A randomized, comparative study of combination chemotherapies in advanced gastric cancer: 5-fluorouracil and cisplatin (FP) versus 5-fluorouracil, cisplatin, and 4'-epirubicin (FPEPIR). Kyoto Research Group for Chemotherapy of Gastric Cancer (KRGCGC).

Sixty patients with inoperable or recurrent gastric cancers were randomly assigned into 2 treatment regimens: the FP regimen, consisting of cisplatin (CDDP, 50 mg/body, d1) + 5-fluorouracil (5-FU, 250 mg/body, d2-d5), or the FPEPIR regimen, CDDP+5-FU (FP) + 4'-epirubicin (EPIR, 30 mg/m2, d2), administered intravenously every 2 weeks. The objective responses were evaluated in 43 patients (FP: 21; FPEPIR: 22). The response rates were 24% (5PR/21) for FP and 27% (6PR/22) for FPEPIR. Objective responses were seen in 1 primary lesion and 4 metastatic lesions in patients on the FP regimen, and in 3 primary lesions and 4 metastatic lesions in patients on the FPEPIR regimen. The 6 month and 1 year survival rates were 34% and 13% for FP, and 55% and 27% for FPEPIR, respectively (not significant). Significantly higher survival rates were demonstrated in those patients with recurrent cancers (p < 0.01) and those who responded to the FPEPIR regimen (p < 0.05). Drug toxicities were assessed in 56 patients, and were in general mild and well tolerated. However, the FP regimen induced significantly less neutropenia (p < 0.01) and less complete alopecia (p < 0.01) than the did FPEPIR regimen. These results suggest that FPEPIR may be a more beneficial regimen for the treatment of gastric cancer than FP, and may be indicated for further clinical trials.

RCT Entities:   Population Interventions Outcomes