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Surufatinib plus toripalimab in patients with advanced neuroendocrine tumours and neuroendocrine carcinomas: An open-label, single-arm, multi-cohort phase II trial

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收录情况： ◇ SCIE

作者：
Zhang Panpan[1] * ; Shi Si[2] * ; Xu Jianming[3] ; Chen Zhendong[4] ; Song Lijie[5] ; Zhang Xing[6] ; Cheng Ying[7] ; Zhang Yanqiao[8] ; Ye Feng[9] ; Li Zhiping[10] ; Yin Fei[11] ; Ji Dongmei[12] ; Gao Heli[2] ; Li Yi[3] ; Chen Wei[4] ; Yang Minjie[5] ; Weng Desheng[6] ; Wu Chunjiao[13] ; Ma Yue[8] ; Sheng Wang[9] ; Zhao Yaqin[10] ; Yin Xiaolei[11] ; Shen Weina[14] ; Su Weiguo[15] ; Shi Michael[16] ; Fan Songhua[16] ; Tan Panfeng[16] ; Xu Qian[16] ; Lu Ming[17] ; Shen Lin[17] ;
机构： [1]Key laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Early Drug Development Centre, Peking University Cancer Hospital & Institute, Beijing 100142, China [2]Department of Pancreatic Hepatobiliary Surgery, Fudan University Shanghai Cancer Center, No.270 Dong’an Road, Xuhui district, Shanghai, China [3]Department of Gastrointestinal Oncology, The Fifth Medical Center of Chinese PLA General Hospital, No.8 East Avenue, Fengtai District, Beijing, China [4]Department of Oncology, The Second Affiliated Hospital of Anhui Medical University, No.678 Furong Road, Economic and Technological Development Zone, Hefei, Anhui, China [5]First Department of Oncology, The First Affiliated Hospital of Zhengzhou University, No.1 East Jianshe Road, Erqi District, Zhengzhou, Henan, China [6]Biotherapy Center, Sun Yat-sen University Cancer Center, No.651 East Dongfeng Road, Yuexiu District, Guangzhou, Guangdong, China [7]Department of Thoracic Oncology, Jilin Cancer Hospital, No.1066 Jinghu Avenue, Gaoxin District, Changchun, Jilin,China [8]Second Department of Gastroenterology, Harbin Medical University Cancer Hospital, No.150 Haping Road, Nangang District, Harbin, Heilongjiang, China [9]Department of Medical Oncology, The First Affiliated Hospital of Xiamen University, No.55 Zhenhai Road, Siming District, Xiamen, Fujian, China [10]Department of Abdominal Oncology, West China Hospital of Sichuan University, No.37 Guoxue Lane, Wuhou District, Chengdu, Sichuan, China [11]Department of Gastroenterology, The Fourth Hospital of Hebei Medical University, No.12 Jiankan Road, Shijiazhuang, Hebei, China [12]Department of Medical Oncology, Fudan University Shanghai Cancer Center, No.270 Dong’an Road, Xuhui district, Shanghai, China [13]Phase I Study Ward, Jilin Cancer Hospital, No.1066 Jinghu Avenue, Gaoxin District, Changchun, Jilin, China [14]Phase I Study Ward, Fudan University Shanghai Cancer Center, No.270 Dong’an Road, Xuhui district, Shanghai, China [15]HUTCHMED Limited, Building 4, 720 Cailun Road, Pilot Free Trade Zone, Shanghai, China [16]Clinical & Regulatory Department, HUTCHMED Limited, Building 4, 720 Cailun Road, Pilot Free Trade Zone, Shanghai, China [17]State Key Laboratory of Holistic Integrative Management of Gastrointestinal Cancers, Beijing Key Laboratory of Carcinogenesis and Translational Research, Department of Gastrointestinal Oncology, Peking University Cancer Hospital & Institute, Beijing 100142, China
出处：
DOI： 10.1016/j.ejca.2024.113539
ISSN：

关键词： Surufatinib Toripalimab Neuroendocrine tumour Neuroendocrine carcinoma Mixed neuroendocrine non-neuroendocrine neoplasms NET NEC Anti-PD1

摘要：
The programmed death 1 inhibitor toripalimab plus the angio-immuno kinase inhibitor surufatinib revealed a tolerable safety profile and preliminary efficacy in patients with advanced solid tumours in a phase I study.This was an open-label, single-arm, multi-cohort phase II study in China. Patients with advanced neuroendocrine tumours (NETs) or neuroendocrine carcinomas (NECs) or mixed neuroendocrine non-neuroendocrine neoplasms (MiNENs) who had failed or were intolerable of standard treatment were given surufatinib (250 mg orally, once daily) plus toripalimab (240 mg intravenously, once every 3 weeks). Primary end-point was investigator-assessed objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors version 1.1. Secondary end-points included duration of response (DoR), disease control rate, progression-free survival (PFS), overall survival (OS), and safety.Forty patients were enrolled into two cohorts by tumour types (NET, n = 19; NEC-MiNEN, n = 21). ORRs (95% CIs) were 21.1% (6.1-45.6) and 23.8% (8.2-47.2) in the NET and NEC-MiNEN cohorts, respectively. Median DoR was 7.1 months (6.9-not evaluable [NE]) and 4.1 months (3.0-NE), respectively. Median PFS was 9.6 months (4.1-NE) and 4.1 months (1.5-5.5); median OS was 27.3 (15.3-NE) and 10.9 months (9.1-14.6), respectively. Overall, grade ≥ 3 treatment-related adverse events occurred in 18 (45.0%) patients.Surufatinib plus toripalimab showed antitumour activity and a tolerable safety profile in patients with previously treated NETs/NECs/MiNENs. Further study of this combination regimen is ongoing for advanced NECs, for which current therapeutic options remain limited.gov: NCT04169672.Copyright © 2024. Published by Elsevier Ltd.

基金：
Science and Technology Innovation - Biomedical Science and Technology Support Project, provided by the Shanghai Committee of Science and Technology, China [20S11907500] and HUTCHMED limited.
语种：
外文
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出版当年[2024]版：
无
最新[2023]版：
大类 | 1 区 医学
小类 | 2 区 肿瘤学
JCR分区：
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[2023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]Key laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Early Drug Development Centre, Peking University Cancer Hospital & Institute, Beijing 100142, China
共同第一作者：
通讯作者：
推荐引用方式(GB/T 7714)：
Zhang Panpan,Shi Si,Xu Jianming,et al.Surufatinib plus toripalimab in patients with advanced neuroendocrine tumours and neuroendocrine carcinomas: An open-label, single-arm, multi-cohort phase II trial[J].EUROPEAN JOURNAL OF CANCER.2024,199:113539.doi:10.1016/j.ejca.2024.113539.
APA：
Zhang Panpan,Shi Si,Xu Jianming,Chen Zhendong,Song Lijie...&Shen Lin.(2024).Surufatinib plus toripalimab in patients with advanced neuroendocrine tumours and neuroendocrine carcinomas: An open-label, single-arm, multi-cohort phase II trial.EUROPEAN JOURNAL OF CANCER,199,
MLA：
Zhang Panpan,et al."Surufatinib plus toripalimab in patients with advanced neuroendocrine tumours and neuroendocrine carcinomas: An open-label, single-arm, multi-cohort phase II trial".EUROPEAN JOURNAL OF CANCER 199.(2024):113539

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