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Postoperative Chemoradiotherapy With Capecitabine and Oxaliplatin vs Capecitabine for Stage II to III Rectal Cancer A Randomized Clinical Trial

文献类型：期刊论文

作者Li, Ning4; Zhu, Yuan3; Liu, Lu-Ying3; Feng, Yan-Ru3; Wang, Wen-Ling2; Wang, Jun8; Wang, Hao1; Li, Gao-Feng5; Tang, Yuan4; Hu, Chen7
刊名JAMA NETWORK OPEN
出版日期2021-11-30
卷号4
ISSN号2574-3805
DOI10.1001/jamanetworkopen.2021.36116
通讯作者Li, Ye-Xiong(yexiong12@163.com) ; Jin, Jing(jingjin1025@163.com)
英文摘要IMPORTANCE Several studies have explored the efficacy and toxic effects of concurrent 5-fluorouracil (5-FU)- or capecitabine-based chemoradiotherapy (CRT) with or without oxaliplatin in the neoadjuvant setting. Addition of oxaliplatin to 5-FU or capecitabine elicited similar outcomes but with significantly increased toxic effects; however, there is a need for randomized clinical trials comparing 2 CRT regimens for patients receiving CRT in the adjuvant setting. OBJECTIVE To explore the efficacy and toxic effects of oxaliplatin combined with postoperative concurrent capecitabine and radiotherapy (RT) for pathological stage II and III rectal cancer. DESIGN, SETTING, AND PARTICIPANTS This multicenter randomized clinical trial enrolled patients from 7 centers in China between April 1, 2008, and December 30, 2015. Patients with pathologically confirmed stage II and III rectal cancer were randomized (1:1) to receive concurrent CRT with capecitabine or capecitabine plus oxaliplatin. Analysis was conducted from December 31, 2019, to March 15, 2020. INTERVENTIONS RT comprised 45 to 50 Gy in 25 fractions of 1.8 to 2.0 Gy over 5 weeks. In the capecitabine with RT group, concurrent chemotherapy included 2 cycles of capecitabine (1600 mg/m(2)) on days 1 to 14 and 22 to 35. The capecitabine and oxaliplatin with RT group received identical postoperative RT to that in the capecitabine with RT group combined with capecitabine (1300mg/m(2)) on days 1 to 14 and 22 to 35 and a 2-hour infusion of oxaliplatin (60mg/m(2)) on weeks 1, 2, 4, and 5. Patients in both groups received adjuvant chemotherapy (capecitabine or fluorouracil and oxaliplatin) after CRT. MAIN OUTCOMES AND MEASURES The primary end point was 3-year disease-free survival (DFS). RESULTS A total of 589 patients (median [IQR] age, 55 [47-52] years; 375 [63.7%] men and 214 [36.3%] women) were enrolled, including 294 patients randomized to the capecitabine with RT group and 295 patients randomized to the capecitabine and oxaliplatin with RT group. Median (IQR) follow-up was 68 (45-96) months. Most patients had stage III disease (574 patients [75.9%]). Three-year DFS was 76.3% for the capecitabine with RT group and 74.1% for the capecitabine and oxaliplatin with RT group, and 5-year DFSwas 72.0% for the capecitabine with RT group and 71.1% for the capecitabine and oxaliplatin with RT group (hazard ratio [HR], 1.07; 95% CI, 0.79-1.44; P = .68). There was no significant difference between groups in overall survival (HR, 0.93; 95% CI, 0.64-1.34; P = .70) or local recurrence (HR, 0.61; 95% CI, 0.31-1.22; P = .16). More grade 3 and 4 acute toxic effects were observed