Issues and controversies of hepatocellular carcinoma-targeted therapy clinical trials in Asia: Experts'opinion
Journal
Liver International
Journal Volume
30
Journal Issue
10
Pages
1427-1438
Date Issued
2010
Author(s)
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. ? 2010 John Wiley & Sons A/S.
SDGs
Other Subjects
adefovir dipivoxil; antivirus agent; bevacizumab; brivanib; cisplatin; doxorubicin; entecavir; epirubicin; erlotinib; fluorouracil; interferon; lamivudine; linifanib; mitomycin C; pazopanib; sorafenib; sunitinib; vandetanib; alanine aminotransferase blood level; Asia; cancer radiotherapy; cancer surgery; cancer therapy; chemoembolization; Chinese medicine; clinical protocol; disease severity; hand foot skin reaction; hand foot syndrome; Hepatitis B virus; human; hyperbilirubinemia; liver cell carcinoma; liver transplantation; medical practice; microwave therapy; patient selection; prognosis; radiofrequency ablation; review; side effect; skin disease; transarterial embolization and chemoembolization; treatment outcome
Publisher
Blackwell Publishing Ltd
Type
review