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

被引：250

作者：

Jin, Jing ^{[1
,2
,3
,4
]}

Tang, Yuan ^{[1
,2
]}

Hu, Chen ^{[5
]}

Jiang, Li-Ming ^{[1
,6
]}

Jiang, Jun ^{[1
,6
]}

Li, Ning ^{[1
,2
]}

Liu, Wen-Yang ^{[1
,2
]}

Chen, Si-Lin ^{[1
,2
]}

Li, Shuai ^{[7
]}

Lu, Ning-Ning ^{[1
,2
]}

Cai, Yong ^{[7
]}

Li, Yong-Heng ^{[7
]}

Zhu, Yuan ^{[8
]}

Cheng, Guang-Hui ^{[9
]}

Zhang, Hong-Yan ^{[10
]}

Wang, Xin ^{[11
]}

Zhu, Su-Yu ^{[12
,13
]}

Wang, Jun ^{[14
]}

Li, Gao-Feng ^{[15
]}

Yang, Jia-Lin ^{[16
]}

Zhang, Kuan ^{[17
]}

Chi, Yihebali ^{[1
,18
]}

Yang, Lin ^{[1
,18
]}

Zhou, Hai-Tao ^{[1
,19
]}

Zhou, Ai-Ping ^{[1
,18
]}

Zou, Shuang-Mei ^{[1
,20
]}

Fang, Hui ^{[1
,2
]}

Wang, Shu-Lian ^{[1
,2
]}

Zhang, Hai-Zeng ^{[1
,19
]}

Wang, Xi-Shan ^{[1
,19
]}

Wei, Li-Chun ^{[21
]}

Wang, Wen-Ling ^{[22
]}

Liu, Shi-Xin ^{[23
]}

Gao, Yuan-Hong ^{[24
]}

Li, Ye-Xiong ^{[1
,2
]}

机构：

[1] State Key Lab Mol Oncol, Beijing 100021, Peoples R China

[2] 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

[3] Canc Hosp, Dept Radiat Oncol, Natl Clin Res Ctr Canc, Natl Canc Ctr, Shenzhen, Guangdong, Peoples R China

[4] Shenzhen Hosp, CAMS & PUMC, Shenzhen, Peoples R China

[5] Johns Hopkins Univ, Sidney Kimmel Comprehens Canc Ctr, Div Biostat & Bioinformat, Sch Med, Baltimore, MD USA

[6] Canc Hosp, Dept Radiol, CAMS & PUMC, Natl Canc Ctr,Natl Clin Res Ctr Canc, Beijing, Peoples R China

[7] Peking Univ Canc Hosp & Inst, Dept Radiat Oncol, Key Lab Carcinogenesis & Translat Res, Minist Educ Beijing, Beijing, Peoples R China

[8] Zhejiang Canc Hosp, Univ Chinese Acad Sci, Inst Basic Med & Canc IBMC, Dept Radiat Oncol,Canc Hosp,Chinese Acad Sci, Hangzhou, Peoples R China

[9] Jilin Univ, China Japan Union Hosp, Dept Radiat Oncol, Changchun, Peoples R China

[10] Univ Sci & Technol China, Affiliated Hosp USTC 1, Dept Radiat Oncol, Div Life Sci & Med, Hefei, Anhui, Peoples R China

[11] Sichuan Univ, West China Hosp, Dept Radiat Oncol, Chengdu, Peoples R China

[12] Hunan Canc Hosp, Dept Radiat Oncol, Changsha, Peoples R China

[13] Xiangya Sch Med, Affiliated Canc Hosp, Changsha, Peoples R China

[14] Hebei Med Univ, Dept Radiat Oncol, Hosp 4, Shijiazhuang, Hebei, Peoples R China

[15] Beijing Hosp, Natl Ctr Gerontol, Inst Geriatr Med, Dept Radiat Oncol,CAMS, Beijing, Peoples R China

[16] Sichuan Prov Canc Hosp, Dept Radiat Oncol, Chengdu, Peoples R China

[17] Qinghai Red Cross Hosp, Dept Radiat Oncol, Xining, Qinghai, Peoples R China

[18] Canc Hosp, Dept Med Oncol, Natl Canc Ctr, Natl Clin Res Ctr Canc,CAMS & PUMC, Beijing, Peoples R China

[19] Canc Hosp, Dept Colorectal Surg, Natl Canc Ctr, Natl Clin Res Ctr Canc,CAMS & PUMC, Beijing, Peoples R China

[20] Canc Hosp, Dept Pathol, Natl Canc Ctr, Natl Clin Res Ctr Canc,CAMS & PUMC, Beijing, Peoples R China

[21] Air Force Med Univ, Xijing Hosp, Dept Radiat Oncol, Xian, Peoples R China

[22] Guizhou Med Univ, Dept Oncol, Affiliated Hosp, Guiyang, Peoples R China

[23] Jilin Prov Canc Hosp, Dept Radiat Oncol, Changchun, Jilin, Peoples R China

[24] Sun Yat Sen Univ, Collaborat Innovat Ctr Canc Med, Dept Radiat Oncol, State Key Lab Oncol South China,Canc Ctr, Guangzhou, Peoples R China

来源：

JOURNAL OF CLINICAL ONCOLOGY | 2022年 / 40卷 / 15期

基金：

中国国家自然科学基金;

关键词：

TOTAL MESORECTAL EXCISION; PREOPERATIVE CHEMORADIOTHERAPY; ADJUVANT CHEMOTHERAPY; OPEN-LABEL; CHEMORADIATION; OXALIPLATIN; CAPECITABINE; FLUOROURACIL; OUTCOMES;

D O I：

10.1200/JCO.21.01667

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

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

引用

页码：1681 / +

页数：15

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