Evidence Based Medicine on FHIR Implementation Guide
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Evidence Based Medicine on FHIR Implementation Guide, published by HL7 International / Clinical Decision Support. This guide is not an authorized publication; it is the continuous build for version 2.0.0-ballot built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/ebm/ and changes regularly. See the Directory of published versions

Example Citation: 19091394 Endocrine treatment, with or without radiotherapy, in locally advanced prostate cancer (SPCG-7/SFUO-3): an open randomised phase III trial.

Active as of 2024-12-19

Generated Narrative: Citation 179627

version: 8; Last updated: 2024-11-22 19:15:57+0000

Profile: JournalArticleCitation

url: Citation 19091394 Endocrine treatment, with or without radiotherapy, in locally advanced prostate cancer (SPCG-7/SFUO-3): an open randomised phase III trial.

identifier: FEvIR Object Identifier/https://fevir.net/FOI/179627, https://pubmed.ncbi.nlm.nih.gov/19091394, Uniform Resource Identifier (URI)/urn:oid:2.16.840.1.113883.4.642.40.44.15.29

version: 2.0.0-ballot

title: 19091394 Endocrine treatment, with or without radiotherapy, in locally advanced prostate cancer (SPCG-7/SFUO-3): an open randomised phase III 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

description:

This Citation Resource is referenced in an example for the EBMonFHIR Implementation Guide.

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https://creativecommons.org/licenses/by-nc-sa/4.0/

approvalDate: 2009-02-05

lastReviewDate: 2022-03-30

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relatedIdentifier: ISRCTN01534787

Titles

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*Primary titleEnglish

Endocrine treatment, with or without radiotherapy, in locally advanced prostate cancer (SPCG-7/SFUO-3): an open randomised phase III trial.

Abstracts

-Text
*

BACKGROUND: Several studies have shown the efficacy of endocrine therapy in combination with radiotherapy in high-risk prostate cancer. To assess the effect of radiotherapy, we did an open phase III study comparing endocrine therapy with and without local radiotherapy, followed by castration on progression. METHODS: This randomised trial included men from 47 centres in Norway, Sweden, and Denmark. Between February, 1996, and December, 2002, 875 patients with locally advanced prostate cancer (T3; 78%; PSA<70; N0; M0) were centrally randomly assigned by computer to endocrine treatment alone (3 months of total androgen blockade followed by continuous endocrine treatment using flutamide; 439 patients), or to the same endocrine treatment combined with radiotherapy (436 patients). The primary endpoint was prostate-cancer-specific survival, and analysis was by intention to treat. This study is registered as an international standard randomised controlled trial, number ISRCTN01534787. FINDINGS: After a median follow-up of 7.6 years, 79 men in the endocrine alone group and 37 men in the endocrine plus radiotherapy group had died of prostate cancer. The cumulative incidence at 10 years for prostate-cancer-specific mortality was 23.9% in the endocrine alone group and 11.9% in the endocrine plus radiotherapy group (difference 12.0%, 95% CI 4.9-19.1%), for a relative risk of 0.44 (0.30-0.66). At 10 years, the cumulative incidence for overall mortality was 39.4% in the endocrine alone group and 29.6% in the endocrine plus radiotherapy group (difference 9.8%, 0.8-18.8%), for a relative risk of 0.68 (0.52-0.89). Cumulative incidence at 10 years for PSA recurrence was substantially higher in men in the endocrine-alone group (74.7%vs 25.9%, p<0.0001; HR 0.16; 0.12-0.20). After 5 years, urinary, rectal, and sexual problems were slightly more frequent in the endocrine plus radiotherapy group. INTERPRETATION: In patients with locally advanced or high-risk local prostate cancer, addition of local radiotherapy to endocrine treatment halved the 10-year prostate-cancer-specific mortality, and substantially decreased overall mortality with fully acceptable risk of side-effects compared with endocrine treatment alone. In the light of these data, endocrine treatment plus radiotherapy should be the new standard.

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Lancet. 2009 Apr 4;373(9670):1174

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Lancet. 2009 Jan 24;373(9660):274-6. doi: 10.1016/S0140-6736(08)61816-4

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Nat Rev Urol. 2009 May;6(5):250-1. doi: 10.1038/nrurol.2009.56

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Ann Intern Med. 2009 Jun 16;150(12):JC6-6. doi: 10.7326/0003-4819-150-12-200906160-02006

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Eur Urol. 2009 May;55(5):1240. doi: 10.1016/j.eururo.2009.01.059

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title: Lancet (London, England)

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volume: 373

issue: 9660

articleDate: 2009-01-24

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contributor: Scandinavian Prostate Cancer Group Study 7

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