直肠癌新辅助放化疗后等待观察策略疗效分析  

Long-term outcomes of watch&wait(W&W)after neoadjuvant treatment in patients with rectal cancer

作　　者：赵莹 唐源 刘文扬 李宁 陈司霖 史金明 马慧颖 曾强 宋永文 王淑莲 刘跃平 房辉 卢宁宁 唐玉 亓姝楠 杨勇 陈波 李晔雄 金晶 Zhao Ying;Tang Yuan;Liu Wenyang;Li Ning;Chen Silin;Shi Jinming;Ma Huiying;Zeng Qiang;Song Yongwen;Wang Shulian;Liu Yueping;Fang Hui;Lu Ningning;Tang Yu;Qi Shunan;Yang Yong;Chen Bo;Li Yexiong;Jin Jing(Department of Radiation Oncology,National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College,Beijing 100021,China;Clinical Trials Center,National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College,Beijing 100021,China;Department of Radiation Oncology,National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital&Shenzhen Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College,Shenzhen 518116,China)

机构地区：[1]国家癌症中心/国家肿瘤临床医学研究中心/中国医学科学院北京协和医学院肿瘤医院放疗科,北京100021 [2]国家癌症中心/国家肿瘤临床医学研究中心/中国医学科学院北京协和医学院肿瘤医院GCP中心,北京100021 [3]国家癌症中心/国家肿瘤临床医学研究中心/中国医学科学院北京协和医学院肿瘤医院深圳医院放疗科,深圳518116

出　　处：《中华放射肿瘤学杂志》2022年第3期253-259,共7页Chinese Journal of Radiation Oncology

摘　　要：目的比较局部进展期直肠癌新辅助治疗后临床完全缓解(cCR)的患者等待观察(W&W)与直肠癌全系膜切除术(TME)后病理完全缓解(pCR)患者的疗效。方法回顾性队列研究,收集2014—2019年中国医学科学院肿瘤医院收治的新辅助放化疗Ⅱ-Ⅲ期直肠癌患者,纳入标准为完成新辅助治疗后规律随访≥1年且达到cCR者(W&W组),或者TME手术后病理pCR者(pCR组)。研究终点主要为3、5年总生存(OS)、无结肠造瘘生存(CFS)、无瘤生存(DFS)、非局部再生DFS(NR-DFS)、器官保留率。采用Kaplan-Meier法生存分析和log-rank检验,并使用倾向评分配比进行验证。结果共118例患者入组,中位随访49.5个月(12.1~79.9个月),W&W组、pCR组3年OS率分别为97.1%、96.7%,5年的分别为93.8%、90.9%(P=0.696);3、5年CFS率分别均为89.1%、43.5%(P<0.001);3年DFS率分别为83.6%、97.0%,5年的分别为83.6%、91.2%(P=0.047);3年NR-DFS率分别为95.9%、97.0%,5年的分别为92.8%、97.0%(P=0.407)。W&W组6例发生局部再生,87.7%患者成功保留了直肠。经倾向评分匹配后W&W组CFS仍明显优于pCR组(90.1%∶26.5%,P<0.001)。W&W组达cCR的中位时间为17.5周,在放疗结束后5~12周初次评效时仅23.9%患者达cCR,且与标准长程CRT相比,短程放疗者达cCR间隔时间更长(P<0.001)。结论局部进展期直肠癌新辅助治疗后达cCR者等待观察安全有效,显著改善生活质量,进一步延长cCR评价时间可提高直肠器官保留率。Objective To compare the outcomes of watch&wait(W&W)strategy in patients with locally advanced rectal cancer who achieved complete clinical response(cCR)after neoadjuvant therapy,with those who obtained pathological complete response(pCR)after total mesorectal excision(TME).Methods This is a retrospective cohort analysis study.Patients histologically proven with locally advanced rectal adenocarcinoma(stageⅡ-Ⅲ)who had received neoadjuvant chemotherapy were eligible between January 2014 and December 2019.In whom we included patients who had cCR offered management with W&W strategy after completing neoadjuvant therapy and follow-up≥1 year(W&W group),and patients who did not have cCR but pCR after TME(pCR group).The primary endpoints were 3-year and 5-year overall survival(OS),colostomy-free survival(CFS),disease-free survival(DFS),non-local regrowth disease-free survival(NR-DFS),and organ preservation rate.Kaplan-Meier analysis was used for survival analysis and log-rank test was performed.For comparative analysis,we also derived one-to-one paired cohorts of W&W versus pCR using propensity-score matching(PSM).Results A total of 118 patients were enrolled,49 of whom had cCR and managed by W&W,69had pCR,with a median follow-up period of 49.5 months(12.1-79.9 months).No difference was observed in the 3-year OS(97.1%vs.96.7%)and 5-year OS(93.8%vs.90.9%,P=0.696)between the W&W and pCR groups.Patients managed by W&W had significantly better 3-year and 5-year CFS(89.1%vs.43.5%,P<0.001),better 3-year DFS(83.6%vs.97.0%)and 5-year DFS(83.6%vs.91.2%,P=0.047)compared with those achieving pCR.The 3-year NR-DFS(95.9%vs.97.0%)and 5-year NR-DFS(92.8%vs.97.0%,P=0.407)did not significantly differ between the W&W and pCR groups.Local regeneration occurred in six cases,and 87.7% of patients had successful rectum preservation in the W&W group.In the PSM analysis(34 patients in each group),absolutely better CFS(90.1%vs.26.5%,P<0.001)was noted in the W&W group.A median interval of 17.5 weeks was observed for achieving cCR,while only

关 键 词：直肠癌 局部进展期 等待观察 直肠癌全系膜切除术 临床完全缓解 器官保留 

分 类 号：R735.37[医药卫生—肿瘤]