局部晚期阴茎鳞状细胞癌的新辅助托利帕利单抗加尼莫妥珠单抗联合紫杉醇化疗

IF 48.8 1区医学 Q1 CELL BIOLOGY

Cancer Cell Pub Date : 2025-04-10 DOI:10.1016/j.ccell.2025.03.023

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, Hui Han

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引用次数: 0

摘要

传统的新辅助化疗方案治疗局部晚期阴茎鳞状细胞癌（La-PSCC）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，即四个周期的托利单抗（抗pd -1抗体）、尼莫单抗（抗egfr抗体）和基于紫杉醇的化疗（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。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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

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

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.

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来源期刊

Cancer Cell 医学-肿瘤学

CiteScore

55.20

自引率

1.20%

发文量

179

审稿时长

4-8 weeks

期刊介绍： Cancer Cell is a journal that focuses on promoting major advances in cancer research and oncology. The primary criteria for considering manuscripts are as follows: Major advances: Manuscripts should provide significant advancements in answering important questions related to naturally occurring cancers. Translational research: The journal welcomes translational research, which involves the application of basic scientific findings to human health and clinical practice. Clinical investigations: Cancer Cell is interested in publishing clinical investigations that contribute to establishing new paradigms in the treatment, diagnosis, or prevention of cancers. Insights into cancer biology: The journal values clinical investigations that provide important insights into cancer biology beyond what has been revealed by preclinical studies. Mechanism-based proof-of-principle studies: Cancer Cell encourages the publication of mechanism-based proof-of-principle clinical studies, which demonstrate the feasibility of a specific therapeutic approach or diagnostic test.