Pembrolizumab在晚期上尿路上皮癌患者中的应用:来自ARON-2项目的真实世界研究。

IF 4.2 3区 医学 Q2 ONCOLOGY
Clinical & Experimental Metastasis Pub Date : 2024-10-01 Epub Date: 2024-06-08 DOI:10.1007/s10585-024-10296-0
Alessandro Rizzo, Sebastiano Buti, Patrizia Giannatempo, Samer Salah, Javier Molina-Cerrillo, Francesco Massari, Ray Manneh Kopp, Ondřej Fiala, Luca Galli, Zin W Myint, Deniz Tural, Andrey Soares, Renate Pichler, Alessia Mennitto, Halima Abahssain, Fabio Calabrò, Fernando Sabino M Monteiro, Anna Albano, Veronica Mollica, Giulia Claire Giudice, Hideki Takeshita, Matteo Santoni
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引用次数: 0

摘要

上尿路尿路上皮癌(UTUC)占所有尿路上皮癌(UC)的5%-10%。在这项分析中,我们报告了ARON-2研究(NCT05290038)中pembrolizumab对铂类化疗后复发或进展的UTUC患者疗效的真实世界数据。研究人员审查了来自 14 个国家 34 家机构、接受过 pembrolizumab 二线治疗的转移性 UTUC 患者的医疗记录。对患者的总生存期(OS)、无进展生存期(PFS)和总反应率(ORR)进行了评估。采用单变量和多变量分析来探讨相关变量与OS和PFS的关系。235名患者纳入了我们的分析。中位OS为8.6个月(95% CI 6.6-12.1),1年OS率为43%,2年OS率为29%。中位生存期为5.1个月(95% CI 3.9-6.9);46%的患者在6个月时存活,34%在12个月时存活,25%在24个月时存活。根据 RECIST 1.1,18 名患者(8%)出现完全反应(CR),57 名患者(24%)出现部分反应(PR),44 名患者(19%)病情稳定(SD),116 名患者(49%)病情进展(PD),ORR 为 32%。我们的研究证实了pembrolizumab对接受铂类药物联合治疗的患者的有效性,无论他们对一线治疗的敏感性如何,也无论他们的组织学如何。此外,我们还强调了pembrolizumab治疗对肝转移和ECOG表现不佳患者的有限益处。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

Pembrolizumab in patients with advanced upper tract urothelial carcinoma: a real-world study from ARON-2 project.

Pembrolizumab in patients with advanced upper tract urothelial carcinoma: a real-world study from ARON-2 project.

Upper tract urothelial carcinoma (UTUC) accounts for the 5-10% of all urothelial carcinomas (UCs). In this analysis, we reported the real-world data from the ARON-2 study (NCT05290038) on the efficacy of pembrolizumab in patients with UTUC who recurred or progressed after platinum-based chemotherapy. Medical records of patients with metastatic UTUC treated with pembrolizumab as second-line therapy were reviewed from 34 institutions in 14 countries. Patients were assessed for overall survival (OS), progression-free survival (PFS), and overall response rate (ORR). Univariate and multivariate analyses were used to explore the association of variables of interest with OS and PFS. 235 patients were included in our analysis. Median OS was 8.6 months (95% CI 6.6-12.1), the 1 year OS rate was 43% while the 2 years OS rate 29%. The median PFS was 5.1 months (95% CI 3.9-6.9); 46% of patients were alive at 6 months, 34% at 12 months and 25% at 24 months. According to RECIST 1.1, 18 patients (8%) experienced complete response (CR), 57 (24%) partial response (PR), 44 (19%) stable disease (SD), and 116 (49%) progressive disease (PD), with an ORR of 32%. Our study confirms the effectiveness of pembrolizumab in patients pretreated with a platinum-based combination, irrespective of their sensitivity to the first-line treatment and of their histology. In addition, we emphasized the limited benefit of the treatment with pembrolizumab in patients with hepatic metastases and poor ECOG performance status.

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来源期刊
CiteScore
7.80
自引率
5.00%
发文量
55
审稿时长
12 months
期刊介绍: The Journal''s scope encompasses all aspects of metastasis research, whether laboratory-based, experimental or clinical and therapeutic. It covers such areas as molecular biology, pharmacology, tumor biology, and clinical cancer treatment (with all its subdivisions of surgery, chemotherapy and radio-therapy as well as pathology and epidemiology) insofar as these disciplines are concerned with the Journal''s core subject of metastasis formation, prevention and treatment.
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