Caren van Roekel

58 Chapter 2 Recently, two trials have compared radioembolization with sorafenib: the Study to Compare Selective Internal Radiation Therapy (SIRT) Versus Sorafenib in Locally Advanced Hepatocellular Carcinoma (SIRveNIB) and the SorAfenib Versus Radioembolization in Advanced Hepatocellular carcinoma (SARAH) trial (clinicaltrials.gov identifiers NCT01135056 and NCT01482442). The results of the SIRveNIB trial are not published yet, but they have been presented at an international congress. Both trials were developed to identify whether radioembolization improves OS compared to the standard treatment with sorafenib. The results from the SARAH trial showed no significant difference in OS (median OS 8.0 months for radioembolization and 9.9 months for sorafenib in the intention-to-treat groups, and median OS 9.9 months for radioembolization and 9.9 months for sorafenib in the per protocol analysis). Median progression- free survival was a bit longer for the radioembolization group (4.1 versus 3.7 months) but this was not significantly different. However, progression in the liver as first site was significantly lower in the radioembolization group (HR 0.72, 95% CI 0.56-0.93, p=0.01) and tumor response rate was significantly better (19% of evaluable patients in the radioembolization group achieved a complete or partial response, versus 12% of evaluable patients in the sorafenib group (p=0.04). Most important, the number of adverse events was lower with radioembolization and the quality of life over time was significantly better (Figure 11) (121). FIGURE 11. Quality of life (as depicted by the mean global health status subscore from the EORTC QLQ-C30 questionnaire) over time of patients treated in the SARAH trial. Reprinted with permission from Elsevier.