Safety and efficacy of immune checkpoint inhibitors in advanced penile cancer: report from the Global Society of Rare Genitourinary Tumors

Talal El Zarif(Harvard University), Amin H. Nassar(Yale Cancer Center), Gregory R. Pond(McMaster University), Tony Zhuang(Emory University), Viraj A. Master(Emory University), Bassel Nazha(Emory University), Scot A. Niglio(New York University), Nicholas I. Simon(National Institutes of Health), Andrew W. Hahn(The University of Texas MD Anderson Cancer Center), Curtis A. Pettaway(The University of Texas MD Anderson Cancer Center), Shi‐Ming Tu(Winthrop Rockefeller Foundation), Noha Abdel‐Wahab(The University of Texas MD Anderson Cancer Center), Maud Velev(Université Paris-Saclay), Ronan Flippot(Institut Gustave Roussy), Sebastiano Buti(University of Parma), Marco Maruzzo(Istituto Oncologico Veneto), Arjun Mittra(The Ohio State University), Jinesh Gheeya(The Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute), Yuanquan Yang(The Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute), Pablo Alvarez Rodriguez(Hospital Universitario 12 De Octubre), Daniel Castellano(Hospital Universitario 12 De Octubre), Guillermo de Velasco(Hospital Universitario 12 De Octubre), Giandomenico Roviello(University of Florence), Lorenzo Antonuzzo(Azienda Ospedaliero-Universitaria Careggi), Rana R. McKay(University of California San Diego), Bruno Vincenzi(Campus Bio Medico University Hospital), Alessio Cortellini(Hammersmith Hospital), Gavin Hui(University of California, Los Angeles), Alexandra Drakaki(University of California, Los Angeles), Michael Glover(Stanford University), Ali Raza Khaki(Stanford University), Edward El‐Am(Mayo Clinic in Arizona), Nabil Adra(Indiana University Health), Tarek H. Mouhieddine(Icahn School of Medicine at Mount Sinai), Vaibhav G. Patel(Icahn School of Medicine at Mount Sinai), A. Piedra(Hospital de Sant Pau), Angela Gernone, Nancy B. Davis(Vanderbilt University Medical Center), Harrison Matthews(Prostate Cancer Foundation), Michael R. Harrison(Prostate Cancer Foundation), Ravindran Kanesvaran(National Cancer Centre Singapore), Giulia Claire Giudice(University of Parma), Pedro C. Barata(University Hospitals Seidman Cancer Center), Alberto Farolfi(Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori), Jae‐Lyun Lee(Ulsan College), Matthew I. Milowsky(University of North Carolina at Chapel Hill), Charlotte N. Stahlfeld(University of Pittsburgh), Leonard J. Appleman(University of Pittsburgh), Joseph W. Kim(Yale Cancer Center), Dory Freeman(Harvard University), Toni K. Choueiri(Harvard University), Philippe E. Spiess(Moffitt Cancer Center), Andrea Necchi(Vita-Salute San Raffaele University), Andrea B. Apolo(National Institutes of Health), Guru Sonpavde(Florida Hospital Cancer Institute)
JNCI Journal of the National Cancer Institute
August 11, 2023
10.1093/jnci/djad155
Cited by 54Open Access
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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.

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