Abstract
Simple SummaryHepatocellular 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.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, LifePearlTM, loaded with anthracyclines. Materials and methods: 97 patients diagnosed with HCC were prospectively enrolled and treated using LifePearlTM 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 LifePearlTM 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 LifePearlTM. The trial was registered in National Library of Medicine (ID: NCT03053596).
Highlights
Hepatocellular carcinoma (HCC) is among the six most common types of cancer in the world and the third leading cause of cancer death [1], often associated with concomitant liver impairment [2,3].Patient stratification and treatment allocation are based on factors related to tumor burden, liver function and performance status, according to the Barcelona Clinic Liver Cancer (BCLC) staging system which is commonly used for HCC management in Europe and the United States [2,3,4,5]
Most of the baseline characteristics were similar in patients treated by doxorubicin and idarubicin except for cirrhosis that was higher in doxorubicin group (91.7% versus 59.1%; p = 0.0002) and for the sum of tumor diameters that were higher in idarubicin group (57.2 ± 35.7 mm vs. 84.4 ± 53.9 mm; p = 0.023), respectively
There was no significant difference in progression-free survival (PFS): 15.2 (10.3; 17.0) vs. 13.4 (9.9; 15.6) p = 0.44), time to transarterial chemoembolization (TACE) untreatable progression (TTUP) (median: 16.5 (11.4; not estimable (n.e.)) vs. not estimable (11.7; n.e.) p = 0.98), or overall survival (OS) (median: 22.5 (95%CI: 16.2; n.e.) months vs. not-estimable; p = 0.30) between patients with or without hepatobiliary toxicities (HBT), respectively (Figure 2)
Summary
Hepatocellular carcinoma (HCC) is among the six most common types of cancer in the world and the third leading cause of cancer death [1], often associated with concomitant liver impairment [2,3].Patient stratification and treatment allocation are based on factors related to tumor burden, liver function and performance status, according to the Barcelona Clinic Liver Cancer (BCLC) staging system which is commonly used for HCC management in Europe and the United States [2,3,4,5]. Liver transplantation, and local ablation are considered potentially curative in carefully selected patients, with 5-year survival rates of 40–70%, compared with 20% in untreated patients [3,4,5]. Following the BCLC staging system and treatment strategy, transarterial chemoembolization (TACE) is the first-line treatment for intermediate-stage disease, a possible option to maintain a patient on the waiting list or to downstage a patient for liver transplantation and can be used according to treatment stage migration for early-stage disease when curative treatments are not feasible or failed [2,5]. There are two TACE techniques: conventional TACE (cTACE) and TACE with drug-eluting microspheres (DEM-TACE). 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, LifePearlTM , loaded with anthracyclines
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