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优福定(UFT)II期研究的全国汇总数据及队列调查结果报告

Report on nationwide pooled data and cohort investigation in UFT phase II study.

作者信息

Ota K, Taguchi T, Kimura K

机构信息

Aichi Cancer Center, Nagoya, Japan.

出版信息

Cancer Chemother Pharmacol. 1988;22(4):333-8.

PMID:3139315
Abstract

UFT is a compound in which futraful (FT) and uracil are combined at a ratio of 1:4. UFT was given orally at a daily dose of 300-600 mg in a phase II study. Pooled data on a UFT phase II study of 438 evaluable patients, at 104 institutions revealed a response in carcinoma of the stomach (27.7%), pancreas (25.0%), gallbladder and bile duct (25.0%), liver (19.2%), colon and rectum (25.0%), breast (32.0%), and lung (7.0%). The mainly gastrointestinal toxicity resulted in anorexia (24.3%), nausea and vomiting (12.5%), and diarrhea (11.8%). On the other hand, hematological toxicity was rare and mild. To analyze the life-prolonging effect of the therapy, a cohort study was carried out in 438 cases collected in the UFT phase II study 5 years after the commencement of the therapy. The 50% survival time for 185 patients with gastric cancer was 185 days. The corresponding times in 54 patients with colorectal cancer and 49 with breast cancer were 227 and 505 days, respectively. A historical comparative study of UFT and FT, which was administered in the same institutions for equal evaluation, revealed that UFT had a significantly better effect than FT without more pronounced side effects with the equivalent dose schedule. In conclusion, UFT can be considered a useful against cancers over a broad spectrum, especially in gastrointestinal cancer.

摘要

优福定(UFT)是一种以1:4的比例将呋喃氟尿嘧啶(FT)和尿嘧啶结合而成的化合物。在一项II期研究中,优福定的口服日剂量为300 - 600毫克。对104家机构的438例可评估患者进行的优福定II期研究的汇总数据显示,其对胃癌(27.7%)、胰腺癌(25.0%)、胆囊和胆管癌(25.0%)、肝癌(19.2%)、结肠直肠癌(25.0%)、乳腺癌(32.0%)和肺癌(7.0%)有疗效。主要的胃肠道毒性表现为厌食(24.3%)、恶心和呕吐(12.5%)以及腹泻(11.8%)。另一方面,血液学毒性罕见且轻微。为分析该疗法的延长生命效果,在治疗开始5年后,对优福定II期研究中收集的438例病例进行了队列研究。185例胃癌患者的50%生存时间为185天。54例结肠直肠癌患者和49例乳腺癌患者的相应时间分别为227天和505天。在相同机构进行同等评估的优福定和呋喃氟尿嘧啶的历史对照研究表明,在等效剂量方案下,优福定的效果明显优于呋喃氟尿嘧啶,且副作用不更明显。总之,优福定可被认为是一种对多种癌症有效的药物,尤其是对胃肠道癌症。

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Report on nationwide pooled data and cohort investigation in UFT phase II study.优福定(UFT)II期研究的全国汇总数据及队列调查结果报告
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2
[Report on nationwide pooled data and cohort investigation in UFT phase II study].
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Gan To Kagaku Ryoho. 2006 Oct;33(10):1423-9.
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[Phase I study of orally administered UFT plus l-leucovorin].
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