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. 2022 Mar 5:14:983-993.
doi: 10.2147/CMAR.S346235. eCollection 2022.

Development and Multicentre Validation of the Modena Score to Predict Survival in Advanced Biliary Cancers Undergoing Second-Line Chemotherapy

Massimiliano Salati  1   2 , Luigi Marcheselli  1 , Carlo Messina  3 , Valeria Merz  3   4 , Marco Messina  5 , Pietro Carotenuto  6 , Francesco Caputo  1 , Fabio Gelsomino  1 , Andrea Spallanzani  1 , Luca Reggiani Bonetti  7 , Stefania Caramaschi  7 , Gabriele Luppi  1 , Massimo Dominici  1 , Michele Ghidini  8
Affiliations

Development and Multicentre Validation of the Modena Score to Predict Survival in Advanced Biliary Cancers Undergoing Second-Line Chemotherapy

Massimiliano Salati et al. Cancer Manag Res. .

Abstract

Background: The role of second-line chemotherapy in advanced biliary cancers (ABCs) has only recently been established in phase III randomized trial and the optimal selection of patients most likely to benefit from it remains challenging.

Methods: A cohort of 98 ABC treated second-line chemotherapy was used as a developmental dataset to identify covariates independently associated with overall survival (OS). Kaplan-Meier analysis was used to investigate the association between variables and OS and those retaining statistically significance were combined in a multiplexed score.

Results: The following pretreatment variables were independently associated with OS: ECOG PS > 0, peritoneal disease, LDH > 430 UI/L, albumin <3.5 gr/dL, gamma-GT >100 UI/L, sodium <140 mEq/L, absolute lymphocyte count <1000/mmc, and PFS to first-line <6 months. Based on these results, a scoring system was developed that identified three subgroups with statistically different OS: low-risk (mOS 18 months), intermediate-risk (mOS 9.4 months) and high-risk (mOS 2.9 months) (p < 0.001). The prognostic model was both internally and externally validated in a multicentre cohort of 120 ABCs.

Conclusion: The Modena score is a multiplexed scoring system capable of accurately risk-stratified ABCs treated with second-line chemotherapy. Based on its reproducibility, usability and generalizability, it has the potential for assisting therapeutic decision-making in the clinic and risk-stratification in future trials.

Keywords: biliary tract cancer; chemotherapy; prognostic score; second-line; survival.

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Conflict of interest statement

Dr Luigi Marcheselli reports scientific consultant for Sandoz Spa during Jan 2021–Sep 2022, free of fee. Dr Fabio Gelsomino reports personal fees from Servier, Iqvia, Eli Lilly, Merck Serono, and Amgen, outside the submitted work. The authors report no other conflicts of interest in this work.

Figures

None
Graphical abstract
Figure 1
Figure 1
Overall survival by risk groups in the training cohort (n=98). Kaplan–Meier curves of overall survival (OS) according to the Modena score in the training cohort. The prognostic score assigned patients to three risk groups with statistically different OS: low-risk (n=27; mOS 18 months), intermediate-risk (n=35; mOS 9.4 months) and high-risk (n=27; mOS 2.9 months) (p<0.001).
Figure 2
Figure 2
Nomogram for overall survival of biliary cancers treated with second-line chemotherapy. Using and interpreting the nomogram. Each variable incorporated in the Modena score has been listed separately together with the corresponding number of points reflecting its magnitude. For each variable, draw an upward vertical line to the “Points” bar to calculate points, then sum the points for each variable and locate this sum on the “Total Points” axis. Draw a downward vertical line from the “Total Points” line to calculate 6-month and 12-month overall survival probability.
Figure 3
Figure 3
Overall survival by risk groups in the validation cohort (n=120). Kaplan–Meier curves of overall survival (OS) according to the Modena score in the validation cohort. The prognostic score assigned patients to three risk groups with statistically different OS: low-risk (n=22; mOS 12.8 months), intermediate-risk (n=43; mOS 6.4 months) and high-risk (n=55; mOS 2.5 months) (p<0.001).
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