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

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收录情况： ◇ SCIE

作者：
Mei Wei-Jian[1] ; Wang Xiao-Zhong[2] ; Li Yun-Feng[3] ; Sun Yue-Ming[4] ; Yang Chun-Kang[5] ; Lin Jun-Zhong[1] ; Wu Zu-Guang[6] ; Zhang Rui[7] ; Wang Wei[8] ; Li Yong[9,10] ; Zhuang Ye-Zhong[11] ; Lei Jian[12] ; Wan Xiang-Bin[13] ; Ren Ying-Kun[13] ; Cheng Yong[14] ; Li Wen-Liang[15] ; Wang Zi-Qiang[16] ; Xu Dong-Bo[17] ; Mo Xian-Wei[18] ; Ju Hai-Xing[19] ; Ye Sheng-Wei[20] ; Zhao Jing-Lin[21] ; Zhang Hong[22] ; Gao Yuan-Hong[23] ; Zeng Zhi-Fan[23] ; Xiao Wei-Wei[23] ; Zhang Xiao-Peng[2] ; Zhang Xuan[3] ; Xie E[24] ; Feng Yi-Fei[4] ; Tang Jing-Hua[1] ; Wu Xiao-Jun[1] ; Chen Gong[1] ; Li Li-Ren[1] ; Lu Zhen-Hai[1] ; Wan De-Sen[1] ; Bei Jin-Xin[25] ; Pan Zhi-Zhong[1,*1] ; Ding Pei-Rong[1,*1] ;
机构： [1]Department of Colorectal Surgery, 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. [2]Shantou Central Hospital, Shantou, P. R. China. [3]The Third Affiliated Hospital of Kunming Medical University/Yunnan Cancer Hospital, Kunming, P. R. China. [4]The First Affiliated Hospital of Nanjing Medical University, Nanjing, P. R. China. [5]Fujian Medical University Cancer Hospital, Fuzhou, P. R. China. [6]Department of Gastrointestinal Surgery, Meizhou People's Hospital, Meizhou, P. R. China. [7]Liaoning Cancer Hospital & Institute, Shenyang, P. R. China. [8]Guangdong Provincial Hospital of Traditional Chinese Medicine, Guangzhou, P. R. China. [9]Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences,Guangzhou, P. R. China. [10]The Second School of Clinical Medicine, Southern Medical University, Guangzhou, P. R. China. [11]Cancer Hospital of Shantou University Medical college, Shantou, P. R. China. [12]The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, P. R. China. [13]Department of General Surgery, The Affiliated Cancer Hospital of Zhengzhou University, Henan Provincial Cancer Hospital, Zhengzhou, P. R. China. [14]The First Affiliated Hospital of Chongqing Medical University, Chongqing, P. R. China. [15]First Affiliated hospital of Kunming Medical University, Kunming, P. R. China. [16]West China Hospital of Sichuan University, Chengdu, P. R. China. [17]Longyan First Hospital, Longyan, P. R. China. [18]Guangxi Medical University Cancer Center, Nanning, P. R. China. [19]Cancer Hospital of the University of Chinese Academy of Sciences, Hangzhou, P. R. China. [20]Hubei Cancer Hospital, Wuhan, P. R. China. [21]Department of Gastrointestinal Surgery, Jiangmen Central Hospital, Affiliated Jiangmen Hospital of Sun Yat-sen University, Jiangmen, Guangdong, P. R. China. [22]Shengjing Hospital of China Medical University, Shenyang, P. R. China. [23]Department of Radiation Oncology, 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. [24]Shantou Hospital of Traditional Chinese Medicine, Shantou, P. R. China. [25]Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, 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.
出处：
DOI： 10.1097/SLA.0000000000005780
ISSN：

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

摘要：
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).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.Patients between June 2014 and October 2020 with LARC within 12 cm from anal verge and uninvolved MRF were randomly assigned to nCT group with four 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/m² 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 results of secondary end points: histopathologic response, surgical events, and toxicity.Of the 663 initially enrolled patients, 589 received the allocated treatment (nCT, n=300; nCRT, n=289). Pathological complete response (pCR) 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 non-surgical approach. Similar results were observed in subgroup analysis.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.Copyright © 2022 The Author(s). Published by Wolters Kluwer Health, Inc.

基金：
Sun Yat-Sen University Clinical Research 5010 Program (grant number 2014013), the National Natural Science Foundation of China (82073159 and 81871971), and the Guangdong Basic and Applied Basic Research Foundation (2020A1515110544).
语种：
外文
被引次数：
WOS：
PubmedID：
中科院(CAS)分区：
出版当年[2024]版：
无
最新[2023]版：
大类 | 1 区 医学
小类 | 1 区 外科
JCR分区：
出版当年[2023]版：
Q1 SURGERY
最新[2023]版：
Q1 SURGERY

影响因子： 最新[2023版] 最新五年平均 出版当年[2023版] 出版当年五年平均 出版前一年[2022版]

第一作者：
第一作者机构： [1]Department of Colorectal Surgery, 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.
共同第一作者：
通讯作者：
通讯机构： [1]Department of Colorectal Surgery, 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. [*1]Department of Colorectal Surgery, Sun Yat-sen University Cancer Center, 651 Dongfeng East Road, Guangzhou 510060, P. R. China
推荐引用方式(GB/T 7714)：
Mei Wei-Jian,Wang Xiao-Zhong,Li Yun-Feng,et al.Neoadjuvant Chemotherapy with CAPOX versus Chemoradiation for Locally Advanced Rectal Cancer with Uninvolved Mesorectal Fascia (CONVERT): Initial Results of a Phase III Trial[J].ANNALS OF SURGERY.2023,277(4):557-564.doi:10.1097/SLA.0000000000005780.
APA：
Mei Wei-Jian,Wang Xiao-Zhong,Li Yun-Feng,Sun Yue-Ming,Yang Chun-Kang...&Ding Pei-Rong.(2023).Neoadjuvant Chemotherapy with CAPOX versus Chemoradiation for Locally Advanced Rectal Cancer with Uninvolved Mesorectal Fascia (CONVERT): Initial Results of a Phase III Trial.ANNALS OF SURGERY,277,(4)
MLA：
Mei Wei-Jian,et al."Neoadjuvant Chemotherapy with CAPOX versus Chemoradiation for Locally Advanced Rectal Cancer with Uninvolved Mesorectal Fascia (CONVERT): Initial Results of a Phase III Trial".ANNALS OF SURGERY 277..4(2023):557-564

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