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.

{"article_title":"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.","author":"Bartley AN, Washington MK, Ventura CB, Ismaila N, Colasacco C, Benson AB 3rd, Carrato A, Gulley ML, Jain D, Kakar S, Mackay HJ, Streutker C, Tang L, Troxell M, Ajani JA","journal_title":"American journal of clinical pathology","issn":"1943-7722","isbn":"","publication_date":"2016-12-01","volume":"146","issue":"6","first_page":"647","page_count":"","accession_number":"28077399","doi":"10.1093\/ajcp\/aqw206","publisher":"Oxford University Press","doctype":"Journal Article","subjects":"Adenocarcinoma diagnosis; Clinical Decision-Making; Esophageal Neoplasms diagnosis; Esophagogastric Junction pathology; Receptor, ErbB-2 genetics; Stomach Neoplasms diagnosis; Adenocarcinoma drug therapy; Adenocarcinoma genetics; Adenocarcinoma pathology; Antineoplastic Agents therapeutic use; Esophageal Neoplasms drug therapy; Esophageal Neoplasms genetics; Esophageal Neoplasms pathology; Genetic Testing; Humans; Medical Oncology; Stomach Neoplasms drug therapy; Stomach Neoplasms genetics; Stomach Neoplasms pathology; United States","interest_area":["Gastroenterology"," Oncology"],"abstract":"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. \u00a9 2016 College of American Pathologists, American Society for Clinical Pathology, and the American Society of Clinical Oncology. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.","url":"https:\/\/search.ebscohost.com\/login.aspx?direct=true&db=mdl&AN=28077399","isPdfLink":false,"isSAML":false,"an":"28077399","number_other":"","type_pub":"","issn_electronic":"1943-7722","languages":"English","language":"eng","date_entry":"Date Created: 20170113 Date Completed: 20170227 Latest Revision: 20231004","date_update":"20240104","titleSource":"American journal of clinical pathology [Am J Clin Pathol] 2016 Dec; Vol. 146 (6), pp. 647-669. Date of Electronic Publication: 2016 Nov 14.","date_pub_cy":"","type_document":"","contract_publisher":"","authored_on":"2016-12-01","description":"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.<br \/>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.<br \/>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.<br \/>Results: The panel is proposing 11 recommendations with strong agreement from the open-comment participants.<br \/>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.<br \/>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.<br \/> (© 2016 College of American Pathologists, American Society for Clinical Pathology, and the American Society of Clinical Oncology. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)","upload_link":"https:\/\/search.ebscohost.com\/login.aspx?direct=true&site=eds-live&scope=site&db=mdl&AN=28077399&authtype=shib&custid=ns346513&group=main&profile=eds","no_of_pages":"","authored_by":"Bartley AN, Washington MK, Ventura CB, Ismaila N, Colasacco C, Benson AB 3rd, Carrato A, Gulley ML, Jain D, Kakar S, Mackay HJ, Streutker C, Tang L, Troxell M, Ajani JA"}