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Prospective Multi-Center Korean Registry of Transcatheter Arterial Chemoembolization with Drug-Eluting Embolics for Nodular Hepatocellular Carcinoma: A Two-Year Outcome Analysis

  • Myungsu Lee (Department of Radiology, Seoul National University Hospital, Seoul National University College of Medicine) ;
  • Jin Wook Chung (Department of Radiology, Seoul National University Hospital, Seoul National University College of Medicine) ;
  • Kwang-Hun Lee (Department of Radiology, Gangnam Severance Hospital, Research Institute of Radiological Science, Yonsei University College of Medicine) ;
  • Jong Yun Won (Department of Radiology, Severance Hospital, Research Institute of Radiological Science, Yonsei University College of Medicine) ;
  • Ho Jong Chun (Department of Radiology, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea) ;
  • Han Chu Lee (Department of Gastroenterology, Asan Liver Center, Asan Medical Center, University of Ulsan College of Medicine) ;
  • Jin Hyoung Kim (Department of Radiology and Research Institute of Radiology, Asan Liver Center, Asan Medical Center, University of Ulsan College of Medicine) ;
  • In Joon Lee (Department of Radiology, National Cancer Center) ;
  • Saebeom Hur (Department of Radiology, Seoul National University Hospital, Seoul National University College of Medicine) ;
  • Hyo-Cheol Kim (Department of Radiology, Seoul National University Hospital, Seoul National University College of Medicine) ;
  • Yoon Jun Kim (Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine) ;
  • Gyoung Min Kim (Department of Radiology, Severance Hospital, Research Institute of Radiological Science, Yonsei University College of Medicine) ;
  • Seung-Moon Joo (Department of Radiology, Gangnam Severance Hospital, Research Institute of Radiological Science, Yonsei University College of Medicine) ;
  • Jung Suk Oh (Department of Radiology, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea)
  • Received : 2019.10.21
  • Accepted : 2021.02.22
  • Published : 2021.10.01

Abstract

Objective: To assess the two-year treatment outcomes of chemoembolization with drug-eluting embolics (DEE) for nodular hepatocellular carcinoma (HCC). Materials and Methods: This study was a prospective, multicenter, registry-based, single-arm trial conducted at five university hospitals in Korea. Patients were recruited between May 2011 and April 2013, with a target population of 200. A DC Bead loaded with doxorubicin was used as the DEE agent. Patients were followed up for two years. Per-patient and per-lesion tumor response analysis, per-patient overall survival (OS) and progression-free survival (PFS) analysis, and per-lesion tumor control analysis were performed. Results: The final study population included 152 patients, with 207 target lesions for the per-lesion analysis. At one-month, six-month, one-year, and two-year per-patient assessments, complete response (CR) rates were 40.1%, 43.0%, 33.3%, and 19.6%, respectively. The objective response (OR) rates were 91.4%, 55.4%, 35.1%, and 19.6%, respectively. The cumulative two-year OS rate was 79.7%. The cumulative two-year PFS rate was 22.4% and the median survival was 9.3 months. In multivariable analysis, the Child-Pugh score (p = 0.019) was an independent predictor of OS, and tumor multiplicity (p < 0.001), tumor size (p = 0.020), and Child-Pugh score (p = 0.006) were independent predictors of PFS. In per-lesion analysis, one-month, six-month, one-year and two-year CR rates were 57.5%, 58.5%, 45.2%, and 33.3%, respectively, and the OR rates were 84.1%, 65.2%, 46.6%, and 33.3%, respectively. The cumulative two-year per-lesion tumor control rate was 36.2%, and the median time was 14.1 months. The Child-Pugh score (p < 0.001) was the only independent predictor of tumor control. Serious adverse events were reported in 11 patients (7.2%). Conclusion: DEE chemoembolization for nodular HCCs in the Korean population showed acceptable survival, tumor response, and safety profiles after a two-year follow-up. Good liver function (Child-Pugh score A5) was a key predictor of per-patient OS, PFS, and per-lesion tumor control.

Keywords

Acknowledgement

This study was supported, in the form of a grant and provision of drug-eluting embolics, by Biocompatibles UK (Farnham, United Kingdom).

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