Publicaciones científicas
Impact of adjuvant sorafenib treatment after local ablation for HCC in the phase II SORAMIC trial
Max Seidensticker 1 , Osman Öcal 1 , Kerstin Schütte 2 , Peter Malfertheiner 3 , Thomas Berg 4 , Christian Loewe 5 , Heinz Josef Klümpen 6 , Otto van Delden 7 , Muzaffer Reha Ümütlü 1 , Najib Ben Khaled 3 , Enrico Narciso de Toni 3 , Ricarda Seidensticker 1 , Ali Aghdassi 8 , Albert Tran 9 , Jean-Pierre Bronowicki 10 , Bora Peynircioglu 11 , Bruno Sangro 12 , Maciej Pech 13 , Jens Ricke 1
Background & aims: The aim of the study was to evaluate the efficacy and safety of adjuvant sorafenib treatment compared with placebo in patients with hepatocellular carcinoma who underwent local ablation.
Methods: The SORAMIC trial is a randomised controlled trial with diagnostic, local ablation, and palliative sub-study arms. After initial imaging within the diagnostic study, patients were assigned to local ablation or palliative arms. In the local ablation cohort, patients were randomised 1:1 to local ablation + sorafenib vs. local ablation + placebo. The primary endpoint was time-to-recurrence (TTR). Secondary endpoints were local control rate and safety in terms of adverse events and quality-of-life.
Results: The recruitment was terminated prematurely after 104 patients owing to slow recruitment. One patient was excluded because of a technical failure. Fifty-four patients were randomised to local ablation + sorafenib and 49 to local ablation + placebo. Eighty-eight patients who underwent standardised follow-up imaging comprised the per-protocol population. The median TTR was 15.2 months in the sorafenib arm and 16.4 months in the placebo arm (hazard ratio 1.1; 95% CI 0.53-2.2; p = 0.82). Out of 136 lesions ablated within the trial, there was no difference in local recurrence rate between sorafenib (6/69, 8.6%) and placebo groups (5/67, 5.9%; p = 0.792).Overall (92.5% vs. 71.4%, p = 0.008) and drug-related (81.4% vs. 55.1%, p = 0.003) adverse events were more common in the sorafenib arm compared with the placebo arm. Dose reduction because of adverse events were common in the sorafenib arm (79.6% vs. 30.6%, p <0.001).
Conclusions: Adjuvant sorafenib did not improve in TTR or local control rate after local ablation in patients with hepatocellular carcinoma within the limitations of an early terminated trial.
Impact and implications: Local ablation is the standard of care treatment in patients with early stages of hepatocellular carcinoma, along with surgical therapies. However, there is a risk of disease recurrence during follow-up. Sorafenib, an oral medication, is a routinely used treatment for patients with advanced hepatocellular carcinoma. This study found that sorafenib treatment after local ablation in people with early hepatocellular carcinoma did not significantly improve the disease-free period compared with placebo.
CITA DEL ARTÍCULO JHEP Rep. 2023 Feb 15;5(5):100699. doi: 10.1016/j.jhepr.2023.100699
Nuestros autores
