Issues and controversies of hepatocellular carcinoma-targeted therapy clinical trials in Asia: experts' opinion.
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.
Chen
Pei-Jer
PJ
National Taiwan University Hospital, Taipei, Taiwan. peijer@ha.mc.ntu.edu.tw
Furuse
Junji
J
Han
Kwang-Hyub
KH
Hsu
Chiun
C
Lim
Ho-Yeong
HY
Moon
Hanlim
H
Qin
Shukui
S
Ye
Sheng-Long
SL
Yeoh
Ee-Min
EM
Yeo
Winnie
W
D000970:Antineoplastic Agents / Q000627:therapeutic use*; D044466:Asian People; D006528:Carcinoma, Hepatocellular / Q000188:drug therapy* / Q000208:ethnology / Q000209:etiology / Q000473:pathology; D002986:Clinical Trials as Topic; D019317:Evidence-Based Medicine; D006498:Hepatectomy; D006801:Humans; D008113:Liver Neoplasms / Q000188:drug therapy* / Q000208:ethnology / Q000209:etiology / Q000473:pathology; D016031:Liver Transplantation / Q000208:ethnology; D058990:Molecular Targeted Therapy; D009367:Neoplasm Staging; D010818:Practice Patterns, Physicians'; D012307:Risk Factors; D016896:Treatment Outcome
D000970:Antineoplastic Agents