Background: Trastuzumab with fluoropyrimidine and cisplatin is the standard first-line treatment in patients with HER2-positive advanced gastro-esophageal adenocarcinoma. However, there are no safety and efficacy data of trastuzumab with FOLFIRI.
Objective: To evaluate safety and efficacy of FOLFIRI plus trastuzumab in patients with HER2-positive advanced gastro-esophageal adenocarcinoma.
Patients and methods: This retrospective multicenter study included all consecutive patients with HER2-positive advanced gastro-esophageal adenocarcinoma treated with FOLFIRI plus trastuzumab between 2012 and 2015.
Results: A total of 33 patients (median age, 60.3; performance status 0-1, 78.8%) with HER2-positive advanced gastro-esophageal adenocarcinoma treated with FOLFIRI plus trastuzumab in first (n = 3), second (n = 20) or third (n = 10) line of chemotherapy were included. There was one case of a severe non-hematological adverse event corresponding to a left ventricular systolic dysfunction. The most common hematological grade 3 or 4 adverse events were neutropenia (12.9%) and thrombocytopenia (6.4%). There was no febrile neutropenia. For patients treated with FOLFIRI plus trastuzumab in second-line chemotherapy, the median overall survival was 9.5 months.
Conclusions: This is the first western population-based study of FOLFIRI plus trastuzumab reporting a satisfactory safety profile and a potential efficacy in advanced HER2-positive gastric cancer.