Department of Urology, Cancer Institute Hospital, Japanese Foundation for Cancer Research, Tokyo, Japan.
Department of Medical Oncology, Cancer Institute Hospital, Japanese Foundation for Cancer Research, Tokyo, Japan.
Cancer Rep (Hoboken). 2021 Dec;4(6):e1398. doi: 10.1002/cnr2.1398. Epub 2021 May 2.
The paradigm of medical treatment for metastatic urothelial carcinoma is dramatically changing through the introduction of pembrolizumab.
We investigated the treatment effectiveness, the safety profile, and the prognostic factors of pembrolizumab in Japanese real-world clinical practice.
The medical records of 74 consecutive Japanese patients with metastatic urothelial cancer (UC), who started pembrolizumab as a second- or later-line treatment at our institution between January 2018 and March 2020, were reviewed and statistically analyzed. The median follow-up period after initiation of pembrolizumab was 8.5 (interquartile range: 3.5-15.7) months. The objective response rate was 30.2%, the median progression-free survival period was 4.9 months, and the median overall survival (OS) period was 13.3 months. Evaluation revealed that 39 (52.9%) patients experienced adverse events (AEs), among whom eight patients (10.9%) had severe AEs (grade 3 or more), including grade 5 hemophagocytic syndrome. Multivariate analysis indicated that the presence of liver metastasis, worse performance status (≥2), elevated serum lactate dehydrogenase, and increased C-reactive protein were predictive of shorter OS.
We studied the effectiveness and safety profile of pembrolizumab therapy in Japanese UC patients. We believe that the data presented here will be useful for clinical physicians.
随着帕博利珠单抗的引入，转移性尿路上皮癌的治疗模式发生了重大变化。
我们研究了派姆单抗在日本真实临床实践中的治疗效果、安全性概况和预后因素。
回顾性分析了 2018 年 1 月至 2020 年 3 月期间在我院接受派姆单抗二线或后线治疗的 74 例转移性尿路上皮癌（UC）日本患者的病历，并进行了统计学分析。从开始使用派姆单抗到进行统计分析的中位随访时间为 8.5 个月（四分位距：3.5-15.7）。客观缓解率为 30.2%，中位无进展生存期为 4.9 个月，中位总生存期（OS）为 13.3 个月。评估发现，39 例（52.9%）患者出现不良反应（AE），其中 8 例（10.9%）发生严重 AE（3 级或以上），包括 5 级噬血细胞综合征。多变量分析表明，肝转移、较差的体力状态（≥2 级）、血清乳酸脱氢酶升高和 C 反应蛋白升高是 OS 较短的预测因素。
我们研究了派姆单抗治疗日本 UC 患者的有效性和安全性概况。我们相信，这里提供的数据将对临床医生有用。
