Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that HER2-positive status confers therapeutic sensitivity to Capecitabine, Cisplatin, Trastuzumab in patients with Esophagogastric Adenocarcinoma.
The European Medicines Agency (EMA) has authorized trastuzumab in combination with capecitabine or 5-fluorouracil and cisplatin for the treatment of adult patients with HER2 positive metastatic adenocracinoma of the stomach or gastroesophageal junction who have not received prior anti-cancer treatment for their metastatic disease. The production information for trastuzumab in this indication further specifies that trastuzumab should only be used in patients with metastatic gastric cancer whose tumors have HER2 overexpressed as defined by IHC 2+ and a confirmatory SISH or FISH result, or by an IHC 3+ result, as measured by an accurate and validated assay.
This statement is based on a regulatory approval from the European Medicines Agency:
Herceptin in combination with capecitabine or 5-fluorouracil and cisplatin is indicated for the treatment of adult patients with HER2 positive metastatic adenocarcinoma of the stomach or gastro-esophageal junction who have not received prior anti-cancer treatment for their metastatic disease.