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IHC single marker with reporting C-erb-B2 for Gastric carcinoma Her2 Neu
Cancer
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IHC Single Marker with Reporting C-erb-B2 for Gastric Carcinoma Her2 Neu
- Why is it done?
- Detects HER2 (Human Epidermal Growth Factor Receptor 2) protein expression in gastric cancer tissue using immunohistochemistry (IHC) to assess protein overexpression or amplification
- Determines eligibility for HER2-targeted therapy (trastuzumab/Herceptin) in patients with newly diagnosed gastric or gastroesophageal junction adenocarcinoma
- Provides prognostic information about tumor behavior and patient outcomes in gastric cancer
- Routinely performed on gastric cancer tissue samples obtained from endoscopic biopsy or surgical resection specimens
- Essential component of comprehensive histopathological workup for newly diagnosed gastric malignancy to guide personalized treatment planning
- Normal Range
- IHC Scoring Scale (0 to 3+):
- Score 0: Negative - No staining or membranous staining in <10% of tumor cells. Normal/expected result indicating no HER2 overexpression.
- Score 1+: Weak/Negative - Faint membranous staining in ≥10% of tumor cells. Considered HER2 negative; patient unlikely to benefit from HER2-targeted therapy.
- Score 2+: Borderline/Equivocal - Moderate membranous staining in ≥10% of tumor cells. Requires reflex testing with FISH (Fluorescence In Situ Hybridization) or CISH (Chromogenic In Situ Hybridization) to confirm HER2 status.
- Score 3+: Positive - Strong, complete membranous staining in ≥30% of tumor cells. Indicates HER2 overexpression; patient is HER2-positive and eligible for targeted therapy such as trastuzumab.
- Interpretation Categories:
- HER2 Negative: Scores 0 and 1+ (no HER2-targeted therapy indicated)
- HER2 Positive: Score 3+ (candidate for HER2-targeted therapy)
- HER2 Equivocal: Score 2+ (requires additional confirmatory testing with FISH/CISH)
- Interpretation
- Score 0 (Negative):
- No HER2 protein overexpression detected; tumor is HER2 negative. Patient does not qualify for trastuzumab-based therapy. Standard chemotherapy regimens without HER2-targeted agents are recommended.
- Score 1+ (Negative):
- Minimal HER2 protein expression; clinically considered negative. No HER2-targeted therapy indicated. Treated as HER2-negative gastric cancer with conventional oncologic approaches.
- Score 2+ (Equivocal/Borderline):
- Intermediate HER2 expression requiring confirmation by FISH or CISH analysis to determine true HER2 gene amplification status. Results guide final therapeutic decisions. Do not provide definitive treatment recommendation until reflex testing completed.
- Score 3+ (Positive):
- Strong HER2 protein overexpression; tumor is HER2 positive. Patient is eligible for HER2-targeted immunotherapy including trastuzumab (anti-HER2 monoclonal antibody) combined with chemotherapy. Associated with more aggressive tumor behavior but better response to targeted therapy.
