Neoadjuvant Chemotherapy With CAPOX Versus Chemoradiation for Locally Advanced Rectal Cancer With Uninvolved Mesorectal Fascia (CONVERT): Initial Results of a Phase III Trial

作者全名："Mei, Wei-Jian; Wang, Xiao-Zhong; Li, Yun-Feng; Sun, Yue-Ming; Yang, Chun-Kang; Lin, Jun-Zhong; Wu, Zu-Guang; Zhang, Rui; Wang, Wei; Li, Yong; Zhuang, Ye-Zhong; Lei, Jian; Wan, Xiang-Bin; Ren, Ying-Kun; Cheng, Yong; Li, Wen-Liang; Wang, Zi-Qiang; Xu, Dong-Bo; Mo, Xian-Wei; Ju, Hai-Xing; Ye, Sheng-Wei; Zhao, Jing-Lin; Zhang, Hong; Gao, Yuan-Hong; Zeng, Zhi-Fan; Xiao, Wei-Wei; Zhang, Xiao-Peng; Zhang, Xuan; Xie, E.; Feng, Yi-Fei; Tang, Jing-Hua; Wu, Xiao-Jun; Chen, Gong; Li, Li-Ren; Lu, Zhen-Hai; Wan, De-Sen; Bei, Jin-Xin; Pan, Zhi-Zhong; Ding, Pei-Rong"

作者地址："[Mei, Wei-Jian; Lin, Jun-Zhong; Tang, Jing-Hua; Wu, Xiao-Jun; Chen, Gong; Li, Li-Ren; Lu, Zhen-Hai; Wan, De-Sen; Pan, Zhi-Zhong; Ding, Pei-Rong] Sun Yat sen Univ Canc Ctr, Dept Colorectal Surg, Guangzhou, Guangdong, Peoples R China; [Gao, Yuan-Hong; Zeng, Zhi-Fan; Xiao, Wei-Wei] Sun Yat sen Univ Canc Ctr, Dept Radiat Oncol, Guangzhou, Guangdong, Peoples R China; [Bei, Jin-Xin] Sun Yat sen Univ Canc Ctr, Collaborat Innovat Ctr Canc Med, Guangdong Key Lab Nasopharyngeal Carcinoma Diag &, State Key Lab Oncol South China, Guangzhou, Guangdong, Peoples R China; [Zhao, Jing-Lin] Sun Yat sen Univ, Jiangmen Cent Hosp, Jiangmen Hosp, Dept Gastrointestinal Surg, Jiangmen, Peoples R China; [Wang, Wei] Southern Med Univ, Guangdong Prov Hosp Tradit Chinese Med, Guangzhou, Peoples R China; [Li, Yong] Southern Med Univ, Guangdong Acad Med Sci, Guangdong Prov Peoples Hosp, Guangzhou, Peoples R China; [Lei, Jian] Guangzhou Med Univ, Affiliated Hosp 1, Guangzhou, Peoples R China; [Li, Yong] Southern Med Univ, Sch Clin Med 2, Guangzhou, Peoples R China; [Wang, Xiao-Zhong; Zhang, Xiao-Peng] Shantou Cent Hosp, Shantou, Peoples R China; [Zhuang, Ye-Zhong] Shantou Univ, Canc Hosp, Med Coll, Shantou, Peoples R China; [Xie, E.] Shantou Hosp Tradit Chinese Med, Shantou, Peoples R China; [Li, Yun-Feng; Zhang, Xuan] Kunming Med Univ, Yunnan Canc Hosp, Affiliated Hosp 3, Kunming, Peoples R China; [Li, Wen-Liang] Kunming Med Univ, Affiliated Hosp 1, Kunming, Peoples R China; [Sun, Yue-Ming; Feng, Yi-Fei] Nanjing Med Univ, Affiliated Hosp 1, Nanjing, Peoples R China; [Yang, Chun-Kang] Fujian Med Univ, Canc Hosp, Fuzhou, Peoples R China; [Wu, Zu-Guang] Meizhou Peoples Hosp, Dept Gastrointestinal Surg, Meizhou, Peoples R China; [Zhang, Rui] Liaoning Canc Hosp & Inst, Shenyang, Peoples R China; [Zhang, Hong] China Med Univ, Shengjing Hosp, Shenyang, Peoples R China; [Wan, Xiang-Bin; Ren, Ying-Kun] Zhengzhou Univ, Henan Prov Canc Hosp, Affiliated Canc Hosp, Dept Gen Surg, Zhengzhou, Peoples R China; [Cheng, Yong] Chongqing Med Univ, Affiliated Hosp 1, Chongqing, Peoples R China; [Wang, Zi-Qiang] Sichuan Univ, West China Hosp, Chengdu, Peoples R China; [Xu, Dong-Bo] Longyan First Hosp, Longyan, Peoples R China; [Mo, Xian-Wei] Guangxi Med Univ, Canc Ctr, Nanning, Peoples R China; [Ju, Hai-Xing] Univ Chinese Acad Sci, Cancer Hosp, Hangzhou, Peoples R China; [Ye, Sheng-Wei] Hubei Canc Hosp, Wuhan, Peoples R China"

