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Neoadjuvant short-course radiotherapy followed by camrelizumab and chemotherapy in locally advanced rectal cancer (UNION): early outcomes of a multicenter randomized phase III trial

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收录情况： ◇ SCIE

作者：
Lin Z Y[1,2,3] * ; Zhang P[4] * ; Chi P[5] * ; Xiao Y[6] * ; Xu X M[7] * ; Zhang A M[8] ; Qiu X F[9] ; Wu J X[10] ; Yuan Y[11] ; Wang Z N[12] ; Qu X J[13] ; Li X[14] ; Nie X[15] ; Yang M[15] ; Cai K L[4] ; Zhang W K[4] ; Huang Y[5] ; Sun Z[6] ; Hou Z G[16] ; Ma C[16] ; Cheng F Z[16] ; Kaixiong Tao[4] ; Tao Zhang[1,2,3] ;
机构： [1]Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China [2]Hubei Key Laboratory of Precision Radiation Oncology, Wuhan, China [3]Institute of Radiation Oncology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China. [4]Department of Gastrointestinal Surgery, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China. [5]Department of Colorectal Surgery, Fujian Medical University Union Hospital, Fuzhou, China. [6]Department of Basic Surgery, Peking Union Medical College Hospital, Beijing, China. [7]Cancer Center, Renmin Hospital of Wuhan University, Wuhan, China. [8]Department of Gastrointestinal Surgery, Affiliated Hospital of Hebei University, Baoding, China. [9]Department of Gastrointestinal Surgery, Zhongshan Hospital Xiamen University, Xiamen, China. [10]Radiotherapy Department of Abdominal Tumors, Fujian Cancer Hospital, Fuzhou, China. [11]Department of Medical Oncology, Second Affiliated Hospital, Zhejiang University College of Medicine, Hangzhou, China. [12]Department of Surgical Oncology and General Surgery, The First Hospital of China Medical University, Shenyang, China. [13]Department of Medical Oncology, The First Hospital of China Medical University, Shenyang, China. [14]Department of Radiology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China. [15]Department of Pathology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China. [16]Jiangsu Hengrui Pharmaceuticals Co., Ltd., Shanghai, China.
出处：
DOI： 10.1016/j.annonc.2024.06.015
ISSN：

关键词： locally advanced rectal cancer short-course radiotherapy camrelizumab pathological complete response

摘要：
Neoadjuvant short-course radiotherapy (SCRT) followed by CAPOX and camrelizumab (a PD-1 monoclonal antibody) has shown potential clinical activity for locally advanced rectal cancer (LARC) in a phase II trial. This study aimed to further confirm the efficacy and safety of SCRT followed by CAPOX and camrelizumab compared to long-course chemoradiotherapy (LCRT) followed by CAPOX alone as neoadjuvant treatment for LARC.In this randomized, phase III trial, patients with T3-4/N+ rectal adenocarcinoma were randomly assigned (1:1) to receive SCRT or long-course chemoradiotherapy (LCRT), followed by 2 cycles of camrelizumab and CAPOX or CAPOX alone, respectively. After surgery, each arm underwent either 6 cycles of camrelizumab and CAPOX, followed by up to 17 doses of camrelizumab, or 6 cycles of CAPOX. The primary endpoint was pathological complete response (pCR) rate (ypT0N0) assessed by a blinded independent review committee. Key secondary endpoints tested hierarchically were 3-year event-free survival (EFS) rate and overall survival (OS).Between July 2021 and March 2023, the intention-to-treat population comprised 113 patients in experimental arm and 118 patients in control arm, with surgery performed in 92% and 83.9%, respectively. At data cutoff (July 11, 2023), the pCR rate were 39.8% (95% CI, 30.7 to 49.5) in experimental arm compared to 15.3% (95% CI, 9.3 to 23.0) in control arm (difference, 24.6%; odds ratio, 3.7; 95% CI, 2.0 to 6.9; p < 0.001). In each arm, surgical complication rates were 40.0% and 40.8%, grade ≥ 3 treatment-related adverse events were 29.2% and 27.2%. 3-year EFS rate and OS continue to mature.In LARC patients, neoadjuvant SCRT followed by camrelizumab plus CAPOX demonstrated a significantly higher pCR rate than LCRT followed by CAPOX, with a well-tolerated safety profile. SCRT followed by camrelizumab and chemotherapy can be recommended as a neoadjuvant treatment modality for these patients.Copyright © 2024 The Author(s). Published by Elsevier Ltd.. All rights reserved.

基金：
This study was funded by Jiangsu Hengrui Pharmaceuticals Co., Ltd (no grant number).
语种：
外文
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出版当年[2025]版：
无
最新[2025]版：
大类 | 1 区 医学
小类 | 1 区 肿瘤学
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出版当年[2024]版：
无
最新[2023]版：
Q1 ONCOLOGY

影响因子： 最新[2023版] 最新五年平均 出版当年[2024版] 出版当年五年平均 出版前一年[2023版]

第一作者：
第一作者机构： [1]Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China [2]Hubei Key Laboratory of Precision Radiation Oncology, Wuhan, China [3]Institute of Radiation Oncology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
共同第一作者：
通讯作者：
通讯机构： [1]Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China [2]Hubei Key Laboratory of Precision Radiation Oncology, Wuhan, China [3]Institute of Radiation Oncology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
推荐引用方式(GB/T 7714)：
Lin Z Y,Zhang P,Chi P,et al.Neoadjuvant short-course radiotherapy followed by camrelizumab and chemotherapy in locally advanced rectal cancer (UNION): early outcomes of a multicenter randomized phase III trial[J].Annals Of Oncology : Official Journal Of The European Society For Medical Oncology.2024,35(10):882-891.doi:10.1016/j.annonc.2024.06.015.
APA：
Lin Z Y,Zhang P,Chi P,Xiao Y,Xu X M...&Tao Zhang.(2024).Neoadjuvant short-course radiotherapy followed by camrelizumab and chemotherapy in locally advanced rectal cancer (UNION): early outcomes of a multicenter randomized phase III trial.Annals Of Oncology : Official Journal Of The European Society For Medical Oncology,35,(10)
MLA：
Lin Z Y,et al."Neoadjuvant short-course radiotherapy followed by camrelizumab and chemotherapy in locally advanced rectal cancer (UNION): early outcomes of a multicenter randomized phase III trial".Annals Of Oncology : Official Journal Of The European Society For Medical Oncology 35..10(2024):882-891

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