Avelumab First-Line Maintenance for Locally Advanced or Metastatic Urothelial Carcinoma: Results From the Real-World US PATRIOT-II Study

作者：Petros Grivas, Pedro Barata, Helen Moon, Shilpa Gupta, Thomas Hutson, Cora N. Sternberg, Jason R. Brown, Vaidehi Dave, Chad Downey, Alicia C. Shillington, Howard M. Katzenstein, Melissa Kirker, Sarah Hanson, Frank X. Liu, Valerie Morris, Abhijeet Bhanegaonkar, Guru Sonpavde · 发表于：Clinical Genitourinary Cancer · 年份：2024 · DOI：10.1016/j.clgc.2024.102238 · 被引用次数：19 · 研究领域：Bladder and Urothelial Cancer Treatments、Renal cell carcinoma treatment、Ferroptosis and cancer prognosis

INTRODUCTION: In JAVELIN Bladder 100, avelumab first-line maintenance (1LM) improved overall survival (OS) and progression-free survival (PFS) in patients with locally advanced/metastatic urothelial carcinoma (la/mUC) without progression following 1L platinum-based chemotherapy (PBC) versus best supportive care. PATRIOT-II describes real-world outcomes with avelumab 1LM. PATIENTS AND METHODS: This observational, retrospective study of avelumab 1LM in US community/academic centers used medical record data collected from avelumab initiation for ≥12 months to assess survival, safety, and healthcare resource utilization; analyses are descriptive. RESULTS: The study included 160 patients from 37 centers (median age, 70 years; 77% male). Avelumab 1LM was initiated at a median of 4 weeks (IQR 3-6) after PBC completion. Median follow-up from avelumab 1LM was 16 months (IQR 11-21). At study end, 19.4% of patients continued avelumab; 73.7% had discontinued due to progression, adverse events (AEs), or performance status deterioration. Median PFS and OS from avelumab initiation were 5.4 months (95% CI, 3.8-6.9) and 24.4 months (95% CI, 20.4-28.4), respectively. Grade ≥3 treatment-related AEs (TRAEs) occurred in 15 patients (9.4%); 35 (21.9%) had any-grade immune-related AEs, and 23 (14.3%) received high-dose systemic corticosteroids for AEs. Forty-four patients (27.5%) were hospitalized during the avelumab treatment period, of whom 13 (8.1%) were hospitalized due to TRAEs. Limitations of...