Predicting Survival Outcomes in Patients with Hepatocellular Carcinoma Receiving Lenvatinib by Using the Up7-ALBI Score.

[INTRODUCTION] Lenvatinib effectively manages unresectable hepatocellular carcinoma (HCC). Current prognostic models do not integrate tumor burden with liver function. By combining the Up-to-7 criteria and the albumin-bilirubin (ALBI) grade, we developed the Up7-ALBI score, a novel scoring system for predicting survival outcomes in patients with unresectable HCC receiving lenvatinib.

[METHODS] This multicenter, retrospective study analyzed 205 patients with unresectable HCC. Tumor burden and liver function were assessed using the up-to-7 criteria and the ALBI grade, respectively. Cox proportional-hazards models evaluated their impact on survival. The Up7-ALBI score was developed to categorize patients into distinct prognostic groups. Its prognostic value was validated in a cohort of HCC patients receiving immunotherapy.

[RESULTS] The overall response rate (assessed as per the Response Evaluation Criteria in Solid Tumors [RECIST] 1.1 criteria) was 13.2%. This rate was significantly higher for patients without metastases (18.6%) and those with a radiologic tumor burden within the up-to-7 criteria (22.7%). The median progression-free survival and overall survival (OS) were 7.3 and 12.2 months, respectively. Exceeding the up-to-7 criteria (hazard ratio [HR]: 1.61; 95% confidence interval [CI]: 1.00-2.57) and an ALBI grade of 2 or 3 (HR: 1.62; 95% CI: 1.06-2.47) emerged as independent risk factors of OS. A novel Up7-ALBI score stratified patients into low-, intermediate-, and high-risk groups for survival (30.8 vs. 14.2 vs. 9.3 months; < 0.01). A validation cohort of 58 HCC patients with immunotherapy showed the consistent prognostic value of Up7-ALBI score. The Akaike information criterion value of the Cox proportional-hazards model for BCLC stage, ALBI grade, and Up7-ALBI score was 1,203, 1,174, and 1,170, respectively.

[CONCLUSION] The Up7-ALBI score, incorporating tumor burden and liver function, effectively stratified survival outcomes in HCC patients treated with lenvatinib. Further validation in larger cohorts and across different systemic therapies is required to confirm its broad clinical applicability.