First-line PD-1 Inhibitor & EGFR Blockade & Platinum-based Chemotherapy (PEP) for Stage IV Penile Cancer.

To evaluate the anti-tumor activity and the safety of anti-PD-1 antibody plus EGFR blockade combined with platinum-based chemotherapy (PEP) as first-line therapy for stage IV PSCC.

Retrospective review of 17 patients with stage IV PSCC undergoing first-line PEP at Sun Yat-sen University Cancer Center between January 2018 and September 2021. Clinical responses were assessed by the RECIST version 1.1. Progression-free survival (PFS) and overall survival (OS) were estimated using the Kaplan-Meier method. Adverse events (AEs) were graded by the CTCAE version 5.0.

Among 17 patients who received first-line PEP, 13 (76.5%) were observed to have partial responses. Twelve patients received subsequently consolidated surgery, and 10 (83.3%) of them achieved pN0 status, of which six locally advanced PSCC achieved pathological complete response. The median follow-up time was 24.87 months (range 3.63-29.40). Both median PFS and OS were not reached, with 2-year PFS and OS rates being 68.4% (95%CI 48.7-96.1) and 62.9% (95%CI 41.6-95), respectively. Eight (47.1%) patients suffered grade 3 or 4 treatment-related AEs. No grade 5 AEs or death associated with treatment was observed.

PEP showed promising anti-tumor activity, acceptable toxicity, and satisfying long-term survival for stage IV PSCC. Larger clinical trials are needed to validate our findings.

BJU international. 2022 Jun 15 [Epub ahead of print]

Ru Yan, Huali Ma, Lijuan Jiang, Shengjie Guo, Yanxia Shi, Xinan Sheng, Yijun Zhang, Philippe E Spiess, Tingyu Liu, Ting Xue, Xiaofeng Chen, Zhiyong Li, Xin An, Kai Yao, Fangjian Zhou, Hui Han

Department of Urology, Sun Yat-sen University Cancer Center, Guangzhou, China., State Key Laboratory of Oncology in South China, Collaborative Innovation Centre for Cancer Medicine, Guangzhou, China., Peking University Cancer Hospital and Institute, Beijing., Department of Genitourinary Oncology, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL, USA., Department of Urology, The First People's Hospital, Chenzhou, China.