改良FOLFOX方案一线治疗晚期大肠癌的临床观察

A phase Ⅱ trial of modified FOLFOX4 as first-line Chemotherapy inAdvanced Colorectal Cancer

目的以FOLFOX4方案为基础,改变奥沙利铂、5-氟脲嘧啶和亚叶酸钙的使用方法及剂量,设计改良的FOLFOX方案,一线治疗晚期大肠癌,观察其疗效和毒副反应。方法51例晚期大肠癌患者接受奥沙利铂85mg/m2静脉点滴2h,第1天;亚叶酸钙400mg/m2静脉点滴2h,第1天;5-氟脲嘧啶2.6g/m2,持续静脉输注46h,每2周重复。结果完全缓解2例、部分缓解22例、稳定14例、疾病进展13例,全组有效率47.0%(24/51)。生活质量明显改善38例(74.6%)。毒副反应主要是恶心呕吐、骨髓抑制、手足麻木,程度均较轻。结论改良FOLFOX方案一线治疗晚期大肠癌疗效确切,毒副反应可耐受。

Objective To evaluate the efficacy and toxicity of our modified FOLFOX4 regimen when it was given as first line in advanced colorectal cancer. Methods 51 patients with measurable disease received a 2-hour infusion of leucovorin （400 mg/m^2/d） on day 1 followed by a 46-hour continuous infusion of 5-FU （2.6 g/m^2） every 2 weeks, together with oxaliplatin 85 mg/m^2 as a 2-hour infusion on day 1. Results The overall response rate （OR） was 47.0% （24/51）, with 2 complete responses （CR）、22 partial responses （PR）、14 stable diseases （SD） and 13 progressive diseases （PD）. Quality of life （QOL） was improved obviously in 38 patients （74.6%）. The most common toxicities, observed mild and moderate, were nausea and vomiting、myelosuppression、dysesthesia. Conclusion Modified FOLFOX4 regimen was active to advanced eolorectal cancer with good tolerability.