Practice patterns and deterioration of liver function after transarterial chemoembolization (TACE) in hepatocellular carcinoma (HCC): Final analysis of OPTIMIS in Europe and Canada

Abstract

Background: TACE is commonly used in patients (pts)with unresectableHCC (uHCC). However, there is no global consensus on appropriate TACE use. Evaluating the risks associated with TACE is critical to ensure pt eligibility for subsequent effective therapies. Methods: OPTIMIS is an international, prospective, non-interventional study of uHCC pts for whom the decision to treat with TACE was made prior to enrollment. Here we report practice patterns, subsequent treatments, and liver deterioration data from Europe and Canada (Eur/Can) and the global population. TACE ineligibility was defined using international and regional guidelines. Results: Overall, 1650 enrolled pts received TACE including 497 from Eur/Can (n=447 Eur, n=50 Can). Of those, 40% of pts in Eur/Can and 39% globally were TACE ineligible according to guidelines (Table). After exclusion of pts with prior sorafenib use, 35% of pts in Eur/Can and 31% globally became TACE ineligible during the study (to be assessed for primary endpoint). Of those, 8% in Eur/Can and 9% globally received sorafenib immediately after TACE ineligibility. At inclusion, most pts were BCLC stage B, and the presence of extrahepatic spread and portal vein thrombosis was lower in Eur/Can vs globally (Table). In pts with available laboratory values, chronic liver function deterioration (worsening in CTCAE grade 30-90 days post TACE) after first TACE was noted in Eur/Can and the global population: ALT 19% and 19%, albumin 30% and 29%, AST 25% and 24%, bilirubin 9% and 11%, and INR 15% and 14%, respectively. Conclusions: Adherence to TACE eligibility guidelines appear to be similar in Eur/Can and the global population. In the Eur/Can subgroup, chronic deterioration of liver function was observed. These results also suggest that systemic therapies are not commonly used after TACE ineligibility in Eur/Can clinical practice.