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

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57 Citations (Scopus)

Abstract

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 (166Ho)/chitosan complex injection (PHI) therapy for small hepatocellular carcinoma as a local ablative treatment. 166Ho is a radioactive isotope derived from natural hotmium-165. We developed a 166Ho/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.

Original languageEnglish
Pages (from-to)543-548
Number of pages6
JournalClinical Cancer Research
Volume12
Issue number2
DOIs
Publication statusPublished - 2006 Jan 15

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Hepatocellular Carcinoma
Clinical Trials
Injections
Chitosan
Neoplasms
Therapeutics
Korea
Radioisotopes
(166)holmium-chitosan complex
Hospitalization
Research Design
Necrosis
Survival Rate
Transplantation
Bone Marrow
Safety
Recurrence
Pharmaceutical Preparations
Population

All Science Journal Classification (ASJC) codes

  • Oncology
  • Cancer Research

Cite this

Kim, Ja Kyung ; Han, Kwang Hyub ; Lee, Jong Tae ; Paik, Yong Han ; Ahn, Sang Hoon ; Lee, Jong Doo ; Lee, Kwan Sik ; Chon, Chae Yoon ; Moon, Young Myoung. / 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. In: Clinical Cancer Research. 2006 ; Vol. 12, No. 2. pp. 543-548.
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abstract = "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 (166Ho)/chitosan complex injection (PHI) therapy for small hepatocellular carcinoma as a local ablative treatment. 166Ho is a radioactive isotope derived from natural hotmium-165. We developed a 166Ho/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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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. / Kim, Ja Kyung; Han, Kwang Hyub; Lee, Jong Tae; Paik, Yong Han; Ahn, Sang Hoon; Lee, Jong Doo; Lee, Kwan Sik; Chon, Chae Yoon; Moon, Young Myoung.

In: Clinical Cancer Research, Vol. 12, No. 2, 15.01.2006, p. 543-548.

Research output: Contribution to journalArticle

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T1 - 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

AU - Kim, Ja Kyung

AU - Han, Kwang Hyub

AU - Lee, Jong Tae

AU - Paik, Yong Han

AU - Ahn, Sang Hoon

AU - Lee, Jong Doo

AU - Lee, Kwan Sik

AU - Chon, Chae Yoon

AU - Moon, Young Myoung

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Y1 - 2006/1/15

N2 - 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 (166Ho)/chitosan complex injection (PHI) therapy for small hepatocellular carcinoma as a local ablative treatment. 166Ho is a radioactive isotope derived from natural hotmium-165. We developed a 166Ho/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.

AB - 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 (166Ho)/chitosan complex injection (PHI) therapy for small hepatocellular carcinoma as a local ablative treatment. 166Ho is a radioactive isotope derived from natural hotmium-165. We developed a 166Ho/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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