154P - Adverse events (AEs) as potential predictive factors of activity in patients with advanced hepatocellular carcinoma (HCC) treated with atezolizumab plus bevacizumab (AB)

Background

This retrospective multicenter real-world study aims to investigate the potential prognostic value of AEs in HCC patients treated with AB in first-line setting.

Methods

The study’s population consisted of 823 HCC patients from five countries (Italy, Germany, Portugal, Japan, and the Republic of Korea) treated with AB between October 2018 and April 2022.

Results

Median overall survival (OS) was 15.9 months and median progression-free survival (PFS) was 7.6 months. 73.3% of patients presented at least one AE during the study period. The most common AEs were proteinuria (29.6%), arterial hypertension (27.2%), and fatigue (26.0%). 17.3% of the AEs were grade (G) 3. One death due to bleeding was reported. The multivariate analysis confirmed the appearance of decreased appetite G < 2 versus G ≥ 2 [hazard ratio (HR): 0.60; p < 0.01] and immunotoxicity G < 2 versus G ≥ 2 (HR: 0.70; p = 0.04) as independent prognostic factors for OS, and the appearance of decreased appetite G < 2 versus G ≥ 2 (HR: 0.73; p = 0.01), diarrhea of any G versus no diarrhea (HR: 0.57; p = 0.01), fatigue of any G versus no fatigue (HR: 0.82; p < 0.01), arterial hypertension G < 2 versus G ≥ 2 (HR: 0.68; p < 0.01), and proteinuria of any G versus no proteinuria (HR: 0.79; p = 0.03) as independent prognostic factors for PFS. The objective response rate (ORR) was 27.3%: complete responses (CR) were 35 (4.2%), partial response 190 (23.1%), stable disease 428 (52.0%), and progressive disease 170 (20.7%). The appearance of hypothyroidism of any G (odds ratio: 0.52; p = 0.04) and immunotoxicity of any G (odds ratio: 0.54; p < 0.01) were correlated with higher ORR, while the absence of fatigue of any G (odds ratio: 3.90; p = 0.02) and decreased appetite of any G (odds ratio: 9.71; p = 0.02) were correlated with more CR.

Conclusions

As also demonstrated for other therapies, also for the combination of AB there is a correlation between the occurrence of AEs and HCC patient outcomes.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

The authors.

Funding

Has not received any funding.

Disclosure

All authors have declared no conflicts of interest.