Phase I trial of chemoradiotherapy with the combination of S-1 plus cisplatin for patients with unresectable locally advanced squamous cell carcinoma of the head and neck
Phase I trial of chemoradiotherapy with the combination of S-1 plus cisplatin for patients with unresectable locally advanced squamous cell carcinoma of the head and neck
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DOI：
10.1111/j.1349-7006.2010.01799.x
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发表时间：
2011-02-01
期刊：
影响因子：
5.7
通讯作者：
Ohtsu, Atsushi
中科院分区：
文献类型：
--
作者：
Tahara, Makoto;Minami, Hironobu;Ohtsu, Atsushi
本研究的目的是在不可切除的局部晚期头颈部鳞状细胞癌患者中确定S-1联合放化疗（CRT）的最大耐受剂量（MTD），并评价S-1混悬液通过饲管给药或口服胶囊给药时的药代动力学差异。化疗包括在第1-14天以40、60和80 mg/m2/天的递增剂量给予S-1，每日两次，在第8-11天以20 mg/m2/天的剂量给予顺铂，每隔5周重复两次。从第1天开始，同时给予每日单次70戈伊辐射（分35次）。CRT完成后，计划再进行2个周期的化疗。在开始CRT之前，每例患者通过两种不同的给药方法接受S-1。22例患者入组。S-1 80 mg/m2/d达到MTD，6例患者中有2例发生持续4天以上的发热性中性粒细胞减少症。所有四名患者的肌酸酐清除率均下降至
The aim of the present study was to determine the maximum tolerated dose (MTD) of S-1 in combination with chemoradiotherapy (CRT) in patients with unresectable locally advanced squamous cell carcinoma of the head and neck, and evaluate the difference in pharmacokinetics of S-1 when administered as a suspension via a feeding tube or orally as a capsule. Chemotherapy consisted of administration of S-1 twice daily on days 1-14 at escalating doses of 40, 60 and 80 mg/m(2) per day, and cisplatin at 20 mg/m(2) per day on days 8-11, repeated twice at a 5-week interval. Single daily radiation of 70 Gy in 35 fractions was given concurrently starting on day 1. Two additional cycles of chemotherapy were planned after the completion of CRT. Before starting CRT, each patient received S-1 via two different administration methods. Twenty-two patients were enrolled. The MTD was reached with S-1 at 80 mg/m(2) per day, with two of six patients experiencing febrile neutropenia lasting more than 4 days. All four patients whose creatinine clearance was decreased to