Hepatoprotective effects and safety profile of donafenib combined with transarterial chemoembolization in unresectable hepatocellular carcinoma.

Abstract

e16176 Background: The efficacy of donafenib in combination with transarterial chemoembolization (TACE) has been established for unresectable hepatocellular carcinoma (HCC); However, its effects on liver function preservation remain to be elucidated. This investigation sought to evaluate the hepatic protective effects and safety profile of this combination therapy through comprehensive analysis of albumin-bilirubin (ALBI) grade modifications. Methods: In this real world, a cohort of 36 patients with unresectable HCC was enrolled to receive a combination therapy of donafenib plus TACE, either with or without immune checkpoint inhibitors. Throughout the study, ALBI scores were systematically evaluated, beginning with baseline measurements and continuing at predetermined intervals during the treatment course.Statistical analyses were conducted to examine the associations between ALBI grade modifications, tumor response, and survival outcomes. Results: A prospective analysis of 36 patients receiving donafenib-TACE combination therapy demonstrated both significant antitumor efficacy and favorable hepatic safety profiles. The therapeutic regimen achieved an objective response rate of 69.4% and a disease control rate of 91.7%, with a median progression-free survival of 10.7 months. Notably, the median time to response of 1.4 months indicated rapid therapeutic onset.Hepatic function remained stable throughout treatment, as evidenced by consistent ALBI scores from baseline to progression/final follow-up (-2.41±0.41 versus -2.45±0.52, p=0.67). Among the cohort, 58.3% maintained stable hepatic function, while 25.0% demonstrated improvement from ALBI grade 2 to grade 1.Treatment response analysis revealed that hepatic function deterioration occurred less frequently in responders compared to non-responders (12.0% versus 27.3%).ALBI score modification emerged as a potential predictive biomarker (AUC=0.665), with patients below the threshold of -0.177 achieving superior clinical outcomes, including higher response rates (84.6% versus 56.5%) and longer progression-free survival (not reached versus 5.63 months, p=0.017). These findings establish hepatic function preservation as both a safety indicator and efficacy predictor for donafenib-TACE combination therapy. Conclusions: The combination of donafenib and TACE demonstrates favorable hepatic function preservation while maintaining therapeutic efficacy. ALBI grade improvement exhibits correlation with enhanced treatment response and survival outcomes, suggesting potential synergistic benefits in tumor control and hepatic function preservation. Clinical trial information: ChiCTR2100054041 .