[Late phase II study of S-1 in patients with advanced head and neck cancer].
[Late phase II study of S-1 in patients with advanced head and neck cancer].
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发表时间：
2001-10
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通讯作者：
Y. Inuyama;A. Kida;M. Tsukuda;N. Kohno;B. Satake
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作者：
Y. Inuyama;A. Kida;M. Tsukuda;N. Kohno;B. Satake
1995年8月至1998年3月，日本25个机构以多机构合作研究的形式，对晚期/复发性头颈癌患者进行了新型氟化嘧啶口服抗肿瘤药S-1的后期II期临床研究。在59名符合条件的患者中，客观缓解为4例完全缓解（CR）和13例部分缓解（PR）。缓解率为 28.8%（17/59，95% CI：17.8-42.1%）。既往接受过治疗的患者的缓解率为 28.3% (15/53)，而未接受治疗的患者的缓解率为 33.3% (2/6)。既往化疗患者的缓解率为26.7% (12/45)。 2级或以上的主要不良反应为贫血（25.4%，15/59）、白细胞减少（22.0%，13/59）、中性粒细胞减少（25.4%，15/59）、血小板减少（3.4%，2/59）、厌食（6.8%，4/59）、恶心/呕吐（1.7%，1.7%）。 1/59）、口腔炎（1.7%，1/59）、皮肤症状，包括出疹或脱屑（5.1%，3/59）和不适（1.7%，1/59）。 4级贫血1例；然而，在停止给药和输血后，该值恢复到正常水平。因此，该事件被证实是可逆的。基于这些结果，我们得出结论，S-1 是治疗晚期/复发性头颈癌的活性药物。
A late phase II clinical study of S-1, a novel oral antitumor agent of fluorinated pyrimidines, in patients with advanced/recurrent head and neck cancer was conducted in 25 institutions across Japan as a multi-institutional cooperative study from August 1995 to March 1998. Out of 59 eligible patients, the objective responses were 4 complete responses (CR) and 13 partial responses (PR). The response rate was 28.8% (17/59, 95% CI: 17.8-42.1%). The response rate in previously treated patients was 28.3% (15/53), whereas that in treatment naive patients was 33.3% (2/6). The response rate in patients with prior chemotherapy was 26.7% (12/45). Major adverse reactions of grade 2 or more were anemia (25.4%, 15/59), leucopenia (22.0%, 13/59), neutropenia (25.4%, 15/59), thrombocytopenia (3.4%, 2/59), anorexia (6.8%, 4/59), nausea/vomiting (1.7%, 1/59), stomatitis (1.7%, 1/59), skin symptoms including eruptions or desquamation (5.1%, 3/59), and malaise (1.7%, 1/59). Grade 4 anemia was observed in one case; however, this returned to the normal level after the termination of drug administration and the blood transfusion. Therefore, this event was confirmed to be reversible. Based on these results, we conclude that S-1 is an active agent for the treatment of advanced/recurrent head and neck cancer.