5-Fu静脉泵持续输注与口服希罗达治疗消化道肿瘤的安全性及疗效的观察

The Observation of Safety and Efficacy of Continuous-Infusion 5-Fluorouracil Versus Xeloda for Gastrointestinal Cancer

目的 观察静脉持续输注5-Fu＋草酸铂（或顺铂）±紫杉醇，与口服希罗达＋草酸铂（或顺铂）±紫杉醇治疗消化道肿瘤的安全性及近期疗效。方法 2003年5月至2005年5月收治的胃肠道肿瘤患者中，接受5-Fu静脉泵持续输注者44例（A组），口服希罗达者40例（B组），5-Fu0．375静脉泵持续静脉输注24h共14天；希罗达1000mg口服，2次／天，连续14d；紫杉醇60～75mg／m^2溶于250mL生理盐水后静脉滴入d1,8,15；顺铂25mg／m^2水化后静脉滴入d1-3（或草酸铂75mg／m^2溶于5％葡萄糖500mL后静脉滴入d1,8,15），28d后重复。结果 两组口腔炎Ⅲ～Ⅳ度发生率比较有统计学差异（P〈0．05）；Ⅲ～Ⅳ度恶心、呕吐发生率比较无统计学差异（P〉0．05）；Ⅲ～Ⅳ度腹泻发生率比较差异有统计学意义（P〈0．05）；脱发、手足综合征及对肝功能影响相似（P〉0．05）；白细胞下降及血小板减少Ⅲ～Ⅳ度发生率，两组比较无统计学差异。A组和B组有效率分别为40．9％和40．0％，两组比较无统计学差异；两组的临床受益率分别为A组43．2％和B组65．0％，有统计学差异（P〈0．05）。结论 口服希罗达方案疗效满意，治疗简便，相对安全，有可能代替5-Fu应用于消化道肿瘤患者。

Objective We assessed the safety and efficacy of two regimens, continuous-infusion （CI） schedules of 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 （regimen B） in patients with gastrointestinal cancers. Methods From May 2003 to May 2005, 84 patients diagnosed in Jiangsu Tumor Hospital with locally advanced esophageal, gastric or colorectal cancers were registered. Regimens A and B consisted of either 5-Fu, 200 mg/m^2 CI days 1 - 14, every 28 days （n = 44）, or Xeloda 1000mg po twice daily, days 1 - 14 every 28 days （n = 40）. For both regimens A and B, Cisplatin 25 mg/m^2 was administered for day 1, 2 and 3 （or Oxaliplatin 75mg/m^2 to days 1, 8 and 15） with or without Paclitaxel （60 - 75mg/m^2 for days 1, 8 and 15）. Results The patients who received regimen B experienced significantly less stomatitis （P 〈 0.05） and diarrhea （P 〈 0.01 ）, than those who received regimen A. Prevalence of nausea/vomiting, alopecia, neutropenia, and hand-foot syndrome was not different between the two regimens. No treatment related to death occurred during the study period. Regimen B demonstrated a similar, favorable safety profile in this study. Response rates and rates of clinical benefit for regimens A and B were 40.9%, 40.0% and 43.2%, 65.0% respectively. Conclusions 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.