中国科学院机构知识库网格系统: Multicenter, Randomized, Phase III Trial of Short-Term Radiotherapy Plus Chemotherapy Versus Long-Term Chemoradiotherapy in Locally Advanced Rectal Cancer (STELLAR)

Multicenter, Randomized, Phase III Trial of Short-Term Radiotherapy Plus Chemotherapy Versus Long-Term Chemoradiotherapy in Locally Advanced Rectal Cancer (STELLAR)

文献类型：期刊论文


作者	Jin, Jing 1,3,4,5; Tang, Yuan 1,3; Hu, Chen6 ; Jiang, Li-Ming 3,7; Jiang, Jun 3,7; Li, Ning 1,3; Liu, Wen-Yang 1,3; Chen, Si-Lin 1,3; Li, Shuai 8; Lu, Ning-Ning 1,3
刊名	JOURNAL OF CLINICAL ONCOLOGY
出版日期	2022-05-20
卷号	40
ISSN号	0732-183X
DOI	10.1200/JCO.21.01667
通讯作者	Jin, Jing(jinjing@csco.org.cn)
英文摘要	PURPOSE To ascertain if preoperative short-term radiotherapy followed by chemotherapy is not inferior to a standard schedule of long-term chemoradiotherapy in patients with locally advanced rectal cancer. MATERIALS AND METHODS Patients with distal or middle-third, clinical primary tumor stage 3-4 and/or regional lymph node-positive rectal cancer were randomly assigned (1:1) to short-term radiotherapy (25 Gy in five fractions over 1 week) followed by four cycles of chemotherapy (total neoadjuvant therapy [TNT]) or chemoradiotherapy (50 Gy in 25 fractions over 5 weeks, concurrently with capecitabine [chemoradiotherapy; CRT]). Totalmesorectal excision was undertaken 6-8 weeks after preoperative treatment, with two additional cycles of CAPOX (intravenous oxaliplatin [130 mg/m(2), once a day] on day 1 and capecitabine [1,000 mg/m(2), twice a day] from days 1 to 14) in the TNT group and six cycles of CAPOX in the CRT group. The primary end point was 3-year disease-free survival (DFS). RESULTS Between August 2015 and August 2018, a total of 599 patients were randomly assigned to receive TNT (n = 302) or CRT (n = 297). At a median follow-up of 35.0 months, 3-year DFS was 64.5% and 62.3% in TNT and CRT groups, respectively (hazard ratio, 0.883; one-sided 95% CI, not applicable to 1.11; P < .001 for noninferiority). There was no significant difference in metastasis-free survival or locoregional recurrence, but the TNT group had better 3-year overall survival than the CRT group (86.5% v 75.1%; P = .033). Treatment effects on DFS and overall survival were similar regardless of prognostic factors. The prevalence of acute grade III-V toxicities during preoperative treatment was 26.5% in the TNT group versus 12.6% in the CRT group (P < .001). CONCLUSION Short-term radiotherapy with preoperative chemotherapy followed by surgery was efficacious with acceptable toxicity and could be used as an alternative to CRT for locally advanced rectal cancer. (C) 2022 by American Society of Clinical Oncology
WOS关键词	TOTAL MESORECTAL EXCISION ; PREOPERATIVE CHEMORADIOTHERAPY ; ADJUVANT CHEMOTHERAPY ; OPEN-LABEL ; CHEMORADIATION ; OXALIPLATIN ; CAPECITABINE ; FLUOROURACIL ; OUTCOMES
