Five-Years Outcome Analysis of 142 Consecutive Hepatocellular Carcinoma Patients Treated with Doxorubicin Eluting Microspheres 30-60 μm: Results from a Single-Centre Prospective Phase II Trial

Purpose To assess prospectively long-term results of doxorubicin-loaded HepaSphere 30-60 mu m in consecutive patients with hepatocellular carcinoma (HCC) not amenable to curative treatments. Patients and Methods Single-center study from June 2011 to December 2015 in 151 patients treated with 75 mg of doxorubicin per HepaSphere vial. Baseline: Barcelona Clinic Liver Cancer BCLC A/B was 49.3%/50.7%, and median diameter 6.1 cm (mean 6.7 +/- 2.0). Liver function, local response (mRECIST), liver time to progression (LTTP), progression-free survival (PFS), overall survival (OS) and adverse events (AEs) were recorded. Results Final analysis included 142 patients with median follow-up of 46.8 months (range 4-72) without grade 4/5 AEs, and 30-day mortality was 0%. Mean number of scheduled treatments was 2.6 (range 1-3) and on demand 3 (range 1-8). Complete response for single tumor <= 5 cm was 75.0% and 66.7% for Child A and Child B, while for >5 cm was 28.6% and 11.8%, respectively. OS was 31.0 months (mean 33.3 +/- 15.2; range 8-69), notably for BCLC A 41 months (mean 41.1 +/- 15.3; range 13-69) and for BCLC B 26.0 (mean 26.0 +/- 10.5; range 8-51). OS at 1, 3 and 5 years: 95.8%, 75.7% and 21.4% for BCLC A, and 94.4%, 36.1% and 2.7% for BCLC B. Median LTTP for BCLC A was 11 months (mean 11.9 +/- 4.7; range 3-24) and 7.5 for BCLC B (mean 7.9 +/- 2.9). Local response was significant for OS and LTTP (p < 0.0001), while size and lesion number affected LPFS and OS (p < 0.001). Conclusions HepaSphere 30-60 lm loaded with doxorubicin provides a safe and effective treatment option for patients with HCC.