HER2 Testing in Gastric Cancer: Algorithm for Pathologists

Tissue sample from patient diagnosed with GEA

Perform
HER2 test
using IHC

Surgical Specimen Surgical Specimen Surgical Specimen Surgical Specimen

Strong, complete basolateral Weak to moderate, complete Faint/barely perceptible No reactivity or
or lateral membranous basolateral or lateral membranous reactivity membranous
reactivity in ≥10% of membranous reactivity in ≥10% of tumor cells; cells reactivity in ‹10%
tumor cells in ≥10% of tumor cells reactive only in part of their of tumor cells
membrane
Biopsy Specimen Biopsy Specimen Biopsy Specimen
Tumor cell cluster* with Tumor cell cluster* with Biopsy Specimen No reactivity in
strong, complete basolateral weak to moderate, complete Tumor cell cluster* with any tumor cells
or lateral membranous basolateral or lateral faint or barely membranous
activity irrespective of membranous activity reactivity irrespective of
percentage of tumor irrespective of percentage tumor cells stained
cells stained of tumor cells stained

IHC 3+ IHC 2+ IHC 1+ IHC 0

Positive Equivocal Negative Negative

No further No further
Perform
ISH testing ISH testing
ISH testing
is required required

Bartley AN, Washington K, Ventura CB, et al. 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. Arch Pathol Lab Med. 2016;140(12):1345-1363. doi: 10.5858/arpa.2016-0331-CP

© 2016 College of American Pathologists. All rights reserved.

25211.1116