Department of Oral Surgery, Oral Restitution, Division of Oral Health Sciences, Graduate School, Tokyo Medical and Dental University, Japan.
J Exp Clin Cancer Res. 2010 Apr 20;29(1):33. doi: 10.1186/1756-9966-29-33.
This study was conducted to identify a recommended dose for S-1, used in combination with 40-Gy radiation.
Thirty patients, 15 each with stage III and IVA oral carcinoma, were enrolled. All patients received a total dose of 40-Gy. For the S-1 treatment, patients were given either the standard Japanese dose, calculated according to body surface area, or a reduced dose. Groups consisting of at least three patients were given S-1 according to one of 8 regimens.
Hematologic toxicity was mild and reversible. The most common nonhematologic toxicity was mucositis. At level 8 that was the standard S-1 dose for 5 days per week for 4 weeks, dose-limiting toxicity was observed when 2 patients had grade 4 mucositis. This level was thus deemed the maximum tolerated dose for the regimen.
The recommended dose of S-1 with concurrent radiotherapy was the reduced dose of S-1 given for 5 days per week, for 4 consecutive weeks. Preoperative S-1 and concurrent radiotherapy was well tolerate and feasible and warrants a phase II study.
本研究旨在确定 S-1 与 40Gy 放疗联合应用的推荐剂量。
共纳入 30 例 III 期和 IVA 期口腔癌患者，各 15 例。所有患者均接受 40Gy 的全剂量照射。S-1 治疗时，患者采用体表面积计算的标准日本剂量或减少剂量。至少 3 例患者分为 8 组，采用 8 种方案中的一种给予 S-1。
血液学毒性较轻且可恢复。最常见的非血液学毒性是黏膜炎。在标准 S-1 剂量（每周 5 天，4 周）的 8 级，2 例患者出现 4 级黏膜炎，达到剂量限制毒性。因此，该水平被认为是该方案的最大耐受剂量。
同步放化疗中 S-1 的推荐剂量为每周 5 天，连续 4 周的减少剂量。术前 S-1 联合同步放化疗耐受性良好，可行，值得进行 II 期研究。
