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...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/m^2 was administered twice daily from d 1 to 14 in X group, while CF 200 mg/m^2 was taken as a 2-h intravenous infusion followed by 5-FU 600 mg/m^2 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/m^2 by hyperthermic intraperitoneal administration, and oxaliplatin 130 mg/m^2 intravenouslyfor 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 vs5.95 too, 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 Xelocla-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 ￥9 137.35 （X group） and ￥8 961.72 （control group）, or US ＄1 100.89 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 ￥1 506.17 （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.展开更多
Objective： We assessed the safety and efficacy of two regimens for patients with gastrointestinal cancers： continuous-infusion （CI） schedules of 5-Fluorouracil （5-Fu） plus a platinum （cisplatin or oxaliplatin）...Objective： We assessed the safety and efficacy of two regimens for patients with gastrointestinal cancers： continuous-infusion （CI） schedules of 5-Fluorouracil （5-Fu） plus a platinum （cisplatin or oxaliplatin） with/or without paclitaxel （regimen A） versus Xeloda plus a platinum （cisplatin or oxaliplatin） with/or without paclitaxel for oral use （regimen B） in patients with gastrointestinal cancers. Methods： Between May 2003 and May 2005, 84 patients diagnosed in Jiangsu Cancer Hospital ＆ Research Institute with locally advanced esophageal, gastnc or colorectal cancer were registered. Regimen A and B consisted of either 5-Fu 0.375 CI days 1-14, every 28 days （n = 44）, or Xeloda 1000 mg twice daily, days 1-14, every 28 days （n = 40）. For both regimen A and B, IV cisplatin 25 mg/m^2 was administered on day 1, 2 and 3 （or Oxaliplatin 75mg/m^2 on day 1, 8 and 15） with or without paclitaxel 60-75 mg/m^2 on day1, 8 and 15. Results： Patients receiving regimen B experienced significantly less stomatitis （P 〈 0.05） and diarrhea （P 〈 0.05）, than those receiving regimen A. Prevalence of nausea/vomiting, alopecia, neutropenia, and hand-foot syndrome without significant difference between two regimens. No treatment related death occurred during study period. Regimen B demonstrates a similar, favorable safety profile in this study. Response rates and rates of clinical benefit for regimen A and B were 40.9%, 40.0% and 43.2%, 65.0% respectively. Conclusion： Based on its improved safety profile and improved rate of clinical benefit, Xeloda has the potential to replace CI 5-FU as an alternative treatment for patients with gastrointestinal cancers.展开更多
基金Supported by the Funds of Clinical New Technology from Xijing Hospital, Fourth Military Medical University, No. XJGXO4018M13
文摘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/m^2 was administered twice daily from d 1 to 14 in X group, while CF 200 mg/m^2 was taken as a 2-h intravenous infusion followed by 5-FU 600 mg/m^2 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/m^2 by hyperthermic intraperitoneal administration, and oxaliplatin 130 mg/m^2 intravenouslyfor 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 vs5.95 too, 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 Xelocla-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 ￥9 137.35 （X group） and ￥8 961.72 （control group）, or US ＄1 100.89 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 ￥1 506.17 （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.
基金Supported by grants from the Jiangsu Provincial Personnel Department "the Great of Six Talented Man Peak" Project and the Jiangsu Cancer Hospital Emphasis Project (No. ZK200602).
文摘Objective： We assessed the safety and efficacy of two regimens for patients with gastrointestinal cancers： continuous-infusion （CI） schedules of 5-Fluorouracil （5-Fu） plus a platinum （cisplatin or oxaliplatin） with/or without paclitaxel （regimen A） versus Xeloda plus a platinum （cisplatin or oxaliplatin） with/or without paclitaxel for oral use （regimen B） in patients with gastrointestinal cancers. Methods： Between May 2003 and May 2005, 84 patients diagnosed in Jiangsu Cancer Hospital ＆ Research Institute with locally advanced esophageal, gastnc or colorectal cancer were registered. Regimen A and B consisted of either 5-Fu 0.375 CI days 1-14, every 28 days （n = 44）, or Xeloda 1000 mg twice daily, days 1-14, every 28 days （n = 40）. For both regimen A and B, IV cisplatin 25 mg/m^2 was administered on day 1, 2 and 3 （or Oxaliplatin 75mg/m^2 on day 1, 8 and 15） with or without paclitaxel 60-75 mg/m^2 on day1, 8 and 15. Results： Patients receiving regimen B experienced significantly less stomatitis （P 〈 0.05） and diarrhea （P 〈 0.05）, than those receiving regimen A. Prevalence of nausea/vomiting, alopecia, neutropenia, and hand-foot syndrome without significant difference between two regimens. No treatment related death occurred during study period. Regimen B demonstrates a similar, favorable safety profile in this study. Response rates and rates of clinical benefit for regimen A and B were 40.9%, 40.0% and 43.2%, 65.0% respectively. Conclusion： Based on its improved safety profile and improved rate of clinical benefit, Xeloda has the potential to replace CI 5-FU as an alternative treatment for patients with gastrointestinal cancers.
