Clinical studies in HCC
Two large studies of SIR-Spheres® Y-90 resin microspheres in primary liver cancer reported results in 2017.
The SARAH trial in Europe and the SIRveNIB trial in Asia compared the efficacy and safety of SIR-Spheres Y-90 resin microspheres with sorafenib, a cancer medication that is the standard therapy for advanced HCC.
The results from the SARAH study1 were presented at the International Liver Congress in late April 2017, while the results of SIRveNIB2 were presented in June 2017 at the annual meeting of the American Society of Clinical Oncology (ASCO).
In addition to these two studies, directly comparing one treatment against the other, a third large European study called SORAMIC compared treatment of HCC with SIR-Spheres Y-90 resin microspheres followed by sorafenib to treatment with sorafenib alone. Results from SORAMIC3 were presented at the International Liver Congress in April 2018.
What is the SARAH study and what did it show?
The SARAH study directly compared the efficacy of one or two treatments with SIR-Spheres Y-90 resin microspheres versus a twice-daily dose of sorafenib. With 459 patients treated in 25 clinical centres across France, SARAH is the largest randomised study ever to compare SIRT against the standard-of-care systemic therapy for primary liver cancer.
The SARAH study showed clearly that, in patients with locally-advanced and inoperable HCC, treatment with SIR-Spheres Y-90 resin microspheres was better tolerated and resulted in significantly less frequent and serious side effects and better quality of life. It did not show a significant benefit in overall survival compared to patients who received two daily doses of sorafenib.
What is the SIRveNIB study and what did it show?
The 360-patient SIRveNIB study directly compared the efficacy of one treatment with SIR-Spheres Y-90 resin microspheres versus a twice-daily dose of sorafenib in an Asian population.
The findings of SIRveNIB essentially mirrored the findings of the SARAH study showing that, in patients with locally-advanced and inoperable HCC, treatment with SIR-Spheres Y-90 resin microspheres was better tolerated and resulted in significantly less frequent and serious side effects. It did not show a significant benefit in overall survival compared to patients who received two daily doses of sorafenib. In addition the SIRveNIB study demonstrated that the treatments with SIRT extended the time before tumours in the liver start to grow again.
Based on these results, SIRT is a treatment option that may be offered to patients with advanced HCC. Only your hepatologist or medical oncologist, in consultation with the multidisciplinary team, can assess if SIRT is right for you. Please contact your treating doctor to learn more about SIRT and the results of the SARAH and SIRveNIB studies.
What is the SORAMIC study and what did it show?
The 424-patient SORAMIC study directly compared treatment of HCC with SIR-Spheres Y-90 resin microspheres followed by sorafenib to treatment with sorafenib alone.
The study did not show a significant benefit in overall survival compared to patients who received sorafenib alone in the whole population. However, for patients who received both treatments per-protocol there was a trend in improvement in median overall survival of 3 months with the addition of SIR-Spheres Y-90 resin microspheres (median OS per protocol 14.1 in SIRT + sorafenib arm (n=114) vs. 11.1 months in the sorafenib arm (n=174)).
We now have a better understanding of which HCC patients might benefit most from treatment with SIR-Spheres Y-90 resin microspheres either alone or in combination with sorafenib. It is already understood that not all patients are eligible for SIRT.
SARAH and SIRveNIB studies showed that patients treated with SIR-Spheres had a better quality of survival versus sorafenib hence providing a better tolerated treatment alternative.
Worldwide HCC Patient survey
In order to better understand the experiences and needs of patients with hepatocellular carcinoma (HCC) along their patient journey, Sirtex supported a global partnership of patient advocacy organisations and medical centres to conduct the first world survey of patients living with HCC. The results, including responses from almost 300 patients, were presented at the World Congress of GastroIntestinal Cancers in late June 2017 and published in Future Oncology early 2018.4 The main findings were that most patients with HCC lack accessible information and that people with incurable HCC require treatments that preserve Quality of Life.
1. Vilgrain V et al. Lancet Oncol 2017; 18: 1624–36.
2. Chow PKH et al. J Clin Oncol 2018; 36: 1913-21.
3. Ricke J et al. J Hepatol 2018; 68 (Suppl 1): Abs. LBO-005.
4. Gill J et al. Future Oncol 2018 ; 14: 1701-10.