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177Lu-Dotatate versus high-dose long-acting octreotide for the treatment of patients with advanced, grade 1-2, well-differentiated gastroenteropancreatic neuroendocrine tumours (XT-XTR008-3-01): an open-label, randomised, phase 3 trial

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Pubmed体系：
作者：
Xu J[1] * ; Chen J[2,3] * ; Song S[3,4,5,6] * ; Song L[7] * ; Wang R[8] * ; Hao J[9] ; Du X[10] ; Cao D[11] ; Gao Y[12] ; Lan X[13] ; Yang A[14] ; Miao W[15] ; Xu H[16] ; Chen Y[17,18,19] ; Li L[20] ; Shi H[21,22,23] ; Yuan X[24] ; Ye F[25] ; Wang J[26] ; Xu N[27] ; Han X[28] ; Li X[29] ; Huang R[30] ; Zhang T[31,32,33] ; Li E[34] ; Wang R[35] ; Zhou Y[36] ; Chen H[37] ; Zhu X[38] ; Zhao J[39] ; Su X[40] ; Cui Y[41] ; Ren P[42] ; Wang P[43] ;
机构： [1]Senior Department of Oncology, Chinese PLA General Hospital, Beijing [2]Center for Neuroendocrine Tumors, Fudan University Shanghai Cancer Center, Shanghai [3]Department of Oncology, Shanghai Medical College, Fudan University, Shanghai [4]Department of Nuclear Medicine, Fudan University Shanghai Cancer Center, Shanghai [5]Center for Biomedical Imaging, Fudan University, Shanghai [6]Shanghai Engineering Research Center of Molecular Imaging Probes, Shanghai [7]Department of Oncology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou [8]Department of Nuclear Medicine, The First Medical Center, Chinese PLA General Hospital, Beijing [9]Department of Medical Oncology, Qilu Hospital of Shandong University, Jinan [10]Department of Oncology, Mianyang Central Hospital, Mianyang [11]Division of Abdominal Tumor, Department of Medical Oncology, Cancer Center, State Key Laboratory of Biotherapy, West China Hospital and Sichuan University, Chengdu [12]Department of Nuclear Medicine, People’s Hospital of Zhengzhou University, Henan Provincial People’s Hospital, Zhengzhou [13]Department of Nuclear Medicine, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan [14]The First Affiliated Hospital of Xi’an Jiaotong University, Xi’an [15]Department of Nuclear Medicine, The First Affiliated Hospital, Fujian Medical University, Fuzhou [16]Department of Nuclear Medicine, The First Affiliated Hospital of Jinan University, Guangzhou [17]Department of Nuclear Medicine, Affiliated Hospital of Southwest Medical University, Luzhou [18]Nuclear Medicine and Molecular Imaging Key Laboratory of Sichuan Province, Luzhou [19]Institute of Nuclear Medicine, Southwest Medical University, Luzhou [20]Department of Nuclear Medicine, Zhejiang Cancer Hospital, Hangzhou [21]Department of Nuclear Medicine, Zhongshan Hospital, Fudan University, Shanghai [22]Shanghai Institute of Medical Imaging, Shanghai [23]Institute of Nuclear Medicine, Fudan University, Shanghai [24]Department of Oncology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan [25]Department of Medical Oncology, Xiamen Key Laboratory of Antitumor Drug Transformation Research, The First Affiliated Hospital of Xiamen University, School of Medicine, Xiamen University, Xiamen [26]Department of Nuclear Medicine, Xijing Hospital, Xi’an [27]Department of Medical Oncology, The First Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou [28]The First Affiliated Hospital of Zhengzhou University, Zhengzhou [29]Department of Nuclear Medicine, Qilu Hospital of Shandong University, Jinan [30]Department of Nuclear Medicine, West China Hospital, Sichuan University, Chengdu [31]Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan [32]Institute of Radiation Oncology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan [33]Hubei Key Laboratory of Precision Radiation Oncology, Wuhan [34]Department of Medical Oncology, The First Affiliated Hospital of Xi’an Jiaotong University, Xi’an [35]Department of Medical Oncology, The First Affiliated Hospital of Fujian Medical University, Fuzhou [36]Zhongshan Hospital, Fudan University, Shanghai [37]Department of Nuclear Medicine, The First Affiliated Hospital of Xiamen University, School of Medicine, Xiamen University, Xiamen [38]Department of Nuclear Medicine, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan [39]Research Center of Cancer Diagnosis and Therapy, Department of Oncology, The First Affiliated Hospital of Jinan University, Guangzhou [40]Department of Nuclear Medicine, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou [41]Department of Oncology, Henan Provincial People’s Hospital, Zhengzhou [42]Affiliated Hospital of Southwest Medical University, Luzhou [43]Beijing Sinotau Intl. Pharmaceutical Technology Co., Ltd., Beijing, China
出处：
DOI： 10.1016/j.annonc.2025.08.3758
ISSN：

