Introduction
Treatment strategy of hepatocellular carcinoma (HCC) is a complex decision-making process that considers several variables in clinical practice. A “multiparametric therapeutic approach” has been proposed (Lancet Oncol 2023): the feasibility of all treatments is evaluated systematically in a hierarchical order, to match each patient with the optimal therapy.
Aims & Methods
The aim of the study is to validate the reliability of the new multiparametric decisional framework (MPDF) and the impact of the different variables included in the framework on the final treatment decision in clinical practice. This is a prospective ongoing study with a first monocentric phase (A) and a second multicentric validation phase. Primary endpoints are: 1) adherence to MPDF for treatment allocation, 2) identification of the relative weight of variables involved in this MPDF for treatment decision, while secondary endpoints are overall survival and radiological response after treatment. The study includes all consecutive patients with HCC managed in each center from September 1st, 2023. The disease is staged according to Barcelona Clinic Liver Cancer (BCLC) classification, while patient’s characterization is conducted by Charlson Comorbidity Index (CCI), Liver Frailty Index (LFI), Child-Pugh (CPT) and ALBI, MELD and skeletal muscle mass index by CT. Each patient is allocated to treatment according to MPDF, BCLC 2022 was the benchmark.
Results
As of November 1st, 2023, 48 patients were recruited into phase A of the study [median age 70 (52-87) years, 81% male, 37% HCV, 27% first treatment for HCC]. Thirteen (27%) patients were classified BCLC 0, 17 (35%) A, 6 (12.5%) B, 6 (12.5%) C and 6 (12.5%) D. The median CCI was 8 (4-13), the median LFI was 4.15 (2.99-4.81). Thirty-nine (81%) patients were in CPT class A, 7 (15%) in B and 2 (4%) in C, while 32 (67%) were classified ALBI grade 1 and 16 (33%) ALBI grade 2, and the median MELD score was 8.5 (6-22). Forty-four (92%) patients received treatment through a multidisciplinary team (MDT). According to the MPDF, 9 (19%) patients were allocated to liver transplant, 5 (10%) to laparoscopic surgical resection, 10 (21%) to microwave thermal ablation (MWTA), 7 (15%) to transarterial treatments (4 TACE and 3 TARE), 3 (6%) to other locoregional therapies (2 MWTA+TACE and 1 electrochemotherapy), 6 (13%) to systemic treatment and 5 (10%) to palliative care only. In 4 cases, the MDT decided for reassessment at 3 months. The treatment allocation was coherent to the BCLC 2022 in 69% BCLC 0, 82% BCLC A, 83% BCLC B, 67% BCLC C and 100% BCLC D.
Conclusion
Preliminary data of our ongoing prospective study suggest that personalized approach for HCC treatment by MPDF is feasible in clinical practice and might help ensuring a customized approach in a standardized framework. Updated data will be presented at the meeting.
