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Moving Toward Personalized Treatment for Gastric Cancer: Role of HER2 Testing

Moving Toward Personalized Treatment for Gastric Cancer: Role of HER2 Testing. Frédérique Penault-Llorca, MD, PhD Professor of Pathology Centre Jean Perrin Université d'Auvergne Clermont Clermont-Ferrand, France. HER2 Testing in Gastric Cancer: Common Characteristics and Unique Features.

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Moving Toward Personalized Treatment for Gastric Cancer: Role of HER2 Testing

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  1. Moving Toward Personalized Treatment for Gastric Cancer: Role of HER2 Testing Frédérique Penault-Llorca, MD, PhD Professor of PathologyCentre Jean Perrin Université d'Auvergne Clermont Clermont-Ferrand, France

  2. HER2 Testing in Gastric Cancer: Common Characteristics and Unique Features Tissue collection Tissue morphology • Multiple biopsies (6–8) recommended • Representative samples of surgical specimens HER2 testing algorithm Turn-around time Scoring criteria HER2 = human epidermal growth factor receptor 2

  3. The Need for Multiple Biopsies Images property of Frédérique Penault-Llorca, MD, PhD.

  4. HER2 Testing in Gastric Cancer: Common Characteristics and Unique Features Tissue collection Tissue morphology • High level of tumor heterogeneity (small HER2-positive foci) • Screening of the entire specimen required for FISH • Multiple biopsies (6–8) recommended • Representative samples of surgical specimens HER2 testing algorithm Turn-around time Scoring criteria FISH = fluorescence in situ hybridization

  5. Tumor Heterogeneity Images property of Frédérique Penault-Llorca, MD, PhD.

  6. Complete, Basolateral or Lateral Membranous Staining • HER2-positive gastric and gastroesophageal junction tumors may show complete, basolateral, or lateral membranous staining • Basolateral/lateral staining occurs due to the structure of low-grade gastric adenocarcinoma cells Image property of Frédérique Penault-Llorca, MD, PhD. Hofmann M et al. Histopathology. 2008;52:797-805.

  7. HER2 Testing in Gastric Cancer: Common Characteristics and Unique Features Tissue collection Tissue morphology • High level of tumor heterogeneity (small HER2-positive foci) • Screening of the entire specimen required for FISH • Multiple biopsies (6–8) recommended • Representative samples of surgical specimens HER2 testing algorithm • Similar to breast cancer • Primary IHC testing • HER2-positive: IHC 3+ or IHC 2+/FISH+ • Bright-field methodologies preferred Turn-around time Scoring criteria IHC = immunohistochemistry

  8. Recommended HER2 Testing Algorithm in Metastatic Gastric and Gastroesophageal Junction Cancer Patient tumor sample IHC 0 1+ 2+ 3+ FISH – + Eligible for trastuzumab Trastuzumab EU SmPC: http://www.ema.europa.eu/humandocs/PDFs/EPAR/Herceptin/emea-combined-h278en.pdf.

  9. HER2-Positivity Rate in Advanced Gastric Cancer ToGA population Exploratory analysis EMA licensed population (IHC 2+/FISH+ or IHC 3+) Eligible for ToGA (IHC 3+ and/orFISH+) 16% 22% IHC 0/FISH+ or IHC 1+/FISH+ 6% 78% 78% Not eligible for ToGA Not eligible for ToGA Chung H et al. Eur J Cancer Suppl. 2 009; 7:364.

  10. HER2 Testing in Gastric Cancer: Common Characteristics and Unique Features Tissue collection Tissue morphology • High level of tumor heterogeneity (small HER2-positive foci) • Screening of the entire specimen required for FISH • Multiple biopsies (6–8) recommended • Representative samples of surgical specimens HER2 testing algorithm • Similar to breast cancer • Primary IHC testing • HER2-positive: IHC 3+ or IHC 2+/FISH+ • Bright-field methodologies preferred Turn-around time Scoring criteria • Strong basolateral, lateral or complete membrane staining in ≥10% of tumor cells is considered positive (IHC) • No percentage cut-off for biopsies

  11. HER2 Scoring Criteria in Gastric Cancer Trastuzumab EU SmPC: http://www.ema.europa.eu/humandocs/PDFs/EPAR/Herceptin/emea-combined-h278en.pdf.

  12. HER2 Testing in Gastric Cancer: Common Characteristics and Unique Features Tissue collection Tissue morphology • High level of tumor heterogeneity (small HER2-positive foci) • Screening of the entire specimen required for FISH • Multiple biopsies (6–8) recommended • Representative samples of surgical specimens HER2 testing algorithm • Similar to breast cancer • Primary IHC testing • HER2-positive: IHC 3+ or IHC 2+/FISH+ • Bright-field methodologies preferred Turn-around time Scoring criteria • Strong basolateral, lateral or complete membrane staining in ≥10% of tumor cells is considered positive (IHC) • No percentage cut-off for biopsies • Turn-around times should not exceed 5 working days (metastatic gastric cancer progresses very quickly) • Need for a multidisciplinary approach

  13. Successful HER2 Testing Requires a Multidisciplinary Approach Oncologist/Gastroenterologist Request appropriate tests & arrange sample collection Test interpretation and reporting Pathologist Surgeon/Endoscopist Patient Tissue removal, orientation & storage until collection Sample processing Test methodology Medical technician

  14. HER2 Testing in Gastric Cancer: Conclusions • All patients with gastric cancershould be tested for HER2 • Patients with HER2-positive metastatic gastric cancer are eligible to receive trastuzumab • Testing should be performed by experienced pathologists • Quality assurance/control procedures should be followed to ensure quality of HER2 testing

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