Randomized phase Ⅱ trial of selenomethionine as a modulator of efficacy and toxicity of chemoradiation in squamous cell carcinoma of the head and neck

作     者：Michael Mix Anurag K Singh Michael Tills Shiva Dibaj Adrienne Groman Wainwright Jaggernauth Youcef Rustum Michael B Jameson 

作者机构：Roswell Park Cancer Institute Regional Cancer CentreWaikato Hospital 

出 版 物：《World Journal of Clinical Oncology》 (世界临床肿瘤学杂志（英文版）)

年 卷 期：2015年第6卷第5期

页      面：166-173页

学科分类：1002[医学-临床医学] 100214[医学-肿瘤学] 10[医学] 

基　　金：Supported by A grant from the Health Research Council of New Zealand(in part) 

主　　题：Selenium Chemotherapy Radiation therapy Squamous cell cancer Radioprotector Chemoprotective 

摘      要：AIM: To investigate whether selenomethionine(SLM) reduces mucositis incidence in patients with head and neck squamous cell cancer(HNSCC) undergoing concurrent chemoradiation(CRT).METHODS: In this multi-institutional, randomized, double-blind phase Ⅱ trial, patients with Stage Ⅲ or Ⅳ HNSCC received SLM 3600 μg/m2 or placebo twice daily for 7 d prior to CRT, once daily during CRT, and daily for 3 wk following CRT. CRT consisted of 70 Gy at 2 Gy per fraction with cisplatin 100 mg/m2 Ⅳ on days 1, 22, and 43. RESULTS: Eighteen patients were randomized, 10 received SLM, and there were no differences in baseline factors. There was no difference in mucositis or patientreported side effects between groups. There was no difference in overall or relapse-free survival at 12 ***: Addition of SLM to CRT for HNSCC was well-tolerated but did not lower the incidence of severe mucositis or improve quality of life or survival outcomes.