Chemotherapy with Epirubicin, Cisplatin, and Continuous 5-Fluorouracil for Advanced Gastric Adenocarcinoma

Objective: There is no widely accepted standard chemotherapy regimen for advanced adenocarcinoma of the stomach. An impressive 77% response rate with epirubicin, cisplatin, and 5-fluorouracil chemotherapy was obtained in a phase II trial and subsequently confirmed in a phase III trial. This regimen has been adopted for the treatment of patients with advanced gastric cancer in Israel and a study was performed to document the experience with this regimen. Patients and Methods: From January 1998 to December 2001, thirty patients with pathologically confirmed advanced adenocarcinoma of the stomach were treated with epirubicin 50 mg/m² and cisplatin 60 mg/m² given intravenously every 3 weeks, and 5-fluorouracil 200 mg/m²/day given by continuous intravenous infusion. The median age was 57 years. Twenty three patients (77%) presented with stage IV disease, and 7 patients (23%) had relapsed after initial surgery. The treatment was continued until unacceptable toxicity or disease progression. Results: All patients were eligible for evaluation of response and toxicity. The total number of cycles given was 129 (mean, 4 cycles). The average given relative-dose intensity was 0.82. Therapy was well-tolerated. Five patients (17%) developed grade 3 to 4 vomiting in 7 cycles. Grade 3 to 4 haematological toxicities were neutropenia in 15 patients (50%) in 33 cycles (26%), and anaemia in 1 patient. Three episodes of febrile neutropenia in 3 patients (10%) were registered. Five patients required admission to hospital for toxicity. No treatment related deaths were reported. One patient (3%) with liver metastases achieved complete response and remained disease-free for 7.5 months. Partial response was registered in 5 patients (17%). Disease remained stable in 9 patients (30%). The median progression-free survival was 4.5 months, median survival was 7.5 months, and 1-year survival was 23%. Conclusion: Epirubicin, cisplatin, and 5-fluorouracil chemotherapy for advanced gastric adenocarcinoma is well tolerated with acceptable toxicity, but the response and survival rates in community practice are lower than reported in clinical trials.