Sorafenib-pravastatin combo does not improve survival in hepatocellular carcinoma
The combination of pravastatin and sorafenib does not appear to improve survival in patients with hepatocellular carcinoma (HCC), a recent study has shown.
A total of 312 patients with advanced HCC and who were naïve to systemic treatment were assigned to receive sorafenib either in combination with pravastatin (n=162; median age, 68 years; 96.3 percent male) or alone (n=161; median age, 68 years; 88.2 percent male). The primary study outcome was overall survival (OS), while progression-free survival (PFS), safety, time to treatment failure, quality of life and time to progression were secondary endpoints.
Patients who received the combination treatment survived for a median period of 34.7 months. This outcome was not significantly better than in those who were given sorafenib alone (median, 36.1 months).
A total of 269 deaths were reported, 135 of which occurred in the combination arm. The resulting OS rates were comparable between the two treatment arms (sorafenib alone vs combination: 44.9 percent vs 47.2 percent; hazard ratio [HR], 1.00, 95 percent CI, 0.79–1.28; p=0.975).
The same was true for 1-year PFS (16.5 percent vs 18.8 percent; HR, 1.00, 0.80–1.25; p=0.986), time to progression (28.3 percent vs 26.9 percent; HR, 1.06, 0.80–1.38; p=0.698) and time to treatment failure (19.3 percent vs 25.2 percent; HR, 0.92, 0.73–1.16; p=0.502).
Multivariate analysis further confirmed these findings, showing that only scores in the Cancer of Liver Italian Program were significant predictors of survival (HR, 2.54, 1.88–3.44; p<0.0001) and that the assigned treatment was not (HR, 0.94, 0.71–1.25; p=0.688).