A phase II trial of epirubicin plus oxaliplatin and fluorouracil as first-line chemotherapy for advanced gastric cancer.

BACKGROUND AND OBJECTIVE

The prognosis of advanced gastric cancer (AGC) is poor. No standard chemotherapy regimens for AGC are available so far. Randomized studies have revealed that epirubicin plus oxaliplatin and 5-fluorouracil (5-FU) (EOF) regimen could improve the response rate and prolong survival in patients with AGC. This study was to evaluate the efficacy and toxicity of EOF regimen as first-line chemotherapy for AGC patients.

METHODS

Fifty-two patients with pathologically confirmed AGC were entered into the study. On day 1, patients were intravenously injected with 50 mg/m(2) epirubicin, infused with 85 mg/m(2) oxaliplatin over 2 h, infused with 400 mg/m(2) calcium folinate (CF) over 2 h, followed by a 46-h infusion of 5-FU at 2600 mg/m(2). The cycle was repeated every three weeks. Treatment efficacy was evaluated every two cycles based on the RECIST standard. All patients received at least two cycles of therapy.

RESULTS

Patients received a total of 220 cycles of treatment, and all were evaluable for efficacy and toxicity. The overall response rate was 46.15%. Three cases (5.77%) achieved complete response (CR), 21 (40.38%) achieved partial response (PR), 18 (34.62%) had stable disease (SD), and 10 had progression disease (PD). The median time to progression (TTP) was 6.5 months and the median survival time (MST) was 9.8 months. Hematologic toxicities included 14 cases (26.92%) of grades 3-4 neutropenia, two of which were accompanied with fever, and four cases of grade 3 thrombocytopenia. The main non-hematologic toxicities included six cases of grade 3 nausea and vomiting (11.54%), and 28 cases of grades 1-3 neurotoxicity (53.84%). No treatment related deaths occurred.

CONCLUSION

EOF regimen is effective and well tolerated as first-line chemotherapy for AGC patients.