Fuhrmann Christian, Struck Julian P, Ivanyi Philipp, Kramer Mario W, Hupe Marie C, Hensen Bennet, Fürschke Alexander, Peters Inga, Merseburger Axel S, Kuczyk Markus A, von Klot Christoph-A J
Clinic for Urology and Urological Oncology, Hanover Medical School, Hanover, Germany.
Department of Urology, University Hospital Schleswig-Holstein, Luebeck, Luebeck, Germany.
Front Oncol. 2020 May 21;10:808. doi: 10.3389/fonc.2020.00808. eCollection 2020.
The introduction of checkpoint inhibitors is a long-awaited new option for a urothelial cancer with a poor prognosis. Apart from clinical studies, the data on real world experience is scarce. Patients for monotherapy with either Atezolizumab, Nivolumab or Pembrolizumab after chemotherapy were included. Adverse events and immune related adverse events as well as survival data and imaging analyses were recorded in a prospectively designed multi-center data base. Duration of response, progression free survival (PFS), and overall survival (OS) were estimated with the Kaplan-Meier method. A total of 28 patients were included. The median follow-up was 8.0 (range, 0.7-41.7) months. Median PFS was 5.8 (95% CI, 2.3-NA) months. Median OS for all patients was 10.0 (95% CI, 8.0-NA) months. The overall response rate (ORR) was 21.4% (6 out of 28 patients). Adverse events were recorded in 20 (71.4%) of patients. Higher grade adverse events (≥Grade 3) were present in 11 (39.3%) patients. No therapy related deaths occurred during the observation period. A total of 13 (46.4%) patients had adverse events that were considered to be immune related. The most commonly affected organ was the thyroid gland with 21.4% of events. Our real-world clinical series confirms an objective response for about every fifth patient, promising OS and a low incidence for severe adverse events (≥Grade 3).
检查点抑制剂的引入是预后不良的尿路上皮癌期待已久的新选择。除了临床研究外,关于真实世界经验的数据很少。纳入了化疗后接受阿特珠单抗、纳武单抗或派姆单抗单药治疗的患者。在一个前瞻性设计的多中心数据库中记录了不良事件、免疫相关不良事件以及生存数据和影像学分析。采用Kaplan-Meier方法估计缓解持续时间、无进展生存期(PFS)和总生存期(OS)。共纳入28例患者。中位随访时间为8.0(范围0.7 - 41.7)个月。中位PFS为5.8(95%CI,2.3 - NA)个月。所有患者的中位OS为10.0(95%CI,8.0 - NA)个月。总缓解率(ORR)为21.4%(28例患者中有6例)。20例(71.4%)患者记录了不良事件。11例(39.3%)患者出现高级别不良事件(≥3级)。观察期内未发生与治疗相关的死亡。共有13例(46.4%)患者出现被认为与免疫相关的不良事件。最常受影响的器官是甲状腺,占事件的21.4%。我们的真实世界临床系列证实约每五名患者中有一名有客观缓解,总生存期有希望,且严重不良事件(≥3级)发生率低。