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晚期尿路上皮癌患者接受 PD-1/L1 抑制剂治疗后停药的临床和患者报告结局。

Clinical and Patient-Reported Outcomes of Advanced Urothelial Carcinoma Following Discontinuation of PD-1/L1 Inhibitor Therapy.

机构信息

Dana-Farber Cancer Institute, Boston, MA.

Seagen Inc., Bothell, WA.

出版信息

Clin Genitourin Cancer. 2022 Dec;20(6):543-552. doi: 10.1016/j.clgc.2022.08.002. Epub 2022 Aug 6.

DOI:10.1016/j.clgc.2022.08.002
PMID:36088235
Abstract

INTRODUCTION

The patterns of care and attrition of locally advanced or metastatic urothelial carcinoma (la/mUC) patients eligible for systemic therapy following PD-1/L1 inhibitors are unclear. The objective of this study was to evaluate the clinical characteristics and treatment patterns among patients with la/mUC following discontinuation of first-line (1L) or second-line (2L) PD-1/L1 inhibitor therapy.

METHODS

An ambispective, multisite, chart review study was conducted in the United States, including patients with la/mUC. Eligible patients had initiated and subsequently discontinued PD-1/L1 therapy in the 1L or 2L setting for la/mUC between May 2016 and July 2018; with follow-up through October 2019. Patient characteristics, treatments, and overall survival (OS) were described. Patients had the option to complete a 1-time patient reported outcomes (PRO) survey.

RESULTS

Among 300 patients included in the chart review, 198 (66%) received 1L PD-1/L1 inhibitor and 102 (34%) received 2L PD-1/L1 inhibitor. Following discontinuation of PD-1/L1 inhibitor therapy, 34% (n = 68) received subsequent therapy in 2L and 29% (n = 30) in third-line (3L). The median OS post-1L PD-1/L1 inhibitor was 9.4 (95% CI 8.6-NA) and 2.5 months (95% CI 2.24-3.50) for those who received and did not receive subsequent therapy, respectively. Following 2L PD-1/L1 inhibitor discontinuation, the median OS was 5.7 (95% CI 5.1-7.8) and 3.98 (95% CI 3.29-4.87) months for those who received and did not receive subsequent therapy, respectively. Among those with PRO data, 64% reported experiencing cancer-related pain and 29.6% received an opioid. Only 12.7% reported having a caregiver, requiring approximately 13 h/d of service.

CONCLUSION

The symptom and caregiver burden are high among real-world patients with la/mUC who discontinued 1L or 2L PD-1/L1 inhibitors and outcomes are dismal, with a minority receiving subsequent therapy. Patterns of care in the setting of 1L maintenance avelumab and novel agents require further investigation.

摘要

简介

接受 PD-1/L1 抑制剂治疗后局部晚期或转移性尿路上皮癌(la/mUC)患者的治疗模式和疾病进展情况尚不清楚。本研究旨在评估一线(1L)或二线(2L)PD-1/L1 抑制剂治疗后停止治疗的 la/mUC 患者的临床特征和治疗模式。

方法

这是一项在美国进行的前瞻性、多中心、病历回顾性研究,纳入了 la/mUC 患者。符合条件的患者在 2016 年 5 月至 2018 年 7 月期间在 1L 或 2L 环境中接受了 PD-1/L1 抑制剂治疗,并随后停止了治疗;随访时间截至 2019 年 10 月。描述了患者的特征、治疗方法和总生存(OS)情况。患者可选择完成一次患者报告的结果(PRO)调查。

结果

在纳入的 300 例病历中,198 例(66%)患者接受了 1L PD-1/L1 抑制剂治疗,102 例(34%)患者接受了 2L PD-1/L1 抑制剂治疗。在停止 PD-1/L1 抑制剂治疗后,34%(n=68)患者接受了 2L 治疗,29%(n=30)患者接受了 3L 治疗。1L PD-1/L1 抑制剂治疗后中位 OS 分别为 9.4(95%CI 8.6-NA)和 2.5 个月(95%CI 2.24-3.50),分别为接受和未接受后续治疗的患者。2L PD-1/L1 抑制剂停药后,中位 OS 分别为 5.7(95%CI 5.1-7.8)和 3.98(95%CI 3.29-4.87)个月,分别为接受和未接受后续治疗的患者。在有 PRO 数据的患者中,64%报告有癌症相关疼痛,29.6%接受了阿片类药物治疗。仅有 12.7%的患者报告有照顾者,需要大约 13 小时/天的服务。

结论

在接受 1L 或 2L PD-1/L1 抑制剂治疗后停止治疗的真实世界中,局部晚期或转移性尿路上皮癌(la/mUC)患者的症状和照顾者负担很高,预后很差,只有少数患者接受了后续治疗。1L 维持治疗avelumab 和新型药物的治疗模式需要进一步研究。

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