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Clinical Trial
. 2016 Dec;151(6):1155-1163.e2.
doi: 10.1053/j.gastro.2016.08.029. Epub 2016 Aug 27.

Y90 Radioembolization Significantly Prolongs Time to Progression Compared With Chemoembolization in Patients With Hepatocellular Carcinoma

Riad Salem  1 , Andrew C Gordon  2 , Samdeep Mouli  2 , Ryan Hickey  2 , Joseph Kallini  2 , Ahmed Gabr  2 , Mary F Mulcahy  3 , Talia Baker  4 , Michael Abecassis  4 , Frank H Miller  5 , Vahid Yaghmai  5 , Kent Sato  2 , Kush Desai  2 , Bartley Thornburg  2 , Al B Benson  3 , Alfred Rademaker  6 , Daniel Ganger  7 , Laura Kulik  7 , Robert J Lewandowski  8
Affiliations
Clinical Trial

Y90 Radioembolization Significantly Prolongs Time to Progression Compared With Chemoembolization in Patients With Hepatocellular Carcinoma

Riad Salem et al. Gastroenterology. 2016 Dec.

Abstract

Background & aims: Conventional transarterial chemoembolization (cTACE) is used to treat patients with hepatocellular carcinoma (HCC). Radioembolization is a minimally invasive procedure that involves implantation of radioactive micron-sized particles loaded with yttrium-90 (Y90) inside the blood vessels that supply a tumor. We performed a randomized, phase 2 study to compare the effects of cTACE and Y90 radioembolization in patients with HCC.

Methods: From October 2009 through October 2015, we 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 our enrollment criteria and were candidates for cTACE or Y90 therapy. Patients were assigned randomly to groups that received Y90 therapy (n = 24; 50% Child-Pugh A) or cTACE (n = 21; 71% Child-Pugh A). The primary outcome was time to progression (TTP), 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. We performed inverse probability of censoring weighting and competing risk analyses.

Results: Patients in the Y90 radioembolization group had significant longer median TTP (>26 mo) than patients in the cTACE group (6.8 mo; 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 in the cTACE group developed diarrhea (21%) than in the Y90 group (0%; P = .031) or hypoalbuminemia (58% in the cTACE group vs 4% in the Y90 group; 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 Y90 group) (P = .433). The median survival time, censored to liver transplantation, was 17.7 months for the cTACE group (95% CI, 8.3-not calculable) vs 18.6 months for the Y90 group (95% CI, 7.4-32.5) (P = .99).

Conclusions: In a randomized phase 2 study of patients with HCC of BCLC stages A or B, we found Y90 radioembolization to provide significantly longer TTP than cTACE. Y90 radioembolization provides better tumor control and could reduce drop-out from transplant waitlists. ClinicalTrials.gov no. NCT00956930.

Keywords: Chemoembolization; Liver Cancer; Radioembolization; Randomized Trial.

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Conflict of interest statement

Declaration of Interest: RJL, LK, RS serve as advisors to BTG. None of the other authors report a conflict of interest.

Figures

Figure 1
Figure 1
CONSORT Study Flowchart.
Figure 2
Figure 2
Time-to-progression.
Figure 3
Figure 3
Waterfall plot of maximum size change for WHO measurements in (n=42) primary index lesions after Y90 (black bars) versus cTACE (white bars). Negative values represent reductions in tumor size with ≥50% reduction (−) defined as partial response and >25% increase (+) in size progressive disease.
Figure 4
Figure 4
Overall survival from randomization censored to liver transplantation.
See this image and copyright information in PMC

Comment in

References

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