80 European Network on Radioembolisation With 90y-Resin Microspheres (Enry) Multicentre Evaluation of Survival, Safety and Liver Function for Unresectable Hepatocellular Carcinoma (Hcc)

Radioembolization for Hepatocellular Carcinoma: Evidence-Based Answers to Frequently Asked Questions

“…Tumor response rates vary from 20% [25] to 42% [26] for glass microspheres, and from 23% [27] to 44% [28] for resin microspheres. Overall survival was remarkably similar when patients were stratified by tumor stage in two of the largest series of patients with HCC studied so far (Figure 2) [26,29,30].…”

“…Despite the higher chance for reduced microsphere availability and relevant liver toxicity, there is now good evidence from large studies to show that radioembolization can be safely and effectively performed in cirrhotic patients with HCC. Response rates are consistently in the range of 30% to 50% [4] and overall survival following radioembolization was not significantly different in patients with cirrhotic and non-cirrhotic livers (Hazard ratio: 1.26 [95% confidence interval [CI] 0.89 -1.77; p=0.19]) [29].…”

“…In fact, an analysis of a large cohort of 680 patients treated with resin microspheres worldwide found that the injected activity was only slightly inferior to prescribed activity (prescribed: 1.2 ± 0.6 GBq; administered: 1.1 ± 0.6) [23]. It could also be argued that for the same reason it would be difficult to administer the full prescribed activity to small single lesions with resin microspheres or that the number of radiation sources would be TAE) or were poor candidates for TACE [29]. Sorafenib (SHARP): patients randomized to the sorafenib arm in the SHARP trial [42].…”

“…Radioembolization-induced liver disease, defined as jaundice and ascites appearing 4 to 8 weeks after radioembolization in the absence of clear tumor progression, was described as Grade 4 in 2.5% of HCC patients treated in a single institution [34] and grade 3 increases in bilirubin (according to CTCAE [35]) were described in less than 6% of patients in a European multicenter study independent of their basal tumor stage and treatment design [29]. The ratio of each of these three subgroups differs with each published series [18,36,37].…”

“…a : HCV only; b : aprox (as per the text); c p=0.232; d p=0.014; e p=0.7 radioembolization compared with broadly matched patients allocated to TACE (Table 1). In other case series evaluations analyzed by BCLC (Barcelona Clinic Liver Cancer) stage of disease for treatment using TACE (n=172) [39], 90 Y-glass microspheres (n=291) [5] or 90 Y-resin microspheres (n=325) [29], the following median overall survivals in months (95% CI) were reported in early (BCLC stage A) disease: 40 (12.8-22.8) and advanced (BCLC stage C) disease: 6.6 (4-9.3), 7.3 (6.5-10.1) for glass microspheres in patients with no extra-hepatic disease and 5.4 (2.7-7.5) in those with extra-hepatic disease, and 10.0 (7.7-10.9), respectively. The overlapping confidence intervals indicate that radioembolization and TACE have broadly similar benefits in terms of overall survival.…”