Y-90 Radioembolization Compared With Chemoembolization for Hepatocellular Carcinoma

August 31, 2016—Online ahead of print in Gastroenterology, Riad Salem, MD, et al published findings from a randomized, phase 2 study comparing the effects of treating patients with hepatocellular carcinoma (HCC) with conventional transarterial chemoembolization (cTACE) versus a minimally invasive radioembolization procedure using implanted radioactive micron-sized particles loaded with yttrium-90 (Y-90) inside the blood vessels that supply a tumor.

As summarized in Gastroenterology, from October 2009 through October 2015, the investigators reviewed patients with HCC of all Barcelona Clinic Liver Cancer (BCLC) stages for eligibility. Of these, 179 patients with BCLC stages A or B met the enrollment criteria and were candidates for cTACE or Y-90 therapy.

Patients were randomly assigned to groups receiveing either Y-90 therapy (n = 24, 50% Child-Pugh A) or cTACE (n = 21, 71% Child-Pugh A). The primary outcome was time to progression (TTP), which was evaluated by intention-to-treat analysis. Secondary outcomes included safety, rate of response (based on tumor size and necrosis criteria), and Kaplan-Meier survival time. The investigators performed inverse probability of censoring weighting and competing risk analyses.

The investigators reported that patients in the Y-90 radioembolization group had significantly longer median TTP (> 26 months) than patients in the cTACE group (6.8 months; P = .0012) (hazard ratio, 0.122; 95% confidence interval [CI], 0.027–0.557; P = .007). This was confirmed by competing risk and inverse probability of censoring weighting analyses accounting for transplantation or death. 

A significantly greater proportion of patients developed diarrhea in the cTACE group than in the Y-90 group (21% vs 0%; P = .031) and developed hypoalbuminemia (58% vs 4%; P < .001). Similar proportions of patients in each group had a response to therapy, marked by necrosis (74% in the cTACE group vs 87% in the Y-90 group; P = .433). Median survival time, censored to liver transplantation, was 17.7 months for the cTACE group (95% CI, 8.3–not calculable) versus 18.6 months for the Y-90 group (95% CI, 7.4–32.5; P = .99).

In this randomized phase 2 study of patients with HCC of BCLC stages A or B, Y-90 radioembolization was found to provide significantly longer TTP than cTACE and provides better tumor control and could reduce dropout from transplant waitlists, concluded the investigators in Gastroenterology.

In comments to Endovascular Today, study investigator Robert J. Lewandowski, who is affiliated with the Department of Radiology, Section of Interventional Radiology, and the Department of Medicine, Division of Hematology and Oncology at Northwestern University in Chicago, Illinois, stated, "At Northwestern, we are actively engaged in research addressing clinical questions.​ We are happy to be the first to provide level 1 evidence comparing Y-90 with different embolotherapies. Our study demonstrated a dramatic reduction in the risk of progression after Y-90 compared to the gold standard conventional chemoembolization (88%). This finding is relevant particularly in the transplant patient population, where the ability to prevent progression is intimately associated with remaining on the transplant list. We have implemented these findings into our local practice, and it appears many other centers have as well. From a big picture standpoint, we interpret these findings as a significantly improved ability to control local disease with outpatient Y-90 when compared to chemoembolization, making this an attractive option for our patients."