Durvalumab in Advanced Biliary Tract Cancer: Real‐World Data From a Large Cohort of Patients Across Multiple International Centers

作者：Margherita Rimini, Lorenzo Fornaro, Masafumi Ikeda, Oluseyi Abidoye, Jessica Lucchetti, Lorenzo Antonuzzo, Jin Won Kim, Federico Nichetti, Anna Saborowski, Tiziana Pressiani, Caterina Vivaldi, Ilario Giovanni Rapposelli, Frederik Peeters, Chiara Braconi, David J. Pinato, Emiliano Tamburini, Chiara Pircher, Stefano Tamberi, Florian Castet, Monica Verrico, Alessandro Parisi, Nuno Couto, Hong Jae Chon, A. Martirena, Ángela Lamarca, Matteo Landriscina, Fabian Fimkelmeier, Ester Oneda, Antonio Avallone, Emanuela Dell’Aquila, Lukas Perkhofer, Il Hwan Kim, C. Pinto, Ingrid Garajová, Beodeul KANG, Salvatore Corallo, Elisabetta Fenocchio, Giovanni Farinea, Alessandro Pastorino, Anna Diana, Changhoon Yoo, Marta Schirripa, Maria Grazia Rodriquenz, Mario Scartozzi, Lucrezia Zumstein, Michele Ghidini, Gerald W. Prager, Giuseppe Aprile, Gian Paolo Spinelli, Su Yung‐Yeh, Stephen L. Chan, Emily Warmington, Alessia Lancianese, Tanios Bekaii‐Saab, Daniele Lavacchi, Min-Su Kang, Sara Lonardi, Arndt Vogel, Alessandra Anna Prete, Silvia Bozzarelli, Francesca Salani, Mara Persano, Gianluca Masi, Rita Balsano, Monica Niger, Silvia Camera, Laura Passeri, Michele Ferrara, Tomoyuki Satake, Lorenza Rimassa, Andrea Casadei‐Gardini · 发表于：Liver International · 年份：2025 · DOI：10.1111/liv.70428 · 被引用次数：10 · 研究领域：Cholangiocarcinoma and Gallbladder Cancer Studies、Gallbladder and Bile Duct Disorders、Pancreatic and Hepatic Oncology Research

BACKGROUND: We recently published the first real-world multicenter and multi-institutional study of cisplatin, gemcitabine, and durvalumab in patients with advanced biliary tract cancer (BTC). Here we present an expanded patient cohort with an increased sample size and longer median follow-up. METHODS: The study population included patients with advanced BTC, who received cisplatin/gemcitabine plus durvalumab at 55 centers across 12 countries in Europe, the United States, and Asia. The primary endpoints of the study were progression-free survival (PFS) and overall survival (OS). Secondary endpoints were overall response rate (ORR) and safety. RESULTS: Overall, 1358 patients were enrolled. Median PFS was 7.6 months (95% CI: 7.2-8.1), and median OS was 15.6 months (95% CI: 14.8-16.5). ORR was 35.6%, and DCR was 82.7%. Any grade AEs occurred in 1213 patients (89.3%). Grade 3-4 AEs occurred in 597 patients (43.2%). The rate of immune-related AEs (irAE) was 20.3%. Grade 3-4 irAE occurred in 3.0% of patients. At the multivariate analysis for OS, normal albumin level (HR 0.68, 95% CI 0.57-0.81, p < 0.0001), CEA levels within normal ranges (HR 0.68, 95% CI 0.57-0.82, p < 0.0001), NLR < 3 (HR 0.62, 95% CI 0.52-0.74, p < 0.0001), ECOG PS 0 (HR 0.51, 95% CI 0.42-0.61, p < 0.0001), and prior surgery (HR 0.80, 95% CI 0.65-0.99, p = 0.036) were positive prognostic factors. CONCLUSION: The updated findings, derived from an expanded cohort, further support the adoption of durvalumab in combi...