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阿替利珠单抗治疗预处理的尿路上皮癌患者:韩国单中心回顾性研究。

Atezolizumab in Patients with Pretreated Urothelial Cancer: a Korean Single-Center, Retrospective Study.

机构信息

Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.

Department of Medicine, Sungkyunkwan University Samsung Changwon Hospital, Changwon, Korea.

出版信息

Cancer Res Treat. 2019 Oct;51(4):1269-1274. doi: 10.4143/crt.2018.604. Epub 2019 Jan 9.

Abstract

PURPOSE

Treatment targeting immune checkpoint with programmed death-1 (PD-1)/programmed death-ligand 1 (PD-L1) inhibitors has demonstrated efficacy and tolerability in the treatment of metastatic urothelial carcinoma (mUC). We investigated the efficacy and safety of atezolizumab in mUC patients who failed platinum-based chemotherapy.

MATERIALS AND METHODS

A retrospective study using the Samsung Medical Center cancer chemotherapy registry was performed on 50 consecutive patients with mUC treated with atezolizumab, regardless of their PD-L1(SP142) status, as salvage therapy after chemotherapy failure between May 2017 and June 2018. Endpoints included overall response rate (RR), progression-free survival (PFS), and safety.

RESULTS

Among 50 patients, men constituted 76% and the median age was 68 years (range, 46 to 82 years). Twenty-three patients (46%) received atezolizumab as second-line therapy. PD-L1 (SP142) status IC0/1 and IC2/3 were found in 21 (42%) and 21 (42%) of patients, respectively; in eight patients (16%), PD-L1 (SP142) expression was not available. Atezolizumab was generally well tolerated, with pruritus and fatigue being the most commonly observed toxicities. As a result, partial response was noted in 20 patients (40%), with 12 (24%) stable diseases. RRwas higherin IC2/3 (62%) than in IC0/1 patients (24%, p=0.013). The median PFS was 7.4 months (95% confidence interval, 3.4 to 11.4 months). As expected, PFS also was significantly longer in IC2/3 patients than in IC0/1 (median, 12.7 vs. 2.1 months; p=0.005). PFS was not significantly influenced by age, sex, performance status, number of previous chemotherapy, site of metastases, or any of the baseline laboratory parameters.

CONCLUSION

In this retrospective study, atezolizumab demonstrated clinically efficacy and tolerability in unselected mUC patients who failed platinum-based chemotherapy.

摘要

目的

针对程序性死亡受体-1(PD-1)/程序性死亡配体 1(PD-L1)抑制剂的免疫检查点治疗在转移性尿路上皮癌(mUC)的治疗中显示出疗效和耐受性。我们研究了阿特珠单抗在铂类化疗失败后接受治疗的 mUC 患者中的疗效和安全性。

材料和方法

使用三星医疗中心癌症化疗登记处进行了一项回顾性研究,纳入了 50 例连续接受阿特珠单抗治疗的 mUC 患者,无论其 PD-L1(SP142)状态如何,这些患者均在 2017 年 5 月至 2018 年 6 月期间铂类化疗失败后作为挽救性治疗。主要终点包括总缓解率(RR)、无进展生存期(PFS)和安全性。

结果

50 例患者中,男性占 76%,中位年龄为 68 岁(范围,46 岁至 82 岁)。23 例(46%)患者接受阿特珠单抗作为二线治疗。21 例(42%)和 21 例(42%)患者的 PD-L1(SP142)状态分别为 IC0/1 和 IC2/3;8 例(16%)患者的 PD-L1(SP142)表达不可用。阿特珠单抗总体耐受性良好,最常见的毒性反应为瘙痒和疲劳。结果显示,20 例(40%)患者部分缓解,12 例(24%)患者病情稳定。IC2/3 患者的 RR 高于 IC0/1 患者(62%比 24%,p=0.013)。中位 PFS 为 7.4 个月(95%置信区间,3.4 至 11.4 个月)。预期的是,IC2/3 患者的 PFS 也明显长于 IC0/1 患者(中位值,12.7 与 2.1 个月;p=0.005)。PFS 不受年龄、性别、表现状态、先前化疗次数、转移部位或任何基线实验室参数的影响。

结论

在这项回顾性研究中,阿特珠单抗在铂类化疗失败的未选择的 mUC 患者中显示出了临床疗效和耐受性。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9803/6790849/b2847ed7704a/crt-2018-604f1.jpg

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