Neoadjuvant chemotherapy with capecitabine combined with oxaliplatin for mid-low locally advanced rectal cancer with negative mesorectal fascia:Long-term outcomes of a prospective trial(PKUCH-R03 trial)  

作　　者：Nan Chen Minghe Zhao Yunfeng Yao Lin Wang Yifan Peng Tingting Sun Tiancheng Zhan Jun Zhao Aiwen Wu 

机构地区：[1]Key Laboratory of Carcinogenesis and Translational Research(Ministry of Education/Beijing),Gastrointestinal Cancer Center,Unit III,Peking University Cancer Hospital&Institute,Beijing 100142,China [2]State Key Laboratory of Holistic Integrative Management of Gastrointestinal Cancers,Beijing Key Laboratory of Carcinogenesis and Translational Research,Gastrointestinal Cancer Center,Unit III,Peking University Cancer Hospital&Institute,Beijing 100142,China

出　　处：《Chinese Journal of Cancer Research》2024年第4期410-420,共11页中国癌症研究（英文版）

基　　金：supported by Beijing Municipal Administration of Hospitals Incubating Program (No.PZ2020027);Beijing Talent Incubating Funding (No.2019-4);National Natural Science Foundation of China (No.81773214);Beijing Hospitals Authority Clinical Medicine Development of Special Funding Support (No.ZYLX202116);2019 Major and Difficult Diseases Chinese and Western Medicine Coordination Capacity Colorectal Cancer Project [No.(2018)275];Science Foundation of Peking University Cancer Hospital-2023 (No.JC202310)

摘　　要：Objective:To evaluate the safety and efficacy of neoadjuvant chemotherapy(NCT)in mid-low locally advanced rectal cancer with negative mesorectal fascia(MRF).Methods:This prospective,single-arm phaseⅡtrial was designed and conducted at Peking University Cancer Hospital.The patients who provided consent received 3 months of NCT(capecitabine and oxaliplatin,CapOX)followed by total mesorectal excision(TME).The primary endpoint was the rate of pathological complete response(pCR).Results:From January 2019 through December 2021,a total of 53 patients were enrolled,7.5%of whom experienced grade 3-4 adverse events during NCT.The pCR rate was 17.0%for the entire cohort,and the overall rate of postoperative complications was 37.7%(1.9%of gradeⅢa patients).The 3-year disease-free survival rate was 91.4%,and 23.5%(12/51)of the patients suffered from major low anterior resection syndrome(LARS).Postoperative complications were independently associated with major LARS.Conclusions:For patients with mid-low rectal cancer with negative MRF,3 months of NCT were found to yield a favorable tumor response with acceptable toxicity.With fair long-term survival,the NCT regimen could be associated with low rates of perioperative complications as well as acceptable anal function.

关 键 词：Neoadjuvant chemotherapy rectal cancer mesorectal fascia disease-free survival anal function 

分 类 号：R735.37[医药卫生—肿瘤]