Atezolizumab plus bevacizumab (A+B) is the new standard of care for first-line treatment of advanced hepatocellular carcinoma (HCC). However, in patients (pts) with poor liver function, there is little evidence to support its use in ordinary clinical practice. This retrospective, multi-center observational study was done across 7 tertiary academic referral centers and gathered 64 HCC patients consecutively treated with (A+B). Overall survival (OS) and progression-free survival (PFS) were determined from the start of (A+B) treatment, and overall response rates (ORR) and disease control rates (DCR) were measured according to the Response Evaluation Criteria in Solid Tumors (RECIST, v1.1). Safety outcomes comprised treatment-related adverse events (trAEs) graded (G) according to CTCAE v5.0.
Patients Of 64 eligible pts, 54 had BCLC C stage HCC (84%), secondary to hepatitis C cirrhosis (n=24; 37%), hepatitis B (n=10; 16%), and non-viral etiologies (n=40; 47%). Liver function was classified as Child-Pugh (CP) A in 46 patients (72%), B7 in 7 (11%), B8 in 8 (12%), and B9 in 3 (5%). Around 61% (n=39) and 35% (n=25) of the patients had an ECOG performance status of 0. Pre-treatment upper-gastrointestinal endoscopy was conducted in 44 patients (69%), with gastro-esophageal varices identified in 18 pts (40%) and graded as 1 (n=12, 27%), 2 (n=4, 9%), and 3 (n=2, 4%) correspondingly. After a median follow-up of 6.8 months (m) (95% confidence interval [CI], 5.5-8.0), the median OS (mOS) was 11.7m (95% CI, 6.2-17.the 3), but median progression-free survival (mPFS) was 6.97m (95% CI, 2.9-11.0). ORR and DCR were 26%, and 62% respectively. About 43 patients (67%), including 12 (18%) with trAEs of G3 (7 (11%) attributable to atezolizumab and 5 (8%) connected to bevacizumab, were reported. Toxicity led to therapy termination in 3 pts (5%). Shorter OS (11.7m [95% CI, 10.3-13.2] vs 6.5m [95% CI, 3.5-9.5], P=0.029) and PFS (9.1m [95% CI, 5.4-12.8] vs 2.3m [95% CI, 1.7-2.9], P=0.001) were seen in CP-B patients compared to CP-A, despite no differences in ORR or DCR.
There was no statistically significant difference in trAE rates across CP groups. However, patients who experienced a radiologic response had a substantially longer median OS (12.7m [95% CI, not attained] vs. 11.0m [95% CI, 5.5-16.5], P=0.04). The presence and grade of varices were not connected to bevacizumab-related trAEs. This investigation supports replicable efficacy and safety of (A+B) in everyday practice. Although(A+B) was associated with similar tolerability and radiologic response in CP-B patients, OS and PFS were lower compared to CP-A; hence, prospective investigation of A+B in this treatment-deprived population is warranted.
Source – ASCO GI 2023
