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 

机构地区：[1]Roswell Park Cancer Institute [2]Regional Cancer Centre,Waikato Hospital

出　　处：《World Journal of Clinical Oncology》2015年第5期166-173,共8页世界临床肿瘤学杂志（英文版）

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

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 mo.CONCLUSION: 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.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 mo.CONCLUSION: 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.

关 键 词：SELENIUM Chemotherapy Radiation therapy SQUAMOUS cell cancer RADIOPROTECTOR Chemoprotective 

分 类 号：R739.91[医药卫生—肿瘤]