不同剂量方克联合草酸铂治疗胃肠道癌的Ⅰ期临床研究

Phase Ⅰ study of tegafur combined with oxaliplatin in patients with gastro in testinal cancer

目的 探索不同剂量方克 (替加氟 )联合草酸铂治疗胃肠道癌的最大耐受剂量 (MTD)和剂量限制性毒性 (DLT)。方法 方克起始剂量为 4 0 0mg/m2 ,然后分别增至 80 0mg/m2 、 110 0mg/m2和 1336mg/m2 ivd1～ 5 ,直至出现剂量限制性毒性。应用方克前给予草酸铂 130mg/m2 d1,CF10 0mgiv 2hd1～ 5。结果 11例胃肠道癌病人共完成化疗 35周期 ,中位数 3周期。MTD为 1336mg/m2 ,DLT为恶心呕吐。结论 方克 80 0～ 110 0mg/ (m2 ·d)ivgtt连用 5天联合草酸铂 130mg/m2 ivgttd1每3周重复的方法可作为国内PS 0～ 2胃肠道癌病人的推荐剂量。

Objective To determine the maximum-tolerated dose(MTD)and dose-limiting toxicity(DLT)of tegafur and oxaliplatin in patients with gastrointestinal cancers.Methods Tegafur was given at escalating doses until MTD was determined,from the initial dose of 400mg/m 2 to 800mg/m 2,1100mg/m 2 and 1336mg/m 2 on d1-5,with CF 100mg/m 2 infused over 2 hours followed by tegafur,oxaliplatin 130mg/m 2 d1.Treatment cycle was repeated every 3 weeks.Results 11 patients received tegafur and oxaliplatin for a total of 32 cycles(median 3 cycles).Nausea and vomiting were dose-limiting toxicities.The MTD of tegafur is 1336mg/m 2.Conclusion We recommend tegafur 800-1100mg/m 2 ivgtt d1-5 combine with oxaliplatin 130mg/m 2 ivgtt d1 at a 3-week interval as suitble dosage for Chinese patients with GI cancer at PS 0-2.