early risk-stratified chemotherapy is a standard treatment for breast, colorectal, and lung cancers, but not for high-risk localised prostate cancer. Combined docetaxel and estramustine improves survival in patients with castration-resistant prostate cancer. We assessed the effects of combined docetaxel and estramustine on relapse in patients with high-risk localised prostate cancer. METHODS: We did this randomised phase 3 trial at 26 hospitals in France. We enrolled patients with treatment-naive prostate cancer and at least one risk factor (ie, stage T3-T4 disease, Gleason score of ≥8, prostate-specific antigen concentration >20 ng/mL, or pathological node-positive). All patients underwent a staging pelvic lymph node dissection. Patients were randomly assigned (1:1) to either androgen deprivation therapy (ADT; goserelin 10·8 mg every 3 months for 3 years) plus four cycles of docetaxel on day 2 at a dose of 70 mg/m(2) and estramustine 10 mg/kg per day on days 1-5, every 3 weeks, or ADT only. The randomisation was done centrally by computer, stratified by risk factor. Local treatment was administered at 3 months. Neither patients nor investigators were masked to treatment allocation. The primary endpoint was relapse-free survival in the intention-to-treat population. Follow-up for other endpoints is ongoing. This study is registered with ClinicalTrials.gov, number NCT00055731. FINDINGS: We randomly assigned 207 patients to the ADT plus docetaxel and estramustine group and 206 to the ADT only group. Median follow-up was 8·8 years (IQR 8·1-9·7). 88 (43%) of 207 patients in the ADT plus docetaxel and estramustine group had an event (relapse or death) versus 111 (54%) of 206 in the ADT only group. 8-year relapse-free survival was 62% (95% CI 55-69) in the ADT plus docetaxel and estramustine group versus 50% (44-57) in the ADT only group (adjusted hazard ratio [HR] 0·71, 95% CI 0·54-0·94, p=0·017). Of patients who were treated with radiotherapy and had data available, 31 (21%) of 151 in the ADT plus docetaxel and estramustine group versus 26 (18%) of 143 in the ADT only group reported a grade 2 or higher long-term side-effect (p=0·61). We recorded no excess second cancers (26 [13%] of 207 vs 22 [11%] of 206; p=0·57), and there were no treatment-related deaths. INTERPRETATION: Docetaxel-based chemotherapy improves relapse-free survival in patients with high-risk localised prostate cancer. Longer follow-up is needed to assess whether this benefit translates into improved metastasis-free survival and overall survival. FUNDING: Ligue Contre le Cancer, Sanofi-Aventis, AstraZeneca, Institut National du Cancer.	Copyright © 2015 Elsevier Ltd. All rights reserved.

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Lancet Oncol. 2015 Jul;16(7):741-2. doi: 10.1016/S1470-2045(15)00012-1

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Nat Rev Urol. 2015 Jul;12(7):358. doi: 10.1038/nrurol.2015.146

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Eur Urol. 2015 Dec;68(6):1098-9. doi: 10.1016/j.eururo.2015.08.047

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Nat Rev Clin Oncol. 2015 Dec;12(12):687-8. doi: 10.1038/nrclinonc.2015.192

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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: 16

issue: 7

articleDate: 2015-07

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type: Chemical

classifier: Androgen Antagonists, Taxoids, Docetaxel, Estramustine, Prostate-Specific Antigen

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

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contributor: Lesaunier F

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contributor: Delva R

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affiliation: Institut de Cancérologie de l'Ouest, Angers, France.

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affiliation: Centre Hospitalier Départemental, La Roche-sur-Yon, France.

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affiliation: Centre Antoine Lacassagne, Nice, France.

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affiliation: Hôpital Européen Georges Pompidou, Paris, France.

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affiliation: Institut Curie, Paris, France.

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affiliation: Unicancer, Paris, France.

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