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Neoadjuvant toripalimab plus nimotuzumab combined with taxol-based chemotherapy in locally advanced penile squamous cell carcinoma

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作者：
An Xin[1] * ; Guo Sheng Jie[2] * ; Yan Ru[2,7] * ; Xue Ting[2] * ; Xiong Long Bin[2] * ; Ma Hua Li[3] ; Xue Cong[1] ; Zhang Ying Chun[4] ; Li Ji Bin[5] ; Chen Mei Ting[1] ; Li Zai Shang[8] ; Liu Ting Yu[6] ; Zhang Zhi Ling[2] ; Dong Pei[2] ; Li Yong Hong[2] ; Yao Kai[2] ; Hu Zhi Quan[9] ; Chen Xiao Feng[10] ; Luo Jie Xin[11] ; Lei Yong Hong[12] ; Liang Pei Yu[13] ; Liu Zhi Zhong[14] ; Qi Lin[15] ; Xu Wen Feng[16] ; Cao Zheng Guo[17] ; Chen Nan Hui[18] ; Li Xiang[19] ; Sheng Xi Nan[20] ; Luo Guang Heng[21] ; Shi Ben Kang[22] ; Xie Qun[23] ; Liu Zhuo Wei[2] ; Zhou Fang Jian[2] ; Spiess Philippe E[24] ; Shi Yan Xia[1] ; Han Hui[2] ;
机构： [1]Department of Medical Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Centre for Cancer Medicine, Guangzhou, China. [2]Department of Urology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Centre for Cancer Medicine, Guangzhou, China. [3]Department of Radiology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Centre for Cancer Medicine, Guangzhou, China. [4]Department of Pathology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Centre for Cancer Medicine, Guangzhou, China. [5]Department of Medical Statistics, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Centre for Cancer Medicine, Guangzhou, China. [6]Department of Experimental Research, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Centre for Cancer Medicine, Guangzhou, China. [7]Department of Medical Oncology, Guizhou Provincial People's Hospital, Guiyang, China. [8]Department of Urology, Shenzhen People's Hospital, Shenzhen, China. [9]Department of Urology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China. [10]Department of Urology, The First People's Hospital, Chenzhou, China. [11]Department of Urology, Dongguan People's Hospital, Southern Medical University, Dongguan, China. [12]Department of Urology, The Third Affiliated Hospital of Kunming Medical University, Yunnan Cancer Hospital, Kunming, China. [13]Department of Urology, The First Affiliated Hospital of Hainan Medical University, Haikou, China. [14]Department of Urology, Hunan Cancer Hospital / The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, China. [15]Department of Urology, Xiangya Hospital, Central South University, Changsha, China. [16]Department of Urology, The First People's Hospital of Foshan, Foshan, China. [17]Department of Urology, Yue Bei People's Hospital, Shaoguan, China. [18]Department of Urology, Meizhou People's Hospital, Meizhou Academy of Medical Sciences, Meizhou, China. [19]Department of Urology, West China Hospital, Sichuan University, Chengdu, China. [20]Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Genitourinary Oncology, Peking University Cancer Hospital & Institute, Beijing, China. [21]Department of Urology, Guizhou Provincial People's Hospital, Guiyang, China. [22]Department of Urology, Qilu Hospital of Shandong University, Jinan, China. [23]Department of Urology, Zhuhai People's Hospital, Zhuhai, China. [24]Department of Genitourinary Oncology, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL, USA.
出处：
DOI： 10.1016/j.ccell.2025.03.023
ISSN：

摘要：
The conventional neoadjuvant chemotherapy regimen for locally advanced penile squamous cell carcinoma (La-PSCC) has shown moderate response rates and survival benefits. This single-arm, phase II trial (NCT04475016) evaluated a neoadjuvant regimen of four cycles of toripalimab (anti-PD-1 antibody), nimotuzumab (anti-EGFR antibody), and taxol-based chemotherapy (TNT), followed by consolidative surgery. The primary endpoint was the pathological complete response (pCR) rate. Among 29 enrolled patients, 24 (82.8%) underwent consolidative surgery, with 14 (48.3%, 95% confidence interval [CI], 29.4-67.5%) achieving pCR. The objective response rate (ORR) was 82.8% (95% CI, 64.2-94.2). Median follow-up was 39.97 months, with two-year overall survival (OS) and progression-free survival (PFS) rates of 72.4% and 65.5%. Grade 3-4 treatment-related adverse events (TRAEs) occurred in 12 (41.4%) patients, with no treatment-related deaths. Biomarker analysis identified PD-L1 expression, TP53 mutation status, and CD8+ T cell density as potential predictive markers. Therefore, neoadjuvant TNT shows promising anti-tumor activity and acceptable toxicity.Copyright © 2025 The Authors. Published by Elsevier Inc. All rights reserved.

基金：
This study was supported by funding from Natural Science Foundation of Guangdong Province (No. 2021A1515220182, 2022A1515012321), Guangdong Province Nature Foundation of China Project (no. 2022A1515012200), Shenzhen Science and Technology Program (no. RCYX20221008093032008) during the conduct of the study.
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外文
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出版当年[2025]版：
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最新[2025]版：
大类 | 1 区 医学
小类 | 1 区 细胞生物学 1 区 肿瘤学
第一作者：
第一作者机构： [1]Department of Medical Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Centre for Cancer Medicine, Guangzhou, China.
共同第一作者：
通讯作者：
推荐引用方式(GB/T 7714)：
An Xin,Guo Sheng Jie,Yan Ru,et al.Neoadjuvant toripalimab plus nimotuzumab combined with taxol-based chemotherapy in locally advanced penile squamous cell carcinoma[J].Cancer Cell.2025,doi:10.1016/j.ccell.2025.03.023.
APA：
An Xin,Guo Sheng Jie,Yan Ru,Xue Ting,Xiong Long Bin...&Han Hui.(2025).Neoadjuvant toripalimab plus nimotuzumab combined with taxol-based chemotherapy in locally advanced penile squamous cell carcinoma.Cancer Cell,,
MLA：
An Xin,et al."Neoadjuvant toripalimab plus nimotuzumab combined with taxol-based chemotherapy in locally advanced penile squamous cell carcinoma".Cancer Cell .(2025)

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