Durvalumab plus gemcitabine and cisplatin in advanced biliary tract cancer: An early exploratory analysis of real‐world data

• DOI: 10.1111/liv.15641
• Publication Date: 2023-07-15T05:56:55Z
• Authors: Margherita Rimini; Lorenzo Fornaro; Sara Lonardi; Monica Niger; Daniele Lavacchi; Tiziana Pressiani; Jessica Lucchetti; Guido Giordano; Andrea Pretta; Emiliano Tamburini; Chiara Pirrone; Ilario Giovanni R...; Anna Diana; Erika Martinelli; Ingrid Garajová; Francesca Simionato; Marta Schirripa; Vincenzo Formica; Caterina Vivaldi; Enrico Caliman; Mario Domenico Ri...; Valentina Zanuso; Federico Nichetti; Lorenzo Angotti; Matteo Landriscina; Mario Scartozzi; Matteo Ramundo; Alessandro Pastorino; Bruno Daniele; Noemi Cornara; Mara Persano; Eleonora Gusmaroli; Riccardo Cerantola; Francesca Salani; Francesca Ratti; Luca Aldrighetti; Stefano Cascinu; Lorenza Rimassa; Lorenzo Antonuzzo; Andrea Casadei‐Ga...
• Keywords: Durvalumab; Biliary Tract Cancer; Real world data

Abstract Background The TOPAZ‐1 phase III trial reported a survival benefit with the anti‐programmed death cell ligand 1 (anti‐PD‐L1) durvalumab in combination gemcitabine and cisplatin patients advanced biliary tract cancer. present study investigated efficacy safety of this new standard treatment real‐world setting. Methods analysed population included unresectable, locally or metastatic adenocarcinoma treated at 17 Italian centres. primary endpoint was progression‐free (PFS), whereas secondary endpoints overall (OS), response rate (ORR) safety. Unadjusted adjusted hazard ratios (HRs) by baseline characteristics were calculated using Cox proportional hazards model. Results From February 2022 to November 2022, 145 enrolled. After median follow‐up 8.5 months (95% CI: 7.9–13.6), PFS 8.9 7.4–11.7). Median OS 12.9 10.9–12.9). investigator‐assessed confirmed ORR 34.5%, disease control 87.6%. Any grade adverse events (AEs) occurred 137 (94.5%). Grades 3–4 AEs 51 (35.2%). immune‐mediated (imAEs) 22.7%. imAEs 2.1% patients. In univariate analysis, non‐viral aetiology, ECOG PS >0 NLR ≥3 correlated shorter PFS. Conclusion results first analysis mostly achieved terms PFS,