Prognostic stratification of patients with biliary tract cancer treated with chemoimmunotherapy: A retrospective multicenter real-world study.
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Persano Mara, Casadei-Gardini Andrea, Fornaro Lorenzo, Satake Tomoyuki, Abidoye Oluseyi, Lo Prinzi Federica, Antonuzzo Lorenzo, Kim Jin Won, Bergamo Francesca, Bathon Melanie, Saborowski Anna, Pressiani Tiziana, Vivaldi Caterina, Rapposelli Ilario Giovanni, Peeters Frederik, Braconi Chiara, Pinato David J, Tamburini Emiliano, Niger Monica, Tamberi Stefano, Castet Florian, Verrico Monica, Parisi Alessandro, Couto Nuno, Chon Hong Jae, Lamarca Angela, Giordano Guido, Finkelmeier Fabian, Oneda Ester, Avallone Antonio, Perkhofer Lukas, Kim Il Hwan, Garajova Ingrid, Corallo Salvatore, Fenocchio Elisabetta, Dell'Aquila Emanuela, Pirrone Chiara, Lucidi Lorenzo, Tesini Giulia, Valenzi Elena, Diana Anna, Yoo Changhoon, Schirripa Marta, Formica Vincenzo, Rodriquenz Maria Grazia, Scartozzi Mario, Adeva Jorge, Ghidini Michele, Prager Gerald W, Aprile Giuseppe, Spinelli Gian Paolo, Yung-Yeh Su, Chan Stephen L, Ikeda Masafumi, Bekaii-Saab Tanios, Lucchetti Jessica, Lavacchi Daniele, Kang Minsu, Balsano Rita, Salani Francesca, Camera Silvia, Masi Gianluca, Lonardi Sara, Vogel Arndt, Rimassa Lorenza, Rimini Margherita
Аннотация
METHODS: This is a retrospective, multicenter, real-world study including 712 patients in the training cohort and 646 patients in the validation cohort. Using multivariate analysis for overall survival (OS) and applying the adjustment methods of Holm-Bonferroni, Benjamini-Hochberg, and Hommel, the authors identified five baseline statistically significant variables: disease stage, neutrophils, carcinoembryonic antigen (CEA), and carbohydrate antigen 19-9 (CA 19-9) levels, and Eastern Cooperative Oncology Group performance status (ECOG PS). According to the HR of each variable, β coefficients were calculated and the following formula was applied: (0.1757 * neutrophils value) + (0.5055 * ECOG PS) + (1.4037 * disease stage) + (0.1108 * CA 19-9) + (0.2126 * CEA). According to tertiles, the authors developed a prognostic model called the SENECA index, dividing the population into three risk groups: low-risk (≤2.14), intermediate-risk (2.15-2.89), and high-risk (>2.89).
RESULTS: Median OS was 23.4 months in low-risk group,16.1 months in intermediate-risk group, and 8.3 months in high-risk group (low-risk hazard ratio [HR], 0.20; intermediate-risk HR, 0.36; high-risk HR, 1; p < .0001). Median progression-free survival was 11.0 months in low-risk group (33.1%), 8.8 months in intermediate-risk group (33.3%), and 5.5 months in high-risk group (33.5%) (low-risk HR, 0.35; intermediate-risk HR, 0.55; and high-risk HR, 1; p < .0001).
CONCLUSIONS: The SENECA index is a practical instrument for prognostic stratification of patients with BTC receiving chemoimmunotherapy.