HER2 Testing and Clinical Decision Making in Gastroesophageal Adenocarcinoma

Guideline From the College of American Pathologists, American Society for Clinical Pathology, and the American Society of Clinical Oncology

Angela N. Bartley, Mary Kay Washington, Carol Colasacco, Christina B. Ventura, Nofisat Ismaila, Al B Benson III, Alfredo Carrato, Margaret L. Gulley, Dhanpat Jain, Sanjay Kakar, Helen J. Mackay, Catherine Streutker, Laura Tang, Megan Troxell, Jaffer A. Ajani

Research output: Contribution to journalArticle

58 Citations (Scopus)

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, 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.

Original languageEnglish (US)
Pages (from-to)446-464
Number of pages19
JournalJournal of clinical oncology : official journal of the American Society of Clinical Oncology
Volume35
Issue number4
DOIs
StatePublished - Feb 1 2017

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Adenocarcinoma
Guidelines
TYK2 Kinase
Clinical Decision-Making
Pathologists
Therapeutics
Combination Drug Therapy
Neoplasms
Research Design
Biomarkers

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

Cite this

Bartley, Angela N. ; Washington, Mary Kay ; Colasacco, Carol ; Ventura, Christina B. ; Ismaila, Nofisat ; Benson III, Al B ; Carrato, Alfredo ; Gulley, Margaret L. ; Jain, Dhanpat ; Kakar, Sanjay ; Mackay, Helen J. ; Streutker, Catherine ; Tang, Laura ; Troxell, Megan ; Ajani, Jaffer A. / HER2 Testing and Clinical Decision Making in Gastroesophageal Adenocarcinoma : Guideline From the College of American Pathologists, American Society for Clinical Pathology, and the American Society of Clinical Oncology. In: Journal of clinical oncology : official journal of the American Society of Clinical Oncology. 2017 ; Vol. 35, No. 4. pp. 446-464.
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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, 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.",
author = "Bartley, {Angela N.} and Washington, {Mary Kay} and Carol Colasacco and Ventura, {Christina B.} and Nofisat Ismaila and {Benson III}, {Al B} and Alfredo Carrato and Gulley, {Margaret L.} and Dhanpat Jain and Sanjay Kakar and Mackay, {Helen J.} and Catherine Streutker and Laura Tang and Megan Troxell and Ajani, {Jaffer A.}",
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HER2 Testing and Clinical Decision Making in Gastroesophageal Adenocarcinoma : Guideline From the College of American Pathologists, American Society for Clinical Pathology, and the American Society of Clinical Oncology. / Bartley, Angela N.; Washington, Mary Kay; Colasacco, Carol; Ventura, Christina B.; Ismaila, Nofisat; Benson III, Al B; Carrato, Alfredo; Gulley, Margaret L.; Jain, Dhanpat; Kakar, Sanjay; Mackay, Helen J.; Streutker, Catherine; Tang, Laura; Troxell, Megan; Ajani, Jaffer A.

In: Journal of clinical oncology : official journal of the American Society of Clinical Oncology, Vol. 35, No. 4, 01.02.2017, p. 446-464.

Research output: Contribution to journalArticle

TY - JOUR

T1 - HER2 Testing and Clinical Decision Making in Gastroesophageal Adenocarcinoma

T2 - Guideline From the College of American Pathologists, American Society for Clinical Pathology, and the American Society of Clinical Oncology

AU - Bartley, Angela N.

AU - Washington, Mary Kay

AU - Colasacco, Carol

AU - Ventura, Christina B.

AU - Ismaila, Nofisat

AU - Benson III, Al B

AU - Carrato, Alfredo

AU - Gulley, Margaret L.

AU - Jain, Dhanpat

AU - Kakar, Sanjay

AU - Mackay, Helen J.

AU - Streutker, Catherine

AU - Tang, Laura

AU - Troxell, Megan

AU - Ajani, Jaffer A.

PY - 2017/2/1

Y1 - 2017/2/1

N2 - 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.

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