Issues and controversies of hepatocellular carcinoma-targeted therapy clinical trials in Asia

Experts'opinion

Pei Jer Chen, Junji Furuse, KwangHyub Han, Chiun Hsu, Ho Yeong Lim, Han Lim Moon, Shukui Qin, Sheng Long Ye, Ee Min Yeoh, Winnie Yeo

Research output: Contribution to journalReview article

29 Citations (Scopus)

Abstract

Asia has a disproportionate share of the world's burden of hepatocellular carcinoma (HCC). However, the highly regarded clinical practice guidelines and recommendations for the design and conduct of clinical trials for HCC largely reflect Western practice. In order to design mutually beneficial international clinical trials of promising targeted therapies, it is imperative to understand how the aetiology, staging and treatment of HCC differ between Asian and Western countries. Our group, comprising experts in oncology and hepatology from countries that constitute the Eastern Asian region, convened to compare and contrast our current practices, evaluate potential compliance with the clinical trial recommendations, and offer suggestions for modifications that would enhance international collaboration. Here, we describe the results of our discussions, including recommendations for appropriate patient stratification based on potentially important differences in HCC aetiology, identification of practices that may confound interpretation of clinical trial outcomes (traditional Chinese medicine; antivirals that target hepatitis B virus; heterogeneous embolization procedures), suggestions for utilizing a common staging system in study protocols, recognition that sorafenib usage is limited by financial constraints and potentially increased toxicity in Asian patients, and expansion of patient populations that should be eligible for initial clinical trials with new agents.

Original languageEnglish
Pages (from-to)1427-1438
Number of pages12
JournalLiver International
Volume30
Issue number10
DOIs
Publication statusPublished - 2010 Jan 1

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Expert Testimony
Hepatocellular Carcinoma
Clinical Trials
Therapeutics
Chinese Traditional Medicine
Gastroenterology
Practice Guidelines
Hepatitis B virus
Antiviral Agents
Population

All Science Journal Classification (ASJC) codes

  • Hepatology

Cite this

Chen, Pei Jer ; Furuse, Junji ; Han, KwangHyub ; Hsu, Chiun ; Lim, Ho Yeong ; Moon, Han Lim ; Qin, Shukui ; Ye, Sheng Long ; Yeoh, Ee Min ; Yeo, Winnie. / Issues and controversies of hepatocellular carcinoma-targeted therapy clinical trials in Asia : Experts'opinion. In: Liver International. 2010 ; Vol. 30, No. 10. pp. 1427-1438.
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abstract = "Asia has a disproportionate share of the world's burden of hepatocellular carcinoma (HCC). However, the highly regarded clinical practice guidelines and recommendations for the design and conduct of clinical trials for HCC largely reflect Western practice. In order to design mutually beneficial international clinical trials of promising targeted therapies, it is imperative to understand how the aetiology, staging and treatment of HCC differ between Asian and Western countries. Our group, comprising experts in oncology and hepatology from countries that constitute the Eastern Asian region, convened to compare and contrast our current practices, evaluate potential compliance with the clinical trial recommendations, and offer suggestions for modifications that would enhance international collaboration. Here, we describe the results of our discussions, including recommendations for appropriate patient stratification based on potentially important differences in HCC aetiology, identification of practices that may confound interpretation of clinical trial outcomes (traditional Chinese medicine; antivirals that target hepatitis B virus; heterogeneous embolization procedures), suggestions for utilizing a common staging system in study protocols, recognition that sorafenib usage is limited by financial constraints and potentially increased toxicity in Asian patients, and expansion of patient populations that should be eligible for initial clinical trials with new agents.",
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Chen, PJ, Furuse, J, Han, K, Hsu, C, Lim, HY, Moon, HL, Qin, S, Ye, SL, Yeoh, EM & Yeo, W 2010, 'Issues and controversies of hepatocellular carcinoma-targeted therapy clinical trials in Asia: Experts'opinion', Liver International, vol. 30, no. 10, pp. 1427-1438. https://doi.org/10.1111/j.1478-3231.2010.02292.x

Issues and controversies of hepatocellular carcinoma-targeted therapy clinical trials in Asia : Experts'opinion. / Chen, Pei Jer; Furuse, Junji; Han, KwangHyub; Hsu, Chiun; Lim, Ho Yeong; Moon, Han Lim; Qin, Shukui; Ye, Sheng Long; Yeoh, Ee Min; Yeo, Winnie.

In: Liver International, Vol. 30, No. 10, 01.01.2010, p. 1427-1438.

Research output: Contribution to journalReview article

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AU - Chen, Pei Jer

AU - Furuse, Junji

AU - Han, KwangHyub

AU - Hsu, Chiun

AU - Lim, Ho Yeong

AU - Moon, Han Lim

AU - Qin, Shukui

AU - Ye, Sheng Long

AU - Yeoh, Ee Min

AU - Yeo, Winnie

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Y1 - 2010/1/1

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AB - Asia has a disproportionate share of the world's burden of hepatocellular carcinoma (HCC). However, the highly regarded clinical practice guidelines and recommendations for the design and conduct of clinical trials for HCC largely reflect Western practice. In order to design mutually beneficial international clinical trials of promising targeted therapies, it is imperative to understand how the aetiology, staging and treatment of HCC differ between Asian and Western countries. Our group, comprising experts in oncology and hepatology from countries that constitute the Eastern Asian region, convened to compare and contrast our current practices, evaluate potential compliance with the clinical trial recommendations, and offer suggestions for modifications that would enhance international collaboration. Here, we describe the results of our discussions, including recommendations for appropriate patient stratification based on potentially important differences in HCC aetiology, identification of practices that may confound interpretation of clinical trial outcomes (traditional Chinese medicine; antivirals that target hepatitis B virus; heterogeneous embolization procedures), suggestions for utilizing a common staging system in study protocols, recognition that sorafenib usage is limited by financial constraints and potentially increased toxicity in Asian patients, and expansion of patient populations that should be eligible for initial clinical trials with new agents.

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SP - 1427

EP - 1438

JO - Liver International

JF - Liver International

SN - 1478-3223

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