Abstract 952P
Background
Regorafenib is a standard therapy for patients with unresectable hepatocellular carcinoma (uHCC) after progression on sorafenib. However, there is no known reliable factor predictive of clinical outcomes for regorafenib. Serum alpha-fetoprotein (AFP) was reported as a significant predictive factor for the outcome of patients with advanced HCC on sorafenib treatment. In this multinational retrospective cohort study, implication of serum alpha-fetoprotein (AFP) in the prediction of effectiveness of regorafenib in uHCC was investigated.
Methods
A total of 581 patients with uHCC treated with regorafenib after failure to sorafenib from 12 institutions in Korea and Italy were included. Baseline AFP (cutoff 400 ng/mL) and on-treatment AFP response (20% reduction from baseline) were correlated with overall survival (OS) and progression-free survival (PFS).
Results
Among 581 patients, median age was 62 years, 507 (87%) were male, and the two most common etiologies for HCC were hepatitis B virus (n=381, 65%) and hepatitis C virus (n=80, 14%). All patients had Child-Pugh class A, and most had BCLC stage C (n=540, 92.9%). Baseline serum AFP ≥400 ng/mL (n=266, 46%) was significantly associated with poorer OS and PFS compared to AFP <400 ng/mL (OS, 9.6 months vs. 13.6 months; p<0.001; and PFS, 2.8 months vs. 3.9 months; p<0.001). Patients with on-treatment AFP response (n=196, 34%) had significantly longer OS and PFS than those without AFP response (OS, 18.7 months vs. 9.7 months; p<0.001; and PFS, 4.8 months vs. 2.8 months; p<0.001). In the multivariable analysis including potential prognostic factors, baseline AFP level and on-treatment AFP response were independent prognostic factors for OS (baseline AFP: HR, 0.59; 95% CI, 0.45-0.78, p<0.001; and AFP response: HR, 0.38; 95% CI, 0.28-0.52; p<0.001) and PFS (baseline AFP: HR, 0.70; 95% CI, 0.58-0.86, p=0.001; and AFP response: HR, 0.55; 95% CI, 0.44-0.68; p<0.001).
Conclusions
Baseline AFP and on-treatment AFP response were independent prognostic factors for advanced HCC patients treated with regorafenib. Serum AFP may be a useful clinical indicator to predict the clinical outcomes of regorafenib treatment in patients with advanced HCC.
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.