探讨氨磷汀对局部晚期直肠癌新辅助放疗同期伊立替康化疗的减毒作用:对154例病例的回顾性队列研究  

Exploring the attenuating effect of amifostine on neoadjuvant radiotherapy with concurrent use of irinotecan for locally advanced rectal cancer:a retrospective cohort study of 154 cases

作　　者：储亚娟 张蕾 李云海 罗伟明 张静 莫晓晨 马金利 CHU Yajuan;ZHANG Lei;LI Yunhai;LUO Weiming;ZHANG Jing;MO Xiaochen;MA Jinli(Department of Radiotherapy,Fudan University Shanghai Cancer Center Minhang Branch,Shanghai 200040,China;Department of Radiation Oncology,Fudan University Shanghai Cancer Center,Department of Oncology,Shanghai Medical College,Fudan University,Shanghai 200032,China)

机构地区：[1]复旦大学附属肿瘤医院闵行分院放疗科,上海200240 [2]复旦大学附属肿瘤医院放射治疗中心,复旦大学上海医学院肿瘤学系,上海200032

出　　处：《中国癌症杂志》2024年第10期957-965,共9页China Oncology

基　　金：闵行区自然科学研究课题(2021MHZ094)。

摘　　要：背景与目的:直肠癌是全球范围内严重危害人群健康的恶性肿瘤之一,发病率位居第三,死亡率排名第二。随着社会经济水平发展,中国的结直肠癌发病率及死亡率呈增高趋势,成为全球结直肠癌高发的国家之一。局部晚期直肠癌推荐治疗方式为新辅助放化疗联合手术治疗,这极大地改善了患者的预后。然而,新辅助放化疗引起的腹泻等肠道不良反应增多,部分患者因严重的毒性和不良反应被迫延迟或中断治疗。氨磷汀是一种广谱正常细胞保护剂,对于多种放化疗毒性都有良好的防护效果。本研究通过回顾性资料分析接受新辅助放疗联合伊立替康同步化疗的局部晚期直肠癌患者,探讨同期使用氨磷汀是否可减轻胃肠道和血液学毒性。方法:本研究采用回顾性队列分析方法。回顾性收集2018年1月1日—2019年12月31日在复旦大学附属肿瘤医院接受新辅助放化疗的局部晚期直肠癌患者的临床数据。按是否同期使用氨磷汀分组。主要研究目的是分析氨磷汀是否能减轻胃肠道与血液学毒性,次要研究目的包括氨磷汀是否能改变肿瘤标志物水平、直肠系膜筋膜侵犯(mesorectal fascia invasion,MRF)阳性率、壁外血管侵犯(extramural vascular invasion,EMVI)阳性率及病理学完全缓解率(pathological complete response,pCR)。采用SAS9.4统计软件,对于连续变量,进行了正态性检验。腹泻等级不符合正态分布行Wilcoxon秩和检验;血液学毒性组内比较行方差分析,组间比较行Wilcoxon秩和检验;肿瘤标志物的变化值因为组间不均衡性,故采用广义估计方程进行前后组间差值的比较。本研究严格遵循流行病学观察性研究报告指南(STrengthening the Reporting of OBservational studies in Epidemiology,STROBE),确保研究方法的透明度和结果的可靠性。结果:最终纳入了154例符合条件的患者,按是否同期使用氨磷汀分组,其中氨磷汀组78例,对�Background and purpose:Rectal cancer is one of the malignant tumors that seriously harm human health in the world,ranking third in incidence and second in mortality.With the development of social and economic level,the incidence and mortality of colorectal cancer in China are increasing,and China becomes one of the countries with high incidence of colorectal cancer disease in the world.The recommended treatment for locally advanced rectal cancer is neoadjuvant chemoradiotherapy combined with surgery,which greatly improves the prognosis of patients.However,intestinal adverse reactions such as diarrhea caused by neoadjuvant chemoradiotherapy are increased,and some patients are forced to delay or interrupt treatment due to serious side effects.Amifostine is a broad-spectrum normal cell protective agent,which has good protective effect against various radiochemotherapy toxicity.We conducted a retrospective analysis of patients with locally advanced rectal cancer who received neoadjuvant radiotherapy combined with irinotecan concurrent chemotherapy to investigate whether concurrent use of amifostine alleviated gastrointestinal and hematological toxicities.Methods:A retrospective cohort analysis was used in this study.Clinical data of patients with locally advanced rectal cancer who received neoadjuvant chemoradiotherapy at the Affiliated Cancer Hospital of Fudan University during the period of discharge from January 1,2018 to December 31,2019 were retrospectively collected.The patients were divided into 2 groups by whether amifostine was used during the same period.The main purpose of the study was to analyze whether amifostine can reduce gastrointestinal and hematological toxicities,and secondary objectives included whether amifostine could alter tumor marker levels,mesorectal fascia invasion(MRF)positive rate,extramural vascular invasion,positive rate of EMVI and pathological complete response(pCR).Using SAS9.4 statistical software,the normality test was carried out for continuous variables.The rank sum test of Wilc

关 键 词：氨磷汀 伊立替康 直肠癌 新辅助放化疗 

分 类 号：R35.37[医药卫生—基础医学]