A Phase I Study of Concurrent Chemoradiotherapy with S-1 for T2N0 Glottic Carcinoma
A Phase I Study of Concurrent Chemoradiotherapy with S-1 for T2N0 Glottic Carcinoma
复制标题
S-1 同步放化疗治疗 T2N0 声门癌的 I 期研究
作者：
H. Tsuji;T. Kiba;Motoki Nagata;Toshiya Inoue;H. Yukawa;T. Yamashita;Y. Shimode;H. Murata;K. Nagata;K. Tomoda
目的：基于S-1（一种新型口服抗肿瘤药物，含氟嘧啶类）的放化疗是T2 N 0声门癌的治疗方法;然而，最佳方案和剂量尚未确定。进行了一项I期研究，以确定S-1的最大耐受剂量，放射治疗为2戈伊/天，每周5天，总剂量为60戈伊。本研究的终点是检查该方案的毒性特征，并确定S-1的推荐剂量。研究方法：与上述放疗同时给予S-1，每天一次，持续2周，从治疗开始当天开始，随后停药2周，继续给药2周，剂量从S-1 60 mg/只/天（水平1）递增至80 mg/只/天（水平2），然后递增至100 mg/只/天（水平3）。结果：21例患者安全有效。18例患者入组剂量递增期。所有患者均接受S-1给药。最大耐受剂量确定为100 mg/人/天，剂量限制性毒性表现为3级放化疗皮炎的发生。因此，确定的S-1推荐剂量为80 mg/只/天。根据实体瘤疗效评价标准，在21例有可测量疾病的患者中有20例（95.2%）观察到客观缓解。结论：同时S-1和放射治疗是可行的，耐受性良好，并建议产生一个值得的反应在T2 N 0声门癌。这些结果值得进一步调查，第二阶段已经开始。
Objective: Chemoradiation based on S-1, a novel oral antitumor agent of fluorinated pyrimidines, is the treatment for T2N0 glottic carcinoma; however, the optimal scheduling and dosing have still not been established. A phase I study was conducted to determine the maximum tolerated dose of S-1 with radiotherapy of 2 Gy/day for 5 days a week to a total dose of 60 Gy. Endpoints of this study were to examine the toxicity profile of this regimen and to determine the recommended dose of S-1. Methods: Concomitant administration with the above-mentioned radiotherapy 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 (level 1) to 80 mg/body/day (level 2), and then to 100 mg/body/day (level 3). Results: Twenty-one patients were valid for safety. Eighteen patients were enrolled in the dose-escalation phase. In all patients, S-1 was administered. The maximum tolerated dose was determined to be 100 mg/body/day and the dose-limiting toxicity was indicated by the onset of grade 3 chemoradiation dermatitis. Therefore, the determined recommended dose of S-1 was 80 mg/body/day. Objective response according to Response Evaluation Criteria in Solid Tumors were observed in 20 of 21 patients who had measurable disease (95.2%). Conclusion: Concurrent S-1 and radiotherapy was feasible and well tolerated, and was suggested to produce a worthwhile response in T2N0 glottic carcinoma. These results warrant further investigation, and a phase II has already been started.
DOI：
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发表时间：
2001-10
期刊：
Gan to kagaku ryoho. Cancer & chemotherapy
影响因子：
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作者：
Y. Inuyama;A. Kida;M. Tsukuda;N. Kohno;B. Satake
通讯作者：
Y. Inuyama;A. Kida;M. Tsukuda;N. Kohno;B. Satake
DOI：
10.1016/s1278-3218(00)00060-3
发表时间：
2000
期刊：
International journal of radiation oncology, biology, physics
影响因子：
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作者：
K. Fu;T. Pajak;A. Trotti;C. Jones;S. Spencer;T. Phillips;A. Garden;J. Ridge;J. Cooper;K. Ang
通讯作者：
K. Fu;T. Pajak;A. Trotti;C. Jones;S. Spencer;T. Phillips;A. Garden;J. Ridge;J. Cooper;K. Ang