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.
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.
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 this study include a small sample size, potential selection bias, and missing/unknown data.
These results align with the JAVELIN Bladder 100 clinical trial and other real-world studies, supporting avelumab 1LM use in patients with la/mUC without progression following 1L PBC.
Clinical genitourinary cancer. 2024 Oct 17 [Epub ahead of print]
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 P Sonpavde
University of Washington, Fred Hutchinson Cancer Center, Seattle, WA., University Hospitals Seidman Cancer Center, Cleveland, OH. Electronic address: ., Kaiser Permanente Southern California, Riverside, CA., Taussig Cancer Institute, Cleveland Clinic Foundation, Cleveland, OH., Texas Oncology, Dallas, TX., Weill Cornell Medicine, Hematology/Oncology, New York, NY., University Hospitals Seidman Cancer Center, Cleveland, OH., RTI Health Solutions, Research Triangle Park, NC., EPI-Q, Inc, Chicago, IL., EMD Serono, Rockland, MA., Pfizer, New York, NY., AdventHealth Cancer Institute, Orlando, FL.