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一项II期试验。晚期胃癌患者口服优福定和亚叶酸钙。

A phase II trial. Oral UFT and leucovorin in patients with advanced gastric carcinoma.

作者信息

Kim Y H, Shin S W, Kim B S, Park Y T, Kim J G, Kim J S

机构信息

Department of Internal Medcine, Korea University Medical College, Seoul, Korea.

出版信息

Oncology (Williston Park). 1997 Sep;11(9 Suppl 10):119-23.

PMID:9348583
Abstract

Thirty-nine patients with locally advanced or metastatic gastric carcinoma received oral UFT (tegafur and uracil) plus leucovorin. Treatment consisted of UFT 360 mg/m2/day plus leucovorin 25 mg/m2/day, given orally in divided daily doses for 21 days followed by a 7-day rest period. The median age of the patients was 64 years, and the median World Health Organization performance status was 2. Patients received a median of two courses of treatment (range, 1 to 25). Among 37 evaluable patients, two patients achieved a complete response, and eight had partial responses, for an overall response rate of 27% (95% confidence interval, 15.4% to 42.9%). Stable disease was reported in 12 patients (32%) and another 15 showed disease progression. The median duration of response was 30 weeks, and the median duration of survival was also 30 weeks (range, 8 to 111). All patients were evaluable for toxicity. Significant toxicity (World Health Organization grade 3 or 4) included diarrhea in seven patients (18%), oral mucositis in six (15%), and nausea/vomiting in six patients. We conclude that oral UFT plus leucovorin, an outpatient regimen, has favorable activity in patients with gastric carcinoma and has tolerable toxicities.

摘要

39例局部晚期或转移性胃癌患者接受了口服优福定(替加氟和尿嘧啶)加亚叶酸钙治疗。治疗方案为优福定360mg/m²/天加亚叶酸钙25mg/m²/天,每日分剂量口服,持续21天,随后休息7天。患者的中位年龄为64岁,世界卫生组织体力状况评分中位数为2。患者接受治疗的中位数为两个疗程(范围1至25个疗程)。在37例可评估的患者中,2例达到完全缓解,8例部分缓解,总缓解率为27%(95%置信区间,15.4%至42.9%)。12例患者(32%)病情稳定,另外15例病情进展。缓解的中位持续时间为30周,生存的中位持续时间也为30周(范围8至111周)。所有患者均对毒性进行了评估。显著毒性(世界卫生组织3级或4级)包括7例患者(18%)出现腹泻,6例(15%)出现口腔黏膜炎,6例患者出现恶心/呕吐。我们得出结论,口服优福定加亚叶酸钙这种门诊治疗方案对胃癌患者具有良好的活性,且毒性可耐受。

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