⁹⁰Y Radioembolization versus Drug-eluting Bead Chemoembolization for Unresectable Hepatocellular Carcinoma: Results from the TRACE Phase II Randomized Controlled Trial

Abstract

with details of the nature of the infringement. We will investigate the claim and if justified, we will take the appropriate steps. Download date: 04. Jul. 2022 ORIGINAL RESEARCH • VASCULAR AND INTERVENTIONAL RADIOLOGYH epatocellular carcinoma (HCC) is the most prevalent primary liver tumor, accounting for 8% of cancer-related deaths (1). Prognosis depends on tumor extension, the degree of liver dysfunction, and the patient's performance status. The European Society for the Study of the Liver endorsed the Barcelona Clinic Liver Cancer (BCLC) classification because it links these three major determinants to dynamic treatment guidelines (2). Very early (a single tumor 2 cm) and early HCC (single tumor or up to three nodules, with none of them 3 cm) is amenable to curative surgical or ablative treatment. For patients with intermediate-stage (BCLC B) unresectable HCC and preserved liver function, transarterial chemoembolization (TACE) is the standard treatment (2,3). For the advanced BCLC stage C-characterized by vascular invasion, extrahepatic spread, or tumor-induced symptoms-systemic treatment is the standard of care.Conventional TACE is a level I evidence treatment for intermediate HCC. The major drawback of TACE is the high variability of the procedure: Miscellaneous Background: Transarterial chemoembolization (TACE) is the recommended treatment for intermediate hepatocellular carcinoma (HCC) according to the Barcelona Clinic Liver Cancer guidelines. Prospective uncontrolled studies suggest that yttrium 90 ( 90 Y) transarterial radioembolization (TARE) is a safe and effective alternative. Purpose: To compare the efficacy and safety of TARE with TACE for unresectable HCC. Materials and Methods: In this single-center prospective randomized controlled trial (TRACE), 90 Y glass TARE was compared with doxorubicin drug-eluting bead (DEB) TACE in participants with intermediate-stage HCC, extended to Eastern Cooperative Oncology Group performance status 1 and those with early-stage HCC not eligible for surgery or thermoablation. Participants were recruited between September 2011 and March 2018. The primary end point was time to overall tumor progression (TTP) (Kaplan-Meier analysis) in the intention-to-treat (ITT) and per-protocol (PP) groups.Results: At interim analysis, 38 participants (median age, 67 years; IQR, 63-72 years; 33 men) were randomized to the TARE arm and 34 (median age, 68 years; IQR, 61-71 years; 30 men) to the DEB-TACE arm (ITT group). Median TTP was 17.1 months in the TARE arm versus 9.5 months in the DEB-TACE arm (ITT group hazard ratio [HR], 0.36; 95% CI: 0.18, 0.70; P = .002) (PP group, 32 and 34 participants, respectively, in each arm; HR, 0.29; 95% CI: 0.14, 0.60; P , .001). Median overall survival was 30.2 months after TARE and 15.6 months after DEB-TACE (ITT group HR, 0.48; 95% CI: 0.28, 0.82; P = .006). Serious adverse events grade 3 or higher (13 of 33 participants [39%] vs 19 of 36 [53%] after TARE and DEB-TACE, respectively; P = .47) and 30-day mortality (0 of 33 participants [0%] vs thr...

Selective internal radiation therapy of metastatic breast cancer to the liver: A meta-analysis

“…More pieces of evidence also became available supporting its use in metastatic cancer to the liver, such as colorectal metastasis and melanoma (7,40). With both TACE and SIRT as the available options, comparative studies showed superior survival in among patients treated with the former (41,42). As for breast cancer with liver metastasis, only Chang et al compared TACE and SIRT in treating liver metastatic breast cancer, suggesting a longer MST (4.9 vs. 12.9 months) and fewer adverse events of SIRT (71% vs. 44%) (9).…”

New concepts in the treatment of hepatocellular carcinoma

“…TACE type (conventional or using drug‐eluting beads) is left to local practice because no RCT has shown an advantages in meaningful clinical endpoints 44 . A recent monocentric phase II RCT comparing TARE with TACE in patients with unresectable HCC showed median time to overall tumor progression was 17.1 versus 9.5 months ([Hazard ratio (HR)], 0.36; 95% CI: 0.18, 0.70; p = 0.002) in the TARE and TACE arm respectively 45 . Median OS was 30.2 months after TARE versus 15.6 months after TACE ([HR], 0.48; 95% CI: 0.28, 0.82; p = 0.006) 45 …”

“… 45 Median OS was 30.2 months after TARE versus 15.6 months after TACE ([HR], 0.48; 95% CI: 0.28, 0.82; p = 0.006). 45 …”

Pathogenesis to management of hepatocellular carcinoma

“…No high-level evidence shows improved survival of TACE compared to DEB-TACE. However, a recent phase 2 randomized controlled study (TRACE) demonstrated improved median overall survival and superior tumor control with TARE compared to DEB-TACE in BCLC Stage A and B patients who were not surgical or ablation candidates [68]. tumor recurrence and overall survival in patients undergoing hepatic resection [69].…”