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|Description: 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;51:1274-1283.)