累及野放疗联合替吉奥治疗老年食管癌的Ⅱ期临床研究  

Efficacy of intensity modulated radiation therapy with concurrent chemotherapy of tegafur for the elderly patients with esophageal cancer:a phaseⅡclincal trial

作　　者：张治[1] 周国仁[2] 叶劲军[3] 顾大勇[3] 李慧 陈薇[3] 方瑛[2] 陈诚[3] 钱普东[3] 陶华[3] 朱向帜[3] 陆进成[3] ZHANG Zhi;ZHOU Guo-ren;FANG Ying;YE Jin-jun;GU Da-yong;LI Hui;CHEN Wei;CHEN Cheng;QIAN Pu-dong;TAO Hua;ZHU Xiang-zhi;LU Jin-cheng(Department of Thoracic Surgery,Jiangsu Cancer Hospital&Jiangsu Institute of Cancer Research&Nanjing Medical University Affiliated Cancer Hospital,Nanjing 210009,China;Department of Chemotherapy,Jiangsu Cancer Hospital&Jiangsu Institute of Cancer Research&Nanjing Medical University Affiliated Cancer Hospital,Nanjing 210009,China;Department of Radiotherapy,Jiangsu Cancer Hospital&Jiangsu Institute of Cancer Research&Nanjing Medical University Affiliated Cancer Hospital,Nanjing 210009,China)

机构地区：[1]江苏省肿瘤医院,南京医科大学附属肿瘤医院胸外科,江苏省南京市210009 [2]江苏省肿瘤医院,南京医科大学附属肿瘤医院化疗科,江苏省南京市210009 [3]江苏省肿瘤医院,南京医科大学附属肿瘤医院放疗科,江苏省南京市210009

出　　处：《实用老年医学》2021年第12期1232-1235,共4页Practical Geriatrics

基　　金：江苏省青年医学人才项目(QNRC2016659,QNRC2016655);吴阶平医学基金会项目(320.6750.19194-60);江苏省“六大人才高峰”创新人才团队项目(TD-SWYY-007)。

摘　　要：目的探讨老年食管癌病人累及野放疗联合替吉奥治疗的安全性和疗效。方法共入组120例≥75岁食管鳞癌病人,采用累及野调强放射治疗(intensity modulated radiation therapy,IMRT)联合同期口服替吉奥治疗,观察主要总生存期(overall survival,OS)、无进展生存期(progression-free survival,PFS)以及不良反应的发生情况。结果病人的中位随访时间为41.2个月(5.9~90.4个月)。1、2、3年的总生存率为81.1%、64.8%、48.0%。1、2、3年的无进展生存率为77.6%、53.4%、39.3%。1、2、3年的肿瘤特异性总生存率为88.2%、78.5%、64.1%。3级以上不良反应均为血液学反应,包括3级血红蛋白下降1例(0.8%),3级白细胞下降9例(7.5%)、4级2例(1.7%),3级粒细胞下降3例(2.5%)、4级1例(0.8%),3级血小板下降4例(3.3%)。结论老年食管鳞癌病人行累及野放疗联合替吉奥同步化疗方案是安全有效的,不良反应是可耐受的,值得进一步开展Ⅲ期临床研究。Objective To evaluate the efficacy and toxic effects of intensity modulated radiation therapy(IMRT)combined with tegafur(S-1)in the elderly patients with esophageal cancer.Methods This was a single-arm,phaseⅡclinical study.A total of 120 elderly patients with esophageal squamous cell carcinoma aged≥75 years old from May 2014 to April 2021 were recruited.The IMRT and chemotherapy were conducted.The adverse reactions and curative effects were observed.Results The median follow-up time was 41.2 months(5.9-90.4 months)by October 2021.One-,two-and three-year overall survival rate was 81.1%,64.8%,and 48.0%,respectively.One-,two-and three-year progression-free survival rate was 77.6%,53.4%,and 39.3%,respectively.One-,two-and three-year tumor specific overall survival rate was 88.2%,78.5%,and 64.1%,respectively.The main toxic and side effects above grade 3 were hematological reactions,including grade 3 hemoglobin decreased in 1 case(0.8%),grade 3 leukocyte decreased in 9 cases(7.5%),grade 4 leukocyte decreased in 2 cases(1.7%),grade 3 granulocyte decreased in 3 cases(2.5%),grade 4 leukocyte decreased in 1 case(0.8%),and grade 3 platelet decreased in 4 cases(3.3%).Conclusions Involving field radiotherapy combined with concurrent chemotherapy with S-1 is safe and effective in the elderly patients with esophageal squamous cell carcinoma,and the toxic and side effects are tolerable.It is worthy of further phaseⅢclinical study.

关 键 词：食管癌 调强放疗 替吉奥 

分 类 号：R735.1[医药卫生—肿瘤]