Alessandro Rizzo, Fernando Sabino Marques Monteiro, Yüksel Ürün, Francesco Massari, Se Hoon Park, Maria T Bourlon, Alexandr Poprach, Mimma Rizzo, Hideki Takeshita, Patrizia Giannatempo, Andrey Soares, Giandomenico Roviello, Javier Molina-Cerrillo, Francesco Carrozza, Halima Abahssain, Carlo Messina, Ray Manneh Kopp, Renate Pichler, Luigi Formisano, Deniz Tural, Francesco Atzori, Fabio Calabrò, Ravindran Kanesvaran, Sebastiano Buti, Matteo Santoni
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In this sub-analysis we focused on patients with ECOG-PS 2.</p><p><strong>Results: </strong>We included 1,040 patients from the ARON-2 dataset; of these, 167 patients (16%) presented an ECOG-PS 2. The median overall survival (OS) was 14.8 months (95% confidence interval (CI) 12.5-16.1) in the overall study population, 18.2 months (95% CI 15.8-22.2) in patients with ECOG-PS 0-1, and 3.7 months (95% CI 3.2-5.2) in subjects with ECOG-PS 2 (p < 0.001). The median progression-free survival (PFS) in the overall study population was 5.3 months (95% CI 4.3-97.1), 6.2 months (95% CI 5.5-97.1) in patients with ECOG-PS 0-1, and 2.8 months (95% CI 2.1-3.4) in patients with ECOG-PS 2. Among the latter, liver metastases and progressive disease during first-line therapy were significant predictors of OS at both univariate and multivariate analyses. For PFS, univariate and multivariate analyses showed a prognostic role for lung metastases, liver metastases, and progressive disease during first-line therapy.</p><p><strong>Conclusions: </strong>This large real-world evidence study suggests the effectiveness of second-line pembrolizumab for mUC patients with poor performance status. 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引用次数: 0
摘要
背景：免疫检查点抑制剂（ICIs）对晚期尿路上皮癌（UC）患者的益处尚不清楚：免疫检查点抑制剂（ICIs）对晚期尿路上皮癌（UC）表现状态不佳患者的益处仍然未知：在本项ARON-2研究的子分析中，我们研究了pembrolizumab对ECOG（东部合作肿瘤学组）表现状态（ECOG-PS）为2的晚期UC患者的作用：纳入年龄≥18岁、细胞学和/或组织学确诊为晚期UC、铂类治疗后进展或复发、2016年1月1日至2024年4月1日期间接受过pembrolizumab治疗的患者。在这项子分析中，我们重点关注ECOG-PS为2.的患者：总研究人群的中位总生存期（OS）为14.8个月（95%置信区间（CI）12.5-16.1），ECOG-PS 0-1患者为18.2个月（95% CI 15.8-22.2），ECOG-PS 2患者为3.7个月（95% CI 3.2-5.2）（P 结论：这一大型真实世界证据研究表明，ECOG-PS 2患者的中位总生存期为14.8个月（95%置信区间（CI）12.5-16.1），ECOG-PS 0-1患者为18.2个月（95% CI 15.8-22.2），ECOG-PS 2患者为3.7个月（95% CI 3.2-5.2）：这项大型真实世界证据研究表明，pembrolizumab 二线治疗表现不佳的 mUC 患者是有效的。在一线治疗期间出现肝转移和疾病进展与较差的临床预后有关，因此在临床实践中做出治疗决定时应将其考虑在内。
Pembrolizumab in Patients with Advanced Urothelial Carcinoma with ECOG Performance Status 2: A Real-World Study from the ARON-2 Project.
Background: The benefit of immune checkpoint inhibitors (ICIs) for poor performance status patients with advanced urothelial carcinoma (UC) remains unknown.
Objective: In the present sub-analysis of the ARON-2 study, we investigated the role of pembrolizumab for advanced UC patients with ECOG (Eastern Cooperative Oncology Group) performance status (ECOG-PS) 2.
Patients and methods: Patients aged ≥ 18 years with a cytologically and/or histologically confirmed diagnosis of advanced UC progressing or recurring after platinum-based therapy and treated with pembrolizumab between 1 January 2016 to 1 April 2024 were included. In this sub-analysis we focused on patients with ECOG-PS 2.
Results: We included 1,040 patients from the ARON-2 dataset; of these, 167 patients (16%) presented an ECOG-PS 2. The median overall survival (OS) was 14.8 months (95% confidence interval (CI) 12.5-16.1) in the overall study population, 18.2 months (95% CI 15.8-22.2) in patients with ECOG-PS 0-1, and 3.7 months (95% CI 3.2-5.2) in subjects with ECOG-PS 2 (p < 0.001). The median progression-free survival (PFS) in the overall study population was 5.3 months (95% CI 4.3-97.1), 6.2 months (95% CI 5.5-97.1) in patients with ECOG-PS 0-1, and 2.8 months (95% CI 2.1-3.4) in patients with ECOG-PS 2. Among the latter, liver metastases and progressive disease during first-line therapy were significant predictors of OS at both univariate and multivariate analyses. For PFS, univariate and multivariate analyses showed a prognostic role for lung metastases, liver metastases, and progressive disease during first-line therapy.
Conclusions: This large real-world evidence study suggests the effectiveness of second-line pembrolizumab for mUC patients with poor performance status. The presence of liver metastases and progressive disease during first-line therapy is associated with worse clinical outcomes and, thus, should be taken into account when making treatment decisions in clinical practice.
期刊介绍：
Targeted Oncology addresses physicians and scientists committed to oncology and cancer research by providing a programme of articles on molecularly targeted pharmacotherapy in oncology. The journal includes:
Original Research Articles on all aspects of molecularly targeted agents for the treatment of cancer, including immune checkpoint inhibitors and related approaches.
Comprehensive narrative Review Articles and shorter Leading Articles discussing relevant clinically established as well as emerging agents and pathways.
Current Opinion articles that place interesting areas in perspective.
Therapy in Practice articles that provide a guide to the optimum management of a condition and highlight practical, clinically relevant considerations and recommendations.
Systematic Reviews that use explicit, systematic methods as outlined by the PRISMA statement.
Adis Drug Reviews of the properties and place in therapy of both newer and established targeted drugs in oncology.
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