in the capecitabine and oxaliplatin with RT group than in the capecitabine with RT group (114 patients [38.6%] vs 84 patients [28.6%]; P = .01). CONCLUSIONS AND RELEVANCE This randomized clinical trial found that addition of oxaliplatin to capecitabine-based postoperative CRT did not improve the efficacy of treatment but increased the risk of severe acute toxic effects. This finding highlights the basic role of postoperative capecitabine with RT for patients with locally advanced rectal cancer.
WOS关键词SHORT-COURSE RADIOTHERAPY ; PREOPERATIVE RADIOTHERAPY ; ADJUVANT TREATMENT ; PHASE-I ; FLUOROURACIL ; CHEMORADIATION ; LEUCOVORIN ; CHEMOTHERAPY ; MULTICENTER
资助项目National Key Projects of Research and Development of China[2016YFC0904600] ; Chinese Academy of Medical Science Innovation Fund for Medical Sciences (CIFMS)[2016-I2M-1-001] ; Chinese Academy of Medical Science Innovation Fund for Medical Sciences (CIFMS)[2017-I2M-1-006] ; Natural Science Foundation of China[81272510] ; Natural Science Foundation of China[81871509] ; Central Public-Interest Scientific Institution Basal Research Fund of the Chinese Academy of Medical Sciences[2018RC310010]
WOS研究方向General & Internal Medicine
语种英语
出版者AMER MEDICAL ASSOC
WOS记录号WOS:000725770600005
资助机构National Key Projects of Research and Development of China ; Chinese Academy of Medical Science Innovation Fund for Medical Sciences (CIFMS) ; Natural Science Foundation of China ; Central Public-Interest Scientific Institution Basal Research Fund of the Chinese Academy of Medical Sciences
源URL[http://ir.hfcas.ac.cn:8080/handle/334002/126770]  
专题中国科学院合肥物质科学研究院
通讯作者Li, Ye-Xiong; Jin, Jing
作者单位1.Peking Univ Third Hosp, Dept Radiat Oncol, Beijing, Peoples R China
2.Guizhou Canc Hosp, Dept Radiat Oncol, Guiyang, Peoples R China
3.Chinese Acad Sci, Dept Radiat Oncol, Canc Hosp, Univ Chinese Acad Sci,Zhejiang Canc Hosp,Inst Can, Hangzhou, Peoples R China
4.Chinese Acad Med Sci, Peking Union Med Coll, State Key Lab Mol Oncol,Canc Hosp, Dept Radiat Oncol,Natl Canc Ctr,Natl Clin Res Ctr, Beijing 100021, Peoples R China
5.Beijing Hosp, Dept Radiat Oncol, Beijing, Peoples R China
6.Beijing Canc Hosp, Dept Radiat Oncol, Beijing, Peoples R China
7.Johns Hopkins Univ, Sch Med, Sidney Kimmel Comprehens Canc Ctr, Div Biostat & Bioinformat, Baltimore, MD USA
8.Tumor Hosp Hebei Prov, Dept Radiat Oncol, Shijiazhuang, Hebei, Peoples R China
推荐引用方式
GB/T 7714		 Li, Ning,Zhu, Yuan,Liu, Lu-Ying,et al. Postoperative Chemoradiotherapy With Capecitabine and Oxaliplatin vs Capecitabine for Stage II to III Rectal Cancer A Randomized Clinical Trial[J]. JAMA NETWORK OPEN,2021,4.
APA Li, Ning.,Zhu, Yuan.,Liu, Lu-Ying.,Feng, Yan-Ru.,Wang, Wen-Ling.,...&Jin, Jing.(2021).Postoperative Chemoradiotherapy With Capecitabine and Oxaliplatin vs Capecitabine for Stage II to III Rectal Cancer A Randomized Clinical Trial.JAMA NETWORK OPEN,4.
MLA Li, Ning,et al."Postoperative Chemoradiotherapy With Capecitabine and Oxaliplatin vs Capecitabine for Stage II to III Rectal Cancer A Randomized Clinical Trial".JAMA NETWORK OPEN 4(2021).

入库方式： OAI收割

来源：合肥物质科学研究院

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