P-53 IMMUNE-MEDIATED ADVERSE EVENTS FOLLOWING ATEZOLIZUMAB PLUS BEVACIZUMAB IS ASSOCIATED WITH DECREASED SURVIVAL IN PATIENTS WITH CIRRHOSIS

No Clinical trials evaluating the efficacy of first line systemic immune therapies for patients with advanced hepatocellular carcinoma (HCC) have recruited a lower proportion of patients with cirrhosis. In this group of patients, immune related adverse events (irAEs) may lead to decreased prognostic outcomes. The aim of this study was describe the incidence rate of irAEs and its impact on survival. A multicenter prospective Latin-American cohort study was conducted including HCC patients who received A+B since its regional approval, either as first or sub-sequent systemic lines, to March 15, 2024. Overall survival since A+B, and survival since date of irAE was compared between patients developing and not developing irAEs (date since A+B), through Cox proportional hazard analysis (Harrell's c-index). Overall, 99 patients treated with A+B were included (n=8 received it as second line post sorafenib), 82.3% presented cirrhosis. The median treatment duration was 6 months [number of cycles 5 (range 3-11.5)], with a median overall survival of 17.0 months (range 12.6-19.8). Over a median follow-up of 7.7 months (range 4.5-17.2), the irAE incidence rate was 2.1 cases per 100 persons-months [cumulative incidence 18.1% (95% CI 11.1-27.2%); n=18]. 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 (Table). Follow-up and treatment duration times were similar regardless irAEs occurrence. On multivariable Cox regression model, AFP values before A+B >400ng/ml [HR 2.9 (95% CI 1.1-7.6)], adjusted for HCC diffuse intrahepatic pattern was associated with irAE development (c-statistic 0.66). Patients developing irAEs presented decreased overall and post-irAE survival [median 2.9 months vs 18.5 months; HR 6.2 (95% CI 2.7-14.2); P<.0001] (Figure). Cautions management in patients with irAEs is of relevant importance in our region, highlighting the role of onco-hepatologists in the clinical-decision making process of these patients.

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Journal
Annals of Hepatology
Published
2024-12-01
DOI
https://doi.org/10.1016/j.aohep.2024.101667
Primary Topic
Liver Disease and Transplantation
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article
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article

P-53 IMMUNE-MEDIATED ADVERSE EVENTS FOLLOWING ATEZOLIZUMAB PLUS BEVACIZUMAB IS ASSOCIATED WITH DECREASED SURVIVAL IN PATIENTS WITH CIRRHOSIS

Adriana Varón, Alexandre de Araújo, Joselin Maritza Vera García, Federico Orozco Ganem et al.
Annals of Hepatology
Liver Disease and Transplantation
article

P-53 IMMUNE-MEDIATED ADVERSE EVENTS FOLLOWING ATEZOLIZUMAB PLUS BEVACIZUMAB IS ASSOCIATED WITH DECREASED SURVIVAL IN PATIENTS WITH CIRRHOSIS

Adriana Varón, Alexandre de Araújo, Joselin Maritza Vera García, Federico Orozco Ganem, Jaime Poníachik, Juan Ignacio Marín, Ezequiel Demirdjian, Leonardo Gomes da Fonseca, J. Flórez, Fernando Bessone, Daniela Pérez, Manuel Mendizábal, Federico Piñero, Ezequiel Ridruejo, Sebastián Marciano, Margarita Anders, Pablo Caballini, Carla Bermúdez, Marina Villa, Oscar Beltrán, Jorge Rodríguez, Marcelo Silva
article en

Abstract

No Clinical trials evaluating the efficacy of first line systemic immune therapies for patients with advanced hepatocellular carcinoma (HCC) have recruited a lower proportion of patients with cirrhosis. In this group of patients, immune related adverse events (irAEs) may lead to decreased prognostic outcomes. The aim of this study was describe the incidence rate of irAEs and its impact on survival. A multicenter prospective Latin-American cohort study was conducted including HCC patients who received A+B since its regional approval, either as first or sub-sequent systemic lines, to March 15, 2024. Overall survival since A+B, and survival since date of irAE was compared between patients developing and not developing irAEs (date since A+B), through Cox proportional hazard analysis (Harrell's c-index). Overall, 99 patients treated with A+B were included (n=8 received it as second line post sorafenib), 82.3% presented cirrhosis. The median treatment duration was 6 months [number of cycles 5 (range 3-11.5)], with a median overall survival of 17.0 months (range 12.6-19.8). Over a median follow-up of 7.7 months (range 4.5-17.2), the irAE incidence rate was 2.1 cases per 100 persons-months [cumulative incidence 18.1% (95% CI 11.1-27.2%); n=18]. 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 (Table). Follow-up and treatment duration times were similar regardless irAEs occurrence. On multivariable Cox regression model, AFP values before A+B >400ng/ml [HR 2.9 (95% CI 1.1-7.6)], adjusted for HCC diffuse intrahepatic pattern was associated with irAE development (c-statistic 0.66). Patients developing irAEs presented decreased overall and post-irAE survival [median 2.9 months vs 18.5 months; HR 6.2 (95% CI 2.7-14.2); P<.0001] (Figure). Cautions management in patients with irAEs is of relevant importance in our region, highlighting the role of onco-hepatologists in the clinical-decision making process of these patients.

Annals of HepatologyVol. 29
University of Mendoza (AR), Universidade Federal do Rio Grande do Sul (BR), Hospital Italiano de Buenos Aires (AR), Instituto do Câncer do Estado de São Paulo (BR), Hospital de Clínicas de Porto Alegre (BR), Hospital Universitario Austral (AR), Hospital Pablo Tobon Uribe (CO), Hospital Provincial de Rosario (AR), Hospital Clínico de la Universidad de Chile (CL), Fundación Santa Fe de Bogotá (CO), Institute of Cardiology (CO), Centro de Educación Médica e Investigaciones Clínicas Norberto Quirno (AR), Servicio Diabetología Hospital Córdoba (AR), Hospital Alemán (AR)
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Liver Disease and Transplantation
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