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

Angela N. Bartley*, Mary Kay Washington, Christina B. Ventura, Nofisat Ismaila, Carol Colasacco, 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

*Corresponding author for this work

Research output: Contribution to journalReview article

21 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, 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.

Original languageEnglish (US)
Pages (from-to)1345-1363
Number of pages19
JournalArchives of Pathology and Laboratory Medicine
Volume140
Issue number12
DOIs
StatePublished - Dec 1 2016

Fingerprint

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

ASJC Scopus subject areas

  • Pathology and Forensic Medicine
  • Medical Laboratory Technology

Cite this

Bartley, Angela N. ; Washington, Mary Kay ; Ventura, Christina B. ; Ismaila, Nofisat ; Colasacco, Carol ; 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 American Society of Clinical Oncology. In: Archives of Pathology and Laboratory Medicine. 2016 ; Vol. 140, No. 12. pp. 1345-1363.
@article{96a70a0794ca4374a10af78ed04f2456,
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",
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.",
author = "Bartley, {Angela N.} and Washington, {Mary Kay} and Ventura, {Christina B.} and Nofisat Ismaila and Carol Colasacco 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.}",
year = "2016",
month = "12",
day = "1",
doi = "10.5858/arpa.2016-0331-CP",
language = "English (US)",
volume = "140",
pages = "1345--1363",
journal = "Archives of Pathology and Laboratory Medicine",
issn = "0003-9985",
publisher = "College of American Pathologists",
number = "12",

}

Bartley, AN, Washington, MK, Ventura, CB, Ismaila, N, Colasacco, C, Benson III, AB, Carrato, A, Gulley, ML, Jain, D, Kakar, S, Mackay, HJ, Streutker, C, Tang, L, Troxell, M & Ajani, JA 2016, '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', Archives of Pathology and Laboratory Medicine, vol. 140, no. 12, pp. 1345-1363. https://doi.org/10.5858/arpa.2016-0331-CP

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. / Bartley, Angela N.; Washington, Mary Kay; Ventura, Christina B.; Ismaila, Nofisat; Colasacco, Carol; 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: Archives of Pathology and Laboratory Medicine, Vol. 140, No. 12, 01.12.2016, p. 1345-1363.

Research output: Contribution to journalReview article

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 American Society of Clinical Oncology

AU - Bartley, Angela N.

AU - Washington, Mary Kay

AU - Ventura, Christina B.

AU - Ismaila, Nofisat

AU - Colasacco, Carol

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 - 2016/12/1

Y1 - 2016/12/1

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, 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.

AB - 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.

UR - http://www.scopus.com/inward/record.url?scp=85004019925&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85004019925&partnerID=8YFLogxK

U2 - 10.5858/arpa.2016-0331-CP

DO - 10.5858/arpa.2016-0331-CP

M3 - Review article

C2 - 27841667

AN - SCOPUS:85004019925

VL - 140

SP - 1345

EP - 1363

JO - Archives of Pathology and Laboratory Medicine

JF - Archives of Pathology and Laboratory Medicine

SN - 0003-9985

IS - 12

ER -