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Exploratory phase II trial of an anti-PD-1 antibody camrelizumab combined with a VEGFR-2 inhibitor apatinib and chemotherapy as a neoadjuvant therapy for triple-negative breast cancer (NeoPanDa03): efficacy, safety and biomarker analysis

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Pubmed体系：

收录情况： ◇ 统计源期刊 ◇ CSCD-C ◇ 卓越：领军期刊

作者：
Liu Xiaoxiao[1,2,3,4] * ; Zhuang Chunying[1] * ; Liu Lei[5,6] * ; Xiong Ling[4] * ; Xie Xin[2,3] ; He Ping[1] ; Li Juanjuan[2,3] ; Wei Bing[7] ; Yan Xi[1] ; Tian Tinglun[1] ; Zhong Xiaorong[1] ; Chen Jie[4,8] ; Cheng Yan[1] ; Zheng Dan[1] ; Cheng Peng[9] ; Sun Tianlin[9] ; Li Weiwei[9] ; Zhu Changbin[9] ; Chen Shuaitong[10] ; Fang Chao[10] ; Fu Jun[10] ; Li Shibao[6] ; Jing Jing[4] ; Luo Ting[1] ;
机构： [1]Institute of Breast Health Medicine, Breast Center, Department of Medical Oncology, Cancer Center, West China Hospital, Sichuan University, Chengdu, Sichuan 610041, China [2]Department of Radiation Oncology, Cancer Center, Affiliated Hospital of Xuzhou Medical University [3]Cancer Institute, Xuzhou Medical University, Xuzhou, Jiangsu 221000, China [4]Institute of Breast Health Medicine, West China Hospital, Sichuan University, Chengdu, Sichuan 610041, China [5]Department of physiology, School of Basic Medical Sciences, Xuzhou Medical University, Xuzhou, Jiangsu 221000, China [6]Department of Laboratory Medicine, Affiliated Hospital of Xuzhou Medical University, Xuzhou, Jiangsu 221000, China [7]Department of Pathology, West China Hospital, Sichuan University, Chengdu, Sichuan 610041, China [8]Division of Breast Surgery, Department of General Surgery, West China Hospital, Sichuan University, Chengdu, Sichuan 610041, China [9]Translational Medicine Department, Amoy Diagnostics Co., Ltd., Xiamen, Fujian 361000, China [10]LC-Bio Technology Co., Ltd., Hangzhou, Zhejiang 310000, China
出处：
DOI： 10.1038/s41392-025-02337-1
ISSN：

摘要：
Chemotherapy serves as the primary therapeutic approach for triple-negative breast cancer (TNBC), yet its efficacy remains unsatisfactory. This study was a single-arm, open-label, single-center clinical trial (NCT05447702) involving patients with newly diagnosed stage II-III TNBC at West China Hospital. The treatment regimen consisted of camrelizumab (200 mg intravenously every 2 weeks, 12 cycles), apatinib (250 mg orally daily), and alternating chemotherapy [nab-paclitaxel (d1, 8, 15 every 4 weeks) for 4 cycles and epirubicin plus cyclophosphamide (every 2 weeks) for 4 cycles]. From June 2023 to April 2024, 35 patients were enrolled, of whom 1 patient withdrew due to adverse reaction intolerance. At treatment completion, the total pathological complete response (tpCR, ypT0/is, ypN0) rate was 67.6% (23/34), and the breast pCR (ypT0/is) rate was 70.6% (24/34). The overall response rate following neoadjuvant treatment reached 94.1% (32/34). Elevated levels of alanine aminotransferase (38.2%) and aspartate aminotransferase (29.4%) were the most common grade 3-4 adverse events, with no significant toxicities or treatment-related deaths reported. Comprehensive analysis of serum and tissue samples collected before and after neoadjuvant therapy via Olink and RNA sequencing revealed that the treatment induced a complex systemic immune response. These findings enabled the development of two novel scoring systems: a pretreatment response predictive score system for stratification and an efficacy assessment score system for treatment response evaluation. In conclusion, camrelizumab and apatinib combined with chemotherapy have good clinical efficacy and good safety as neoadjuvant treatments for stage II-III TNBC, warranting further investigation and potential clinical application.© 2025. The Author(s).

