A prognostic model in patients with advanced biliary tract cancer receiving first-line chemotherapy

Roberto Filippi; Francesco Montagnani; Pasquale Lombardi; Lorenzo Fornaro; Giuseppe Aprile; Andrea Casadei-Gardini; Luca Faloppi; Andrea Palloni; Maria Antonietta Satolli; Mario Scartozzi; Fabrizio Citarella; Stefania Eufemia Lutrino; Caterina Vivaldi; Nicola Silvestris; Giulia Rovesti; Margherita Rimini; Massimo Aglietta; Giovanni Brandi; Francesco Leone

doi:10.1080/0284186X.2021.1953704

A prognostic model in patients with advanced biliary tract cancer receiving first-line chemotherapy

Acta Oncol. 2021 Oct;60(10):1317-1324. doi: 10.1080/0284186X.2021.1953704. Epub 2021 Jul 20.

Authors

Roberto Filippi^{1

2

3}, Francesco Montagnani⁴, Pasquale Lombardi^{1

2}, Lorenzo Fornaro⁵, Giuseppe Aprile^{6

7}, Andrea Casadei-Gardini^{8

9}, Luca Faloppi¹⁰, Andrea Palloni¹¹, Maria Antonietta Satolli^{1

3}, Mario Scartozzi¹², Fabrizio Citarella¹³, Stefania Eufemia Lutrino¹⁴, Caterina Vivaldi^{5

15}, Nicola Silvestris^{16

17}, Giulia Rovesti⁹, Margherita Rimini⁹, Massimo Aglietta^{1

2}, Giovanni Brandi¹¹, Francesco Leone⁴

Affiliations

¹ Department of Oncology, University of Turin, Torino, Italy.
² Division of Medical Oncology, Candiolo Cancer Institute, FPO-IRCCS, Candiolo, Italy.
³ Centro Oncologico Ematologico Subalpino, Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino, Torino, Italy.
⁴ Division of Medical Oncology, ASL BI, Nuovo Ospedale degli Infermi, Ponderano, Italy.
⁵ Unit of Medical Oncology 2, Azienda Ospedaliero-Universitaria Pisana, Pisa, Italy.
⁶ Department of Oncology, University Hospital of Udine, Udine, Italy.
⁷ Department of Oncology, San Bortolo General Hospital, AULSS8, Vicenza, Italy.
⁸ Department of Medical Oncology, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola, Italy.
⁹ Department of Oncology and Haematology, University Hospital of Modena, Italy.
¹⁰ Medical Oncology Unit, Macerata General Hospital, Macerata, Italy.
¹¹ Department of Experimental, Diagnostic and Specialty Medicine, University Hospital S. Orsola-Malpighi, Bologna, Italy.
¹² Department of Medical Oncology, University Hospital, Cagliari, Italy.
¹³ Department of Medical Oncology, Campus Bio-Medico University, Roma, Italy.
¹⁴ Department of Oncology, Ospedale Vito Fazzi, Lecce, Italy.
¹⁵ Department of Translational Research and New Technologies in Medicine and Surgery, University of Pisa, Italy.
¹⁶ Medical Oncology Unit, IRCCS Cancer Institute "Giovanni Paolo II", Bari, Italy.
¹⁷ Department of Biomedical Sciences and Human Oncology (DIMO), University of Bari, Italy.

PMID: 34282710
DOI: 10.1080/0284186X.2021.1953704

Abstract

Background: Standard treatment of advanced biliary tract cancer (aBTC) is represented by first-line chemotherapy (CT1). However, some patients do not gain any benefit from CT1, contributing to the overall dismal prognosis of aBTC. The present study aimed to devise a prognostic model in aBTC patients receiving CT1.

Methods: A large panel of clinical, laboratory, and pathology variables, available before the start of CT1, were retrospectively assessed in a multi-centric cohort to determine their prognostic value on univariate and multivariate regression analysis. The variables that showed a significant correlation with overall survival (OS) were computed in a three-tier prognostic score. External validation of the prognostication performance was carried out.

Results: Clinical histories of 935 patients (median OS 10.3 months), with diagnosis dates ranging from 2001 to 2017, were retrieved from 14 institutions. According to multivariate analysis, Eastern Cooperative Oncology Group performance status, carbohydrate antigen 19.9, albumin levels, and neutrophil/lymphocyte ratio were strongly associated with OS (p <0.01). The prognostic score could generate a highly significant stratification (all between-group p values ≤0.001) into groups of favorable (comprising 51.5% of the sample), intermediate (39.2%), and poor prognosis (9.3%): median OS was 12.7 (CI_95% 11.0-14.4), 7.1 (CI_95% 5.8-8.4), and 3.2 months (CI_95% 1.7-4.7), respectively. This OS gradient was replicated in the validation set (129 patients), with median OS of 12.7 (CI_95% 11.0-14.3), 7.5 (CI_95% 6.1-8.9), and 1.4 months (CI_95% 0.1-2.7), respectively (all between-group p values ≤0.05).

Conclusion: A prognostic score, derived from a limited set of easily-retrievable variables, efficiently stratified a large population of unselected aBTC patients undergoing CT1. This tool could be useful to clinicians, to ascertain the potential benefit from CT1 at the start of treatment.

Keywords: Advanced biliary tract neoplasms; cholangiocarcinoma; gallbladder neoplasms; prognostic factors; prognostic score.

MeSH terms

Antineoplastic Combined Chemotherapy Protocols
Bile Duct Neoplasms*
Biliary Tract Neoplasms* / drug therapy
Humans
Lymphocytes
Prognosis
Retrospective Studies