Introduction
With the advent of effective systemic therapy, transarterial chemoembolization (TACE) is established as a highly effective locoregional treatment modality for carefully selected patients of hepatocellular carcinoma (HCC). This randomized controlled trial was conducted to clarify whether selective TACE with drug-eluting beads loaded with epirubicin (DEB-TACE) or selective conventional TACE with epirubicin-ethiodized oil (cTACE) might be more effective for obtaining complete response (CR) in patients with HCC.
Methods
Between March 2016 and May 2019, Child-Pugh class A or B patients with unresectable HCC who were scheduled to receive selective TACE were randomly assigned at a 1:1 ratio to the DEB-TACE arm or the cTACE arm. The primary endpoint was the CR rate at 3 months, as evaluated according to the modified Response Evaluation Criteria in Solid Tumors (mRECIST) by an independent review committee, and the secondary endpoints were the CR rate at 1 month and incidences of adverse events.
Results
A total of 200 patients (DEB-TACE, 99 patients; cTACE, 101 patients) were enrolled in the study. The CR rates at 3 months and 1 month were significantly higher in the cTACE arm (75.2%, 84.2%) as compared with the DEB-TACE arm (27.6%, 35.7%). However, the frequencies of adverse events of any grade, including pyrexia (DEB-TACE vs. cTACE, 19.4% vs. 45.5%, p=0.0001), fatigue (5.1% vs. 15.8%, p=0.0194), malaise (11.1% vs. 25.7%, p=0.0103), appetite loss (12.1% vs. 28.7%, p=0.0048), abdominal pain (12.1% vs. 23.8%, p=0.0423), increased serum bilirubin (22.2% vs. 48.5%, p=0.0002), hypoalbuminemia (43.4% vs. 60.3%, p=0.0154), increased serum aspartate aminotransferase (35.7% vs. 81.2%, p<0.0001), and increased serum alanine aminotransferase (35.7% vs. 77.2%, p<0.0001), were also significantly higher in the cTACE arm than in the DEB-TACE arm.
Conclusions
Selective cTACE appeared to have higher CR rates for local tumor control as compared to selective DEB-TACE for HCC. However, the frequency of post-embolization syndrome was also significantly higher in the cTACE group than in the DEB-TACE group. Thus, to achieve CR, cTACE may be selected over DEB-TACE in patients who can be expected to tolerate post-embolization syndrome.