AIM: To compare the effect, adverse events, cost-effectiveness and dose intensity (DI) of oral Xeloda vs calcium folinate (CF)/5-FU combination chemotherapy in patients with advanced gastrointestinal malignancies, both combined with bi-platinu two-way chemotherapy. METHODS: A total of 131 patients were enrolled and randomly selected to receive either oral Xeloda (X group) or CF/5-FU (control group). Oral Xeloda 1 000 mg/m2 was administered twice daily from d 1 to 14 in X group, while CF 200 mg/m2 was taken as a 2-h intravenous infusion followed by 5-FU 600 mg/m2 intravenously for 4-6 h on d 1-5 in control group. Cisplatin and oxaliplatin were administered in the same way to both the groups: cisplatin 60-80 mg/m2 by hyperthermic intraperitoneal administration, and oxaliplatin 130 mg/m2 intravenously for 2 h on d 1. All the drugs were recycled every 21 d, with at least two cycles. Pyridoxine 50 mg was given t.i.d. orally for prophylaxis of the hand-foot syndrome (HFS). Then the effect, adverse events, cost-effectiveness and DI of the two groups were evaluated. RESULTS: Hundred and fourteen cases (87.0%) finished more than two chemotherapy cycles. The overall response rate of them was 52.5% (X group) and 42.4% (control group) respectively. Tumor progression time (TTP) was 7.35 mo vs 5.95 mo, and 1-year survival rate was 53.1% vs 44.5%. There was a remarkable statistical significance of TTP and 1-year survival between the two groups. The main Xeloda-related adverse events were myelosuppression, gastrointestinal toxicity, neurotoxicity and HFS, which were mild and well tolerable. Therefore, no patients withdrew from the study due to side effects before two chemotherapy cycles were finished. Both groups finished pre-arranged DI and the relative DI was nearly 1.0. The average cost for 1 patient in one cycle was Y9 137.35 (X group) and Y8 961.72 (control group), or US $1100.89 in X group and $1 079.73 in control group. To add 1% to the response rate costs ￥161.44 vs ￥210.37 respectively (US $19.45 vs $25.35). One-month prolongation of TTP costs ￥1 243.18 vs ￥1506.17 (US $149.78 vs $181.47). Escalation of 1% of 1-year survival costs ￥172.74 vs ￥201.64 (US $20.75 vs $24.29). CONCLUSION: Oral Xeloda combined with bi-platinu two-way combination chemotherapy is efficient and tolerable for patients with advanced gastrointestinal malignancies; meanwhile the expenditure is similar to that of CF/5-FU combined with bi-platinu chemotherapy, and will be cheaper if we are concerned about the increase of the response rate, TTP or 1-year-survival rate pharmacoeconomically. AIM: To compare the effect, adverse events, cost-effectiveness and dose intensity (DI) of oral Xeloda vs calcium folinate (CF) / 5-FU combination chemotherapy in patients with advanced gastrointestinal malignancies, both combined with bi-platinu two-way METHODS: A total of 131 patients were enrolled and randomly selected to receive either oral Xeloda (X group) or CF / 5-FU (control group). Oral Xeloda 1 000 mg / m2 was administered twice daily from d 1 to 14 in X group, while CF 200 mg / m2 was taken as a 2-h intravenous infusion followed by 5-FU 600 mg / m2 intravenously for 4-6 h on d 1-5 in control group. Cisplatin and oxaliplatin were administered in the same way to both the groups: cisplatin 60-80 mg / m2 by hyperthermic intraperitoneal administration, and oxaliplatin 130 mg / m2 intravenously for 2 h on d 1. All the drugs were recycled every 21 d with at least two cycles. Pyridoxine 50 mg was given tid orally for prophylaxis of the hand-foot syndrome (HFS). Then the effect, a RESULTS: Hundred and fourteen cases (87.0%) finished more than two cycles. The overall response rate of them was 52.5% (X group) and 42.4% (control The Tumor progression time (TTP) was 7.35 mo vs 5.95 mo, and 1-year survival rate was 53.1% vs 44.5%. There was a remarkable statistical significance of TTP and 1-year survival between the two groups. Xeloda-related adverse events were myelosuppression, gastrointestinal toxicity, neurotoxicity and HFS, which were mild and well tolerable. Therefore, no patients withdrew from the study due to side effects before two chemotherapy cycles were finished. Both groups finished pre-arranged DI and the relative DI was nearly 1.0. The average cost for 1 patient in one cycle was Y9 137.35 (X group) and Y8 961.72 (control group), or US $ 1100.89 in X group and $ 1 079.73 in control group. To add 1% to the response rate costs ¥ 161.44 vs ¥ 21 0.371-of-1 prolongation of TTP costs ¥ 1 243.18 vs ¥ 1506.17 (US $ 149.78 vs $ 181.47). Escalation of 1-year survival costs ¥ 172.74 vs ¥ 201.64 (US $ 20.75 vs $ 24.29). CONCLUSION: Oral Xeloda combined with bi-platinu two-way combination chemotherapy is efficient and tolerable for patients with advanced gastrointestinal malignancies; meanwhile the expenditure is similar to that of CF / 5-FU combined with bi-platinu chemotherapy, and will be cheaper if we are concerned about the increase of the response rate, TTP or 1-year-survival rate pharmacoeconomically.