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苏呋替尼在晚期实体瘤评估中的疗效与安全性的真实世界研究。

Real world study on efficacy and safety of surufatinib in advanced solid tumors evaluation.

作者信息

Yan Hui-Ping, Zhao Hong-Yang, Qiu An-Chen, Chen Xiao-Chen, Chen Ke, Chen Zhe-Ling, Yang Si-Fu

机构信息

Department of Medical Oncology, Cancer Center, Zhejiang Provincial People's Hospital (Affiliated People's Hospital), Hangzhou Medical College, Hangzhou, 310014, Zhejiang, China.

The Second Clinical Medical College, Zhejiang Chinese Medical University, Hangzhou, China.

出版信息

Sci Rep. 2025 May 10;15(1):16294. doi: 10.1038/s41598-025-00974-8.

Abstract

Surufatinib is a novel, China-developed small-molecule tyrosine kinase inhibitor that demonstrates high selectivity for VEGFR, FGFR1, and CSF1R. Surufatinib has been approved for the treatment of neuroendcrine tumors, including pancreatic neuroendocrine tumors (PNEN) and non-pancreatic neuroendocrine tumors (N-pNEN). The purpose of this retrospective study is to assess Surufatinib's safety and effectiveness in patients with various advanced solid malignancies. The general clinical statistics and follow-up data of patients treated with Surufatinib for advanced solid tumors at Zhejiang Provincial People's Hospital between January 2021 and April 2024 were gathered. Enhanced CT was used to assess the effectiveness during that time, and cases side effects were gathered. Survival rates of different diseases were analyzed using the Kaplan-Meier method. A total of 28 eligible patients were enrolled in this study. At the end of follow-up, treatment with Surufatinib resulted in the following outcomes: Complete response (CR) in 0 cases (0.0%), Partial response (PR) in 5 cases (17.9%), Stable disease (SD) in 7 cases (25.0%), and Progressive disease (PD) in 16 cases (57.1%). Objective response rate (ORR) and Disease control rate (DCR) were 17.9% and 42.9%, respectively. In the PNEN group, ORR was 33.3%, DCR was 66.7%, median progression-free survival (mPFS) was 11 months, while median overall survival (mOS) was 17 months. In the N-pNEN group, ORR was 14.3%, DCR was 42.3%, mPFS was 6 months and mOS was 7 months. ORR was 8.3%, DCR was 25%, mPFS was 2 months, and mOS was 2 months. The most common adverse reactions included hypoproteinemia, proteinuria, bone marrow suppression and gastrointestinal toxicity, and which of them were grade 1 to grade 2. In advanced solid tumors beyond PNEN, Surufatinib demonstrates clinically meaningful survival benefits for patients refractory to standard therapies, with a generally manageable safety profile.

摘要

苏鲁法替尼是一种中国自主研发的新型小分子酪氨酸激酶抑制剂,对血管内皮生长因子受体(VEGFR)、成纤维细胞生长因子受体1(FGFR1)和集落刺激因子1受体(CSF1R)具有高度选择性。苏鲁法替尼已获批用于治疗神经内分泌肿瘤,包括胰腺神经内分泌肿瘤(PNEN)和非胰腺神经内分泌肿瘤(N-pNEN)。本回顾性研究的目的是评估苏鲁法替尼在各种晚期实体恶性肿瘤患者中的安全性和有效性。收集了2021年1月至2024年4月期间在浙江省人民医院接受苏鲁法替尼治疗晚期实体瘤患者的一般临床统计数据和随访资料。在此期间使用增强CT评估疗效,并收集病例的副作用。采用Kaplan-Meier法分析不同疾病的生存率。本研究共纳入28例符合条件的患者。随访结束时,苏鲁法替尼治疗的结果如下:完全缓解(CR)0例(0.0%),部分缓解(PR)5例(17.9%),病情稳定(SD)7例(25.0%),疾病进展(PD)16例(57.1%)。客观缓解率(ORR)和疾病控制率(DCR)分别为17.9%和42.9%。在PNEN组中,ORR为33.3%,DCR为66.7%,中位无进展生存期(mPFS)为11个月,而中位总生存期(mOS)为17个月。在N-pNEN组中,ORR为14.3%,DCR为42.3%,mPFS为6个月,mOS为7个月。其他组的ORR为8.3%,DCR为25%,mPFS为2个月,mOS为2个月。最常见的不良反应包括低蛋白血症、蛋白尿、骨髓抑制和胃肠道毒性,且均为1至2级。在PNEN以外的晚期实体瘤中,苏鲁法替尼对标准治疗难治的患者显示出具有临床意义的生存获益,且安全性总体可控。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/268a/12065879/02c96ed602fa/41598_2025_974_Fig1_HTML.jpg

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