Outcomes of Avelumab Treatment in Advanced Urothelial Carcinoma According to Age, Performance Status, and Timing.

Abstract

Background/aim: The efficacy and safety of avelumab according to age, performance status (PS), and infusion timing in patients with advanced urothelial carcinoma (UC) are unclear.

Patients and methods: We retrospectively analyzed data from patients with advanced UC who received avelumab, without progression to first-line platinum-based chemotherapy. Efficacy and safety were evaluated according to age (<70, ≥70 to <80, and ≥80 years), PS (0 and ≥1), and infusion time of the first dose (early and late).

Results: Twenty-three patients were analyzed [age (<70 years, n=10; ≥70 to <80, n=8; ≥80, n=5; PS (PS0, n=20; PS≥1, n=3); timing (early, n=13; late, n=10)]. Rates of any-grade adverse events (AEs) and grade ≥2 AEs were not significantly influenced by age (p=0.748 and p=0.615, respectively), PS (p>0.999 and p=0.539), or timing (p=0.685 and p=0.618). The disease control rate was not significantly influenced by age (p=0.663), PS (p>0.178), or timing (p=0.417). Median progression-free survival (PFS) was not significantly influenced by age (p=0.979), PS (p=0.620), or timing (p=0.208). Median overall survival (OS) was not significantly influenced by age (p=0.354), PS (p=0.590), or timing (p=0.552). When patients were divided into two groups according to PFS ≥6 months, OS was significantly different between the PFS <6 months group and the ≥6 months group (p=0.016).

Conclusion: The efficacy and safety of avelumab maintenance therapy was not significantly influenced by age, PS, or infusion timing, and PFS ≥6 months could be a surrogate marker for OS.