González-Barón M, Feliu J, de la Gándara I, Espinosa E, Colmenarejo A, Martínez-Martínez B, Blanco E, García-Girón C, Juárez F, Garrido P
Service of Medical Oncology, Hospital La Paseo de la Castellara, Madrid, Spain.
Eur J Cancer. 1995 Dec;31A(13-14):2215-9. doi: 10.1016/0959-8049(95)00487-4.
A phase II study was performed to assess the efficacy and toxicity of UFT (tegafur-uracil in the molar ratio 1:4) modulated with leucovorin (LV) in previously untreated patients with advanced colorectal carcinoma (CRC). 79 patients with measurable advanced colorectal cancer (CRC) and no prior chemotherapy were included. 75 patients were evaluable for toxicity and response. The regimen consisted of LV 500 mg/m2 administered intravenously on day 1, followed by oral UFT 390 mg/m2 on days 1-14. Patients received oral LV 15 mg every 12 h on days 2-14. Treatment was repeated every 28 days for a minimum of four courses per patient. Three hundred and ninety-eight cycles of chemotherapy were delivered (median five per patient). 7 patients (9%) had a complete response, and 22 a partial response for an overall response rate of 39%. Mild gastrointestinal toxicity was dose limiting: grade 3-4 diarrhoea appeared in 9% of patients. Other grade 3-4 toxicities were nausea/vomiting and mucositis in 4% of patients, gastric pain and leucopenia in 3%. Oral UFT modulated by oral LV is active in advanced CRC and can be administered on an outpatient basis with no significant toxicity requiring hospitalisation. Given its excellent tolerance profile and low toxicity, the regimen should be thoroughly studied and compared with 5-fluorouracil modulated by LV.
进行了一项II期研究，以评估亚叶酸钙（LV）调节的优福定（替加氟-尿嘧啶，摩尔比1:4）对先前未接受治疗的晚期结直肠癌（CRC）患者的疗效和毒性。纳入了79例有可测量病灶的晚期结直肠癌患者且此前未接受过化疗。75例患者可进行毒性和反应评估。治疗方案为第1天静脉注射LV 500 mg/m²，随后第1 - 14天口服优福定390 mg/m²。患者在第2 - 14天每12小时口服LV 15 mg。每28天重复治疗，每位患者至少进行4个疗程。共进行了398个化疗周期（每位患者中位数为5个周期）。7例患者（9%）完全缓解，22例部分缓解，总缓解率为39%。轻度胃肠道毒性为剂量限制性毒性：9%的患者出现3 - 4级腹泻。其他3 - 4级毒性反应包括4%的患者出现恶心/呕吐和黏膜炎，3%的患者出现胃痛和白细胞减少。口服LV调节的口服优福定对晚期CRC有效，可在门诊给药，无需要住院治疗的明显毒性。鉴于其良好的耐受性和低毒性，该方案应进行深入研究并与LV调节的5 - 氟尿嘧啶进行比较。
