The quality of evidence is downgraded by inconsistency (variability in results) and by Imprecise results (differences in criteria for assessing response).
A Cochrane review [Abstract] 1 included 9 studies with a total of 645 subjects evaluating efficacy and safety of TACE or TAE for unresectable hepatocellular carcinoma. Six trials assessed TACE versus control and three trials assessed TAE. Three trials were stopped early due to interim inspections and one due to slow accrual.
Meta-analysis of seven trials with low risk of selection bias showed that TACE or TAE versus control does not significantly increase survival (HR 0.88; 95% CI 0.71 to 1.10). Two trials with low risk of selection bias, no early stopping, and no co-intervention did not establish any significant effect of TACE or TAE on OS (HR 1.22, 95% CI 0.82 to 1.83). For all-cause mortality, statistical heterogeneity between trials was low to moderate (I2 = 30%). Substantial differences in criteria for assessing tumour response did not allow quantitative analyses. One trial investigated quality of life but did not detect any significant differences between the intervention groups. A range of adverse events including post-embolisation syndrome and serious complications were reported. Absence of evidence for a beneficial effect of TACE or TAE on survival indicates the need for future randomized trials.
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