title: Surgery with versus without preoperative concurrent chemoradiotherapy for mid/low rectal cancer: an interim analysis of a prospective, randomized trial.
abstract: BACKGROUND
  Multimodality therapy, including preoperative chemoradiotherapy (CRT) and total mesorectal excision (TME), has effectively reduced local recurrence rates of rectal cancer over the past decade. However, the benefits and risks of the addition of neoadjuvant CRT to surgery need to be evaluated. This study was to compare the efficacy of TME with versus without preoperative concurrent chemoradiotherapy (CCRT) involving XELOX regimen (oxaliplatin plus capecitabine) in Chinese patients with stages II and III mid/low rectal adenocarcinoma.
  
  
  METHODS
  We randomly assigned patients to the TME group (TME without preoperative CCRT) or CCRT + TME group (TME with preoperative CCRT). The primary endpoint was disease-free survival (DFS); the secondary endpoints were overall survival (OS), local and distant recurrence, tumor response to CRT, toxicity, sphincter preservation, and surgical complications. An interim analysis of the potential inferiority of DFS in the CCRT + TME group was planned when the first 180 patients had been followed up for at least 6 months.
  
  
  RESULTS
  A total of 94 patients in the TME group and 90 patients in the CCRT + TME group were able to be evaluated. The 3-year DFS and OS rates were 86.3 % and 91.5 % in the whole cohort, respectively. The 3-year DFS rates of the TME and CCRT + TME groups were 85.7% and 87.9 % (P = 0.766), respectively, and the 3-year OS rates were 90.7 % and 92.3 % (P = 0.855), respectively. The functional sphincter preservation rates of the TME and CCRT + TME groups were 71.3 % and 70.0 % (P = 0.849), respectively. In the TME group, 16 (17.0 %) patients were proven to have pTNM stage I disease after surgery. In the CCRT + TME group, 32 (35.6 %) patients achieved a pathologic complete response (pCR).
  
  
  CONCLUSIONS
  Preliminary results indicated no significant differences in the DFS, OS, or functional sphincter preservation rates between the TME and CCRT + TME groups. However, preoperative CCRT with XELOX yielded a high pCR rate. Newer techniques are needed to improve the staging accuracy, and further investigation is warranted.
  
  
  BACKGROUND
  Chi CTR-TRC-08000122.
authors.affiliation: State Key Laboratory of Oncology in South China; Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, 510060, P. R. China. fanwh@sysucc.org.cn.|Department of Colorectal Surgery, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, 510060, P. R. China. fanwh@sysucc.org.cn.
authors.forename: Wen-Hua
authors.initials: WH
authors.lastname: Fan
authors.affiliation: State Key Laboratory of Oncology in South China; Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, 510060, P. R. China. wangful@sysucc.org.cn.|Department of Colorectal Surgery, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, 510060, P. R. China. wangful@sysucc.org.cn.
authors.forename: Fu-Long
authors.initials: FL
authors.lastname: Wang
authors.affiliation: State Key Laboratory of Oncology in South China; Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, 510060, P. R. China. luzhh@sysucc.org.cn.|Department of Colorectal Surgery, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, 510060, P. R. China. luzhh@sysucc.org.cn.
authors.forename: Zhen-Hai
authors.initials: ZH
authors.lastname: Lu
authors.affiliation: State Key Laboratory of Oncology in South China; Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, 510060, P. R. China. panzhzh@sysucc.org.cn.|Department of Colorectal Surgery, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, 510060, P. R. China. panzhzh@sysucc.org.cn.
authors.forename: Zhi-Zhong
authors.initials: ZZ
authors.lastname: Pan
authors.affiliation: State Key Laboratory of Oncology in South China; Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, 510060, P. R. China. lilr@sysucc.org.cn.|Department of Colorectal Surgery, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, 510060, P. R. China. lilr@sysucc.org.cn.
authors.forename: Li-Ren
authors.initials: LR
authors.lastname: Li
authors.affiliation: State Key Laboratory of Oncology in South China; Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, 510060, P. R. China. gaoyh@sysucc.org.cn.|Department of Radiation Oncology, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, 510060, P. R. China. gaoyh@sysucc.org.cn.
authors.forename: Yuan-Hong
authors.initials: YH
authors.lastname: Gao
authors.affiliation: State Key Laboratory of Oncology in South China; Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, 510060, P. R. China. chengong@sysucc.org.cn.|Department of Colorectal Surgery, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, 510060, P. R. China. chengong@sysucc.org.cn.
authors.forename: Gong
authors.initials: G
authors.lastname: Chen
authors.affiliation: State Key Laboratory of Oncology in South China; Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, 510060, P. R. China. wuxj@sysucc.org.cn.|Department of Colorectal Surgery, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, 510060, P. R. China. wuxj@sysucc.org.cn.
authors.forename: Xiao-Jun
authors.initials: XJ
authors.lastname: Wu
authors.affiliation: State Key Laboratory of Oncology in South China; Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, 510060, P. R. China. dingpr@sysucc.org.cn.|Department of Colorectal Surgery, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, 510060, P. R. China. dingpr@sysucc.org.cn.
authors.forename: Pei-Rong
authors.initials: PR
authors.lastname: Ding
authors.affiliation: State Key Laboratory of Oncology in South China; Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, 510060, P. R. China. zengzhifan@sysucc.org.cn.|Department of Radiation Oncology, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, 510060, P. R. China. zengzhifan@sysucc.org.cn.
authors.forename: Zhi-Fan
authors.initials: ZF
authors.lastname: Zeng
authors.affiliation: State Key Laboratory of Oncology in South China; Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, 510060, P. R. China. wands@sysucc.org.cn.|Department of Colorectal Surgery, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, 510060, P. R. China. wands@sysucc.org.cn.
authors.forename: De-Sen
authors.initials: DS
authors.lastname: Wan
mesh_terms: D000230:Adenocarcinoma; D000971:Antineoplastic Combined Chemotherapy Protocols; D000069287:Capecitabine; D059248:Chemoradiotherapy; D003131:Combined Modality Therapy; D003841:Deoxycytidine / Q000031:analogs & derivatives; D018572:Disease-Free Survival; D005472:Fluorouracil / Q000031:analogs & derivatives; D006801:Humans; D020360:Neoadjuvant Therapy; D009367:Neoplasm Staging; D009944:Organoplatinum Compounds; D000077150:Oxaliplatin; D010071:Oxaloacetates; D011379:Prognosis; D011446:Prospective Studies; D012004:Rectal Neoplasms; D015996:Survival Rate
chemical_list: D009944:Organoplatinum Compounds; D010071:Oxaloacetates; D000077150:Oxaliplatin; D003841:Deoxycytidine; D000069287:Capecitabine; D005472:Fluorouracil