1. Prospective Multi-Center Korean Registry of Transcatheter Arterial Chemoembolization with Drug-Eluting Embolics for Nodular Hepatocellular Carcinoma: A Two-Year Outcome Analysis
- Author
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Kwang Hun Lee, Seung Moon Joo, Saebeom Hur, Myungsu Lee, Jin Wook Chung, Jung Suk Oh, Yoon Jun Kim, Gyoung Min Kim, In Joon Lee, Han Chu Lee, Ho Jong Chun, Jin Hyoung Kim, Jong Yun Won, and Hyo Cheol Kim
- Subjects
Drug ,medicine.medical_specialty ,Carcinoma, Hepatocellular ,Hepatocellular carcinoma ,media_common.quotation_subject ,Outcome analysis ,Intervention ,Gastroenterology ,030218 nuclear medicine & medical imaging ,03 medical and health sciences ,0302 clinical medicine ,Internal medicine ,Republic of Korea ,medicine ,Humans ,Radiology, Nuclear Medicine and imaging ,Prospective Studies ,Registries ,Chemoembolization, Therapeutic ,Adverse effect ,Transcatheter arterial chemoembolization ,media_common ,Tumor multiplicity ,Retrospective Studies ,business.industry ,Liver Neoplasms ,Drug-eluting beads ,Drug-eluting embolics ,medicine.disease ,Treatment Outcome ,Pharmaceutical Preparations ,Doxorubicin ,030220 oncology & carcinogenesis ,Population study ,Original Article ,Chemoembolization ,Liver function ,business - 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.
- Published
- 2021