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

杜瓦卢马布 医学 胆道癌 吉西他滨 内科学 顺铂 胆道 肿瘤科 真实世界数据 胰腺癌 胃肠病学 癌症 化疗 计算机科学 数据科学 无容量 免疫疗法
作者
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 Garajovà,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
出处
期刊:Liver International [Wiley]
卷期号:43 (8): 1803-1812 被引量:43
标识
DOI:10.1111/liv.15641
摘要

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 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. Methods The 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. Results From 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. Conclusion The 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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