Locally advanced penile squamous cell carcinoma (PSCC) generally has a poor prognosis. Our aim was to access the efficacy and safety of programmed cell death protein 1 (PD-1) inhibitor tislelizumab combined with chemotherapy for locally advanced PSCC.
In this prospective, single-arm clinical study, eligible patients received Nab-Paclitaxel (175 mg/m2 D1), Cisplatin (70 mg/m2 in 3 days), Bleomycin (30 mg D1, 8), and tislelizumab (200 mg D1) every 3 weeks for 4-6 cycles, followed by consolidative treatment if necessary. The primary endpoint was objective response rate (ORR) and progression-free survival (PFS).
Of all 20 enrolled patients, 75.0% (15/20) had a history of previous penectomy and were recurrence cases. The median treatment cycles was 4 (range: 2-6). The ORR reached 75.0%. 35.0% (7/20) of patients underwent consolidative surgery, and 55.0% (11/20) received maintenance immunotherapy (median 7 cycles). At median follow-up of 29.3 months, the median PFS and the median overall survival (OS) were 12.5 months (95% CI 7.4-NE), 22.8 months (95% CI 13.7-NE), respectively. Grade≥3 treatment-related adverse events (TRAEs) were observed in 40% (8/20) patients. No treatment-related deaths occurred.
The combination of tislelizumab with chemotherapy demonstrated promising antitumor efficacy in locally advanced PSCC, with a manageable safety profile.
British journal of cancer. 2025 Dec 26 [Epub ahead of print]
Xingli Shan, Hongsong Bai, Houshan Ning, Chengming Xie, Yonghai Chen, Sijia Xing, Donglin Ni, Xiaohua Guo, Jingke Zeng, Linjun Hu
Department of Urology, Cancer Hospital of Huanxing Chaoyang District Beijing, Beijing, China., Department of Medical Oncology, Cancer Hospital of Huanxing Chaoyang District Beijing, Beijing, China., Department of Hepatology, Ganzhou Institute of Liver Disease, The Fifth People's Hospital of Ganzhou, Ganzhou, China. ., Department of Urology, Cancer Hospital of Huanxing Chaoyang District Beijing, Beijing, China. .