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Long-term Clinical Outcome of Phase IIb Clinical Trial of Percutaneous Injection with Holmium-166/Chitosan Complex (Milican) for the Treatment of Small Hepatocellular Carcinoma

 Ja Kyung Kim  ;  Kwang-Hyub Han  ;  Jong Tae Lee  ;  Yong Han Paik  ;  Sang Hoon Ahn  ;  Jong Doo Lee  ;  Kwan Sik Lee  ;  Chae Yoon Chon  ;  Young Myoung Moon 
 CLINICAL CANCER RESEARCH, Vol.12(6) : 543-548, 2006 
Journal Title
Issue Date
Administration, Cutaneous ; Adult ; Aged ; Aged, 80 and over ; Carcinoma, Hepatocellular/radiotherapy* ; Chitosan/therapeutic use* ; Female ; Holmium/therapeutic use* ; Humans ; Liver Neoplasms/radiotherapy* ; Male ; Middle Aged ; Neoplasm Recurrence, Local/radiotherapy ; Radioisotopes/therapeutic use* ; Survival Rate ; Treatment Outcome
PURPOSE: The purpose of this study was to evaluate the long-term tumor response after phase IIb clinical study and the safety of percutaneous holmium-166 ((166)Ho)/chitosan complex injection (PHI) therapy for small hepatocellular carcinoma as a local ablative treatment. (166)Ho is a radioactive isotope derived from natural holmium-165. We developed a (166)Ho/chitosan complex (Milican, Dong Wha Pharmaceutical Co., Seoul, Korea) using chitosan as a vehicle to retain the radioactive material within the tumor.
EXPERIMENTAL DESIGN: Forty patients with single hepatocellular carcinoma < 3 cm in maximal diameter were enrolled in this study. The patients either had refused surgery or were poor surgical candidates and were treated with only single session of PHI.
RESULTS: Two months after PHI, complete tumor necrosis was achieved in 31 of 40 patients (77.5%) with hepatocellular carcinoma lesions < 3 cm and in 11 of 12 patients (91.7%) with hepatocellular carcinoma < 2 cm. Tumors recurred in 28 patients during the long-term follow-up period, of which 24 recurred at another intrahepatic site. The 1-year and 2-year cumulative local recurrence rates were 18.5% and 34.9%, respectively. The survival rates at 1, 2, and 3 years were 87.2%, 71.8%, and 65.3%, respectively. Transient bone marrow depression was serious adverse event requiring hospitalization in two patients.
CONCLUSIONS: PHI was found to be a safe and novel local ablative procedure for the treatment of small hepatocellular carcinoma and could be used as a bridge to transplantation. A phase III randomized active control trial is clearly warranted among a larger study population.
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1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
1. College of Medicine (의과대학) > Dept. of Nuclear Medicine (핵의학교실) > 1. Journal Papers
1. College of Medicine (의과대학) > Dept. of Radiology (영상의학교실) > 1. Journal Papers
Yonsei Authors
Paik, Yong Han(백용한)
Ahn, Sang Hoon(안상훈) ORCID logo https://orcid.org/0000-0002-3629-4624
Lee, Kwan Sik(이관식) ORCID logo https://orcid.org/0000-0002-3672-1198
Lee, Jong Doo(이종두)
Lee, Jong Tae(이종태)
Chon, Chae Yoon(전재윤)
Han, Kwang-Hyub(한광협) ORCID logo https://orcid.org/0000-0003-3960-6539
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