不可切除的治疗选择，局部晚期或转移性阴茎鳞状细胞癌（SCC）是有限的。先前的研究表明，40-62％的阴茎SCC患者表达PD-L1。我们报告了3例用pembrolizumab治疗的局部晚期或转移性阴茎SCC病例。
这里，我们介绍了三名复发患者，局部晚期或转移性阴茎SCC，以铂类药物为基础的化疗三联疗法进展，并接受派姆单抗治疗，作为罕见肿瘤的II期临床试验的一部分（NCT02721732）。一名微卫星不稳定性高（MSI-H）肿瘤患者对pembrolizumab有持久的部分反应，接受了手术巩固，38.7个月后仍然没有疾病。两名患者在开始pembrolizumab的3个月内经历了进行性疾病。没有人经历过3级或更严重的治疗相关不良事件。
总之,单药pembrolizumab作为抢救治疗在一小部分不可切除的患者中具有良好的耐受性，局部晚期或转移性阴茎SCC。Pembrolizumab在MSI-H肿瘤中产生客观反应，然而，它没有控制2例MSS阴茎SCC患者的疾病。合理的联合疗法，包括派博利珠单抗,需要进一步调查。
ClinicalTrials.gov标识符：NCT02721732。2016年3月23日注册。
Treatment options for unresectable, locally advanced or metastatic penile squamous cell carcinoma (SCC) are limited. Previous studies have shown that 40-62% of patients with penile SCC express PD-L1. We report three cases of locally advanced or metastatic penile SCC treated with pembrolizumab.
Herein, we present three patients with recurrent, locally advanced or metastatic penile SCC who progressed on a platinum-based chemotherapy triplet and were treated with pembrolizumab, administered as part of a phase II clinical
trial for rare tumors (NCT02721732). One patient with a microsatellite instability high (MSI-H) tumor experienced a durable partial response to pembrolizumab, underwent surgical consolidation, and remains disease-free 38.7 months later. Two patients experienced progressive disease within 3 months of beginning pembrolizumab. No one experienced a grade 3 or worse treatment-related adverse event.
In sum, single-agent pembrolizumab was well tolerated as salvage therapy in a small cohort of patients with unresectable, locally advanced or metastatic penile SCC. Pembrolizumab produced an objective response in an MSI-H tumor, yet it did not control disease in two patients with MSS penile SCC. Rationale combination therapies, including pembrolizumab, warrant further investigation.
ClinicalTrials.gov identifier: NCT02721732 . Registered March 23, 2016.
