Short-term efficacy and safety of callispheres drug-loaded microsphere embolization in primary hepatocellular carcinoma

Background: Drug-eluting beads transarterial chemoembolization (DEB-TACE) is a newly developed local regional therapy for improving the efficacy and safety of conventional transarterial chemoembolization (cTACE), which is now universally used to treat patients with unresectable liver cancer.Cohort studies, clinical trials, and meta-analysis have shown DEB-TACE to be associated with favorable treatment responses, prolonged survival, and at least similar safety profile when compared with cTACE. Aims and Objectives: This study was to evaluate the short term clinical efficacy, side effects, and risk factors affecting the clinical effectiveness of CalliSpheres drug loaded bead transcatheter arterial chemoembolization (DEB TACE) in the treatment of primary hepatocellular carcinoma (HCC). Materials and Methods: A total of 172 consecutive patients with HCC undergoing DEB TACE (loaded with doxorubicin) from January 2017 to December 2018 were prospectively enrolled. Short term local tumor response was evaluated by the modified RECIST criteria. Postoperative complications and liver function disorders were analyzed based on examinations and clinical symptoms. Results: The median follow up period was 310 days. Based on the modified response evaluation criteria in solid tumors criteria, objective response rates(complete response [CR] + partial response [PR]) were 78.7%, 71.6%, and 63.2%, and disease control rates(CR + PR + stable disease) were 95.3%, 92.1%, and 85.9% at 2, 4, and 6 months posttreatment, respectively. Multivariate logistic regression analysis showed that nodule number >3, high BCLC stage, no vascular leak, and previous conventional TACE treatment were associated with poor ORR (P < 0.05). Postoperation, liver function showed transient changes. Postoperative complications were tolerated and relieved by symptomatic treatment. The average interval of TACE before D TACE was 43 days, compared with 70 days for average interval of DEB TACE. The average hospital stay was 1.87 days. Conclusion: DEB TACE has improved short term efficacy and lower incidence of complications in primary HCC and prolongs the interval of TACE. It significantly increases the ORR, especially in patients with no extra hepatic metastasis pretreatment. DEB usage actually improves treatment efficacy and provides more benefits to patients. KEY WORDS: Drug-loaded bead-transcatheter arterial chemoembolization, hepatocellular carcinoma, microsphere embolization

Automated summary

DEB-TACE has shown significant short-term efficacy in the treatment of primary HCC, reducing complications and extending the interval between TACE treatments. Objective response rates were 78.7%, 71.6%, and 63.2% at 2, 4, and 6 months post-treatment, with disease control rates at 95.3%, 92.1%, and 85.9% respectively.