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