Safety and efficacy of immune checkpoint inhibitors in advanced penile cancer: report from the Global Society of Rare Genitourinary Tumors.
|
| Abstract | BACKGROUND: Treatment options for penile squamous cell carcinoma are limited. We sought to investigate clinical outcomes and safety profiles of patients with penile squamous cell carcinoma receiving immune checkpoint inhibitors. METHODS: This retrospective study included patients with locally advanced or metastatic penile squamous cell carcinoma receiving immune checkpoint inhibitors between 2015 and 2022 across 24 centers in the United States, Europe, and Asia. Overall survival and progression-free survival were estimated using the Kaplan-Meier method. Objective response rates were determined per Response Evaluation Criteria in Solid Tumours 1.1 criteria. Treatment-related adverse events were graded per the Common Terminology Criteria for Adverse Events, version 5.0. Two-sided statistical tests were used for comparisons. RESULTS: Among 92 patients, 8 (8.7%) were Asian, 6 (6.5%) were Black, and 24 (29%) were Hispanic and/or Latinx. Median (interquartile range) age was 62 (53-70) years. In all, 83 (90%) had metastatic penile squamous cell carcinoma, and 74 (80%) had received at least second-line treatment. Most patients received pembrolizumab monotherapy (n = 26 [28%]), combination nivolumab-ipilimumab with or without multitargeted tyrosine kinase inhibitors (n = 23 [25%]), or nivolumab (n = 16 [17%]) or cemiplimab (n = 15 [16%]) monotherapies. Median overall and progression-free survival were 9.8 months (95% confidence interval = 7.7 to 12.8 months) and 3.2 months (95% confidence interval = 2.5 to 4.2 months), respectively. The objective response rate was 13% (n = 11/85) in the overall cohort and 35% (n = 7/20) in patients with lymph node-only metastases. Visceral metastases, Eastern Cooperative Oncology Group (ECOG) performance status of 1 or higher, and a higher neutrophil/lymphocyte ratio were associated with worse overall survival. Treatment-related adverse events occurred in 27 (29%) patients, and 9.8% (n = 9) of the events were grade 3 or higher. CONCLUSIONS:
Immune checkpoint inhibitors are active in a subset of patients with penile squamous cell carcinoma. Future translational studies are warranted to identify patients more likely to derive clinical benefit from immune checkpoint inhibitors.
|
|---|---|
| Authors | 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 |
| Journal | Journal of the National Cancer Institute (J Natl Cancer Inst) Vol. 115 Issue 12 Pg. 1605-1615 (12 06 2023) ISSN: 1460-2105 [Electronic] United States |
| PMID | 37563779 (Publication Type: Journal Article) |
| Copyright | © The Author(s) 2023. Published by Oxford University Press. All rights reserved. For permissions, please email: [email protected]. |
| Chemical References |
|
| Topics |
|
Join CureHunter, for free Research Interface BASIC access!
Realize the full power of the drug-disease research graph!