Multi-institutional phase II trial of S-1 in patients with oral squamous cell carcinoma
Multi-institutional phase II trial of S-1 in patients with oral squamous cell carcinoma
复制标题
DOI：
10.1097/cad.0b013e3282f0ce4d
复制
发表时间：
2008-01-01
影响因子：
2.3
通讯作者：
Ryoke, Kazuo
中科院分区：
文献类型：
--
作者：
Harada, Koji;Sato, Mitsunobu;Ryoke, Kazuo
本研究的目的是探讨口服氟嘧啶抗癌药物 S-1 对口腔鳞状细胞癌患者的疗效和安全性。经病理证实患有鳞状细胞癌且至少有一个可测量病变的患者被纳入研究。口服 S-1（40 mg/m(2)，每天两次）28 天，然后休息 14 天。 2002年10月至2004年8月期间，共有41名连续符合条件的患者入组。原发肿瘤部位为牙龈（n=18）、舌头（n=12）、腭（n=5）、口底（n=4）、颊粘膜（n=1）和唇粘膜（n=11）。平均进行两个治疗周期（范围，1-5）。 9 名患者获得完全缓解，8 名患者获得部分缓解，总体缓解率为 41.5%（95% 置信区间，26.4-56.5%）。 3年生存率为76.4%（95%置信区间，62.8-90.0%）。尽管3级贫血和厌食各有2名患者（4.9%），3级中性粒细胞减少、血小板减少、恶心、呕吐、口腔炎和腹泻各1名患者（2.4%），但没有观察到4级毒性。 S-1 在口腔鳞状细胞癌患者中表现出明确的抗肿瘤活性，并且耐受性良好。
The aim of this study was to investigate the efficacy and safety of an oral fluoropyrimidine anticancer agent, S-1, in patients with oral squamous cell carcinoma. Patients with pathologically confirmed squamous cell carcinoma and at least one measurable lesion were enrolled. Oral administration of S-1 (40 mg/m(2) twice daily) for 28 days was followed by a 14-day rest period. A total of 41 consecutive eligible patients were enrolled in the study between October 2002 and August 2004. The sites of the primary tumor were the gingiva (n=18), the tongue (n = 12), the palate (n = 5), the oral floor (n = 4), the buccal mucosa (n=1), and the labial mucosa (n=11). A median of two cycles of treatment (range, 1-5) was administered. A complete response was achieved in nine patients and a partial response in eight patients, for an overall response rate of 41.5% (95% confidence interval, 26.4-56.5%). The 3-year survival rate was 76.4% (95% confidence interval, 62.8-90.0%). Although grade 3 anemia and anorexia occurred in two patients each (4.9%), and grade 3 neutropenia, thrombocytopenia, nausea, vomiting, stomatitis, and diarrhea in one patient each (2.4%), no grade 4 toxicities were observed. S-1 exhibits definite antitumor activity in patients with oral squamous cell carcinoma and is well tolerated.