Outcomes of patients (pts) with hepatocellular carcinoma (HCC) treated with transarterial chemoembolization (TACE): Global OPTIMIS final analysis.

4018 Background: TACE is often used to treat unresectable HCC (uHCC). However, there is no globally accepted consensus on the indication and definition of TACE failure. It is critical to reassess the risk/benefit of continuing TACE after failure as it may delay or prevent pts from receiving subsequent treatments. Methods: OPTIMIS, an international, prospective, observational study, enrolled pts with uHCC for whom a decision to treat with TACE was made at study entry. Practice patterns, safety, subsequent treatments, and outcomes data were collected. TACE ineligibility was defined and consistent with international and regional guidelines. Data were analyzed using descriptive statistical methods. Results: Overall, 1650 pts received TACE; 529 pts (32%) were BCLC stage C, 118 (7%) had extrahepatic spread, and 123 (7%) had portal vein thrombosis. At inclusion visit, 636 pts (39%) received TACE despite being TACE ineligible according to protocol-specified criteria. After first TACE, the proportion of pts with chronic liver function deterioration (worsening in CTCAE grade 30–90 days post TACE) ranged from 11% to 29% across assessed liver parameters. Complete and partial response rates to first TACE (N=1650) were 14% and 26%, respectively, which decreased by second (10% and 16%; n=1002), third (10% and 15%; n=580), and fourth (8% and 17%; n=338) TACE. Progressive disease rate increased by number of TACE procedures: 18%, 21%, 25%, and 27% for first, second, third, and fourth TACE, respectively. In total, only 507 pts (31%) became TACE ineligible during the study. Of those 507 pts, 47 (9%) received sorafenib at the time of TACE ineligibility and 460 (91%) received sorafenib later or not at all. Considerable imbalances between the 2 cohorts were observed; a propensity score analysis is planned to analyze overall survival from TACE ineligibility. Conclusions: These results indicate that real-world TACE use appears to deviate from treatment guidelines. This heterogeneity highlights the need for a globally accepted consensus on the indication and definition of TACE failure. These observations also indicate the importance of monitoring liver function in pts receiving TACE. Clinical trial information: NCT01933945.