期刊
CONTEMPORARY CLINICAL TRIALS
卷 31, 期 1, 页码 55-61出版社
ELSEVIER SCIENCE INC
DOI: 10.1016/j.cct.2009.08.002
关键词
Hepatocellular carcinoma; Placebo/supportive care; Randomized controlled trial; Systemic therapy; Meta-analysis; Meta-regression
资金
- Ministry of Education, Taiwan [9580066-BM01-02]
- National Science Council, Taiwan [NSC-96-3112-B-002-036, NSC-97-3112-B-002-012, NSC98-3112-B-002-007, NSC98-3112-B-002-037]
- Liver Disease Prevention and Treatment Research Foundation, Taiwan
- New Century Health Care Promotion Foundation, Taiwan
In clinical trials of systemic therapy for advanced hepatocellular carcinoma (HCC), Asian trials almost always reported poorer survival than non-Asian trials. This study sought to identify contributory factors for this geographic difference. A systematic review was done on randomized trials for unresectable HCC that used systemic therapy as an experimental arm and placebo or supportive care as control. Meta-analysis was performed with the consideration of fixed and random effects. Then, meta-regression was performed to identify predictors of patient survival in the control arm and the treatment effects (improvement in median survival). Fourteen trials (6 Asians, 8 non-Asians) were eligible for meta-analysis. The median survival of patients in the control arm, which indicated natural history of advanced HCC patients, was 3.57 +/- 1.88 months in Asian trials and 5.96 +/- 1.46 months in non-Asian trials (p=0.02). Independent predictors of better survival included non-Asian trials (p=0.0007), higher percentage of Child A cirrhosis (p=0.01) and hepatitis B (HBV)-related HCC (p=0.02). Sub-group analysis suggested that Asian trials tended to enroll patients with more advanced diseases. Independent predictors of better treatment effect included non-Asian trials, higher percentage of extra-hepatic metastasis, HBV-related HCC, and poorer trial quality. The quantitative estimation of the geographic difference can help design of future clinical trials of advanced HCC. (C) 2009 Elsevier Inc. All rights reserved.
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