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Validated Immunochemical Assay for Comprehensive Determination of the Human Epidermal Growth Factor Receptor 2 Released from and Bound to Cells

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HER2 testing in gastric cancer.

Luca Albarello¹, Lorenza Pecciarini, Claudio Doglioni

¹Department of Pathology, Università Vita-Salute San Raffaele, San Raffaele Scientific Institute, Via Olgettina 60, Milan, Italy.

Advances in Anatomic Pathology

|December 21, 2010

Summary

The ToGA trial demonstrates Trastuzumab improves survival in HER2-positive gastric and gastroesophageal junction cancers. New testing criteria are essential for accurate HER2 assessment in these patients.

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Area of Science:

Oncology
Molecular Biology
Pathology

Background:

HER2-targeted therapies are standard for breast carcinoma.
HER2 overexpression/amplification occurs in over 20% of gastric and 33% of GEJ cancers.

Purpose of the Study:

To evaluate Trastuzumab efficacy in HER2-positive gastric and GEJ cancer.
To establish appropriate HER2 testing criteria for gastric cancer specimens.

Main Methods:

International multicenter phase III clinical trial (ToGA).
HER2 testing by immunohistochemistry (IHC) and fluorescence in situ hybridization (FISH).
Comparison of gastric cancer HER2 testing criteria with breast cancer standards.

Main Results:

Trastuzumab significantly prolonged survival in HER2-positive gastric/GEJ cancer.
Gastric cancer HER2 testing criteria differ from breast cancer, allowing incomplete membrane staining and varying positive cell counts.
Heterogeneity of HER2 positivity and weaker correlation between amplification and overexpression observed in gastric cancer.

Conclusions:

Trastuzumab is an effective treatment for HER2-positive gastric and GEJ adenocarcinoma.
Specific HER2 testing protocols are crucial for accurate patient selection.
Accurate HER2 testing strengthens the pathologist's role in guiding molecular therapy selection.