Delord J-P, Bennouna J, Artru P, Perrier H, Husseini F, Desseigne F, François E, Faroux R, Smith D, Piedbois P, Naman H, Douillard J Y, Bugat R
Institut Claudius Regaud, 20-24 rue du Pont saint Pierre, Toulouse 31052, France.
Br J Cancer. 2007 Aug 6;97(3):297-301. doi: 10.1038/sj.bjc.6603889. Epub 2007 Jul 17.
This phase II trial was performed to evaluate the efficacy and tolerability of oral tegafur-uracil (UFT) with leucovorin (LV) combined with intravenous (i.v.) irinotecan every 3 weeks (TEGAFIRI) as first-line treatment for patients with metastatic colorectal cancer (mCRC). Patients received oral UFT 250 mg m(-2) day(-1) and LV 90 mg day(-1) in three divided daily doses for 14 days followed by a 1-week rest and i.v. irinotecan 250 mg m(-2) as a 90-min infusion every 3 weeks. Tumour responses, assessed every two cycles using RECIST criteria, were reviewed by an independent review committee. In 52 evaluable patients, the best overall response rate was 33% (95% confidence intervals (CI) 20-47%; 1 complete and 16 partial responses). The median time to progression was 5.4 months (95% CI 3.02-7.52 months) and median overall survival was 14.9 months (11.73-17.97 months). A total of 307 cycles were administered, with a median number of five cycles per patient (range: 1-10). The most common grade 3/4 toxicities were neutropenia (25% of patients), diarrhoea (22%), vomiting (11%) and anaemia (11%). The TEGAFIRI regimen is a feasible, well-tolerated and convenient treatment option for patients with non-resectable mCRC.
本II期试验旨在评估口服替加氟-尿嘧啶（UFT）联合亚叶酸钙（LV）并每3周静脉注射（i.v.）伊立替康（TEGAFIRI）作为转移性结直肠癌（mCRC）患者一线治疗的疗效和耐受性。患者接受口服UFT 250 mg m(-2) 天(-1) 和LV 90 mg天(-1)，分三次每日给药，共14天，随后休息1周，每3周静脉注射伊立替康250 mg m(-2)，输注90分钟。使用RECIST标准每两个周期评估一次肿瘤反应，由独立审查委员会进行审查。在52例可评估患者中，最佳总体缓解率为33%（95%置信区间（CI）20 - 47%；1例完全缓解和16例部分缓解）。中位疾病进展时间为5.4个月（95% CI 3.02 - 7.52个月），中位总生存期为14.9个月（11.73 - 17.97个月）。共进行了307个周期的治疗，每位患者的中位周期数为5个（范围：1 - 10）。最常见的3/4级毒性反应为中性粒细胞减少（25%的患者）、腹泻（22%）、呕吐（11%）和贫血（11%）。TEGAFIRI方案对于不可切除的mCRC患者是一种可行、耐受性良好且方便的治疗选择。
