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- W2318607209 abstract "The purpose of this study was to determine comparative effectiveness of conventional transarterial chemoembolization (cTACE) versus yttrium-90 (Y90) radioembolization for patients with unresectable hepatocellular carcinoma (HCC) considered ineligible for ablation in a randomized setting. A single-blind, randomized phase 2 single-center study was conducted from October 2009 to September 2015; 43 enrolled patients (median age 63.8 years; 72% male; 53% solitary HCC) with Barcelona Clinic Liver Cancer (BCLC) stage A/B, ECOG 0-2, Child-Pugh A/B, and no systemic therapy were randomly assigned to cTACE or Y90 (glass). Patients were followed for clinical and laboratory adverse events by CTCAE (v4) as well as baseline and follow-up imaging at 1mo and every 3mo thereafter. The primary outcome was time-to-progression (TTP) evaluated on intent-to-treat from the date of randomization. Secondary outcomes were safety, imaging response rates (WHO and EASL criteria), and overall survival. Serious (Grade 3+) clinical toxicities and objective response rates on follow-up imaging were similar across the two therapies. In total, 12 patients progressed, 15 died prior to liver transplant, and 19 received liver transplants. Median TTP was 6.4mo in the cTACE group (95% confidence interval [CI], 3.2-9.1), and not reached (95% CI, 14.5 – no estimate [NE]) in the Y90 group (p=0.0019). Median overall survival censored to liver transplant was 17.7mo (95% CI, 8.3-NE) and 23.8mo (95% CI, 18.6-NE) in these groups, respectively (p=0.9772). In BCLC A patients, 6/15 cTACE versus 13/18 Y90 received liver transplant (p=0.085) with a trend towards longer median time to transplant at 17.3mo for cTACE (95% CI, 6.8-NE) versus 9.1mo (95% CI, 6.6 to 11.3) after Y90 (p=0.0579). Y90 treatment resulted in significantly longer TTP when compared to cTACE in a randomized trial. Although improved TTP did not result in a significant difference in overall survival, our results translate to Y90 achieving better local tumor control and lower dropout from transplant listing when compared to the standard of care cTACE." @default.
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- W2318607209 date "2016-03-01" @default.
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- W2318607209 title "Prospective randomized phase 2 study of chemoembolization versus radioembolization in hepatocellular carcinoma: results from the PREMIERE trial" @default.
- W2318607209 doi "https://doi.org/10.1016/j.jvir.2015.12.168" @default.
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