Hybridization for human epidermal growth factor receptor 2 testing in gastric carcinoma: a comparison of fluorescence in-situ hybridization with a novel fully automated dual-colour silver in-situ hybridization method
2011

Comparing Two Methods for HER2 Testing in Gastric Cancer

Sample size: 166 publication Evidence: high

Author Information

Author(s): García-García Elena, Gómez-Martín Carlos, Angulo Bárbara, Conde Esther, Suárez-Gauthier Ana, Adrados Magdalena, Perna Cristian, Rodríguez-Peralto José Luis, Hidalgo Manuel, López-Ríos Fernando

Primary Institution: Laboratorio de Dianas Terapéuticas, Centro Integral Oncológico ‘Clara Campal’, Hospital Universitario Madrid Sanchinarro, Universidad San Pablo-CEU

Hypothesis

The study aims to compare fluorescence in-situ hybridization (FISH) with a novel automated dual-colour silver-enhanced in-situ hybridization (SISH) method for HER2 testing in gastric carcinoma.

Conclusion

The dual-colour SISH method is a valid alternative for determining HER2 status in gastric cancer, showing high concordance with FISH.

Supporting Evidence

  • 17.5% of samples were amplified by FISH and 21% by SISH.
  • 96.4% of cases showed concordance between FISH and SISH results.
  • Heterogeneity was identified in up to 52% of cases.
  • All discordant cases were confirmed negative for amplification by real-time PCR.
  • Raising the SISH cut-off for amplification to ≥3 resulted in perfect concordance.

Takeaway

This study looked at two ways to test for a specific gene in stomach cancer, finding that a new method works just as well as the old one.

Methodology

The study involved analyzing 166 gastric carcinoma samples using both FISH and SISH methods, with discordant cases further analyzed by real-time PCR.

Potential Biases

Potential interobserver differences in scoring the hybridization results.

Limitations

The study did not address the variability of pre-analytical phases in different laboratories.

Participant Demographics

The study included gastric adenocarcinoma samples from various Spanish institutions, with 30.1% being endoscopic biopsies and 69.9% surgical specimens.

Statistical Information

P-Value

0.0046

Confidence Interval

0.6–0.9

Statistical Significance

p<0.0001

Digital Object Identifier (DOI)

10.1111/j.1365-2559.2011.03894.x

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