Degradable Starch Microspheres Transarterial Chemoembolization with or without Lipiodol for Liver Metastases from Pancreatic Cancer: A Prospective Randomized Trial

SIMPLE SUMMARY: The treatment of malignant liver tumors can be very challenging, especially in cases of metastatic disease. Systemic chemotherapy is most commonly used in such cases. However, liver metastases can also be treated by various interventional treatments including thermal ablation or TACE, depending on the hepatic tumor burden. This prospective, randomized study aims to compare DSM-TACE with Lipiodol + DSM TACE for patients with liver metastases from pancreatic cancer according to the volume and diameter of metastases, ADC values, and survival time of both groups after treatment of three TACE sessions. The treatment response of both cohorts will be assessed using RECIST 1.1. ABSTRACT: To evaluate and compare the outcome of patients with liver metastases from pancreatic cancer treated by transarterial chemoembolization (TACE) using two different protocols. In this prospective, randomized, single-center trial, patients were randomly assigned to receive TACE therapy either with degradable starch microspheres (DSM) alone or a combination of Lipiodol and DSM. From the initial 58 patients, 26 patients (13 DSM-TACE, 13 Lipiodol + DSM-TACE) who completed 3 TACE treatments at an interval of four weeks were considered for evaluation of tumor responses. Initial and final MRIs were used to evaluate local therapy response by RECIST 1.1; changes in diameter, volume, ADC value, and survival rate were statistically evaluated. The differences between the DSM-TACE and Lipiodol + DSM-TACE were identified for partial response (PR) as 15.4% versus 53.8%, stable disease (SD) as 69.2% versus 46.2%, progressive disease (PD) as 15.4% versus 0%, respectively (p = 0.068). Median overall survival times for DSM-TACE and Lipiodol + DSM-TACE were 20 months (95% CI, 18.1–21.9) and 23 months (95% CI, 13.8–32.2), respectively (p = 0.565). The one-year survival rates for DSM-TACE and Lipiodol + DSM-TACE were 85.4% and 60.4%, the two-year survival rates were 35.9% and 47.7%, and the three-year survival rates were 12% and 30.9%, respectively. The evaluated local therapy response by RECIST 1. was not significantly different between the two studied groups. A longer overall survival time was observed after Lipiodol + DSM-TACE therapy; however, it was not significantly different.