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Treatment-related adverse events as predictive biomarkers of efficacy in patients with advanced neuroendocrine tumors treated with surufatinib: results from two phase III studies.

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收录情况： ◇ SCIE

作者：
J. Liy[1] ; Y. Chengy[1] ; C. Bai[1,*1] ; J. Xu[2,*2] ; L. Shen[3,*3] ; J. Li[3] ; Z. Zhou[4] ; Z. Li[5] ; Y. Chi[6] ; X. Yu[7] ; E. Li[8] ; N. Xu[9] ; T. Liu[10] ; W. Lou[10] ; Y. Bai[11] ; X. Yuan[12] ; X. Wang[13] ; Y. Yuan[14] ; J. Chen[15] ; S. Guan[16] ; S. Fan[16] ; W. Su[16] ;
机构： [1]Department of Medical Oncology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing [2]Department of Gastrointestinal Oncology, The Fifth Medical Center, Chinese PLA General Hospital, Beijing [3]Department of Gastrointestinal Oncology, Key Laboratoryof Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital & Institute, Beijing [4]Department of Gastric Surgery, State KeyLaboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou [5]Department ofAbdominal Oncology, West China Hospital, Sichuan University, Chengdu [6]National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and PekingUnion Medical College, Beijing [7]Department of Pancreatic and Hepatobiliary Surgery, Fudan University Shanghai Cancer Center, Shanghai [8]Department of MedicalOncology, The First Affiliated Hospital of Xi’an Jiaotong University, Xi’an [9]Department of Medical Oncology, The First Affiliated Hospital of Zhejiang University,Hangzhou [10]Department of General Surgery, Zhongshan Hospital of Fudan University, Shanghai [11]Department of Gastrointestinal Oncology, Harbin Medical UniversityCancer Hospital, Harbin [12]Department of Oncology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology,Wuhan [13]Department ofMedical Oncology, Qilu Hospital of Shandong University, Jinan [14]Department of Medical Oncology, The Second Affiliated Hospital, Zhejiang University School ofMedicine, Hangzhou [15]Department of Oncology, Jiangsu Cancer Hospital, Nanjing [16]Department of Clinical and Regulatory Affairs, HUTCHMED, Shanghai, China
出处：
DOI： 10.1016/j.esmoop.2022.100453
ISSN：

关键词： neuroendocrine tumor surufatinib SANET biomarker adverse event

摘要：
No validated biomarkers currently exist for predicting the efficacy outcomes in patients with neuroendocrine tumors (NETs) treated with antiangiogenic therapy. We aimed to evaluate the association between treatment-related adverse events (TRAEs) and efficacy outcomes of surufatinib in patients with advanced NET.We included patients with NET treated with surufatinib in two multicenter, randomized, double-blind, placebo-controlled, phase III trials (SANET-p and SANET-ep) in this study. The main exposure was the presence of any of the TRAEs including hypertension, proteinuria, and hemorrhage in the first 4 weeks of surufatinib treatment. The primary outcome of the study was investigator-assessed progression-free survival (PFS). PFS outcomes were estimated using the Kaplan-Meier method with the log-rank test. Hazard ratios (HRs) were calculated by using univariable and multivariable Cox proportional hazard regression models. Blinded independent image review committee (BIIRC) assessments and 4-week landmark analysis were also performed as supportive evaluations.During the study period, a total of 242 patients treated with surufatinib were included in the analysis, and 164 (68%) patients had at least one of hypertension, proteinuria, and hemorrhage in the first 4 weeks of treatment. The presence of TRAEs in the first 4 weeks was associated with prolonged median PFS [11.1 versus 9.2 months; HR 0.67, 95% confidence interval (CI) 0.47-0.97; P = 0.036]. In multivariable Cox regression analysis, the presence of TRAEs was also significantly associated with longer PFS (HR 0.65, 95% CI 0.44-0.97; P = 0.035). Similar results were obtained in the BIIRC assessments and 4-week landmark analysis.Treatment-related hypertension, proteinuria, and hemorrhage could be potential biomarkers to predict antitumor efficacy of surufatinib in patients with advanced NET. Future prospective studies are needed to validate the findings.ClinicalTrials.govNCT02589821; https://clinicaltrials.gov/ct2/show/NCT02589821 and ClinicalTrials.gov NCT02588170; https://clinicaltrials.gov/ct2/show/NCT02588170.Copyright © 2022 The Authors. Published by Elsevier Ltd.. All rights reserved.

基金：
This work was supported by grants from HUTCHMED.
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外文
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出版当年[2022]版：
大类 | 2 区 医学
小类 | 3 区 肿瘤学
最新[2023]版：
大类 | 2 区 医学
小类 | 2 区 肿瘤学
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出版当年[2022]版：
Q1 ONCOLOGY
最新[2023]版：
Q1 ONCOLOGY

影响因子： 最新[2023版] 最新五年平均 出版当年[2022版] 出版当年五年平均 出版前一年[2021版] 出版后一年[2023版]

第一作者：
第一作者机构： [1]Department of Medical Oncology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing
共同第一作者：
通讯作者：
通讯机构： [1]Department of Medical Oncology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing [2]Department of Gastrointestinal Oncology, The Fifth Medical Center, Chinese PLA General Hospital, Beijing [3]Department of Gastrointestinal Oncology, Key Laboratoryof Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital & Institute, Beijing [*1]Department of Medical Oncology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100032, China. [*2]Department of Gastrointestinal Oncology, The Fifth Medical Center, Chinese PLA General Hospital, Beijing 100071, China [*3]Department of Gastrointestinal Oncology, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital & Institute, Beijing 100142, China
推荐引用方式(GB/T 7714)：
J. Liy,Y. Chengy,C. Bai,et al.Treatment-related adverse events as predictive biomarkers of efficacy in patients with advanced neuroendocrine tumors treated with surufatinib: results from two phase III studies.[J].ESMO OPEN.2022,7(2):doi:10.1016/j.esmoop.2022.100453.
APA：
J. Liy,Y. Chengy,C. Bai,J. Xu,L. Shen...&W. Su.(2022).Treatment-related adverse events as predictive biomarkers of efficacy in patients with advanced neuroendocrine tumors treated with surufatinib: results from two phase III studies..ESMO OPEN,7,(2)
MLA：
J. Liy,et al."Treatment-related adverse events as predictive biomarkers of efficacy in patients with advanced neuroendocrine tumors treated with surufatinib: results from two phase III studies.".ESMO OPEN 7..2(2022)

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