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

ABSTRACT Background 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. 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.

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Journal
Cancer
Published
2026-09-15
DOI
https://doi.org/10.1002/cncr.70601
Primary Topic
Cholangiocarcinoma and Gallbladder Cancer Studies
Type
article
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article

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

Nuno Couto, Emanuela Dell’Aquila, David J. Pinato, Lorenzo Antonuzzo et al.
Cancer
Cholangiocarcinoma and Gallbladder Cancer Studies
article

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

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

Abstract

ABSTRACT Background 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. 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.

CancerVol. 132(18)
University of Foggia (IT), University of Pisa (IT), Champalimaud Foundation (PT), Goethe University Frankfurt (DE), University of Rome Tor Vergata (IT), Ulsan College (KR), Marche Polytechnic University (IT), Hebron University (PS), University of Parma (IT), Humanitas University (IT), Vita-Salute San Raffaele University (IT), University of Cagliari (IT), University of Pavia (IT), Casa Sollievo della Sofferenza (IT), Policlinico Umberto I (IT), Beatson West of Scotland Cancer Centre (GB), Asan Medical Center (KR), Hammersmith Hospital (GB), WinnMed (US), Princess Margaret Cancer Centre (CA), Seoul National University Bundang Hospital (KR), Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico (IT), Medizinische Hochschule Hannover (DE), University of Ulsan (KR), Ospedali Riuniti di Foggia (IT), Ospedale "Santa Maria delle Croci" di Ravenna (IT), Ospedale di Cattinara (IT), Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IT), Inje University Haeundae Paik Hospital (KR), Istituto Oncologico Veneto (IT), Prince of Wales Hospital (CN), Azienda Ospedaliero-Universitaria Careggi (IT), Hospital Universitario HM Madrid (ES), Vall d'Hebron Hospital Universitari (ES), Ospedale di Belcolle (IT), Hospital Universitario Fundación Jiménez Díaz (ES), University Hospital Frankfurt (DE), CHA University Bundang Medical Center (KR), Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale" (IT), Campus Bio Medico University Hospital (IT), National Cancer Center Hospital East (JP), Tumori Foundation (US), Ospedale Policlinico San Martino (IT), Mayo Clinic in Florida (US), Fondazione Poliambulanza Istituto Ospedaliero (IT), Candiolo Cancer Institute (IT), Policlinico San Matteo Fondazione (IT), Istituti di Ricovero e Cura a Carattere Scientifico (IT), University Hospital Ulm (DE), Fondazione IRCCS Istituto Nazionale dei Tumori (IT), National Cheng Kung University Hospital (TW), International Renal Research Institute of Vicenza (IT), IRCCS Humanitas Research Hospital (IT), Azienda Ospedaliera Universitaria Pisana (IT), University of Florence (IT), Imperial College London (GB), Medical University of Vienna (AT), Sapienza University of Rome (IT), University of Bologna (IT)
Openalex Percentile: Top 8%
Cholangiocarcinoma and Gallbladder Cancer Studies
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