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.

• Authors: Angela N Bartley, Mary Kay Washington, Christina B Ventura, Nofisat Ismaila, Carol Colasacco, Al B Benson 3rd, Alfredo Carrato, Margaret L Gulley, Dhanpat Jain, Sanjay Kakar, Helen J Mackay, Catherine Streutker, Laura Tang, Megan Troxell, Jaffer A Ajani
• Journal: Archives of pathology & laboratory medicine (Arch Pathol Lab Med) Vol. 140 Issue 12 Pg. 1345-1363 (Dec 2016) ISSN: 1543-2165 [Electronic] United States
• PMID: 27841667 (Publication Type: Journal Article, Practice Guideline)

Chemical References

• Biomarkers, Tumor
• ERBB2 protein, human
• Receptor, ErbB-2

Topics

• Humans
• Adenocarcinoma (diagnosis, genetics, metabolism, therapy)
• Biomarkers, Tumor (genetics, metabolism)
• Clinical Decision-Making
• Combined Modality Therapy
• Decision Trees
• Diagnosis, Differential
• Esophageal Neoplasms (diagnosis, genetics, metabolism, therapy)
• Evidence-Based Medicine
• Medical Oncology (methods, trends)
• Molecular Diagnostic Techniques (standards)
• Molecular Targeted Therapy
• Mutation
• Neoplasm Grading
• Neoplasm Staging
• Pathology, Clinical (methods, trends)
• Receptor, ErbB-2 (antagonists & inhibitors, genetics, metabolism)
• Societies, Medical
• Stomach Neoplasms (diagnosis, genetics, metabolism, therapy)
• United States
• Systematic Reviews as Topic