Prognostic stratification of patients with biliary tract cancer treated with chemoimmunotherapy: A retrospective multicenter real-world study.
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.
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.
Authors
Persano Persano, Casadei-Gardini Casadei-Gardini, Fornaro Fornaro, Satake Satake, Abidoye Abidoye, Lo Prinzi Lo Prinzi, Antonuzzo Antonuzzo, Kim Kim, Bergamo Bergamo, Bathon Bathon, Saborowski Saborowski, Pressiani Pressiani, Vivaldi Vivaldi, Rapposelli Rapposelli, Peeters Peeters, Braconi Braconi, Pinato Pinato, Tamburini Tamburini, Niger Niger, Tamberi Tamberi, Castet Castet, Verrico Verrico, Parisi Parisi, Couto Couto, Chon Chon, Lamarca Lamarca, Giordano Giordano, Finkelmeier Finkelmeier, Oneda Oneda, Avallone Avallone, Perkhofer Perkhofer, Kim Kim, Garajova Garajova, Corallo Corallo, Fenocchio Fenocchio, Dell'Aquila Dell'Aquila, Pirrone Pirrone, Lucidi Lucidi, Tesini Tesini, Valenzi Valenzi, Diana Diana, Yoo Yoo, Schirripa Schirripa, Formica Formica, Rodriquenz Rodriquenz, Scartozzi Scartozzi, Adeva Adeva, Ghidini Ghidini, Prager Prager, Aprile Aprile, Spinelli Spinelli, Yung-Yeh Yung-Yeh, Chan Chan, Ikeda Ikeda, Bekaii-Saab Bekaii-Saab, Lucchetti Lucchetti, Lavacchi Lavacchi, Kang Kang, Balsano Balsano, Salani Salani, Camera Camera, Masi Masi, Lonardi Lonardi, Vogel Vogel, Rimassa Rimassa, Rimini Rimini
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