scholarly journals HER2 Testing and Clinical Decision Making in Gastroesophageal Adenocarcinoma: Guideline From the College of American Pathologists, American Society for Clinical Pathology, and American Society of Clinical Oncology

2016 ◽  
Vol 140 (12) ◽  
pp. 1345-1363 ◽  
Author(s):  
Angela N. Bartley ◽  
Mary Kay Washington ◽  
Christina B. Ventura ◽  
Nofisat Ismaila ◽  
Carol Colasacco ◽  
...  

Context.— ERBB2 (erb-b2 receptor tyrosine kinase 2 or HER2) is currently the only biomarker established for selection of a specific therapy for patients with advanced gastroesophageal adenocarcinoma (GEA). However, there are no comprehensive guidelines for the assessment of HER2 in patients with GEA. Objectives.— To establish an evidence-based guideline for HER2 testing in patients with GEA, to formalize the algorithms for methods to improve the accuracy of HER2 testing while addressing which patients and tumor specimens are appropriate, and to provide guidance on clinical decision making. Design.— The College of American Pathologists, American Society for Clinical Pathology, and American Society of Clinical Oncology convened an expert panel to conduct a systematic review of the literature to develop an evidence-based guideline with recommendations for optimal HER2 testing in patients with GEA. Results.— The panel is proposing 11 recommendations with strong agreement from the open-comment participants. Recommendations.— The panel recommends that tumor specimen(s) from all patients with advanced GEA, who are candidates for HER2-targeted therapy, should be assessed for HER2 status before the initiation of HER2-targeted therapy. Clinicians should offer combination chemotherapy and a HER2-targeted agent as initial therapy for all patients with HER2-positive advanced GEA. For pathologists, guidance is provided for morphologic selection of neoplastic tissue, testing algorithms, scoring methods, interpretation and reporting of results, and laboratory quality assurance. Conclusions.— This guideline provides specific recommendations for assessment of HER2 in patients with advanced GEA while addressing pertinent technical issues and clinical implications of the results.

2017 ◽  
Vol 35 (4) ◽  
pp. 446-464 ◽  
Author(s):  
Angela N. Bartley ◽  
Mary Kay Washington ◽  
Carol Colasacco ◽  
Christina B. Ventura ◽  
Nofisat Ismaila ◽  
...  

Context ERBB2 (erb-b2 receptor tyrosine kinase 2 or HER2) is currently the only biomarker established for selection of a specific therapy for patients with advanced gastroesophageal adenocarcinoma (GEA). However, there are no comprehensive guidelines for the assessment of HER2 in patients with GEA. Objectives To establish an evidence-based guideline for HER2 testing in patients with GEA, formalize the algorithms for methods to improve the accuracy of HER2 testing while addressing which patients and tumor specimens are appropriate, and to provide guidance on clinical decision making. Design The College of American Pathologists (CAP), American Society for Clinical Pathology (ASCP), and the American Society of Clinical Oncology (ASCO) convened an Expert Panel to conduct a systematic review of the literature to develop an evidence-based guideline with recommendations for optimal HER2 testing in patients with GEA. Results The Panel is proposing 11 recommendations with strong agreement from the open comment participants. Recommendations The Panel recommends that tumor specimen(s) from all patients with advanced GEA, who are candidates for HER2-targeted therapy, should be assessed for HER2 status before the initiation of HER2-targeted therapy. Clinicians should offer combination chemotherapy and an HER2-targeted agent as initial therapy for all patients with HER2-positive advanced GEA. For pathologists, guidance is provided for morphologic selection of neoplastic tissue, testing algorithms, scoring methods, interpretation and reporting of results, and laboratory quality assurance. Conclusion This guideline provides specific recommendations for assessment of HER2 in patients with advanced GEA while addressing pertinent technical issues and clinical implications of the results.


2018 ◽  
Vol 71 (5) ◽  
pp. 388-394 ◽  
Author(s):  
Newton A C S Wong ◽  
Fernanda Amary ◽  
Rachel Butler ◽  
Richard Byers ◽  
David Gonzalez ◽  
...  

The use of biologics targeted to the human epidermal growth factor receptor 2 (HER2) protein is the latest addition to the armamentarium used to fight advanced gastric or gastro-oesophageal junction adenocarcinoma. The decision to treat with the biologic trastuzumab is completely dependent on HER2 testing of tumour tissue. In 2017, the College of American Pathologists, American Society for Clinical Pathology and the American Society of Clinical Oncology jointly published guidelines for HER2 testing and clinical decision making in gastro-oesophageal adenocarcinoma. The Association of Clinical Pathologists Molecular Pathology and Diagnostics Committee has issued the following document as a commentary of these guidelines and, in parallel, to provide guidance on HER2 testing in National Health Service pathology departments within the UK. This guidance covers issues related to case selection, preanalytical aspects, analysis and interpretation of such HER2 testing.


2011 ◽  
Vol 20 (4) ◽  
pp. 121-123
Author(s):  
Jeri A. Logemann

Evidence-based practice requires astute clinicians to blend our best clinical judgment with the best available external evidence and the patient's own values and expectations. Sometimes, we value one more than another during clinical decision-making, though it is never wise to do so, and sometimes other factors that we are unaware of produce unanticipated clinical outcomes. Sometimes, we feel very strongly about one clinical method or another, and hopefully that belief is founded in evidence. Some beliefs, however, are not founded in evidence. The sound use of evidence is the best way to navigate the debates within our field of practice.


1999 ◽  
Vol 15 (3) ◽  
pp. 585-592 ◽  
Author(s):  
Alicia Granados

This paper examines the rationality of the concepts underlying evidence—based medicineand health technology assessment (HTA), which are part of a new current aimed at promoting the use of the results of scientific studies for decision making in health care. It describes the different approaches and purposes of this worldwide movement, in relation to clinical decision making, through a summarized set of specific HTA case studies from Catalonia, Spain. The examples illustrate how the systematic process of HTA can help in several types of uncertainties related to clinical decision making.


2007 ◽  
Vol 15 (3) ◽  
pp. 508-511 ◽  
Author(s):  
Cristina Mamédio da Costa Santos ◽  
Cibele Andrucioli de Mattos Pimenta ◽  
Moacyr Roberto Cuce Nobre

Evidence based practice is the use of the best scientific evidence to support the clinical decision making. The identification of the best evidence requires the construction of an appropriate research question and review of the literature. This article describes the use of the PICO strategy for the construction of the research question and bibliographical search.


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