SARAH and SIRveNIB investigators to undertake combined prospective meta-analysis

Microcatheter releasing microspheres

Liver cancer researchers from France and Singapore collaborate on a prospective meta-analysis of two studies of Y-90 resin microspheres vs. sorafenib in patients with unresectable hepatocellular carcinoma.

Researchers from Assistance Publique – Hôpitaux de Paris (AP-HP) and The Asia-Pacific Hepatocellular Carcinoma Trials Group (AHCC), National Cancer Centre Singapore (NCCS) and Singapore Clinical Research Institute (SCRI) announced that they will collaborate on a prospective meta-analysis that will combine the impending results of two large, randomised controlled studies of Y-90 resin microspheres vs. sorafenib. The two studies, which have completed patient recruitment, enrolled approximately 800 patients with advanced primary liver cancer.

The French HCC study, called SARAH, sponsored by AP-HP with the financial support of the company Sirtex, and the Singapore HCC study, called SIRveNIB (AHCC protocol 06), which also received financial support from Sirtex, use similar research designs to compare the efficacy, safety profiles and quality of life of selective internal radiation therapy (SIRT) with liver-directed Y-90 resin microspheres and sorafenib, a systemic chemotherapy treatment that is the current standard of care in advanced hepatocellular carcinoma. Hepatocellular carcinoma patients enrolled in SARAH and SIRveNIB were ineligible for potentially curative therapies, such as surgical resection, ablation or liver transplantation and had either failed or were unsuitable for treatment with transarterial chemoembolization.

Pierce Chow, principal investigator of the SIRveNIB study, and senior consultant surgeon at the National Cancer Centre Singapore and the Singapore General Hospital, explained: “As we stated when we first announced completion of enrolment in SIRveNIB, the search for more effective and better tolerated treatments of hepatocellular carcinoma is important because so few proven treatment options currently exist. Our study enrolled more than 360 patients from 27 specialist centres in 10 Asia-Pacific countries. While our data will be reported independently, the opportunity to combine these data in a prospective meta-analysis with the results of the French SARAH study presents a compelling scientific undertaking across a much larger patient population that will significantly increase the data available for various pre-planned statistical analyses, including overall survival. This should provide physicians who treat hepatocellular carcinoma with even greater certainty of the applicability of our results in the treatment of this increasingly common and deadly cancer.”

Valérie Vilgrain, principal investigator of the SARAH study, head of Department of Radiology, Beaujon Hospital AP-HP, and professor at the Université Paris Diderot, Sorbonne Paris Cité, France, said: “The SARAH study was conducted in more than 25 specialist centres throughout France and is expected to report results in the first half of 2017. While we will also report the results of SARAH independently, we believe a prospective meta-analysis of our findings combined with those of the SIRveNIB study may be very compelling. Hepatocellular carcinoma in France and most of Europe is found in patients whose livers have become cirrhotic primarily from the Hepatitis C virus and alcohol misuse, while the majority of hepatocellular carcinoma cases in Asia are triggered initially by the Hepatitis B virus. Thus, our prospective meta-analysis will provide safety and efficacy data on patients who presented with a full range of the major hepatocellular carcinoma aetiologies, potentially increasing the clinical applicability of the study results.”

Results of the prospective meta-analysis are expected to be available in 2017. In the interim, further details regarding the methodological and statistical approach to the meta-analysis are to be published in a peer-reviewed journal.