一项使用口服 S-1 进行同期放化疗治疗头颈部癌症的 I 期研究。
A phase I study of concurrent chemoradiotherapy using oral s-1 for head and neck cancer.
机构信息
Department of Otorhinolaryngology, Nagoya University Graduate School of Medicine, 65 Tsurumai-cho, Showa-ku, Nagoya, Aichi 466-8550, Japan.
出版信息
Anticancer Res. 2014 Jan;34(1):209-13.
AIM
S-1 is a novel oral anticancer agent containing a combination of two modulators and tegafur. We conducted a phase I study of concurrent chemoradiotherapy with S-1 for head and neck cancer.
PATIENTS AND METHODS
S-1 was administered once daily, and radiotherapy was performed by 2 Gy/day, five days/week, for a total of 30 fractions. S-1 dosage was started at level 1 (55.3 mg/m(2)/day), and was increased to level 2 (66.7 mg/m(2)/day).
RESULTS
A total of 12 patients were registered. Concerning hematological toxicities, no grade ≥3 or more hematological toxicity was confirmed at any level. With regard to non-hematological toxicities, at level 2, three cases of grade 3 mucositis and two cases of grade 3 dermatitis were confirmed.
CONCLUSION
The results showed that the maximum tolerated dose was level 2 and that dose-limiting toxicity was mucositis. Having determined that the recommended dose is level 1, we have begun the phase II clinical study.
目的
S-1 是一种新型口服抗癌药物，含有两种调节剂和替加氟的组合。我们对 S-1 联合放化疗治疗头颈部癌症进行了 I 期研究。
患者和方法
S-1 每日一次给药，放疗采用 2 Gy/天，每周 5 天，共 30 次。S-1 的起始剂量为 1 级（55.3 mg/m2/天），然后增加至 2 级（66.7 mg/m2/天）。
结果
共登记了 12 例患者。关于血液学毒性，任何级别均未确认≥3 级或更高级别的血液学毒性。关于非血液学毒性，在 2 级时，确认了 3 例 3 级黏膜炎和 2 例 3 级皮炎。
结论
结果表明，最大耐受剂量为 2 级，剂量限制性毒性为黏膜炎。确定推荐剂量为 1 级后，我们已开始进行 II 期临床试验。
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