Harada Koji, Sato Mitsunobu, Ueyama Yoshiya, Nagayama Masaru, Hamakawa Hiroyuki, Nagahata Shunichirou, Yoshimura Yasuro, Osaki Tokio, Ryoke Kazuo
Department of Therapeutic Regulation for Oral Tumor, Institute of Health Bioscience, University of Tokushima Graduate School, Tokushima, Japan.
Anticancer Drugs. 2008 Jan;19(1):85-90. doi: 10.1097/CAD.0b013e3282f0ce4d.
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/m2 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=1). 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.
本研究旨在调查口服氟嘧啶类抗癌药S-1治疗口腔鳞状细胞癌患者的疗效和安全性。纳入病理确诊为鳞状细胞癌且至少有一处可测量病灶的患者。口服S-1（40mg/m²，每日两次），持续28天，随后休息14天。2002年10月至2004年8月期间，共有41例连续符合条件的患者入组本研究。原发肿瘤部位为牙龈（n = 18）、舌（n = 12）、腭（n = 5）、口底（n = 4）、颊黏膜（n = 1）和唇黏膜（n = 1）。中位给予两个周期的治疗（范围1 - 5个周期）。9例患者达到完全缓解，8例患者达到部分缓解，总缓解率为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%）。虽然分别有2例患者（4.9%）出现3级贫血和厌食，各有1例患者（2.4%）出现3级中性粒细胞减少、血小板减少、恶心、呕吐、口腔炎和腹泻，但未观察到4级毒性反应。S-1在口腔鳞状细胞癌患者中表现出明确的抗肿瘤活性，且耐受性良好。
