骨靶向剂(而非放射治疗)可提高接受派姆单抗治疗的晚期尿路上皮癌骨转移患者的生存率:ARON-2 研究的结果。
Bone targeting agents, but not radiation therapy, improves survival in patients with bone metastases from advanced urothelial carcinoma receiving pembrolizumab: results from the ARON-2 study.
发表日期:2023 Nov 02
作者:
Matteo Santoni, Francesco Massari, Hideki Takeshita, Jose Carlos Tapia, Michele Dionese, Renate Pichler, Mimma Rizzo, Elaine T Lam, Enrique Grande, Robert Kemp, Javier Molina-Cerrillo, Fabio Calabrò, Deniz Tural, Zsófia Küronya, Jakub Kucharz, Ondrej Fiala, Emmanuel Seront, Ray Manneh Kopp, Halima Abahssain, Jindrich Kopecky, Angelo Martignetti, Ravindran Kanesvaran, Roubini Zakopoulou, Jawaher Ansari, Johannes Landmesser, Veronica Mollica, Camillo Porta, Joaquim Bellmunt, Samer Salah, Daniele Santini
来源:
CLINICAL PHARMACOLOGY & THERAPEUTICS
摘要:
ARON-2 研究 (NCT05290038) 旨在评估派姆单抗对铂类化疗后复发或进展患者的真实疗效。本回顾性分析报告了患有骨转移 (BM) 的尿路上皮癌 (UC) 患者的结果。对 20 个国家 60 个机构记录的接受派姆单抗作为二线治疗的转移性 UC 患者的医疗记录进行了审查。对患者的总体缓解率(ORR)、无进展生存期(PFS)和总体生存期(OS)进行评估。使用单变量和多变量分析来探讨感兴趣的变量与 OS 和 PFS 的关联。纳入881名患者;其中,263 人(30%)提出了 BM。中位随访时间为 22.7 个月。与无 BM 患者相比,BM 患者的中位 OS(5.9 个月 vs 13.1 个月,p<0.001)和 PFS(3.5 个月 vs 7.3 个月,p<0.001)均较短。接受骨靶向药物 (BTA) 治疗的患者表现出显着更长的中位 OS(8.5 个月 vs 4.6 个月,p = 0.003)和 PFS(6.1 个月 vs 3.2 个月,p = 0.003),而接受骨靶向药物治疗的患者没有观察到生存获益。与未接受派姆单抗治疗期间的 BM 放射治疗相比。在多变量分析中,体能状态、伴随的肝转移以及缺乏 BTA 与较差的 OS 和 PFS 显着相关。接受派姆单抗治疗的 UC 患者骨受累预示生存率较差。体能状态不佳和肝转移可能会进一步恶化结果,而 BTA 的使用与改善结果相关。© 2023。作者获得 Springer Nature Switzerland AG 的独家许可。
The ARON-2 study (NCT05290038) aimed to assess the real-world efficacy of pembrolizumab in patients recurred or progressed after platinum-based chemotherapy. This retrospective analysis reports the outcomes of urothelial carcinoma (UC) patients with bone metastases (BM). Medical records of patients with documented metastatic UC treated by pembrolizumab as second-line therapy were reviewed from60 institutions in 20 countries. Patients were assessed for Overall Response Rate (ORR), Progression-Free Survival (PFS), and Overall Survival (OS). Univariate and multivariate analyses were used to explore the association of variables of interest with OS and PFS. 881 patients were included; of them, 263 (30%) presented BM. Median follow-up time was 22.7 months. Patients with BM showed both shorter median OS (5.9 months vs 13.1 months, p < 0.001) and PFS (3.5 months, vs 7.3 months, p < 0.001) compared to patients without BM. Patients who received bone targeted agents (BTAs) showed a significantly longer median OS (8.5 months vs 4.6 months, p = 0.003) and PFS (6.1 months vs 3.2 months, p = 0.003), while no survival benefits were observed among patients who received radiation therapy for BM during pembrolizumab treatment compared to those who did not. In multivariate analysis, performance status, concomitant liver metastases, and the lack of use of BTAs were significantly associated with worse OS and PFS. Bone involvement in UC patients treated with pembrolizumab predicts inferior survival. Poor performance status and liver metastases may further worsen outcomes, while the use of BTAs is associated with improved outcomes.© 2023. The Author(s), under exclusive licence to Springer Nature Switzerland AG.