1. Conventional or Drug-Eluting Beads? Randomized Controlled Study of Chemoembolization for Hepatocellular Carcinoma: JIVROSG-1302
- Author
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Ikeda, Masafumi, Arai, Yasuaki, Inaba, Yoshitaka, Tanaka, Toshihiro, Sugawara, Shunsuke, Kodama, Yoshihisa, Aramaki, Takeshi, Anai, Hiroshi, Morita, Shinichi, Tsukahara, Yoshinori, Seki, Hiroshi, Sato, Mikio, Kamimura, Kenya, Azama, Kimei, Tsurusaki, Masakatsu, Sugihara, Eiji, Miyazaki, Masaya, Kobayashi, Tatsushi, and Sone, Miyuki
- Abstract
Introduction:With the advent of effective systemic therapy, transarterial chemoembolization (TACE) is established as a highly effective locoregional treatment modality for carefully selected patients with hepatocellular carcinoma (HCC). This randomized controlled trial was conducted to clarify whether selective TACE with drug-eluting beads (DEB-TACE) loaded with epirubicin or selective conventional TACE (cTACE) with epirubicin-ethiodized oil 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 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 postembolization 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 postembolization syndrome.
- Published
- 2022
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