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氟尿嘧啶栓用于头颈癌的II期研究

[A phase II study of Futraful suppository in head and neck cancer].

作者信息

Ohyama M, Matsumura M, Katsuta K, Nobori T, Furuta S, Matsunaga S, Uchizono A, Hanada T, Moriyama I, Kamachi S

机构信息

Dept. of Otorhinolaryngology, Kagoshima University Hospital.

出版信息

Gan To Kagaku Ryoho. 1988 Jul;15(7):2093-100.

PMID:3134860
Abstract

A phase II study of FT-207 suppository (Futraful Suppository) for head and neck cancer was conducted at the Kagoshima University Hospital Dept. of Otorhinolaryngology and its 6 affiliated hospitals. Forty cases with head and neck cancer were entered in the trial, of which 37 were perfectly evaluable. Partial response (PR) (16.7%) was achieved in one of 6 patients with maxillary cancer, in 2 of 9 cases with oral cancer (22.2%), in one of 7 with laryngeal cancer (14.3%), in 3 of 13 with pharyngeal cancer, while 2 of the same 13 achieved a complete response (CR) (38.5%), for a total response rate of 24.3%. FT-207 suppository was continuously administered as standard, at a dose of 750 mg each twice daily, or 1,500 mg/day. The response rate was dose-dependent; 2 CR cases with a total dose of 105 g for administration over a total period of more than 150 days. Adverse effects appearing in 35.0% of the overall were mainly anorexia, nausea and vomiting; none of them, however, were serious.

摘要

在鹿儿岛大学医院耳鼻喉科及其6家附属医院进行了FT - 207栓剂(氟尿嘧啶栓剂)治疗头颈癌的II期研究。40例头颈癌患者进入试验,其中37例可进行完全评估。上颌癌6例中有1例获得部分缓解(PR)(16.7%),口腔癌9例中有2例(22.2%),喉癌7例中有1例(14.3%),下咽癌13例中有3例,而这13例中有2例获得完全缓解(CR)(38.5%),总缓解率为24.3%。FT - 207栓剂作为标准治疗持续给药,剂量为每次750mg,每日两次,即1500mg/天。缓解率呈剂量依赖性;2例CR患者的总给药剂量为105g,给药总时长超过150天。总体35.0%的患者出现的不良反应主要为厌食、恶心和呕吐;然而,均不严重。

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