Ohyama M, Matsumura M, Katsuta K, Nobori T, Furuta S, Matsunaga S, Uchizono A, Hanada T, Moriyama I, Kamachi S
Dept. of Otorhinolaryngology, Kagoshima University Hospital.
Gan To Kagaku Ryoho. 1988 Jul;15(7):2093-100.
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.
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。
