Avelumab First-line Maintenance for Advanced Urothelial Carcinoma: Analysis from JAVELIN Bladder 100 by Duration of First-line Chemotherapy and Interval Before Maintenance

作者：Srikala S. Sridhar, Thomas Powles, Miguel Á. Climent Durán, Se Hoon Park, Francesco Massari, Antoine Thiery-Vuillemin, Begoña P. Valderrama, Anders Ullén, Norihiko Tsuchiya, Jeanny B. Aragon‐Ching, Shilpa Gupta, Daniel P. Petrylak, Joaquim Bellmunt, Jing Wang, Robert J Laliberte, Alessandra di Pietro, Nuno Costa, Petros Grivas, Cora N. Sternberg, Yohann Loriot · 发表于：European Urology · 年份：2023 · DOI：10.1016/j.eururo.2023.08.001 · 被引用次数：25 · 研究领域：Bladder and Urothelial Cancer Treatments、Renal cell carcinoma treatment、Esophageal Cancer Research and Treatment

BACKGROUND: In the JAVELIN Bladder 100 phase 3 trial, avelumab first-line maintenance + best supportive care (BSC) prolonged overall survival (OS) and progression-free survival (PFS) versus BSC alone in patients with advanced urothelial carcinoma (advanced UC) without progression after first-line platinum-based chemotherapy. OBJECTIVE: To report post hoc analyses of subgroups defined by the duration of first-line chemotherapy and interval before maintenance. DESIGN, SETTING, AND PARTICIPANTS: Patients with advanced UC without progression after four to six cycles of platinum-based chemotherapy and a 4-10-wk interval after chemotherapy (n = 700) were randomized to receive avelumab + BSC or BSC alone. Subgroups were defined by duration (quartile [Q]) and estimated number of cycles of chemotherapy, and interval between chemotherapy and maintenance. The median follow-up was >19 mo in both arms. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: OS (primary endpoint), PFS, and safety were assessed. RESULTS AND LIMITATIONS: Hazard ratios (95% confidence interval) for OS with avelumab + BSC versus BSC alone were as follows: by chemotherapy duration-<Q1: 0.65 (0.42-1.02), Q1-Q2: 0.79 (0.50-1.27), Q2-Q3: 0.74 (0.50-1.10), and >Q3: 0.63 (0.39-1.00); by number of cycles-four cycles: 0.69 (0.48-1.00), five cycles: 0.98 (0.57-1.71), and six cycles: 0.66 (0.47-0.92); and by interval-4-<6 wk: 0.75 (0.54-1.04), 6-<8 wk: 0.67 (0.43-1.06), and 8-10 wk: 0.69 (0.47-1.02). Results were similar for PFS...