Oncotarget

Research Papers:

Immune-mediated adverse events following atezolizumab and bevacizumab in a multinational Latin American cohort of unresectable hepatocellular carcinoma

Leonardo Gomes da Fonseca, Federico Piñero _, Margarita Anders, Carla Bermudez, Ezequiel Demirdjian, Adriana Varón, Daniela Perez, Jorge Rodriguez, Oscar Beltrán, Ezequiel Ridruejo, Pablo Caballini, Alexandre Araujo, Juan Diego Torres Florez, Juan Ignacio Marín, Marina Villa, Federico Orozco, Jaime Poniachik, Sebastián Marciano, Fernando Bessone and Manuel Mendizabal

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Oncotarget. 2025; 16:348-360. https://doi.org/10.18632/oncotarget.28721

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Abstract

Leonardo Gomes da Fonseca1,*, Federico Piñero2,*, Margarita Anders3, Carla Bermudez4, Ezequiel Demirdjian5, Adriana Varón6, Daniela Perez7, Jorge Rodriguez8, Oscar Beltrán6, Ezequiel Ridruejo10, Pablo Caballini11, Alexandre Araujo12, Juan Diego Torres Florez13, Juan Ignacio Marín14, Marina Villa15, Federico Orozco3, Jaime Poniachik9, Sebastián Marciano4, Fernando Bessone11 and Manuel Mendizabal2

1 Instituto do Cancer do Estado de São Paulo, Hospital das Clínicas, Universidade São Paulo, Brazil

2 Hepatology and Liver Transplant Unit, Hospital Universitario Austral, Argentina

3 Department of Hepatology, Hospital Alemán, Argentina

4 Department of Hepatology and Liver Transplantation, Hospital Italiano de Buenos Aires, Argentina

5 Department of Liver Transplantation, Sanatorio Sagrado Corazón, Argentina

6 Department of Hepatology, Fundación Cardioinfantil, Colombia

7 Department of Gastroenterology, Hospital Padilla, Tucumán, Argentina

8 Department of Liver Transplantation, Hospital Central de Mendoza, Argentina

9 Department of Gastroenterology, Hospital Clínico de la Universidad de Chile, Chile

10 Department of Hepatology, Centro de Educación Médica e Investigaciones Clínicas (CEMIC), Argentina

11 Department of Gastroenterology, Hospital Centenario de Rosario, Santa Fe, Argentina

12 Department of Gastroenterology, Hospital das Clínicas de Porto Alegre, Universidade Federal do Rio Grande do Sul, Brazil

13 Department of Gastroenterology, Hospital Universitario Fundación Santa Fe de Bogotá, Colombia

14 Department of Hepatology and Liver Transplantation, Hospital Pablo Tobón Uribe, Medellín, Colombia

15 Department of Internal Medicine, Hospital Comarcal de Blanes, Córdoba, Argentina

* Co-first authorship

Correspondence to:

Federico Piñero, email: [email protected]

Keywords: liver cancer; immunotherapy; adverse events; immunology; real-world

Received: January 14, 2025     Accepted: April 28, 2025     Published: May 19, 2025

Copyright: © 2025 da Fonseca et al. This is an open access article distributed under the terms of the Creative Commons Attribution License (CC BY 4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

ABSTRACT

Aims: Latin America has been underrepresented in trials evaluating immunotherapy for hepatocellular carcinoma (HCC). We aimed to describe the incidence of immune-related adverse events (irAEs) and their impact on outcomes in a Latin American cohort.

Methods: A multicenter prospective study was conducted in Argentina, Brazil, Chile, and Colombia, including patients who received atezolizumab plus bevacizumab. A time-covarite proportional hazard analysis evaluated the effect of irAEs.

Results: 99 patients were included. The median treatment duration was 6 months, with a median survival of 17.0 months (95% CI: 12.6–19.8). The irAE incidence rate was 2.1 cases per 100 persons-months (cumulative incidence 18.1% (95% CI: 11.1–27.2%)). Median time to irAE was 2.3 months (range 1.4–4.8), most frequently hepatitis (n = 6), thyroiditis (n = 5), and 8/18 required steroids. Follow-up, treatment duration, and overall survival were similar regardless of the occurrence of irAEs (HR = 1.71, 95% CI: 0.76–3.86; P = 0.19). Baseline alpha-feto protein ≥400 ng/ml (HR: 2.9 (95% CI: 1.1–7.6)) was independently associated with irAE.

Conclusion: The incidence of irAEs in this cohort is lower than reported in controlled trials, withouut impact on survival outcomes. Education and early recognition are crucial to ensure that these events are identified and addressed.


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