直肠癌新辅助治疗后临床完全缓解患者应用等待观察策略与根治性手术治疗的远期疗效对比分析  

Comparison of long-term efficacy between watch and wait strategy and total mesorectal excision in locally advanced rectal cancer patients with clinical complete response after neoadjuvant therapy

作　　者：王小豪 周程静 张术 王俏镟[1] 肖巍魏[1] 丁培荣[2] 陈功[2] 潘志忠[2] 曾智帆[1] 高远红[1] Wang Xiaohao;Zhou Chengjing;Zhang Shu;Wang Qiaoxuan;Xiao Weiwei;Ding Peirong;Chen Gong;Pan Zhizhong;Zeng Zhifan;Gao Yuanhong(Department of Radiation Oncology,Sun Yat-sen University Cancer Center,State Key Laboratory of Oncology in South China,Collaborative Innovation Center for Cancer Medicine,Guangzhou 510060,China;Department of Colorectal Surgery,Sun Yat-sen University Cancer Center,State Key Laboratory of Oncology in South China,Collaborative Innovation Center for Cancer Medicine,Guangzhou 510060,China)

机构地区：[1]中山大学肿瘤防治中心放射治疗科、华南肿瘤学国家重点实验室、肿瘤医学协同创新中心,广州510060 [2]中山大学肿瘤防治中心结直肠科、华南肿瘤学国家重点实验室肿瘤医学协同创新中心,广州510060

出　　处：《中华胃肠外科杂志》2020年第3期266-273,共8页Chinese Journal of Gastrointestinal Surgery

基　　金：国家自然科学基金(81672987)。

摘　　要：目的对比局部进展期期直肠癌患者经新辅助放化疗(nCRT)后获得临床完全缓解(cCR)采用随访等待观察与根治性手术[全直肠系膜切除术(TME)]两种治疗策略的远期临床疗效。方法采用回顾性队列研究。纳入2010年9月16日至2018年1月9日期间,中山大学肿瘤防治中心收治的,接受nCRT并获得cCR的Ⅱ~Ⅲ期局部进展期直肠癌患者,排除5年内确诊其他恶性肿瘤、未在本中心规律随访1年以上以及nCRT后复查项目不全者。共计238例患者入组,男性151例、女性87例;中位年龄57(27~83)岁;临床肿瘤TNM分期Ⅱ期61例、Ⅲ期177例。nCRT采用同期放化疗20例,同期放化疗+诱导/巩固化疗218例。放疗采用调强放射治疗技术,肿瘤靶区(GTV)50 Gy/25次/5周,CTV 45~46 Gy/25次/5周,227例放疗总剂量在45.0~50.6 Gy之间;同期化疗仅氟尿嘧啶或卡培他滨27例,氟尿嘧啶或卡培他滨联合奥沙利铂211例。59例采用等待观察治疗策略(等待观察组),179例在nCRT后6~12周接受TME手术(根治手术组)。两组患者自治疗结束起每3个月随诊1次,至3年后改为每半年随访1次。比较两组的整体生存率(OS)、无远处转移生存率(DMFS)和无局部复发生存率(LRFS)等生存情况,并分析挽救性治疗情况和两组保肛率。采用Kaplan-Meier法绘制生存曲线,并用Log-rank进行时序检验。结果选择TME手术者其nCRT结束距手术的中位时间59 d,术后病理完全缓解(pCR)63.1%(113/179)。中位随访时间41.8(12.0~99.0)个月,全组3、5年OS分别为98.4%和96.5%,3、5年LRFS分别96.5%和96.5%,3、5年无瘤生存率分别为89.8%和88.0%,3、5年DMFS分别为91.0%和87.9%。等待观察组与根治手术组3年OS分别为100%和97.9%,5年OS分别为90.6%和97.9%,差异无统计学意义(P=0.339)。随访期间,等待观察组局部复发7例,均出现在治疗后2年内,3年局部复发率为12.9%,高于根治手术组(0.6%),差异有统计学意义(P=0.003);挽救手术成功率为5/6,挽救性治疗后Objective To compare long-term efficacy between watch and wait(W&W)strategy and total mesorectal excision(TME)in patients who were diagnosed with locally advanced rectal cancer(LARC)and attained clinical complete response(cCR)after neoadjuvant chemoradiotherapy(nCRT).Methods A retrospective cohort study was carried out.A total of 238 patients with stage II-III LARC exhibiting cCR after nCRT in Sun Yat-sen University Cancer Center from September 16,2010 to January 9,2018 were enrolled.Patients who were diagnosed with other malignant tumor within 5 years,did not receive regular follow-up in our center for more than 1 year and had no complete examination items after nCRT were excluded.Of 238 patients,151 were male and 87 were female with a median age of 57(27-83)years old.According to TNM stage,61 cases were cII,177 cases were cIII.Concurrent chemoradiotherapy(CCRT)was performed in 20 patients.CCRT plus induction/consolidated chemotherapy was performed in 218 patients.Intensity-modulated radiotherapy(IMRT)was applied to radiotherapy.The median radiation dose was 50 Gy/25 Fr for both the primary tumor and clinical target volumes,and the total dose was 45.0 to 50.6 Gy for 227 patients.In 27 patients,single-agent fluorouracil or capecitabine was used as concurrent chemotherapy.But in the other 211 patients,a combined regimen of oxaliplatin and fluorouracil or capecitabine was used.After nCRT,59 and 179 patients received W&W(W&W group)and TME 6-12 weeks later(TME group),respectively.After the ending of treatment,patient was interviewed one time every 3 months and after 3 years,one time every six months.Overall survival(OS)rate,distant-metastasis-free survival(DMFS)rate,and local-recurrence-free survival(LRFS)rate were compared between two groups.The salvage treatment and sphincter preservation rate were analyzed.The survival curve was drawn with Kaplan-Meier method and evaluated by log-rank method.Results In the cases treated with TME,the median interval from nCRT to surgery was 59 days.The postoperative pCR rate was 63

关 键 词：直肠肿瘤 局部进展期 新辅助放化疗 临床完全缓解 等待观察 无造口生存率 

分 类 号：R735[医药卫生—肿瘤]