Department of Urology, Iwate Medical University, 1-1-1 Idaidori, Yahaba-cho, Shiwa-gun, Iwate, 020-3694, Japan.
Int J Clin Oncol. 2020 May;25(5):899-905. doi: 10.1007/s10147-019-01613-9. Epub 2020 Jan 7.
Prognostic outcomes and safety following treatment with pembrolizumab in patients with advanced urothelial carcinoma (UC) have not been fully elucidated in clinical practice. The aim of this study was to evaluate the oncological efficacy and safety of pembrolizumab after failure of platinum-based chemotherapy in Japanese patients with advanced UC in a routine clinical setting.
This retrospective study included 41 consecutive Japanese patients with advanced UC treated with pembrolizumab as second-line or greater therapy at Iwate Medical University Hospital from January 2018 to April 2019.
The mean follow-up period was 6.2 months. The objective response rate, median progression-free survival, and median overall survival were 15%, 2.5 months, and 11.9 months, respectively. Univariate analysis identified poor performance status (> 1), liver metastasis, two or more metastatic organs, low hemoglobin levels, two or more prior regimens, high baseline C-reactive protein levels, higher relative C-reactive protein level change after 6 weeks, and higher relative neutrophil-to-lymphocyte ratio change after 6 weeks as significant predictors of overall survival. Among these factors, poor performance status (> 1), two or more metastatic organs, and higher relative neutrophil-to-lymphocyte ratio change after 6 weeks were identified as independent predictors of overall survival in multivariate analysis.
The introduction of pembrolizumab can result in favorable cancer control outcomes in Japanese patients with advanced UC, and the prognosis of these patients can be stratified according to three potential parameters, including poor performance status, high number of metastatic organs, and higher relative neutrophil-to-lymphocyte ratio change.
在临床实践中，尚未充分阐明在接受派姆单抗治疗的晚期尿路上皮癌（UC）患者中的预后结果和安全性。本研究的目的是在常规临床环境中评估派姆单抗在铂类化疗失败后在日本晚期 UC 患者中的肿瘤疗效和安全性。
本回顾性研究纳入了 2018 年 1 月至 2019 年 4 月期间在岩手医科大学医院接受派姆单抗二线或以上治疗的 41 例日本晚期 UC 患者。
中位随访时间为 6.2 个月。客观缓解率、中位无进展生存期和中位总生存期分别为 15%、2.5 个月和 11.9 个月。单因素分析发现，较差的体能状态（>1）、肝转移、两个或更多转移器官、低血红蛋白水平、两个或更多既往治疗方案、高基线 C 反应蛋白水平、6 周后相对 C 反应蛋白水平变化较大以及 6 周后相对中性粒细胞与淋巴细胞比值变化较大是总生存期的显著预测因素。在这些因素中，较差的体能状态（>1）、两个或更多转移器官和 6 周后相对中性粒细胞与淋巴细胞比值变化较大被确定为多因素分析中总生存期的独立预测因素。
派姆单抗的引入可为日本晚期 UC 患者带来有利的癌症控制结果，这些患者的预后可根据三个潜在参数进行分层，包括较差的体能状态、较多的转移器官和相对较高的中性粒细胞与淋巴细胞比值变化。
