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The second-line treatment of hepatocellular carcinoma with CalliSpheres drug-eluting bead transarterial chemoembolization combined with regorafenib: A safety and efficacy analysis

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Abstract

Background

This study aimed to investigate the efficacy and safety of CalliSpheres drug-eluting beads transarterial chemoembolization (DEB-TACE) combined with regorafenib in the second-line treatment of unresectable hepatocellular carcinoma.

Methods

A retrospective analysis was made of 34 patients with unresectable hepatocellular carcinoma (HCC) that had progressed after first-line treatment in Linyi Tumor Hospital from October 2019 to June 2021. These patients were divided into observation group (n = 15) and control group (n = 19) based on their treatment plans, who were respectively treated with regorafenib alone and regorafenib combined with DEB-TACE. The objective response rate (ORR) and the disease control rate (DCR) were evaluated by the modified Response Evaluation Criteria in Solid Tumors (mRECIST), and the progression-free survival (PFS) and the overall survival (OS) were calculated; the factors influencing PFS and OS of patients were analyzed by the Cox proportional hazards model; and the adverse reactions to the treatments were observed and recorded.

Results

After 2 months of treatment, the ORR and the DCR of the observation group were 73.3% (11/15) and 86.7% (13/15) respectively, both higher than 10.5% (2/19) and 47.4% (9/19) of the control group. Their differences are statistically significant (P < 0.05). There were no statistically significant differences in the incidences of regorafenib-related adverse reactions including hand-foot skin reactions, fatigue, hypertension, diarrhea, and proteinuria between the two groups (P > 0.05). In the observation group, the main adverse reactions to DEB-TACE such as fever, pain, nausea, and vomiting were relieved after symptomatic treatment, and no serious complications such as ectopic embolization of CalliSpheres drug-eluting beads occurred. As of July 31, 2022, the median follow-up time was 12.5 months, and the average was (14.00 ± 5.69) months. The median PFS was 9 months in the observation group, and 6 months in the control group, presenting a statistically significant difference (P < 0.05), and the median OS was 18 months in the observation group, and 12 months in the control group, also presenting a statistically significant difference (P < 0.05). The results of monofactor prognostic analysis showed that Child grade, AFP level, and treatment method had an influence on the PFS and the OS of liver cancer patients receiving regorafenib second-line treatment (P < 0.05), and the results of multifactor prognostic analysis showed that child grade and treatment method independently influenced the PFS of patients, while treatment method independently influenced the OS of patients (P < 0.05).

Conclusions

DEB-TACE combined with regorafenib is safe and feasible in the treatment of unresectable HCC, with good efficacy and mild adverse reactions.

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Data availability

All data generated or analyzed during this study are included in this published article.

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Author information

Author notes

  1. Song Liu and Changqing Liu are co-first authors.

Authors and Affiliations

  1. Dalian Medical University, No.9 Western Section, Lvshun South Street, Lvshun District, Dalian, 116044, Liaoning Province, China

    Song Liu, Changqing Liu & Dong Wang

  2. Department of Interventional Therapy, Linyi Cancer Hospital, No. 6 East Lingyuan Street, Linyi, 276000, Shandong Province, China

    Song Liu, Qingdong Wang & Guangji Yu

  3. Department of General Surgery, Dalian Municipal Central Hospital, No. 826 Southwest Road, Shahekou District, Dalian, 116089, Liaoning Province, China

    Changqing Liu & Dong Wang

  4. Hepatobiliary and Pancreatic Center, Beijing Tsinghua Chang geng Hospital, Changping District, Beijing, 102218, China

    Ying Liu

  5. Minimally Invasive Interventional Diagnosis and Treatment Center, Affiliated Zhongshan Hospital of Dalian University, No.6 JieFang Street, Zhongshan District, Dalian, 116001, Liaoning Province, China

    Guangsheng Zhao

Authors
  1. Song Liu
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  2. Changqing Liu
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  3. Qingdong Wang
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  4. Ying Liu
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  5. Dong Wang
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  6. Guangsheng Zhao
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  7. Guangji Yu
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Corresponding authors

Correspondence to Dong Wang, Guangsheng Zhao or Guangji Yu.

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This study was carried out with the approval by Institutional Review Board.

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Liu, S., Liu, C., Wang, Q. et al. The second-line treatment of hepatocellular carcinoma with CalliSpheres drug-eluting bead transarterial chemoembolization combined with regorafenib: A safety and efficacy analysis. Ir J Med Sci (2024). https://doi.org/10.1007/s11845-024-03611-x

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  • DOI: https://doi.org/10.1007/s11845-024-03611-x

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