转移性尿路上皮癌患者接受铂类化疗和阿维单抗维持治疗后的恩福单抗韦多汀：来自 ARON-2EV 研究的回顾性数据。

IF 4.4 3区医学 Q2 ONCOLOGY

Targeted Oncology Pub Date : 2024-10-01 DOI:10.1007/s11523-024-01099-0

Ondřej Fiala, Francesco Massari, Umberto Basso, Patrizia Giannatempo, Enrique Grande, Sebastiano Buti, Zin W Myint, Ugo De Giorgi, Renate Pichler, Francesco Grillone, Yüksel Ürün, Fabio Calabrò, Maria T Bourlon, Luca Galli, Ravindran Kanesvaran, Giandomenico Roviello, Jakub Kucharz, Mimma Rizzo, Se Hoon Park, Linda Cerbone, Emmanuel Seront, Carlo Messina, Javier Molina-Cerrillo, Daniele Santini, Akihiro Yano, Lorena Incorvaia, Martina Catalano, Alvaro Pinto, Luigi Formisano, Andrey Soares, Gaetano Facchini, Giuseppe Fornarini, Alexandr Poprach, Sara Elena Rebuzzi, Cecilia Nasso, Gian Paolo Spinelli, Martin Angel, Marco Stellato, Deniz Tural, Gaetano Aurilio, Ilana Epstein, Francesco Carrozza, Fernando Sabino Marques Monteiro, Giovanni Benedetti, Tomáš Büchler, Cinzia Ortega, Roubini Zakopoulou, Nicola Battelli, Camillo Porta, Joaquin Bellmunt, Shilpa Gupta, Matteo Santoni

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引用次数: 0

摘要

背景：恩福单抗韦多汀（EV）已被批准用于治疗既往接受过铂类化疗后又接受过免疫检查点抑制剂治疗的局部晚期/转移性尿路上皮癌（la/mUC）患者。然而，关键临床试验并不包括曾接受过阿维列单抗维持治疗的患者：本回顾性分析旨在评估ARON-2EV研究入组的mUC患者接受阿维列单抗治疗后EV的有效性：研究纳入了182例在阿维鲁单抗维持治疗后接受EV治疗的mUC患者。主要目的是评估临床结果，包括无进展生存期（PFS）、总生存期（OS）、总反应率（ORR）和反应持续时间（DoR）。统计分析包括费舍尔精确检验、卡普兰-梅耶法、对数秩检验和单变量/多变量考克斯比例危险回归模型：中位OS和PFS分别为12.7个月（95% CI 10.2-14.1）和7.9个月（95% CI 6.4-9.9）。5%的患者获得完全应答（CR），34%的患者获得部分应答（PR），ORR为39%。获得 CR/PR 的患者的 DoR 为 10.9 个月（95% CI 8.1-11.4）。≥3级周围神经病变和皮疹的发生率为9%，其次是8%的≥3级腹泻和4%的≥3级高血糖：我们的大型国际回顾性研究结果证实了EV的有效性，并赞同在前线铂类化疗后接受EV治疗并随后接受阿维列单抗维持治疗的mUC患者中使用EV。

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Enfortumab Vedotin Following Platinum Chemotherapy and Avelumab Maintenance in Patients with Metastatic Urothelial Carcinoma: A Retrospective Data from the ARON-2^EV Study.

Background: Enfortumab vedotin (EV) has been approved for the treatment of patients with locally advanced/metastatic urothelial carcinoma (la/mUC) who previously received platinum-based chemotherapy followed by immune checkpoint inhibitors. However, the pivotal clinical trials did not include patients previously treated with avelumab maintenance therapy.

Objective: The aim of the present retrospective analysis was to assess the effectiveness of EV following avelumab in patients with mUC enrolled in the ARON-2^EV study.

Patients and methods: The study included 182 patients with mUC treated with EV following avelumab maintenance. The primary objective was to assess clinical outcomes, including progression-free survival (PFS), overall survival (OS), overall response rate (ORR), and duration of response (DoR). Statistical analysis involved Fisher exact test, Kaplan-Meier method, log-rank test, and univariate/multivariate Cox proportional hazard regression models.

Results: Median OS and PFS were 12.7 (95% CI 10.2-14.1) and 7.9 (95% CI 6.4-9.9) months, respectively. Complete response (CR) was achieved in 5% and partial response (PR) in 34% of patients, with an ORR of 39%. The DoR in patients who achieved CR/PR was 10.9 months (95% CI 8.1-11.4). The incidence of grade ≥ 3 peripheral neuropathy and skin rash was 9%, followed by 8% of grade ≥ 3 diarrhea and 4% of grade ≥ 3 hyperglycemia.

Conclusions: The results of our large international retrospective study confirm the effectiveness of EV and endorse its use in the population of patients with mUC treated with EV following the frontline platinum-based chemotherapy and subsequent maintenance treatment with avelumab.

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来源期刊

Targeted Oncology 医学-肿瘤学

CiteScore

8.40

自引率

3.70%

发文量

审稿时长

>12 weeks

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.