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

Based on our experience with 1,000 patients over 15 years, we have made a decision to adopt TARE as the first-line transarterial LRT for patients with HCC. Our decision was informed by prospective data and incrementally reported demonstrating outcomes stratified by BCLC, applied as either neoadjuvant or definitive treatment. (Hepatology 2017).

Purpose:To report long-term outcomes of radiation segmentectomy (RS) for early hepatocellular carcinoma (HCC). The authors hypothesized that outcomes are comparable to curative treatments for patients with solitary HCC less than or equal to 5 cm and preserved liver function. Materials and Methods:This retrospective study included 70 patients (median age, 71 years; range, 22-96 years) with solitary HCC less than or equal to 5 cm not amenable to percutaneous ablation who underwent RS (dose of .190 Gy) between 2003 and. Patients who underwent subsequent curative liver transplantation were excluded to eliminate this confounding variable affecting survival. Radiologic response of time to progression and median overall survival were estimated by using the Kaplan-Meier method per the guidelines of the European Association for the Study of the Liver (EASL) and the World Health Organization (WHO). Results:Seventy patients were treated with RS over 14 years. Sixty-three patients (90%) showed response by using EASL criteria, of which 41 (59%) showed complete response. Fifty patients (71%) achieved response by using WHO criteria, of which 11 (16%) achieved complete response. Response rates at 6 months were 86% and 49% by using EASL and WHO criteria, respectively. Median time to progression was 2.4 years (95% confidence interval: 2.1, 5.7), with 72% of patients having no target lesion progression at 5 years. Median overall survival was 6.7 years (95% confidence interval: 3.1, 6.7); survival probability at 1, 3, and 5 years was 98%, 66%, and 57%, respectively. Overall survival probability at 1, 3, and 5 years was 100%, 82%, and 75%, respectively, in patients with baseline tumor size less than or equal to 3 cm (n = 45) and was significantly longer than in patients with tumors greater than 3 cm (P = .026). In our study, we review our longterm outcomes (.10 years) of patients with HCC less than or equal to 5 cm not amenable to resection, radiofrequency ablation, or transplantation who underwent RS. We hypothesize that this approach could be considered potentially curative based on the same rationale as resection, radiofrequency ablation, and transplantation. Conclusion Materials and MethodsR.J.L. and R.S. are advisors to BTG International. There was no funding for this analysis and all authors had control of the data and information submitted for publication. Our study was approved by the institutional review board and was compliant with the Health Insurance Portability and Accountability Act. All patients provided written informed consent prior to receiving treatment after selecting RS over chemoembolization. We searched our prospectively acquired database of HCC (10) for patients treated with 90 Y radioembolization from December 2003 to 2016 (14 years). Inclusion criteria were as follows: solitary HCC less than or equal to 5 cm, preserved liver function (Child-Pugh class A), and no vascular invasion or extrahepatic metastases (7). Patients who underwent transplantation or resection were excluded to mitigate the potential confo...

BackgroundHepatocellular carcinoma (HCC) is a common cause of worldwide mortality. Transarterial radioembolization (TARE) with yttrium-90 (Y90), a transcatheter intra-arterial procedure performed by interventional radiology, has become widely utilized in managing HCC.MethodsThe following is a focused review of TARE covering its commercially available products, clinical considerations of treatment, salient clinical trial data establishing its utility, and the current and future roles of TARE in the management of HCC.ResultsTARE is indicated for patients with unresectable, intermediate stage HCC. The two available products are glass and resin microspheres. All patients undergoing TARE must be assessed with a history, physical examination, clinical laboratory tests, imaging, and arteriography with macroaggregated albumin. TARE is safe and effective in the treatment of unresectable HCC, as it has a safer toxicity profile than chemoembolization, longer time-to-progression, greater ability to downsize and/or bridge patients to liver transplant, and utility in tumor complicated by portal vein thrombosis. TARE can also serve as an alternative to ablation and chemotherapy.ConclusionTARE assumes an integral role in the management of unresectable HCC and has been validated by numerous studies.

Hepatic metastases of colorectal carcinoma are a leading cause of cancer-related mortality. Most colorectal liver metastases become refractory to chemotherapy and biologic agents, at which point the median overall survival declines to 4-5 mo. Radioembolization with 90 Y has been used in the salvage setting with favorable outcomes. This study reports the survival and safety outcomes of 531 patients treated with glass-based 90 Y microspheres at 8 institutions, making it the largest 90 Y study for patients with colorectal liver metastases. Methods: Data were retrospectively compiled from 8 institutions for all 90 Y glass microsphere treatments for colorectal liver metastases. Exposure to chemotherapeutic or biologic agents, prior liver therapies, biochemical parameters before and after treatment, radiation dosimetry, and complications were recorded. Uni-and multivariate analyses for predictors of survival were performed. Survival outcomes and clinical or biochemical adverse events were recorded. Results: In total, 531 patients received 90 Y radioembolization for colorectal liver metastases. The most common clinical adverse events were fatigue (55%), abdominal pain (34%), and nausea (19%). Grade 3 or 4 hyperbilirubinemia occurred in 13% of patients at any time. The median overall survival from the first 90 Y treatment was 10.6 mo (95% confidence interval, 8.8-12.4). Performance status, no more than 25% tumor burden, no extrahepatic metastases, albumin greater than 3 g/dL, and receipt of no more than 2 chemotherapeutic agents independently predicted better survival outcomes. Conclusion: This multiinstitutional review of a large cohort of patients with colorectal liver metastases treated with 90 Y radioembolization using glass microspheres has demonstrated promising survival outcomes with low toxicity and low side effects. The outcomes were reproducible and consistent with prior reports of radioembolization.