改良FOLFOX方案治疗晚期结直肠癌的临床研究

A phase Ⅱ trial of modified FOLFOX4 as first-line chemotherapy in advanced colorectal cancer

目的:以FOLFOX4方案为基础,改变5-氟尿嘧啶的使用方法,设计改良的FOLFOX方案,一线治疗晚期结直肠癌,观察其疗效及不良反应。方法:45例结直肠癌患者接受奥沙利铂(OXA)85mg/m2静脉滴注2h,第1天,亚叶酸钙(LV)200 mg/m2静脉滴注2h,第1-2天,5-氟尿嘧啶(5-FU)1.4 mg/m2持续静脉滴注22h,第1-2天。每2周重复给药。结果:CR 1例(2.2%)、PR 21例(46.7%),总有效率(CR+PR)48.9%(22/45)。中位疾病进展时间为8.0月,中位生存时间为15.6月。不良反应主要是恶心呕吐、手足麻木、中性粒细胞减少,程度均较轻。结论:改良FOLFOX方案一线治疗晚期结直肠癌疗效较好,不良反应可耐受,是一种安全有效的化疗方案。

Objective： To evaluate the efficacy and toxicity of leucovorin plus 5 - fluorouracil combined with oxaliplatin （modified FOLFOX regimen） every 2 weeks on previously untreated advanced eolorectal cancer patients. Methods ： Forty - five inpatients were enrolled to receive a 2 - hour infusion of leueovorin 200 mg/m^2 followed by a 22 - hour infusion of 5 - FU at 1.4 mg/m^2 on daysl and 2 every 2 weeks ,together with oxaliplatin 85mg/m^2 as a 2 - hour infusion on day 1. Results： Of the 45 eligible patients, one complete response and 21 partial responses were observed for an overall response rate of 48.9%. A median time to progression was 8.0 months, and median survial time was 15.6 months. Toxicities were mild, the most common toxicities were nausea, vomiting, neutropenia, and dysesthesia. Conclusion： Modified FOLFOX regimen is active and acceptable tolerability in patients with previously untreated advanced eolorectal cancer.