Efficacy and safety of raltitrexed-eluting CalliSpheres® bead transarterial chemoembolization in patients with intermediate-stage hepatocellular carcinoma: a single-arm, prospective study

Zhanguo Sun; Dechao Jiao; Yi Fang; Yiming Liu; Kaihao Xu; Chengzhi Zhang; Yuanhao Huang; Xinwei Han

doi:10.1177/17588359241229661

Efficacy and safety of raltitrexed-eluting CalliSpheres^® bead transarterial chemoembolization in patients with intermediate-stage hepatocellular carcinoma: a single-arm, prospective study

Ther Adv Med Oncol. 2024 Feb 14:16:17588359241229661. doi: 10.1177/17588359241229661. eCollection 2024.

Authors

Zhanguo Sun¹, Dechao Jiao², Yi Fang¹, Yiming Liu¹, Kaihao Xu¹, Chengzhi Zhang¹, Yuanhao Huang³, Xinwei Han¹

Affiliations

¹ Department of Interventional Medicine, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China.
² Department of Interventional Medicine, The First Affiliated Hospital of Zhengzhou University, No. 1 Jianshe East Road, Zhengzhou, Henan, China.
³ Department of Interventional Medicine, Zhengzhou Central Hospital, Zhengzhou, China.

Abstract

Background: The most common loadable chemotherapeutic drugs in drug-eluting bead transarterial chemoembolization (DEB-TACE) include doxorubicin, epirubicin, etc. CalliSpheres^® beads have exhibited efficient loadability and eluting characteristics for raltitrexed as well as in vitro and animal experiments. However, the efficacy and safety of raltitrexed-loaded DEB-TACE in patients with intermediate-stage hepatocellular carcinoma (HCC) remain unclear.

Objectives: To assess the efficacy and safety of raltitrexed-loaded DEB-TACE in patients with intermediate-stage HCC.

Design: The study was conducted as a single-arm prospective study.

Methods: This study was a prospective, single-arm trial conducted between June 2019 and June 2022. CalliSpheres^® beads loaded with raltitrexed were used in the DEB-TACE procedure. The follow-up lasted for at least 1 year or until death. The primary endpoint was overall survival (OS), and the secondary endpoints were time to progression (TTP), progression-free survival (PFS), objective response rate (ORR), and adverse events (AEs).

Results: The 6-month ORR and disease control rates were 90.1% and 93.8%, respectively. The median OS was 33.0 months. The 1-, 2-, and 3-year survival rates were 95.1%, 82.1%, and 43.6%, respectively. Child-Pugh class and bilobar disease occurrence were identified as independent OS predictors. The median TTP and PFS were 22.7 and 19.8 months, respectively. Eleven (11.5%) patients experienced at least one grade 3 AE, and serious AEs were reported in five participants (5.2%). No patient experienced grade 4 or 5 AEs.

Conclusion: Raltitrexed-loaded DEB-TACE is feasible, safe, and effective in patients with intermediate-stage HCC.

Trial registration: This trial was registered at www.chictr.org.cn under the identifier: 1900024097 on 25 June 2019.

Keywords: DEB-TACE; beads; chemoembolization; hepatocellular carcinoma; raltitrexed; transarterial.

Plain language summary

Efficacy and safety of raltitrexed-loaded DEB-TACE in patients with intermediate-stage hepatocellular carcinoma The utility of raltitrexed-loaded CalliSphere® beads in drug-eluting bead transarterial chemoembolization (DEB-TACE) has been demonstrated in in vitro and animal experiments. However, its efficacy and safety in patients with intermediate-stage hepatocellular carcinoma (HCC) remain unclear. Hence, this study aimed to assess the efficacy and safety profiles of DEB-TACE for such patients. We discovered that raltitrexed-loaded DEB-TACE led to a 6-month ORR of 90.1%, a median OS of 33.0 months, a median TTP of 22.7 months, and a median PFS of 19.8 months. The 1-, 2-, and 3-year survival rates were 95.1%, 82.1%, and 43.6%, respectively. Factors such as Child-Pugh class and bilobar disease occurrence were identified as independent predictors of OS. The study also showed acceptable safety profiles, with a low incidence of grade 3 adverse events and no grade 4 or 5 adverse events. The results indicated that raltitrexed-eluting CalliSpheres® beads for TACE can be a viable option for treating patients with intermediate-stage HCC.