中山大学韩辉研究组提出了特瑞普利单抗联合尼妥珠单抗及紫杉类化疗治疗局部晚期阴茎鳞状细胞癌。相关论文于2025年4月10日发表于国际顶尖学术期刊《癌细胞》杂志上。

局部晚期阴茎鳞状细胞癌（La-PSCC）的传统新辅助化疗方案显示出中等的缓解率和生存益处。这项单组II期试验（NCT04475016）评估了一种新辅助方案，该方案包括特瑞普利单抗（抗PD-1抗体）、尼妥珠单抗（抗EGFR抗体）和基于紫杉类化疗（TNT），然后进行巩固手术。主要终点为病理完全缓解（pCR）率。在29例入组患者中，24例（82.8%）接受了巩固手术，14例（48.3%，95%可信区间[CI]， 29.4-67.5%）实现了pCR。客观有效率（ORR）为82.8% （95% CI, 64.2 ~ 94.2）。中位随访时间为39.97个月，两年总生存期（OS）和无进展生存期（PFS）分别为72.4%和65.5%。12例（41.4%）患者发生3-4级治疗相关不良事件（TRAEs），无治疗相关死亡。生物标志物分析发现，PD-L1表达、TP53突变状态和CD8⁺ T细胞密度是潜在的预测标志物。因此，新佐剂TNT具有良好的抗肿瘤活性和可接受的毒性。

附：英文原文

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

Author: Xin An, Sheng Jie Guo, Ru Yan, Ting Xue, Long Bin Xiong, Hua Li Ma, Cong Xue, Ying Chun Zhang, Ji Bin Li, Mei Ting Chen, Zai Shang Li, Ting Yu Liu, Zhi Ling Zhang, Pei Dong, Yong Hong Li, Kai Yao, Zhi Quan Hu, Xiao Feng Chen, Jie Xin Luo, Yong Hong Lei, Pei Yu Liang, Zhi Zhong Liu, Lin Qi, Wen Feng Xu, Zheng Guo Cao, Nan Hui Chen, Xiang Li, Xi Nan Sheng, Guang Heng Luo, Ben Kang Shi, Qun Xie, Zhuo Wei Liu, Fang Jian Zhou, Philippe E. Spiess, Yan Xia Shi, Hui Han

Issue&Volume: 2025-04-10

Abstract: 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.

DOI: 10.1016/j.ccell.2025.03.023

Source: https://www.cell.com/cancer-cell/abstract/S1535-6108(25)00124-2