Margherita Rimini, Lorenzo Fornaro, Sara Lonardi, Monica Niger, Daniele Lavacchi, Tiziana Pressiani, Jessica Lucchetti, Guido Giordano, Andrea Pretta, Emiliano Tamburini, Chiara Pirrone, Ilario Giovanni Rapposelli, Anna Diana, Erika Martinelli, Ingrid Garajová, Francesca Simionato, Marta Schirripa, Vincenzo Formica, Caterina Vivaldi, Enrico Caliman, Mario Domenico Rizzato, 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‐Gardini

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

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

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