High doses of 5-fluorouracil and epirubicin with or without cisplatin in advanced gastric cancer: A randomized study

Background: A prospective randomized clinical study was performed in patients with locally advanced or metastatic gastric cancer. The purpose of the study was to determine the activity of high doses of 5-fluorouracil and epirubicin (FE) vs the same combination + cisplatin (FEP), and particularly the value of cisplatin in the combination. Patients and methods: A total of 122 patients was included in the study; 110 of them were assessable. In the FE arm, the treatment involved 1000 mg/m(2) in a 6-hr infusion of 5-fluorouracil on days 1, 2, 3, 4 and 5 and 120 mg/m(2) of epirubicin iv on day 1. In the FEP arm, the same combination of cytostatics + cisplatin (30 mg/m(2)) was administered on days 2 and 4. The cycles were repeated after 4 weeks. Altogether, 468 cycles of chemotherapy were given (FE, 240; FEP, 228). Results: In the FE arm, 56 patients were assessable, with 2 complete and 14 partial remissions (28.6%); in the FEP arm, 4 complete and 19 partial remissions (42.6%) were observed in 54 assessable patients. Median survival in the FE group was 7.1 months and in the FEP group 9.6 months. The survival difference was statistically significant (Cox's test, P <0.05). The most frequent side effects included grade 2 and 3 alopecia (FE, 93%; FEP, 94%) and grade 2 and 3 vomiting (FE, 20%; FEP, 35%). Grade 3 and 4 leukopenia was observed in 9% of patients in the FE group and in 13% of patients in the FEP group, with 6 cases of febrile neutropenia (FE, 4%; FEP, 7%). Stenocardia was registered in 1 patient in the FE group and in 2 patients in the FEP group. No treatment-related death was registered. Conclusions: The addition of cisplatin to high doses of 5-fluorouracil and epirubicin resulted in a statistically significant better survival of treated patients.