Abstract：
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.
摘要：
ARON-2研究（NCT05290038）旨在评估pembrolizumab在铂类化疗后复发或进展患者中的真实世界疗效。这项回顾性分析报告了尿路上皮癌（UC）伴骨转移（BM）患者的预后。从20个国家的60个机构审查了通过pembrolizumab作为二线治疗的转移性UC患者的医疗记录。评估患者的总体反应率（ORR），无进展生存期（PFS），总生存率（OS）。使用单变量和多变量分析来探索感兴趣变量与OS和PFS的关联。包括881名患者；其中，263（30%）提出了BM。中位随访时间为22.7个月。BM患者的中位OS均较短（5.9个月vs13.1个月，p<0.001)和PFS(3.5个月，vs7.3个月，p<0.001)与没有BM的患者相比。接受骨靶向药物（BTA）的患者显示出明显更长的中位OS（8.5个月vs4.6个月，p=0.003）和PFS（6.1个月vs3.2个月，p=0.003),而在pembrolizumab治疗期间接受BM放射治疗的患者与未接受放射治疗的患者相比,未观察到生存获益.在多变量分析中，性能状态，伴随肝转移，缺乏使用BTA与OS和PFS恶化显著相关。pembrolizumab治疗的UC患者骨受累预测生存率低。不良的表现状态和肝转移可能会进一步恶化结果，而BTA的使用与改善的结果相关。
