新辅助放化疗联合局部切除对比全直肠系膜切除术治疗T_(2~3ab)N_(0)M_(0)期直肠癌:TAUTEM研究及短期疗效解读  

Interpretation of TAUTEM Study and Short-term Outcomes:Neoadjuvant Chemoradiotherapy Combined with Local Excision versus Total Mesorectal Excision in the Treatment of T_(2~3ab)N_(0)M_(0) Rectal Cancer

作　　者：陈倩萍 谢丽 朱骥 CHEN Qian-ping;XIE Li;ZHU Ji(The Cancer Hospital of the University of Chinese Academy of Sciences(Zhejiang Cancer Hospital),Institute of Basic Medicine and Cancer(IBMC),Chinese Academy of Sciences,Hangzhou 310022,China;Clinical Research Center,Shanghai Jiao Tong University School of Medicine,Shanghai 200025,China)

机构地区：[1]中国科学院大学附属肿瘤医院(浙江省肿瘤医院),中国科学院基础医学与肿瘤研究所,浙江杭州310022 [2]上海交通大学医学院临床研究中心,上海200025

出　　处：《肿瘤学杂志》2022年第10期883-891,共9页Journal of Chinese Oncology

摘　　要：TAUTEM研究是一项随机、对照、前瞻性、多中心的Ⅲ期非劣效性研究,该研究旨在比较新辅助放化疗联合经肛门内镜显微手术(chemoradiotherapy and transanal endoscopic microsurgery,CRT-TEM)与全直肠系膜切除术(total mesorectal excision,TME)在T_(2~3ab)N_(0)M_(0)期直肠癌患者中的局部复发与术后并发症发生情况。该项研究的主要研究终点为2年局部复发率;次要研究终点为CRT的耐受性及其副反应发生率;CRT后的临床缓解率(clinical complete response,c CR)及病理缓解率(pathological complete response,pCR);术后并发症发生率及死亡率;生活质量;患者的3年总生存期等。在接受CRT-TEM的患者中,新辅助放化疗后副反应发生率为29.6%(24/81),p CR率为44.3%(35/79),器官保留率为82.7%(67/81);CRT-TEM组术后并发症发生率为20.7%(17/82),而TME组术后并发症发生率为50.6%(41/81)。TAUTEM研究结果提示新辅助放化疗联合局部切除将为早期浅表直肠癌患者实现器官保留奠定基础。The TAUTEM study is a randomized controlled,prospective,multicentre phaseⅢnon-inferiority trial designed to compare preoperative chemoradiotherapy combined with transanal endoscopic microsurgery (CRT-TEM) with total mesorectal excision (TME) in patients with rectal adenocarcinoma staged as T_(2~3ab)N_(0)M_(0)in terms of local recurrence and postoperative complications.The primary endpoint was the two-year local recurrence rate,while the secondary variables were the tolerance of CRT and its adverse effects;clinical complete response(c CR) and pathological complete response(p CR) after CRT;postoperative complication rate and mortality;quality of life and the 3-year overall survival (OS).A-mong patients undergoing CRT-TEM,the incidence of side effects after neoadjuvant chemoradiotherapy was 29.6%(24/81);the pCR rate was 44.3%(35/79);the organ preservation rate was 82.7%(67/81);the incidence of postoperative complications in the CRT-TEM group was 20.7%(17/82),whereas that in the TME group was 50.6%(41/81).The findings of TAUTEM indicated that neoadjuvant chemoradiotherapy in conjunction with local excision would lay the foundation for organ preservation in patients suffering from early superficial rectal cancer.

关 键 词：直肠癌 新辅助放化疗 局部切除 经肛门内镜显微手术(TEM) 全直肠系膜切除术(TME) 非劣效试验 

分 类 号：R735.37[医药卫生—肿瘤]