RFA plus lyso-thermosensitive liposomal doxorubicin: in search of the optimal approach to cure intermediate-size hepatocellular carcinoma

When heated during a radiofrequency ablation (RFA) procedure to ≥40°C, lyso-thermosensitive liposomal doxorubicin (LTLD) produces high drug concentration in the surrounding margins of the ablation zone. The hypothesis that the RFA + LTLD combination can effectively treat hepatocellular carcinoma (HCC) was investigated in the HEAT study: adding LTLD did not improve the efficacy of normal practice RFA. However, among the 285 patients with a solitary lesion who received at least 45-min RFA dwell time, the hazard ratio for overall survival was 0.63 (95% CI: 0.41-0.96; p = 0.04). The OPTIMA study is currently ongoing to test the hypothesis that adding LTLD to a standardized RFA lasting ≥45 min increases survival compared with standardized RFA alone.