- Factors Affecting Results:
- Tissue fixation method and duration affect antigen preservation and staining intensity
- Specimen quality and tumor cellularity influence interpretability
- Laboratory variation in antibodies, detection systems, and interpretation standards
- Heterogeneous HER2 expression within tumor (some areas positive, others negative) may affect overall scoring
- Gastric cancer subtype (intestinal vs diffuse) influences HER2 positivity rates (higher in intestinal type)
- Associated Organs
- Primary Organ System:
- Stomach and gastroesophageal junction (gastrointestinal tract)
- Conditions Associated with Abnormal Results:
- HER2-positive gastric adenocarcinoma - associated with increased tumor aggressiveness, higher proliferation rates, and enhanced metastatic potential compared to HER2-negative tumors
- Intestinal-type gastric cancer - HER2 positivity occurs in approximately 15-20% of cases
- Gastroesophageal junction adenocarcinoma - approximately 25% of gastroesophageal junction tumors are HER2 positive
- Metastatic gastric cancer - HER2 status in primary tumor often reflective of HER2 status in metastatic sites, guiding systemic therapy across all disease sites
- Complications Associated with Abnormal Results:
- HER2-positive status: Increased risk of early recurrence, progression, and reduced overall survival without HER2-targeted therapy; potential cardiotoxicity with trastuzumab requires cardiac monitoring
- HER2-negative status: Risk of unnecessary HER2-targeted therapy if diagnosis incorrect; may have different prognosis and require alternative therapeutic approaches
- Equivocal (2+) results: Diagnostic uncertainty delays treatment planning and may result in treatment delays or misclassification
- Follow-up Tests
- Recommended for IHC Score 2+ (Equivocal Results):
- FISH (Fluorescence In Situ Hybridization) - Detects HER2 gene amplification; determines if 2+ score represents true HER2 amplification (positive) or polysomy 17. Defines true HER2 status when IHC is borderline.
- CISH (Chromogenic In Situ Hybridization) - Alternative to FISH for HER2 gene amplification detection; provides direct visualization of gene amplification status with standard light microscopy
- Complementary Tumor Marker Tests:
- PD-L1 (Programmed Death-Ligand 1) immunohistochemistry - Determines eligibility for immunotherapy; influences treatment decisions particularly in HER2-negative or immunotherapy-candidate populations
- MSI/MMR (Microsatellite Instability/Mismatch Repair) testing - Identifies microsatellite-high tumors eligible for immunotherapy; particularly relevant if HER2 negative
- Staging and Metastatic Disease Workup:
- CT chest/abdomen/pelvis - Assess extent of disease, metastatic burden, and treatment planning in HER2-positive patients considering trastuzumab
- PET-CT scan - Detects occult metastatic disease particularly in HER2-positive gastric cancer with poor prognostic implications
- Baseline Cardiac Assessment (for HER2-Positive Patients):
- Echocardiogram (ECHO) or MUGA scan - Establishes baseline left ventricular ejection fraction (LVEF) prior to trastuzumab therapy; required to monitor for cardiotoxicity
- Troponin and BNP/NT-proBNP - Baseline cardiac biomarkers; useful for early detection of cardiotoxicity during HER2-targeted therapy
- Ongoing Monitoring During Treatment:
- Repeat echocardiography - Every 3-4 months during trastuzumab therapy and at treatment completion to detect trastuzumab-associated cardiotoxicity
- Tumor markers (CEA, CA 19-9) - Monitored during and after treatment to assess treatment response and detect recurrence; elevated levels may indicate disease progression
- Surveillance imaging - CT imaging every 3-6 months during treatment and follow-up period to assess response and detect metastatic recurrence
- Fasting Required?
- Fasting Requirement: No
- Specimen Type:
- Formalin-fixed, paraffin-embedded (FFPE) tissue block or unstained tissue sections from gastric biopsy or surgical specimen; fasting is not applicable as this is a tissue-based immunohistochemistry test performed on archival specimens
- Patient Preparation Requirements:
- No specific patient preparation needed - tissue has already been collected via endoscopic biopsy or surgical resection prior to IHC testing
- Ensure proper specimen handling: Tissue must be promptly fixed in 10% neutral buffered formalin (typically within 1-2 hours of collection) for optimal preservation and antigen preservation
- Adequate tissue quantity required: Sufficient tumor tissue (≥100 cells on multiple slides) must be present in specimen to allow accurate HER2 assessment
- Labeling and documentation: Proper specimen identification, patient demographics, and clinical history must accompany tissue to pathology laboratory for accurate analysis
- Medications: No medication restrictions apply as this is an in vitro tissue test not affected by patient medications
- Timing of tissue collection: If biopsy required, typically performed during upper endoscopy; no specific timing restrictions other than diagnostic clinical need
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