Document resource
Background and Importance Atezolizumab-Bevacizumab (ATZ-BVZ) is a first-line treatment approved for adult patients with advanced or unresectable hepatocellular carcinoma.Aim and Objectives To evaluate effectiveness and safety of ATZ-BVZ and to compare the results with those obtained with the pivotal trial.Material and Methods An observational and retrospective study was conducted including all patients treated with ATZ-BVZ from May 2021 to April 2025 in a tertiary hospital.The variables studied were demographic data, ECOG, number of cycles received, previous treatments, BCLC (Barcelona Clinic Liver Cancer) stage, treatment duration, reasons for discontinuation, and date of death.To evaluate effectiveness, progression-free survival (PFS) and overall survival (OS) were analysed by Kaplan–Meier method. PFS and OS were expressed in median and 95% confidence interval (95% CI).To evaluate safety, adverse reactions (AR) were recorded.Data were collected using the electronic clinical records and the oncohaematological prescription program. Statistical analysis was performed with SPSS v.22.0.Results We collected 45 patients, of whom 43 were included due to loss to follow-up. The median age was 69 years (56-82). At the start of ATZ-BVZ, 59% had an ECOG 0 (n=25), 41% ECOG 1 (n=18). Previous treatments were sorafenib (n=3) and lenvatinib (n=2).The median number of cycles received was 10 (4-54). The reasons for treatment discontinuation were: progression (n=8), death (n=4) and toxicity (n=3): immune-mediated colitis. 58% had BCLC stage C, 28% stage B and 14% stage A.PFS and OS in our study were 9.1 months (95% CI:4.46-19.7) and 12.8 months (95% CI 6.79-14.3), respectively. In pivotal trial IMbrave150, PFS was 6.8 months and OS was 19.2 months.In our cohort, safety results were comparable to the pivotal study: hypertension 33% vs 29.8%; asthenia 28% vs 20.4%; proteinuria 12% vs 20.1%; bleeding 20% vs 14.9%; infusion reaction 14% vs 11.2%. 6.9% experienced an AR leading to withdrawal of ATZ-BVZ vs 7% in pivotal trial.Conclusion and Relevance The PFS obtained in our study was superior to that reported in the pivotal trial, probably because only 58% of our patients had stage C compared with 85% in IMbrave150.The AR identified showed a similar incidence to our study.It would be necessary to continue with this study to extend the follow-up time in order to analyse more precisely the effectiveness of the treatment.Conflict of Interest No conflict of interest