免疫检查点抑制剂在晚期阴茎癌中的安全性和疗效：全球罕见泌尿生殖肿瘤学会报告。
Safety and efficacy of immune checkpoint inhibitors in advanced penile cancer: report from the Global Society of Rare Genitourinary Tumors.
发表日期：2023 Aug 11
作者：
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
来源：
Experimental Hematology & Oncology
摘要：
阴茎鳞状细胞癌（PeCa）的治疗选择有限。我们旨在研究接受免疫检查点抑制剂（ICIs）治疗的PeCa患者的临床结果和安全性。本回顾性研究纳入了2015年至2022年期间在美国、欧洲和亚洲的24个中心接受ICIs治疗的局部晚期或转移性PeCa患者。我们应用Kaplan-Meier方法估计了总生存期（OS）和无进展生存期（PFS）。按照RECIST 1.1标准确定了客观缓解率（ORRs）。治疗相关的不良事件（trAEs）按照Adverse Events v5.0的通用术语标准分级。双侧统计检验用于比较。在92名患者中，有8名亚洲人（8.7%），6名黑人（6.5%）和24名西班牙/拉丁裔患者（29%）。年龄中位数为62岁（四分位数范围：53至70岁）。83名患者（90%）患有转移性PeCa，74名（80%）接受了≥2线治疗。大多数患者接受了pembrolizumab单药疗法（n=26，28%），联合应用nivolumab/ipilimumab加多靶酪氨酸激酶抑制剂（n=23，25%），nivolumab（n=16，17%）或cemiplimab（n=15，16%）单药疗法。中位OS和PFS分别为9.8（95% CI：7.7-12.8）个月和3.2（95% CI：2.5-4.2）个月。总队列中ORR为13%（n=11/85），淋巴结转移患者中为35%（n=7/20）。内脏转移、ECOG表现状态≥1以及更高的中性粒细胞/淋巴细胞比值（NLR）与较差的OS有关。TrAEs发生率为29%（n=27），其中有9.8%（n=9）达到≥3级。ICIs在PeCa患者的一部分中具有活性。未来的转化研究有必要确定更可能从ICIs获得临床益处的患者。© 作者2023。由牛津大学出版社发表。版权所有。如需权限，请发送电子邮件至：journals.permissions@oup.com。
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.© The Author(s) 2023. Published by Oxford University Press. All rights reserved. For permissions, please email: journals.permissions@oup.com.