通信作者："Ding, PR (通讯作者)，Sun Yat sen Univ Canc Ctr, Dept Colorectal Surg, Guangzhou, Guangdong, Peoples R China."

来源：ANNALS OF SURGERY

ESI学科分类：CLINICAL MEDICINE

WOS号：WOS:000970519000005

JCR分区：Q1

影响因子：7.5

年份：2023

卷号：277

期号：4

开始页：557

结束页：564

文献类型：Article

关键词：locally advanced rectal cancer; neoadjuvant chemotherapy; neoadjuvant chemoradiotherapy; randomized clinical trial

摘要："Objective:To compare neoadjuvant chemotherapy (nCT) with CAPOX alone versus neoadjuvant chemoradiotherapy (nCRT) with capecitabine in locally advanced rectal cancer (LARC) with uninvolved mesorectal fascia (MRF). Background Data:nCRT is associated with higher surgical complications, worse long-term functional outcomes, and questionable survival benefits. Comparatively, nCT alone seems a promising alternative treatment in lower-risk LARC patients with uninvolved MRF. Methods:Patients between June 2014 and October 2020 with LARC within 12 cm from the anal verge and uninvolved MRF were randomly assigned to nCT group with 4 cycles of CAPOX (Oxaliplatin 130 mg/m2 IV day 1 and Capecitabine 1000 mg/m2 twice daily for 14 d. Repeat every 3 wk) or nCRT group with Capecitabine 825 mg/m(2) twice daily administered orally and concurrently with radiation therapy (50 Gy/25 fractions) for 5 days per week. The primary end point is local-regional recurrence-free survival. Here we reported the results of secondary end points: histopathologic response, surgical events, and toxicity. Results:Of the 663 initially enrolled patients, 589 received the allocated treatment (nCT, n=300; nCRT, n=289). Pathologic complete response rate was 11.0% (95% CI, 7.8-15.3%) in the nCT arm and 13.8% (95% CI, 10.1-18.5%) in the nCRT arm (P=0.33). The downstaging (ypStage 0 to 1) rate was 40.8% (95% CI, 35.1-46.7%) in the nCT arm and 45.6% (95% CI, 39.7-51.7%) in the nCRT arm (P=0.27). nCT was associated with lower perioperative distant metastases rate (0.7% vs. 3.1%, P=0.03) and preventive ileostomy rate (52.2% vs. 63.6%, P=0.008) compared with nCRT. Four patients in the nCT arm received salvage nCRT because of local disease progression after nCT. Two patients in the nCT arm and 5 in the nCRT arm achieved complete clinical response and were treated with a nonsurgical approach. Similar results were observed in subgroup analysis. Conclusions:nCT achieved similar pCR and downstaging rates with lower incidence of perioperative distant metastasis and preventive ileostomy compared with nCRT. CAPOX could be an effective alternative to neoadjuvant therapy in LARC with uninvolved MRF. Long-term follow-up is needed to confirm these results."

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