Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2025 Aug 14:1-26.
doi: 10.1159/000546856. Online ahead of print.

Impact of antibiotic therapy in patients with cholangiocarcinoma treated with chemoimmunotherapy

Francesco Vitiello, Caterina Vivaldi, Mario Domenico Rizzato, Anna Saborowski, Lorenzo Antonuzzo, Federico Rossari, Francesca Salani, Jin Won Kim, Ilario Giovanni Rapposelli, Emiliano Tamburini, Margherita Rimini, Federica Lo Prinzi, Tomoyuki Satake, Frederik Peeters, Tiziana Pressiani, Jessica Lucchetti, Oluseyi Abidoye, Chiara Gallio, Stefano Tamberi, Fabian Finkelmeier, Guido Giordano, Chiara Pircher, Hong Jae Chon, Chiara Braconi, Aitzaz Qaisar, Alessandro Pastorino, Florian Castet, Changhoon Yoo, Mario Scartozzi, Gerald W Prager, Antonio Avallone, Marta Schirripa, Il Hwan Kim, Lukas Perkhofer, Ester Oneda, Monica Verrico, Alessandro Parisi, Anna Diana, Nuno Couto, Stephen Lam Chan, Ingrid Garajova, Ricardo Roque, Masafumi Ikeda, Monica Niger, Giuseppe Tonini, Vera Himmelsbach, Matteo Landriscina, Gianluca Masi, Arndt Vogel, Sara Lonardi, Lorenzo Fornaro, Lorenza Rimassa, Andrea Casadei-Gardini, Jorge Adeva, Gian Paolo Spinelli, Nicola Personeni, Maria Grazia Rodriguez, Silvana Leo, Cecilia Melo Alvim, Giovanni Farinea, Virginia Genovesi, Antonio De Rosa, Daniele Lavacchi, Silvia Camera, Jeroen Dekervel, Rita Balsano, Minsu Kang, Giulia Tesini, Luca Esposito, Alessandro Boccancino, Selma Ahcene Djaballah, Tanios Bekaii-Saab

Impact of antibiotic therapy in patients with cholangiocarcinoma treated with chemoimmunotherapy

Francesco Vitiello et al. Oncology. .

Abstract

Background: Patients with biliary tract cancers (BTC) often require antibiotic therapy before starting systemic treatment that includes an immune checkpoint inhibitor. This study aims to evaluate the prognostic impact of antibiotic therapy administered in the 15 days prior to the start of chemoimmunotherapy in patients with BTC.

Material and methods: The study population included patients with metastatic or locally advanced BTC from western and eastern populations treated with first-line chemoimmunotherapy. The aim of the study is to evaluate the impact of antibiotic therapy in the 15 days prior to starting oncological treatment (AT population) compared to patients who did not receive antibiotic therapy (NAT). Univariate and multivariate analyses were used to evaluate predictive factors for overall survival (OS) and progression free survival (PFS) while prognostic factors were analyzed by univariate and multivariate analysis using Cox regression model.

Results: 666 patients were enrolled in the study: 93 (14%) in AT cohort and 573 (86%) in NAT cohort. In the AT population, the incidence of cholangitis (p = 0.0017), ALT elevation (p = 0.0009), fever (p = 0.0021), decreased appetite (p = 0.0007), itching (p = 0.0081), and rash (p = 0.012) was significantly higher compared to the NAT. The median OS was 15.9 months (95% CI 13.8 - 18.3) in NAT cohort vs 10.1 months (95% CI 7.9 - 12.4) in AT cohort (NAT vs AT, HR 0.43,95% CI 0.27 - 0.70-15.6 p=0.0006) while median PFS was 8.5 months in NAT cohort vs 5.4 months in AT cohort (NAT vs AT, HR 0.49 ,95% CI 0.34 - 0.71 p=0.0001). Multivariate analysis confirmed the prognostic role of antibiotic for OS and PFS. Finally, NAT cohort showed better overall response rate compared with AT cohort (31.4% vs 20.4 %, p=0.03).

Conclusions: The use of antibiotic therapy in the 15 days prior to starting chemoimmunotherapy is an independent unfavorable prognostic factor for survival in our cohort of patients with advanced BTC treated with cisplatin, gemcitabine and durvalumab.

PubMed Disclaimer

LinkOut - more resources