Evidence Based Medicine on FHIR Implementation Guide
1.0.0-ballot - ballot
Evidence Based Medicine on FHIR Implementation Guide
1.0.0-ballot - ballot
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 1.0.0-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
| Active as of 2024-04-27 |
Resource Citation "179624" Version "1" Updated "2023-11-26 22:35:20+0000"
url: https://fevir.net/resources/Citation/179624
identifier: FEvIR Object Identifier/179624, https://pubmed.ncbi.nlm.nih.gov/24598155
version: 1.0.0-ballot
title: 24598155 Long-term results of a phase II study with neoadjuvant docetaxel chemotherapy and complete androgen blockade in locally advanced and high-risk prostate cancer.
status: active
date: 2024-04-27 20:42:39+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://pubmed.ncbi.nlm.nih.gov/24598155,https://www.ncbi.nlm.nih.gov/pmc//PMC3974001,https://doi.org/10.1186/1756-8722-7-20, pii/1756-8722-7-20Titles
Type Language Text Primary title (Title Type#primary) English (Tags for the Identification of Languages#en) Long-term results of a phase II study with neoadjuvant docetaxel chemotherapy and complete androgen blockade in locally advanced and high-risk prostate cancer. Abstracts
Text **BACKGROUND:** Patients with locally advanced and high-risk prostate cancer (LAPC) are prone to experience biochemical recurrence despite radical prostatectomy (RP). We evaluated feasibility, safety and activity of a neoadjuvant chemohormonal therapy (NCHT) with 3-weekly full dose docetaxel and complete androgen blockade (CAB) in locally advanced and high-risk prostate cancer patients (LAPC) undergoing RP. **METHODS:** Patients (n = 30) were selected by Kattans' preoperative score and received trimestral buserelin 9,45 mg, bicalutamide 50 mg/day and 3 cycles docetaxel (75 mg/m²) followed by RP. Primary endpoints were biochemical (PSA) and local downstaging. Secondary endpoints included toxicity and operability assessments, pathological complete response (pCR), time to PSA progression, 5-year biochemical recurrence free survival (bRFS) and overall survival (OS). **RESULTS:** Median baseline PSA was 25.8 ng/ml (2.1-293), and the predicted probability of 5-year bRFS was 10% (0-55). NCHT induced PSA-reduction was 97.3% (81.3-99.9%; p < 0.001) and post-RP 96.7% of patients were therapy responders, with undetectable PSA-values. Post- vs. pretreatment MRI indicated a median tumor volume reduction of 46.4% (-31.3-82.8; p < 0.001). A pathological downstaging was observed in 48.3%. Severe hematologic toxicities (≥CTC3) were frequent with 53.8% leucopenia, 90% neutropenia and 13.3% febrile neutropenia. RP was performed in all patients. While resectability was hindered in 26.7%, continence was achieved in 96.7%. Pathologic analyses revealed no pCR. Lymph node- and extracapsular involvement was observed in 36.7% and 56.7% with 33.3% positive surgical margins. After a median of 48.6 (19.9-87.8) months, 55.2% of therapy responders experienced PSA-recurrence. The estimated median time to PSA-progression was 38.6 months (95%CI 30.9-46.4) and 85.3 months (95%CI 39.3-131.3) for OS. The 5-year bRFS was improved to 40%, but limiting for interpretation adjuvant treatment was individualized. **CONCLUSIONS:** NCHT is feasible despite high hematotoxicity, with excellent functional results. Significant downstaging was observed without pCR. NCHT seems to improve the cohort adjusted 5-year bRFS, but clinical value needs further investigation in randomized trials. relatesTo
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classifier: Journal Article (Citation Artifact Classifier#D016428)
artifactAssessment: : Classifier added by Computable Publishing LLC
classification
type: Citation Subset (Cited Artifact Classification Type#citation-subset)
classifier: IM (elements_descriptions.html#citationsubset#IM)
contributorship
complete: true
entry
name: Mark Thalgott
forenameInitials: M
affiliation: : Department of Urology, Klinikum rechts der Isar, Technische Universität München, Ismaninger Str, 22, Munich 81675, Germany. mark.thalgott@lrz.tum.de.
entry
name: Thomas Horn
forenameInitials: T
entry
name: Matthias M Heck
forenameInitials: MM
entry
name: Tobias Maurer
forenameInitials: T
entry
name: Matthias Eiber
forenameInitials: M
entry
name: Margitta Retz
forenameInitials: M
entry
name: Michael Autenrieth
forenameInitials: M
entry
name: Kathleen Herkommer
forenameInitials: K
entry
name: Bernd J Krause
forenameInitials: BJ
entry
name: Jürgen E Gschwend
forenameInitials: JE
entry
name: Uwe Treiber
forenameInitials: U
entry
name: Hubert R Kübler
forenameInitials: HR
Generated Narrative: Practitioner #author0
name: Mark Thalgott
Generated Narrative: Practitioner #author1
name: Thomas Horn
Generated Narrative: Practitioner #author2
name: Matthias M Heck
Generated Narrative: Practitioner #author3
name: Tobias Maurer
Generated Narrative: Practitioner #author4
name: Matthias Eiber
Generated Narrative: Practitioner #author5
name: Margitta Retz
Generated Narrative: Practitioner #author6
name: Michael Autenrieth
Generated Narrative: Practitioner #author7
name: Kathleen Herkommer
Generated Narrative: Practitioner #author8
name: Bernd J Krause
Generated Narrative: Practitioner #author9
name: Jürgen E Gschwend
Generated Narrative: Practitioner #author10
name: Uwe Treiber
Generated Narrative: Practitioner #author11
name: Hubert R Kübler
Generated Narrative: ArtifactAssessment #meshHeading0
artifact: #
content
informationType: classifier
type: components (if present) include qualifier codings (Cited Artifact Classification Type#mesh-heading "MeSH heading")
classifier: Aged (#D000368)
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: Androgen Antagonists (#D000726)
freeToShare: true
component
type: qualifier ()
classifier: is not a major topic ()
component
type: qualifier ()
classifier: therapeutic use (#Q000627)
component
content
informationType: classifier
type: components (if present) include qualifier codings (Cited Artifact Classification Type#mesh-heading "MeSH heading")
classifier: Disease Progression (#D018450)
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: Docetaxel (#D000077143)
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: Humans (#D006801)
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: Male (#D008297)
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: Middle Aged (#D008875)
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: Neoadjuvant Therapy (#D020360)
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: 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: surgery (#Q000601)
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: adverse effects (#Q000009)
component
component
type: qualifier ()
classifier: therapeutic use (#Q000627)
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 2024-04-27
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