BACKGROUND.
Gastric carcinoma is a substantial health problem in Turkey, and the majority of patients present with inoperable disease. The aim of this randomized trial was to assess the activity of 5-fluorouracil versus etoposide when combined with epirubicin plus cisplatin in patients with advanced gastric carcinoma (AGC).
METHODS.
In this prospective, randomized, multicenter Phase III study, previously untreated patients with histopathologically proven AGC enrolled after giving informed consent. Patients were allocated to receive either EEP (etoposide 120 mg/m 2 , epirubicin 30 mg/m 2 , and cisplatin 40 mg/m 2 on Days 1 and 8) or FEP
(5-fluorouracil 600 mg/m 2 , epirubicin 60 mg/m 2 , and cisplatin 80 mg/m 2 on Day 1), and the regimens were to be repeated every fourth week.
RESULTS.
Of a total of 131 eligible patients, 64 were in the EEP group and 67 were in the FEP group. The objective response (complete ϩ partial) rates for evaluable patients (n ϭ 118) were comparable (P ϭ 0.63) in the EEP (20.3%, 12/59) and FEP (15.3%, 9/59) groups, respectively. Actuarial analyses revealed comparable median progression free survival (6 vs. 7 months, P Ͼ 0.05) and overall survival (6 vs. 5 months, P Ͼ 0.05) duration in the EEP and FEP groups. Both regimens were well tolerated. The most common toxicity was Grade 1-2 nausea with or without vomiting. No chemotherapy-related death occurred.
CONCLUSIONS.
The current study resulted in inadequate response rates for EEP and FEP regimens. Neither combination, as used at the doses and schedules in this study, can be recommended as standard treatment for patients with AGC.