Supplementary Material for: Conventional or drug-eluting beads? Randomized study of chemo-embolization for hepatocellular carcinoma: JIVROSG-1302
datasetposted on 15.06.2022, 12:26 authored by Ikeda M., Arai Y., Inaba Y., Tanaka T., Sugawara S., Kodama Y., Aramaki T., Anai H., Morita S., Tsukahara Y., Seki H., Sato M., Kamimura K., Azama K., Tsurusaki M., Sugihara E., Miyazaki M., Kobayashi T., Sone M.
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.