资助项目	Chinese Academy of Medical Science Innovation Fund for Medical Sciences (CIFMS)[2016I2M-1-001] ; National Key Projects of Research and Development of China[2016YFC0904600] ; National Natural Science Foundation of China[82073352] ; Key Projects of Capital Health Development[20201-402] ; Collaborative Innovation Center for Cancer Medicine (CICCM)[XT2015-03] ; Beijing Hope Run Special Fund of Cancer Foundation of China[LC2015L23] ; Sanming Project of Medicine in Shenzhen[SZSM201612063]
WOS研究方向	Oncology
语种	英语
出版者	LIPPINCOTT WILLIAMS & WILKINS
WOS记录号	WOS:000809890800011
资助机构	Chinese Academy of Medical Science Innovation Fund for Medical Sciences (CIFMS) ; National Key Projects of Research and Development of China ; National Natural Science Foundation of China ; Key Projects of Capital Health Development ; Collaborative Innovation Center for Cancer Medicine (CICCM) ; Beijing Hope Run Special Fund of Cancer Foundation of China ; Sanming Project of Medicine in Shenzhen
源URL	[http://ir.hfcas.ac.cn:8080/handle/334002/131303]
专题	中国科学院合肥物质科学研究院
通讯作者	Jin, Jing
作者单位	1.Canc Hosp, Dept Radiat Oncol, Chinese Acad Med Sci CAMS & Peking Union Med Coll, Natl Canc Ctr,Natl Clin Res Ctr Canc, Beijing 100021, Peoples R China 2.Sichuan Univ, West China Hosp, Dept Radiat Oncol, Chengdu, Peoples R China 3.State Key Lab Mol Oncol, Beijing 100021, Peoples R China 4.Canc Hosp, Dept Radiat Oncol, Natl Clin Res Ctr Canc, Natl Canc Ctr, Shenzhen, Guangdong, Peoples R China 5.Shenzhen Hosp, CAMS & PUMC, Shenzhen, Peoples R China 6.Johns Hopkins Univ, Sidney Kimmel Comprehens Canc Ctr, Div Biostat & Bioinformat, Sch Med, Baltimore, MD USA 7.Canc Hosp, Dept Radiol, CAMS & PUMC, Natl Canc Ctr,Natl Clin Res Ctr Canc, Beijing, Peoples R China 8.Peking Univ Canc Hosp & Inst, Dept Radiat Oncol, Key Lab Carcinogenesis & Translat Res, Minist Educ Beijing, Beijing, Peoples R China 9.Zhejiang Canc Hosp, Univ Chinese Acad Sci, Inst Basic Med & Canc IBMC, Dept Radiat Oncol,Canc Hosp,Chinese Acad Sci, Hangzhou, Peoples R China 10.Jilin Univ, China Japan Union Hosp, Dept Radiat Oncol, Changchun, Peoples R China
推荐引用方式 GB/T 7714	Jin, Jing,Tang, Yuan,Hu, Chen,et al. Multicenter, Randomized, Phase III Trial of Short-Term Radiotherapy Plus Chemotherapy Versus Long-Term Chemoradiotherapy in Locally Advanced Rectal Cancer (STELLAR)[J]. JOURNAL OF CLINICAL ONCOLOGY,2022,40.
APA	Jin, Jing.,Tang, Yuan.,Hu, Chen.,Jiang, Li-Ming.,Jiang, Jun.,...&Li, Ye-Xiong.(2022).Multicenter, Randomized, Phase III Trial of Short-Term Radiotherapy Plus Chemotherapy Versus Long-Term Chemoradiotherapy in Locally Advanced Rectal Cancer (STELLAR).JOURNAL OF CLINICAL ONCOLOGY,40.
MLA	Jin, Jing,et al."Multicenter, Randomized, Phase III Trial of Short-Term Radiotherapy Plus Chemotherapy Versus Long-Term Chemoradiotherapy in Locally Advanced Rectal Cancer (STELLAR)".JOURNAL OF CLINICAL ONCOLOGY 40(2022).

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来源：合肥物质科学研究院

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Multicenter, Randomized, Phase III Trial of Short-Term Radiotherapy Plus Chemotherapy Versus Long-Term Chemoradiotherapy in Locally Advanced Rectal Cancer (STELLAR)

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