Preliminary results of retrospective analysis Atezolizumab and Bevacizumab in first-line therapy of advanced HCC

Introduction. HCC is a challenge for clinical oncology. 1-year mortality for advanced HCC accounts for 66% in theRussian Federation. The results obtained in the combined Atezolizumab and Bevacizumab therapy in the advanced HCC cases are reported.Objective. To assess efficacy and safety of anti-VEGF/PD-L1 Atezolizumab plus Bevacizumab therapy in 20 unresectable HCC patients.Materials and methods. This analyses carried out in Blokhin National Cancer Research Centre included 20 patients with unresectable HCC treated with the first-line Atezolizumab (1200 mg) and Bevacizumab (15 mg/kg) once every 21 days, 11 patients participated into the global open-label phase 3 trial IMbrave150 23,24 (NCT03434379 / YO40245; Sponsor of study F. Hoffmann-La Roche, Ltd). The therapy was discontinued in cases of tumor progression or intolerant toxicity. The efficacy was evaluated according to RECICT 1.1 criteria. The results were analyzed and visualized on the basis of statistical calculations R 3.6.3 (R Foundation for Statistical Computing, Vienna, Austria). Descriptive statistics for quantitative variables are presented as mean (standard devia[1]tion) and median (lower and upper quartiles), for categorial variables as absolute number of observations (%). To compare quan[1]titative variables (AFP level) in progress Wilcoxon test was used. The differences were considered statistically significant with p < 0.05. Overall survival (OS) and progression-free survival (PFS) data were evaluated according to Kaplan-Meier methodology.Results and discussion. Median follow up was 9.3 months (quartile 1–3: 6.0–14.4) for 20 patients. Median progression free sur[1]vival was 14.9 months (lower bound, 95% CI, 9.0 months, upper bound NA). 12–month progression-free survival rate from the fixed date of the initial therapy was 56.2% (95% CI: 34.4–91.8%). One-year survival for 20 patients from the fixed date of the initial therapy was 70.0% (95% CI: 49–100). Treatment resulted in objective response (partial regression) in 3 (15%) pts, stable disease in 13 (65.0%) and progression in 4 (20.0%), patients. 35% of patients experienced Gr 3–4 adverse events with Gr3–4 arterial hypertension was the most common one in 20%. In 1 case esophageal varices hemorrhage Gr3 took place.Conclusion. Atezolizumab and Bevacizumab seems to be highly efficient in advanced HCC.