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

By R. Salem, A. Gordon, S. Mouli, R. Hickey, J. Kallini, A. Gabr, M. Mulcahy, Talia B. Baker, Michael M. Abecassis, F. Miller and 9 more. Gastroenterology, 2016

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Background and 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 randomly assigned 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 KM 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 months) than patients in the cTACE group (6.8 months) (P=.0012) (hazard ratio=0.122; 95% 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). Median survival time, censored to liver transplantation, was 17.7 months for the cTACE group (95% CI, 8.3–NC) vs 18.6 months for the Y90 group (95% CI, 7.4–32.5) (P=.99). Conclusions In a 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 dropout from transplant waitlists. ClinicalTrials.gov no. NCT00956930

Subfields: Genetics, Hepatology, Surgery

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Citations in the corpus

Diagnosis, Staging, and Management of Hepatocellular Carcinoma: 2018 Practice Guidance by the American Association for the Study of Liver Diseases (2018, methodology): “(159) TACE and TARE were evaluated in a small phase 2 randomized trial.(160) This study demonstrated a significant improvement in time to progression (TTP), the primary endpoint, but there was no significant difference in OS, a secondary endpoint of the trial.”
EASL Clinical Practice Guidelines: Management of hepatocellular carcinoma. (2018, background): “In a small series, patients treated with SIRT showed better tumour control and a higher proportion received liver transplantation than those with TACE, leading to speculation that SIRT could reduce drop-out from transplant waiting lists.(560) SIRT has also been tested in patients with borderline res”
Diagnosis, Staging, and Management of Hepatocellular Carcinoma: 2018 Practice Guidance by the American Association for the Study of Liver Diseases (2019, methodology): “(159) TACE and TARE were evaluated in a small phase 2 randomized trial.(160) This study demonstrated a significant improvement in time to progression (TTP), the primary endpoint, but there was no significant difference in OS, a secondary endpoint of the trial.”
AASLD guidelines for the treatment of hepatocellular carcinoma (2018, background): “Importantly, a single-center RCT comparing TARE with TACE performed at a United States transplantation center has just been reported and has demonstrated longer time to progression for waitlisted patients with HCC receiving TARE compared with TACE.((88)) This trial was not adequately powered to dete”
Global trends in hepatocellular carcinoma epidemiology: implications for screening, prevention and therapy (2023, background): “…with TARE compared with TACE (median >26 months versus 6.8 months; HR 0.12, 95% CI 0.03–0.56; P = 0.007), but similar OS (censored at the time of liver transplantation: 18.6 months versus 17.7 months; P = 0.99) 174 , a pattern supported by data from uncontrolled, nonrandomized studies 175 .”
AASLD Practice Guidance on prevention, diagnosis, and treatment of hepatocellular carcinoma (2023, unknown): “[299] TARE using Y90 was granted FDA approval in 2021 based on results of the LEGACY Trial, [175] a single-arm retrospective analysis of 162 patients with Child-Turcotte-Pugh A cirrhosis and solitary HCC up to 8 cm (median size 2.7 cm).”