13 April 2018, Paris, France: The final results of the palliative cohort of the SORAMIC study in patients with unresectable, locally advanced primary liver cancer have confirmed no clinical advantage to adding selective internal radiation therapy (SIRT) to standard sorafenib treatment compared with using sorafenib alone. However, although the overall survival rates in the total patient population did not differ significantly between treatment groups, subgroup analyses suggested possible survival benefits with adding SIRT to sorafenib in some patient groups.
'SORAMIC is the first large, randomized controlled trial to compare the efficacy and safety of combining liver-directed SIRT and sorafenib with using sorafenib alone', explained study director, Prof. Dr Jens Ricke from the Ludwig-Maximilians-University in Munich, Germany, who presented the results today at The International Liver Congress™ 2018 in Paris, France. 'Although we were disappointed to find no overall survival benefit of adding SIRT to sorafenib across the entire study population, we did observe a survival benefit in younger patients, those with a non-alcoholic aetiology of the cirrhosis, and those with no cirrhosis at all'.
Hepatocellular carcinoma (HCC) is the most common form of primary liver cancer and the second most common cause of cancer-related death.1,2 HCC can be treated surgically by resection or transplantation, however, many patients are not candidates for surgical interventions and, for these patients, the prognosis remains poor.1 Sorafenib is the standard, first-line systemic therapy for individuals with advanced HCC,1 with the SHARP study demonstrating an increased median overall survival from 7.9 months to 10.7 months with sorafenib treatment compared with placebo in this population.3
The SORAMIC (SORAfenib in combination with local MICro-therapy guided by gadolinium-EOB-DTPA-enhanced MRI; NCT01126645) study was initiated in February 2010 and comprises three separate diagnostic, local ablation, and palliative sub-studies.4 The palliative sub-study presented today randomized 424 patients with inoperable HCC who were not candidates for transarterial chemoembolization (TACE) to receive treatment with either SIRT with yttrium-90 resin microspheres (SIR-Spheres®) plus sorafenib (target dose 400 mg bid) or sorafenib alone. The primary endpoint of the study was overall survival (OS) in the intention-to-treat population.
As Prof. Dr Ricke reported, the median OS was 12.1 months (95% CI: 10.6, 14.6) in the SIRT + sorafenib arm (n=216) and 11.5 months (95% CI: 9.8, 13.9) in the sorafenib arm (n=208) (HR: 1.01; 95% CI: 0.82, 1.25; p=0.93). In the per-protocol group, the median OS was 14.1 months (95% CI: 10.9, 16.4) in the SIRT + sorafenib arm (n=114) and 11.1 months (95% CI: 9.7, 13.9) in the sorafenib arm (n=174) (HR: 0.86; 95% CI: 0.67, 1.11; p=0.25).
A subgroup analysis of the per-protocol population in this study revealed a survival benefit of SIRT + sorafenib for patients ?65 years of age (HR: 0.652), those with a non-alcoholic aetiology of the cirrhosis (HR: 0.632), and those with no cirrhosis (HR: 0.465). Adverse events grade 3 or higher were reported in 115/159 (72.3%) patients in the SIRT + sorafenib arm and in 135/197 (68.5%) patients in the sorafenib arm.
'There remains a significant unmet need for new treatment approaches in patients with unresectable HCC, and SIRT had shown promising results in previous, non-randomized studies',5,6 said Prof. Dr Ricke. 'We believe our results have generated some very interesting new hypotheses in terms of the types of HCC patients that might benefit from combination therapy of SIRT and sorafenib, and we hope to explore these further in the future'. 'The SORAMIC trial is the first reported randomized controlled trial evaluating the survival benefit of adding SIRT to sorafenib in unresectable, locally advanced HCC not suitable for TACE', said Prof. Alejandro Forner from the Hospital Clinic Barcelona, Spain, and EASL Governing Board Member. 'Regrettably, the study failed to meet the primary endpoint and the addition of SIRT to sorafenib did not show an overall survival that was superior to sorafenib alone. Further studies are needed to identify which specific population might benefit from this treatment approach'.
About The International Liver Congress™
This annual congress is the biggest event in the EASL calendar, attracting scientific and medical experts from around the world to learn about the latest in liver research. Attending specialists present, share, debate and conclude on the latest science and research in hepatology, working to enhance the treatment and management of liver disease in clinical practice. This year, the congress is expected to attract approximately 10,000 delegates from all corners of the globe. The International Liver Congress™ 2018 will take place from 11¬-15 April 2018 at the Paris Convention Centre, Paris, France.
About The European Association for the Study of the Liver (EASL)
Since its foundation in 1966, this not-for-profit organization has grown to over 4,000 members from all over the world, including many of the leading hepatologists in Europe and beyond. EASL is the leading liver association in Europe, having evolved into a major European association with international influence, and with an impressive track record in promoting research in liver disease, supporting wider education and promoting changes in European liver policy.
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Onsite location reference
Session title: Late breaker session
Time, date and location of session: 14. April 2018, 05:00 PM - 05:15 PM, Main Plenary
Presenter: Jens Ricke, Germany
Abstract: The impact of combining selective internal radiation therapy (SIRT) with sorafenib on overall survival in patients with advanced
hepatocellular carcinoma: The SORAMIC trial palliative cohort (5449)
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2. Ferlay J, et al. Cancer incidence and mortality worldwide: sources, methods and major patterns in GLOBOCAN 2012. Int J Cancer. 2015;136(5):E359-86.
3. Llovet JM, et al. Sorafenib in advanced hepatocellular carcinoma. N Engl J Med. 2008;359(4):378-90.
4. National Institutes of Health, US National Library of Medicine: ClinicalTrials.gov. Sorafenib and Micro-therapy Guided by Primovist Enhanced MRI in Patients With Inoperable Liver Cancer (SORAMIC). Available from: https:/
5. Salem R, et al. Radioembolization for hepatocellular carcinoma using yttrium-90 microspheres: a comprehensive report of long-term outcomes. Gastroenterology. 2010;138(1):52-64.
6. Sangro B, et al. Survival after yttrium-90 resin microsphere radioembolization of hepatocellular carcinoma across Barcelona clinic liver cancer stages: a European evaluation. Hepatology. 2011;54(3):868-78. ?