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A meta-analysis of survival rates of untreated patients in randomized clinical trials of hepatocellular carcinoma†
Article first published online: 4 DEC 2009
Copyright © 2009 American Association for the Study of Liver Diseases
Volume 51, Issue 4, pages 1274–1283, April 2010
How to Cite
Cabibbo, G., Enea, M., Attanasio, M., Bruix, J., Craxì, A. and Cammà, C. (2010), A meta-analysis of survival rates of untreated patients in randomized clinical trials of hepatocellular carcinoma. Hepatology, 51: 1274–1283. doi: 10.1002/hep.23485
Potential conflict of interest: Nothing to report.
- Issue published online: 26 MAR 2010
- Article first published online: 4 DEC 2009
- Accepted manuscript online: 4 DEC 2009 12:00AM EST
- Manuscript Accepted: 16 NOV 2009
- Manuscript Received: 8 AUG 2009
Knowing the spontaneous outcome of hepatocellular carcinoma (HCC) is important for designing randomized controlled trials (RCTs) of new therapeutic approaches; however, survival of patients in the absence of treatment is highly variable, and prognostic factors influencing outcomes are incompletely defined. The aims of this meta-analysis were to estimate the 1-year and 2-year survival rates of untreated HCC patients enrolled in RCTs of palliative treatments, and to identify prognostic factors. RCTs evaluating therapies for HCC with placebo or no-treatment arms were identified on MEDLINE through April 2009. Data were combined in a random effect model. Primary outcomes were 1-year and 2-year survival. Thirty studies met the inclusion criteria. The pooled estimates of the survival rates were 17.5% at 1 year (95% confidence interval [95%CI], 11%-27%; range, 0%-75%) and 7.3% at 2 years (95%CI, 3.9%-13%; range, 0%-50%). Heterogeneity among studies was highly significant (P < 0.0001) both for 1-year and 2-year survival, and persisted when RCTs were stratified according to all patient and study features. Through meta-regression, impaired performance status, Child-Pugh B-C class, and presence of portal vein thrombosis were all independently associated with shorter survival. Ascites was strongly linked to a worse outcome in intermediate/advanced Barcelona Clinic Liver Cancer stages. Conclusion: This meta-analysis confirms the heterogeneity of behavior of untreated HCC and provides a sound basis for stratifying patients with HCC according to expected survival in future trials of new anti-cancer agents. (HEPATOLOGY 2010.)