Avelumab first-line maintenance for advanced urothelial carcinoma: long-term outcomes from the JAVELIN Bladder 100 trial in older patients

作者：Shilpa Gupta, Miguel Á. Climent Durán, S.S. Sridhar, T. Powles, J. Bellmunt, S.H. Park, Howard Gurney, Norihiko Tsuchiya, Daniel P. Petrylak, Yoshihiko Tomita, A. di Pietro, Juliane Manitz, Karin Tyroller, Justin Hoffman, N. Jacob, P. Grivas · 发表于：ESMO Open · 年份：2025 · DOI：10.1016/j.esmoop.2025.104506 · 被引用次数：11 · 研究领域：Bladder and Urothelial Cancer Treatments、Esophageal Cancer Research and Treatment、Ferroptosis and cancer prognosis

BACKGROUND: In the JAVELIN Bladder 100 phase III trial, avelumab first-line (1L) maintenance plus best supportive care (BSC) significantly prolonged overall survival (OS) versus BSC alone in patients with locally advanced or metastatic urothelial carcinoma (la/mUC) without progression following platinum-based chemotherapy. Older age (≥65 years) is a known risk factor for bladder cancer with a median age at diagnosis of 73.0 years. We report exploratory analyses in subgroups based on older age (≥65 years). MATERIALS AND METHODS: Eligible patients with la/mUC without progression after 1L platinum-based chemotherapy were randomized to receive avelumab plus BSC (n = 350) or BSC alone (n = 350). This exploratory analysis included subgroups aged ≥65 years, ≥65-<75 years, ≥75 years, and the subset aged ≥80 years. OS (primary endpoint) and progression-free survival (PFS) from randomization were analyzed using the Kaplan-Meier method. RESULTS: Of 700 patients, 464 (66.3%) were aged ≥65 years. Median OS with avelumab plus BSC versus BSC alone was 26.1 versus 15.5 months (hazard ratio 0.70, 95% confidence interval 0.56-0.89) in all patients aged ≥65 years and 28.7 versus 17.1, 24.0 versus 13.5, and 24.9 versus 10.0 months, respectively, in patients aged ≥65-<75, ≥75, and ≥80 years. PFS analyses favored avelumab plus BSC versus BSC alone in all subgroups. No new safety concerns were identified in patients aged ≥65 years, including those treated for ≥12 months. Quality-adjusted time witho...