局部晚期非小细胞肺癌同步放化疗中紫杉醇两种用法的多中心、随机对照研究  

A Randomized Phase Ⅰ/Ⅱ Trial to Compare Weekly Usage with Triple Weekly Usage of Paclitaxel in Concurrent Radiochemotherapy for Patients with Locally Advanced Non-small Cell Lung Cancer

作　　者：石安辉[1,2,3] 朱广迎[1,2,3] 余荣[1,2,3] 王颖杰[4] 夏廷毅[4] 

机构地区：[1]北京大学临床肿瘤学院 [2]北京肿瘤医院 [3]北京市肿瘤防治研究所放射治疗科恶性肿瘤发病机制及转化研究教育部重点实验室,北京100142 [4]空军总医院放射治疗科,北京100142

出　　处：《中国肺癌杂志》2011年第3期227-232,共6页Chinese Journal of Lung Cancer

基　　金：吴阶平医学基金会(No.WKJ2005-3-006);国家自然科学基金(No.30870738)资助~~

摘　　要：背景与目的尽管美国国立综合癌症网络推荐同步放化疗为不可手术局部晚期非小细胞肺癌的标准治疗手段,但同步放化疗方案仍有争议,本研究旨在比较适形或调强放疗合并紫杉醇每周三次用法和相同总剂量的每周一次用法治疗局部晚期非小细胞肺癌的优劣,以优选放疗中紫杉醇的最佳给药方案。方法 2006年4月-2009年4月,全国多中心顺序入选符合条件的局部晚期非小细胞肺癌患者,采用随机数字表法将入组患者随机分为两组,放疗要求95%PTV达(60-70)Gy/(30-35)次/(6-7)周。结果共38例患者入组,每周三次用法组18例,1例治疗结束后1年出现3度放射性肺损伤,后因肺内感染呼吸衰竭死亡,3例患者出现1度-2度放射性肺炎,1例患者出现3度放射性食道炎,12例患者出现1度-2度放射性食道炎,13例患者出现1度-2度白细胞减少;每周一次用法组20例,3例患者出现3度放射性肺炎,3例患者出现2度放射性肺炎,1例患者出现3度放射性食道炎,10例患者出现1度-2度放射性食道炎,1例患者出现4度白细胞减少,14例患者出现1度-3度白细胞减少。两组患者有效率分别为88.8%和50.0%(P=0.026)。两组患者1年生存率分别为79%和67%(P=0.607)。结论适形或调强放疗合并紫杉醇每周三次用法较每周一次用法治疗局部晚期非小细胞肺癌安全、有效。Background and objective Although the guidelines of the National Comprehensive Cancer Network of USA recommend that the standard therapy for locally advanced non-small cell lung cancer（LANSCLC） is concurrent chemoradiotherapy.ere is ongoing controversy about the treatment regimen which combines chemotherapy concurrently with radiotherapy.e aim of this study is to compare weekly usage with triple weekly usage of paclitaxel in concurrent radiochemotherapy for patients with LANSCLC,and to obtain the best paclitaxel regimen in the concurrent radiochemotherapy. Methods From April 2006 to April 2009,some LANSCLC patients in multicenter were randomly divided into weekly usage（45 mg/m 2,1 times/week,a total of 270 mg/m 2 in six weeks） and triple weekly usage（15 mg/m 2,3 times/week,a total of 270 mg/ m 2 in six weeks） group of paclitaxel by a random number table.All patients were treated with 3D radiotherapy,and 95%planning target volume（PTV） received a prescription dose of（60-70） Gy/（30-35） times/（6-7） weeks,（1.8-2.0） Gy/fraction.en the side e ects,response and overall survival rate were compared between two groups of patients.Results irty-eight LANSCLC patients were enrolled.Weekly usage and triple weekly usage group were 20 and 18 patients,respectively.In the triple weekly usage group,the side e ects were 12 patients had radiation esophagitis of Ⅰ-Ⅱ degree,1 patient had radiation esophagitis of III degree,2 patients had radiation pneumonitis of I degree,1 patient had radiation pneumonitis of II degree,1 patient had radiation pneumonitis of III degree and died of respiratory failure,2 patients developed weight loss of I degree.In the weekly usage group,the side e ects were 11 patients had radiation esophagitis of Ⅰ-Ⅲ degree,6 patients had radiation pneumonitis ofIⅠ-Ⅲ degree,2 patients developed weight loss of I degree,6 patients developed leucopenia of III-IV degree.e response rate of two groups was 88.8%and 50.0%,respectively（P=0.026） .1-year survival rate of two groups w

关 键 词：肺肿瘤 综合疗法 放射疗法 紫杉醇 

分 类 号：R734.2[医药卫生—肿瘤]