Back to the science, for a change. Small study, but impressive...

Back to the science, for a change.
Small study, but impressive data compared to Sorafenib. Almost double the OS.
P-097
SIRT therapy with Yttrium-90 resin microspheres in patients with liver cirrhosis Child Pugh B7-9 and unresectable nonmetastatic hepatocellular cancer

J Eick   M Burbelko   M Plotkin   J Steinberg   W Ring   C Schwertner
Annals of Oncology, Volume 29, Issue suppl_5, 1 June 2018, mdy151.096, https://doi.org/10.1093/annonc/mdy151.096
Published:
20 June 2018

• Introduction: Treatment options of unresectable hepatocellular cancer (HCC) are limited. Drug therapy with sorafenib, regorafenib or lenvatinib was approved only for HCC-patients with good liver function, i.e. liver cirrhosis Child Pugh A. Sorafenib therapy in HCC-patients with Child Pugh B-cirrhosis results in a median overall survival of 5.2 months (GIDEON trial: Marrero J et al., J Hepatology 2016, 65: 1140–47). Yttrium-90 (Y-90) resin microspheres are effective in nonmetastatic HCC but have not been studied in advanced cirrhosis. We evaluated the safety and efficacy of Y-90 microspheres in HCC-patients with liver cirrhosis B7-9.

Methods: 12 patients (8 men, 4 women) with a median age of 64.5 years [range 44-83] suffering from both liver cirrhosis B7-B9 and unresectable nonmetastatic HCC were treated once or twice with Y-90 resin microspheres in our hospital in the years 2013-2017. In most patients alcohol abuse was the cause of liver cirrhosis. TACE was considered not to be effective in these patients. Our exclusion criteria for selective internal radiotherapy (SIRT) were either serum bilirubin >2.4 mg%, infiltration of the portal vein by tumor, portal vein thrombosis, extrahepatic metastasis, significant ascites, renal insufficiency, concurrent infection, uncontrolled bleeding or significant encephalopathy. Patients with bilobar HCC were scheduled for 2 separate unilobar SIRT sessions (1 right-sided, 1 left-sided, 4-6 weeks apart).
Results: All patients adhered well to therapy and follow-up. Y-90 resin microspheres were well tolerated by the patients. In 2 patients transient flares of AST and/or ALT and/or bilirubin were noted. Epigastric discomfort for 1-2 days was reported by 5 patients. 10 patients died due to progressive disease, 2 patients are still alive. At 3 months after 1st SIRT the disease control rate was 50%. A median overall survival of 10.0 [range 4-16] months as calculated from 1st unilobar application of Y-90 microspheres was observed at this interim analysis; mean overall survival (after SIRT) amounts now to 9.3 + 3.7 months (11.8 months for B7 and 7.5 months for B9 patients). Due to angiographic evaluation and ordering of Y-90 microspheres from overseas 4-6 weeks (without specific treatment) passed by between decision making and the first SIRT.
Conclusion: SIRT therapy is safe in patients with unresectable nonmetastatic HCC and liver cirrhosis Child Pugh B7-9, as the chosen exclusion criteria are respected. Overall survival of our patients is better than the one reported for sorafenib treatment in HCC-patients with liver cirrhosis B7-9 of the GIDEON trial. Thus, SIRT with Y-90 resin microspheres should be considered for patients with unresectable nonmetastatic HCC and liver cirrhosis B7-9, if our exclusion criteria are observed.