Impact of Antibiotic Therapy in Patients with Cholangiocarcinoma Treated with Chemoimmunotherapy
Year: 2025
Type: article
Study design: Observational Study
Abstract: INTRODUCTION: Patients with biliary tract cancers (BTCs) often require antibiotic therapy before starting systemic treatment that includes an immune checkpoint inhibitor. This study aimed to evaluate the prognostic impact of antibiotic therapy administered in the 15 days prior to the start of chemoimmunotherapy in patients with BTC. 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 was 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: A total of 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), alanine aminotransferase 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% confidence interval [CI]: 13.8-18.3) in NAT cohort versus 10.1 months (95% CI: 7.9-12.4) in AT cohort (NAT vs. AT, hazard ratio [HR]: 0.43, 95% CI: 0.27-0.70, p = 0.0006), while median PFS was 8.5 months in NAT cohort versus 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.
Source: Oncology
DOI: 10.1159/000546856
Authors: Francesco Vitiello, Caterina Vivaldi, Margherita Rimini, Federica Lo Prinzi, Mario Domenico Rizzato, Anna Saborowski, Lorenzo Antonuzzo, Federico Rossari, Tomoyuki Satake, Frederik Peeters, Francesca Salani, Tiziana Pressiani, Jessica Lucchetti, Jin Won Kim, Oluseyi Abidoye, Ilario Giovanni Rapposelli, Chiara Gallio, Stefano Tamberi, Fabian Finkelmeier, Guido Giordano, Chiara Pircher, Hong Jae Chon, Chiara Braconi, Aitzaz Qaisar, Alessandro Pastorino, Florian Castet, Emiliano Tamburini, Changhoon Yoo, Alessandro Parisi, Anna Diana, Mario Scartozzi, Gerald W. Prager, Antonio Avallone, Marta Schirripa, Il Hwan Kim, Lukas Perkhofer, Ester Oneda, Monica Verrico, Nuno Couto, Jorge Adeva, Stephen Lam Chan, Gian Paolo Spinelli, Nicola Personeni, Ingrid Garajova, Maria Grazia Rodriguez, Silvana Leo, Cecilia Melo Alvim, Ricardo Roque, Giovanni Farinea, Virginia Genovesi, Antonio De Rosa, Daniele Lavacchi, Silvia Camera, Masafumi Ikeda, Jeroen Dekervel, Monica Niger, Rita Balsano, Giuseppe Tonini, Minsu Kang, Giulia Tesini, Luca Esposito, Alessandro Boccancino, Vera Himmelsbach, Matteo Landriscina, Selma Ahcene Djaballah, Tanios Bekaii-Saab, Gianluca Masi, Arndt Vogel, Sara Lonardi, Lorenzo Fornaro, Lorenza Rimassa, Andrea Casadei-Gardini
Institutions: Vita-Salute San Raffaele University, IRCCS Ospedale San Raffaele, Azienda Ospedaliera Universitaria Pisana, Campus Bio Medico University Hospital, Istituto Oncologico Veneto, Medizinische Hochschule Hannover, Azienda Ospedaliero-Universitaria Careggi, University of Florence, National Cancer Center Hospital East, Universitair Ziekenhuis Leuven, University of Pisa, IRCCS Humanitas Research Hospital, Seoul National University Bundang Hospital, Mayo Clinic, Mayo Clinic Hospital, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Ospedale "Santa Maria delle Croci" di Ravenna, University Hospital Frankfurt, University of Foggia, Ospedali Riuniti di Foggia, Fondazione IRCCS Istituto Nazionale dei Tumori, CHA University Bundang Medical Center, CHA University, Beatson West of Scotland Cancer Centre, University of Glasgow, Ospedale Policlinico San Martino, Vall d'Hebron Hospital Universitari, Vall d'Hebron Institute of Oncology, Pia Fondazione di Culto e Religione Azienda Ospedaliera "Card. G. Panico", University of Ulsan, Marche Polytechnic University, Azienda Ospedaliero-Universitaria delle Marche, Regione Campania, University of Cagliari, Medical University of Vienna, Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale", Ospedale di Belcolle, Inje University, Inje University Haeundae Paik Hospital, Inje University Busan Paik Hospital, Universität Ulm, University Hospital Ulm, Fondazione Poliambulanza Istituto Ospedaliero, Policlinico Umberto I, Sapienza University of Rome, Centro Champalimaud, University of Turin, Chinese University of Hong Kong, Prince of Wales Hospital, Azienda Socio Sanitaria Territoriale del Garda, Casa Sollievo della Sofferenza, Ospedale Vito Fazzi, Centro Hospitalar Lisboa Norte, Hospital de Santa Maria, Instituto Português de Oncologia de Coimbra Francisco Gentil, University of Padua, Humanitas University, Università Campus Bio-Medico, Princess Margaret Cancer Centre, Occupational Cancer Research Centre
Language: English
Subfield: Surgery
Field: Medicine
Domain: Health Sciences
Open Access status: green
OpenAlex ID: W4413139401