Eastern asian expert panel opinion: Designing clinical trials of molecular targeted therapy for hepatocellular carcinoma
Journal
BMC Cancer
Journal Volume
10
Pages
620
Date Issued
2010
Author(s)
Abstract
The largest burden of hepatocellular carcinoma (HCC) lies in Asia, secondary to hepatitis B virus (HBV) infection. Improved survival with sorafenib has fostered new research but many challenges remain in designing clinical trials. The disease, its management, and populations affected by it are heterogeneous worldwide and within Asia. An expert conference of Eastern Asian oncologists and hepatologists was convened to foster consensus in clinical trial design. The panel identified key areas that need to be addressed to facilitate clinical trials in Asia. Stratification by viral etiology is desirable within Asia and by region in global trials. Antiviral therapy should also be considered as a stratification factor and incorporated into HCC management in trials. The panel agreed that histological diagnosis is not required for trial entry and that Barcelona-Clinic Liver Cancer (BCLC) staging is acceptable for trials as long as portal hypertension can be better defined with standardized methodology. Consensus in treatment must be sought to allow multi-national trials and it must be recognized that first-line sorafenib is not largely feasible in Asia. Finally, Asian nations must be urged to participate in clinical trials, many of which are ongoing, to advance new treatment options in this challenging disease.? 2010 Yeo et al; licensee BioMed Central Ltd.
SDGs
Other Subjects
1 [4 (3 amino 1h indazol 4 yl)phenyl] 3 (2 fluoro 5 methylphenyl)urea; antivirus agent; ave 1642; bevacizumab; bortezomib; brivanib; capecitabine; celecoxib; cisplatin; cytotoxic agent; docetaxel; doxorubicin; epirubicin; erlotinib; everolimus; fluorouracil; gemcitabine; interferon; lamivudine; mitomycin C; oxaliplatin; pazopanib; pi 88; placebo; sorafenib; sunitinib; thalidomide; UFT; unindexed drug; vandetanib; antiviral therapy; article; artificial embolism; Asian; bleeding disorder; cancer staging; Chinese medicine; clinical study; clinical trial; consensus development; continuous infusion; diarrhea; drug megadose; fatigue; feasibility study; foot disease; hand disease; heart left ventricle failure; hepatitis B; hepatitis C; Hepatitis C virus; human; hyponatremia; liver cell carcinoma; liver function test; low drug dose; medical expert; molecularly targeted therapy; neutropenia; portal hypertension; side effect; skin toxicity; thrombocytopenia; treatment planning; unspecified side effect; Asia; clinical trial (topic); liver cell carcinoma; liver tumor; methodology; oncology; Asia; Carcinoma, Hepatocellular; Clinical Trials as Topic; Humans; Liver Neoplasms; Medical Oncology; Molecular Targeted Therapy; Neoplasm Staging; Research Design
Publisher
BioMed Central Ltd.
Type
journal article