Real Life Prospective Evaluation of New Drug-Eluting Platform for Chemoembolization of Patients with Hepatocellular Carcinoma: PARIS Registry

SIMPLE SUMMARY: Hepatocellular carcinoma treatment options depend on stage of disease. In intermediate stage transarterial chemoembolization with drug-eluting microspheres (DEM-TACE) is recommended. DEM-TACE is simultaneous embolization of tumour feeding arteries and local delivery of anticancer drugs. We assessed real-life practice, safety, toxicity and efficacy of this therapy using new embolization microspheres in 97 patients. Toxicity of the treatment in our study was within or below rates reported so far, and the healthy liver parenchyma, the bile ducts and the portal vein were well preserved when compared with previous study using other type of DEM. Tumour response rate was high, achieving disease control in almost all patients. Hepatocellular carcinoma was controlled during 16.7 months with DEM-TCE as the only treatment. At one year 81% and at two years 66% of patients were alive. Our study showed that DEM-TACE in patients from every-day clinical practice is safe and efficient treatment modality. ABSTRACT: Background and aim: Transarterial chemoembolization with drug-eluting microspheres (DEM-TACE) is recommended for patients with BCLC stage B hepatocellular carcinoma (HCC) and stage 0-A unsuitable for curative treatments. We assessed efficacy and safety along with hepatobiliary toxicities (HBT) of DEM-TACE using a novel microsphere, LifePearl(TM), loaded with anthracyclines. Materials and methods: 97 patients diagnosed with HCC were prospectively enrolled and treated using LifePearl(TM) loaded with doxorubicin (77%) or idarubicin (23%). Safety and tolerability were assessed using CTCAE, HBT by CT/MRI scans, and tumor response by applying modified Response Evaluation Criteria in Solid Tumors (mRECIST). Follow-up was after 2 years. Results: Adverse events (AE) were reported in 73.2% of patients, majority being Grade 1–2. Grade ≥ 3 AE reported in 13.4% of patients were mainly related to postembolization syndrome. HBT were observed after 15.5% (29/187) of the DEM-TACEs. Objective response and disease control rates were 81% and 99%, respectively, as the best responses. Survival rates at one and two years were 81% and 66%, respectively, while the median overall survival (OS) was not reached. Median progression free survival was 13.7 months (95% CI: 11.3; 15.6) and median time to TACE untreatable progression was 16.7 months (95% CI: 12.7; not estimable (n.e.)). Conclusions: DEM-TACE using LifePearl(TM) provides a high tumor response rate in HCC patients. HBT rates within or below previously reported results for cTACE and DEM-TACE indicate a good safety profile for LifePearl(TM). The trial was registered in National Library of Medicine (ID: NCT03053596).