Aim: To compare the efficacy and safety of paclitaxel combined with fluorouracil plus cisplatin (PCF), and oxaliplatin combined with fluorouracil plus leucovorin (FOLFOX-4) regimens for advanced gastric cancer (AGC).
Methods: Ninety-four patients with AGC were randomly assigned to receive paclitaxel (50 mg/m(2) iv) on days 1, 8 and 15, cisplatin (20 mg/m(2) iv) and fluorouracil (750 mg/m(2) iv) on days 1-5, or oxaliplatin (85 mg/m(2) iv) and leucovorin (200 mg/m(2) iv) on day 1, followed by bolus fluorouracil (400 mg/m(2) iv) and fluorouracil (600 mg/m(2) iv) on days 1 and 2. The primary end point was the 1-year survival time.
Results: The overall response rate (ORR) of the patients was 48.0% and 45.5% to PCF and FOLFOX-4, respectively. The disease control rate (DCR) of PCF and FOLFOX-4 was 82.0% and 81.8%, respectively. The median survival times (MSTs) of the patients were 10.8 and 9.9 mo, respectively, after treatment with PCF and FOLFOX-4. The 1-year survival rate of the patients was 36.0% and 34.1%, respectively, after treatment with PCF and FOLFOX-4. No significant difference was observed in ORR, DCR, MST or 1-year survival rate between the two groups. The most common adverse events were anemia, nausea and vomiting, and grade 3/4 alopecia in PCF treatment group, and anemia, grade 1/2 neurotoxic effect and grade 3/4 neutropenia in FOLFOX-4 treatment group.
Conclusion: Patients with AGC have a similar response rate to PCF and FOLFOX-4 regimens with a similar survival rate. The PCF and FOLFOX-4 regimens are efficacious and tolerable as a promising therapy for AGC.
Keywords: Advanced gastric cancer; Oxaliplatin; Paclitaxel.