{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,15]],"date-time":"2026-10-15T07:50:36Z","timestamp":1792050636975,"version":"4.4.0"},"reference-count":61,"publisher":"Oxford University Press (OUP)","issue":"12","license":[{"start":{"date-parts":[[2023,8,11]],"date-time":"2023-08-11T00:00:00Z","timestamp":1691712000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/pages\/standard-publication-reuse-rights"}],"funder":[{"DOI":"10.13039\/100000002","name":"NIH","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100000002","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2023,12,6]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>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.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>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.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>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\u2009=\u200926 [28%]), combination nivolumab-ipilimumab with or without multitargeted tyrosine kinase inhibitors (n\u2009=\u200923 [25%]), or nivolumab (n\u2009=\u200916 [17%]) or cemiplimab (n\u2009=\u200915 [16%]) monotherapies. Median overall and progression-free survival were 9.8 months (95% confidence interval\u2009=\u20097.7 to 12.8 months) and 3.2 months (95% confidence interval\u2009=\u20092.5 to 4.2 months), respectively. The objective response rate was 13% (n\u2009=\u200911\/85) in the overall cohort and 35% (n\u2009=\u20097\/20) in patients with lymph node\u2013only 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\u2009=\u20099) of the events were grade 3 or higher.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>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.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/jnci\/djad155","type":"journal-article","created":{"date-parts":[[2023,8,11]],"date-time":"2023-08-11T04:36:26Z","timestamp":1691728586000},"page":"1605-1615","source":"Crossref","is-referenced-by-count":56,"title":["Safety and efficacy of immune checkpoint inhibitors in advanced penile cancer: report from the Global Society of Rare Genitourinary Tumors"],"prefix":"10.1093","volume":"115","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-4507-2396","authenticated-orcid":false,"given":"Talal","family":"El Zarif","sequence":"first","affiliation":[{"name":"Lank Center for Genitourinary Oncology, Dana-Farber Cancer Institute , Boston, MA, USA ; Harvard Medical School, Boston, MA, USA"},{"name":"Yale Cancer Center, Yale School of Medicine , New Haven, CT, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Amin H","family":"Nassar","sequence":"additional","affiliation":[{"name":"Yale Cancer Center, Yale School of Medicine , New Haven, CT, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gregory R","family":"Pond","sequence":"additional","affiliation":[{"name":"Department of Oncology, McMaster University , Hamilton, ON, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tony Zibo","family":"Zhuang","sequence":"additional","affiliation":[{"name":"Department of Medicine, Emory University School of Medicine , Atlanta, GA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Viraj","family":"Master","sequence":"additional","affiliation":[{"name":"Department of Hematology and Medical Oncology, Emory University School of Medicine, Winship Cancer Institute , Atlanta, GA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6385-1329","authenticated-orcid":false,"given":"Bassel","family":"Nazha","sequence":"additional","affiliation":[{"name":"Department of Hematology and Medical Oncology, Emory University School of Medicine, Winship Cancer Institute , Atlanta, GA, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Scot","family":"Niglio","sequence":"additional","affiliation":[{"name":"New York University Grossman School of Medicine , New York, NY, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nicholas","family":"Simon","sequence":"additional","affiliation":[{"name":"Genitourinary Malignancies Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health , Bethesda, MD, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4153-205X","authenticated-orcid":false,"given":"Andrew W","family":"Hahn","sequence":"additional","affiliation":[{"name":"University of Texas MD Anderson Cancer Center , Houston, TX, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Curtis A","family":"Pettaway","sequence":"additional","affiliation":[{"name":"University of Texas MD Anderson Cancer Center , Houston, TX, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shi-Ming","family":"Tu","sequence":"additional","affiliation":[{"name":"Division of Hematology and Oncology, University of Arkansas for Medical Sciences, Winthrop P. 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