Evidence Based Medicine on FHIR Implementation Guide
1.0.0-ballot - ballot
Evidence Based Medicine on FHIR Implementation Guide
1.0.0-ballot - ballot
This page is part of the Evidence Based Medicine on FHIR Implementation Guide (v1.0.0-ballot: STU1 Ballot 1) based on FHIR (HL7® FHIR® Standard) v5.0.0. . For a full list of available versions, see the Directory of published versions
| Active as of 2023-12-17 |
Resource Citation "179621" Version "1" Updated "2023-11-26 22:35:14+0000"
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identifier: FEvIR Object Identifier: 179621, id: 26028518
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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.
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date: 2023-12-17 16:55:23+0000
publisher: HL7 International / Clinical Decision Support
contact: HL7 International / Clinical Decision Support: http://www.hl7.org/Special/committees/dss
description: This Citation Resource is referenced in an example for the EBMonFHIR Implementation Guide.
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lastReviewDate: 2022-03-30
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identifier: id: 26028518, id: 10.1016/S1470-2045(15)00011-X, pii: S1470-2045(15)00011-X
relatedIdentifier: id: NCT00055731
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Type Language Text Primary title (Title Type#primary) English (Tags for the Identification of Languages#en) 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. relatesTo
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citation: Lancet Oncol. 2015 Jul;16(7):741-2
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Url https://pubmed.ncbi.nlm.nih.gov/26028517/ resourceReference: id: 26028517
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citation: Nat Rev Urol. 2015 Jul;12(7):358
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Url https://pubmed.ncbi.nlm.nih.gov/26077993/ resourceReference: id: 26077993
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citation: Eur Urol. 2015 Dec;68(6):1098-9
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citation: Nat Rev Clin Oncol. 2015 Dec;12(12):687-8
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type: components (if present) include qualifier codings (Cited Artifact Classification Type#mesh-heading "MeSH heading")
classifier: Neoplasm Staging (#D009367)
freeToShare: true
Components
Type Classifier qualifier () is not a major topic () content
informationType: classifier
type: components (if present) include qualifier codings (Cited Artifact Classification Type#mesh-heading "MeSH heading")
classifier: Proportional Hazards Models (#D016016)
freeToShare: true
Components
Type Classifier qualifier () is not a major topic () content
informationType: classifier
type: components (if present) include qualifier codings (Cited Artifact Classification Type#mesh-heading "MeSH heading")
classifier: Prostate-Specific Antigen (#D017430)
freeToShare: true
component
type: qualifier ()
classifier: is not a major topic ()
component
type: qualifier ()
classifier: blood (#Q000097)
component
content
informationType: classifier
type: components (if present) include qualifier codings (Cited Artifact Classification Type#mesh-heading "MeSH heading")
classifier: Prostatic Neoplasms (#D011471)
freeToShare: true
component
type: qualifier ()
classifier: is not a major topic ()
component
type: qualifier ()
classifier: drug therapy (#Q000188)
component
component
type: qualifier ()
classifier: mortality (#Q000401)
component
component
type: qualifier ()
classifier: pathology (#Q000473)
component
content
informationType: classifier
type: components (if present) include qualifier codings (Cited Artifact Classification Type#mesh-heading "MeSH heading")
classifier: Survival Analysis (#D016019)
freeToShare: true
Components
Type Classifier qualifier () is not a major topic () content
informationType: classifier
type: components (if present) include qualifier codings (Cited Artifact Classification Type#mesh-heading "MeSH heading")
classifier: Taxoids (#D043823)
freeToShare: true
component
type: qualifier ()
classifier: is not a major topic ()
component
type: qualifier ()
classifier: administration & dosage (#Q000008)
component
content
informationType: classifier
type: components (if present) include qualifier codings (Cited Artifact Classification Type#mesh-heading "MeSH heading")
classifier: Treatment Outcome (#D016896)
freeToShare: true
Components
Type Classifier qualifier () is not a major topic ()
IG © 2022+ HL7 International / Clinical Decision Support. Package hl7.fhir.uv.ebm#1.0.0-ballot based on FHIR 5.0.0. Generated 2023-12-17
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