基金：
the Young Talent Program of the Affiliated Hospital of Xuzhou Medical University, the Advanced Program of the Affiliated Hospital of Xuzhou Medical University (PYJH2024210),Xuzhou City Clinical Technical Backbone Training Program Project (2025211001), the Key Medical Talent Program of Xuzhou City (XWRCHT20220065), the Noncommunicable Chronic Diseases-National Science and Technology Major Project (No.2023ZD0502300 [2023ZD0502304]), the Medical Research Project of Jiangsu Provincial Health Commission (H2023050), the National Natural Science Foundation of China (No. 32301278), the Sichuan Provincial Department of Science and Technology (2023YFH0095), the Technological Innovation Research Project of Chengdu Science and Technology Bureau (2024-YF05-00723-SN), and the National Guidance Fund on Developing Local Science and Technology for Sichuan Province (No. 2023ZYD0167).
语种：
外文
PubmedID：
中科院(CAS)分区：
出版当年[2025]版：
大类 | 1 区 医学
小类 | 1 区 生化与分子生物学 1 区 细胞生物学
最新[2025]版：
大类 | 1 区 医学
小类 | 1 区 生化与分子生物学 1 区 细胞生物学
第一作者：
第一作者机构： [1]Institute of Breast Health Medicine, Breast Center, Department of Medical Oncology, Cancer Center, West China Hospital, Sichuan University, Chengdu, Sichuan 610041, China [2]Department of Radiation Oncology, Cancer Center, Affiliated Hospital of Xuzhou Medical University [3]Cancer Institute, Xuzhou Medical University, Xuzhou, Jiangsu 221000, China [4]Institute of Breast Health Medicine, West China Hospital, Sichuan University, Chengdu, Sichuan 610041, China
共同第一作者：
通讯作者：
通讯机构： [1]Institute of Breast Health Medicine, Breast Center, Department of Medical Oncology, Cancer Center, West China Hospital, Sichuan University, Chengdu, Sichuan 610041, China [2]Department of Radiation Oncology, Cancer Center, Affiliated Hospital of Xuzhou Medical University [3]Cancer Institute, Xuzhou Medical University, Xuzhou, Jiangsu 221000, China [4]Institute of Breast Health Medicine, West China Hospital, Sichuan University, Chengdu, Sichuan 610041, China
推荐引用方式(GB/T 7714)：
Liu Xiaoxiao,Zhuang Chunying,Liu Lei,et al.Exploratory phase II trial of an anti-PD-1 antibody camrelizumab combined with a VEGFR-2 inhibitor apatinib and chemotherapy as a neoadjuvant therapy for triple-negative breast cancer (NeoPanDa03): efficacy, safety and biomarker analysis[J].Signal Transduction And Targeted Therapy.2025,10(1):237.doi:10.1038/s41392-025-02337-1.
APA：
Liu Xiaoxiao,Zhuang Chunying,Liu Lei,Xiong Ling,Xie Xin...&Luo Ting.(2025).Exploratory phase II trial of an anti-PD-1 antibody camrelizumab combined with a VEGFR-2 inhibitor apatinib and chemotherapy as a neoadjuvant therapy for triple-negative breast cancer (NeoPanDa03): efficacy, safety and biomarker analysis.Signal Transduction And Targeted Therapy,10,(1)
MLA：
Liu Xiaoxiao,et al."Exploratory phase II trial of an anti-PD-1 antibody camrelizumab combined with a VEGFR-2 inhibitor apatinib and chemotherapy as a neoadjuvant therapy for triple-negative breast cancer (NeoPanDa03): efficacy, safety and biomarker analysis".Signal Transduction And Targeted Therapy 10..1(2025):237

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