关键词： XTR008 177Lu-Dotatate gastroenteropancreatic neuroendocrine tumour GEP-NET peptide receptor radionuclide therapy PRRT

摘要：
The phase 3 XT-XTR008-3-01 trial evaluated the efficacy and safety of XTR008, a novel no-carrier-added 177Lu-Dotatate, in later-line therapy setting for gastroenteropancreatic neuroendocrine tumours (GEP-NETs) of all origins for the first time.Patients with grade 1-2, unresectable, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumours (GEP-NETs) who had progressed within the last 12 months before randomization were randomly allocated 1:1 to XTR008 (4 cycles every 8 weeks) or octreotide 60 mg LAR (every 4 weeks), stratified by primary tumour site (pancreatic vs non-pancreatic), pathological tumour grade (1 vs 2), and duration of prior somatostatin analogues treatment (≤6 vs >6 months). Primary endpoint was progression-free survival (PFS) by a blinded independent review committee (BIRC). The key second endpoints included overall response rate (ORR), overall survival (OS), quality of life by EORTC QLQ-C30 and QLQ-GI.NET21 questionnaires, safety, pharmacokinetics and dosimetry.196 patients were randomized to XTR008 (n=99) or control (n=97). Primary tumour sites: pancreas (59%), rectum (28%), midgut (7%). Median follow-up: 11.1 months (IQR 8·5-11·5, XTR008) vs 10.2 months (IQR 8·5-11·9, control). With 78 PFS events, median PFS was not reached (95% CI 16.13-not estimated) vs 5.8 months (95% CI 5.65-8.41); stratified HR 0.06 (p<0.0001). ORR: 43.4% (95%CI 33.50-53.77) vs 1.0% (95% CI 0.03-5.61). Overall survival (OS) data was immature for both groups, with XTR008 showing longer survival trend (HR 0.24, p=0.0550). Treatment-related adverse events (TRAEs): 98% vs 89%; SAEs: 16.3% vs 12.5% (6.1% vs 3.1% drug-related). Myelodysplastic syndrome and grade ≥3 renal toxicity occurred in 1% patients in XTR008 group; no acute myeloid leukemia or drug-related deaths.XTR008 monotherapy showed superior efficacy versus high-dose octreotide long-acting repeatable in advanced gastroenteropancreatic neuroendocrine tumors of all origins in later-line treatment setting, with manageable safety, supporting its use as a new treatment option.Copyright © 2025 European Society for Medical Oncology. Published by Elsevier Ltd. All rights reserved.

基金：
This work was supported by Sinotau Pharmaceutical Group, which had a role in study design, data collection, data interpretation, and writing of the clinical study report (no grant number).
语种：
外文
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出版当年[2025]版：
大类 | 1 区 医学
小类 | 1 区 肿瘤学
最新[2025]版：
大类 | 1 区 医学
小类 | 1 区 肿瘤学
第一作者：
第一作者机构： [1]Senior Department of Oncology, Chinese PLA General Hospital, Beijing
共同第一作者：
通讯作者：
推荐引用方式(GB/T 7714)：
Xu J,Chen J,Song S,et al.177Lu-Dotatate versus high-dose long-acting octreotide for the treatment of patients with advanced, grade 1-2, well-differentiated gastroenteropancreatic neuroendocrine tumours (XT-XTR008-3-01): an open-label, randomised, phase 3 trial[J].Annals Of Oncology : Official Journal Of The European Society For Medical Oncology.2025,doi:10.1016/j.annonc.2025.08.3758.
APA：
Xu J,Chen J,Song S,Song L,Wang R...&Wang P.(2025).177Lu-Dotatate versus high-dose long-acting octreotide for the treatment of patients with advanced, grade 1-2, well-differentiated gastroenteropancreatic neuroendocrine tumours (XT-XTR008-3-01): an open-label, randomised, phase 3 trial.Annals Of Oncology : Official Journal Of The European Society For Medical Oncology,,
MLA：
Xu J,et al."177Lu-Dotatate versus high-dose long-acting octreotide for the treatment of patients with advanced, grade 1-2, well-differentiated gastroenteropancreatic neuroendocrine tumours (XT-XTR008-3-01): an open-label, randomised, phase 3 trial".Annals Of Oncology : Official Journal Of The European Society For Medical Oncology .(2025)

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