Tsuji Hiroyuki, Nagata Motoki, Inoue Toshiya, Minami Toyohiko, Iwai Hiroshi, Ohnishi Sumio, Yukawa Hisaya, Ogura Manabu, Yamashita Toshio, Nagata Kenji
Dept. of Otolaryngology, Kanazawa Medical University, Ishikawa, Japan.
Gan To Kagaku Ryoho. 2006 Jun;33 Suppl 1:163-6. doi: 10.2217/14750708.3.1.163.
We conducted a phase I study to determine a recommended dose (RD) of S-1 for chemo-radiotherapy consisting of S-1+ radiotherapy for T 2 N 0 larynx cancer. The method of administration used to assess the RD was irradiation with 2 Gy/day for 5 days a week until a total dose of 60 Gy, and concomitant administration of S-1 once a day for 2 weeks beginning on the day therapy was started followed by 2 weeks off the drug and 2 weeks on the drug with the dose escalating from S-1 60 mg/body/day (level 1) to 80 mg/body/day (level 2), and then to 100 mg/body/day (level 3). 18 patients were enrolled. 4 patients developed an adverse event of grade 3 radiation dermatitis which became a dose-limiting toxicity (DLT) at level 3. We then concluded that 100 mg/body/day was the maximum tolerated dose (MTD) of S-1 and decided that the RD of S-1 was 80 mg/body/day.
我们开展了一项I期研究，以确定S-1在T2N0喉癌同步放化疗（S-1联合放疗）中的推荐剂量（RD）。评估推荐剂量所采用的给药方法是，每周5天，每天照射2 Gy，直至总剂量达60 Gy，从开始治疗当天起，S-1每天给药1次，持续2周，随后停药2周，再给药2周，剂量从60 mg/体/天（1级）逐步增至80 mg/体/天（2级），然后增至100 mg/体/天（3级）。共入组18例患者。4例患者发生3级放射性皮炎不良事件，该事件在3级时成为剂量限制性毒性（DLT）。我们随后得出结论，100 mg/体/天是S-1的最大耐受剂量（MTD），并确定S-1的推荐剂量为80 mg/体/天。
