Treatment options for penile squamous cell carcinoma (PeCa) are limited. We sought to investigate clinical outcomes and safety profiles of patients with PeCa receiving immune checkpoint inhibitors (ICIs).
This retrospective study included patients with locally advanced or metastatic PeCa receiving ICIs during 2015-2022 across 24 centers in the United States, Europe, and Asia. Overall survival (OS) and progression-free survival (PFS) were estimated by the Kaplan-Meier method. Objective response rates (ORRs) were determined per RECIST 1.1 criteria. Treatment-related adverse events (trAEs) were graded per the Common Terminology Criteria for Adverse Events v5.0. Two-sided statistical tests were used for comparisons.
Among 92 patients, 8 were Asian (8.7%), 6 (6.5%) were Black, and 24 (29%) were Hispanic/Latinx. Median age was 62 (inter-quartile range: 53 to 70) years. 83 (90%) had metastatic PeCa, and 74 (80%) received ≥2nd line treatment. Most patients received pembrolizumab monotherapy (n = 26, 28%), combination nivolumab/ipilimumab +/- multi-targeted tyrosine kinase inhibitors (n = 23, 25%), nivolumab (n = 16, 17%) or cemiplimab (n = 15, 16%) monotherapies. Median OS and PFS were 9.8 (95% CI: 7.7-12.8) months and 3.2 (95% CI: 2.5-4.2) months, respectively. ORR was 13% (n = 11/85) in the overall cohort and 35% (n = 7/20) in patients with lymph node-only metastases. Visceral metastases, ECOG performance status ≥1, and higher Neutrophil/Lymphocyte ratio (NLR) were associated with worse OS. TrAEs occurred in 29% (n = 27) and 9.8% (n = 9) were grade ≥3.
ICIs are active in a subset of patients with PeCa. Future translational studies are warranted to identify patients more likely to derive clinical benefit from ICIs.
Journal of the National Cancer Institute. 2023 Aug 11 [Epub ahead of print]
Talal El Zarif, Amin H Nassar, Gregory R Pond, Tony Zibo Zhuang, Viraj Master, Bassel Nazha, Scot Niglio, Nicholas Simon, Andrew W Hahn, Curtis A Pettaway, Shi-Ming Tu, Noha Abdel-Wahab, Maud Velev, Ronan Flippot, Sebastiano Buti, Marco Maruzzo, Arjun Mittra, Jinesh Gheeya, Yuanquan Yang, Pablo Alvarez Rodriguez, Daniel Castellano, Guillermo de Velasco, Giandomenico Roviello, Lorenzo Antonuzzo, Rana R McKay, Bruno Vincenzi, Alessio Cortellini, Gavin Hui, Alexandra Drakaki, Michael Glover, Ali Raza Khaki, Edward El-Am, Nabil Adra, Tarek H Mouhieddine, Vaibhav Patel, Aida Piedra, Angela Gernone, Nancy B Davis, Harrison Matthews, Michael R Harrison, Ravindran Kanesvaran, Giulia Claire Giudice, Pedro Barata, Alberto Farolfi, Jae Lyun Lee, Matthew I Milowsky, Charlotte Stahlfeld, Leonard Appleman, Joseph W Kim, Dory Freeman, Toni K Choueiri, Philippe E Spiess, Andrea Necchi, Andrea B Apolo, Guru P Sonpavde
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