Prognostic stratification of patients with biliary tract cancer treated with chemoimmunotherapy: A retrospective multicenter real-world study.

Authors

Mara Persano, Andrea Casadei-Gardini, Lorenzo Fornaro, Tomoyuki Satake, Oluseyi Abidoye, Federica Lo Prinzi, Lorenzo Antonuzzo, Jin Won Kim, Francesca Bergamo, Melanie Bathon, Anna Saborowski, Tiziana Pressiani, Caterina Vivaldi, Ilario Giovanni Rapposelli, Frederik Peeters, Chiara Braconi, David J Pinato, Emiliano Tamburini, Monica Niger, Stefano Tamberi, Florian Castet, Monica Verrico, Alessandro Parisi, Nuno Couto, Hong Jae Chon, Angela Lamarca, Guido Giordano, Fabian Finkelmeier, Ester Oneda, Antonio Avallone, Lukas Perkhofer, Il Hwan Kim, Ingrid Garajova, Salvatore Corallo, Elisabetta Fenocchio, Emanuela Dell'Aquila, Chiara Pirrone, Lorenzo Lucidi, Giulia Tesini, Elena Valenzi, Anna Diana, Changhoon Yoo, Marta Schirripa, Vincenzo Formica, Maria Grazia Rodriquenz, Mario Scartozzi, Jorge Adeva, Michele Ghidini, Gerald W Prager, Giuseppe Aprile, Gian Paolo Spinelli, Su Yung-Yeh, Stephen L Chan, Masafumi Ikeda, Tanios Bekaii-Saab, Jessica Lucchetti, Daniele Lavacchi, Minsu Kang, Rita Balsano, Francesca Salani, Silvia Camera, Gianluca Masi, Sara Lonardi, Arndt Vogel, Lorenza Rimassa, Margherita Rimini

Published in

Cancer. Volume 132. Issue 18. Pages e70601. Sep 15, 2026.

Abstract

The objective of this study is to explore and validate a novel prognostic index for patients with locally advanced or metastatic biliary tract cancer (BTC) treated with first-line therapy with cisplatin, gemcitabine, and durvalumab.
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).
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).
The SENECA index is a practical instrument for prognostic stratification of patients with BTC receiving chemoimmunotherapy.

PMID:
42745498
Bibliographic data and abstract were imported from PubMed on 16 Sep 2026.

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