Impact of adjuvant sorafenib treatment after local ablation for HCC in the phase II SORAMIC trial.
Adjuvant
BCLC, Barcelona Clinic Liver Cancer
CONSORT, Consolidated Standards of Reporting Trials
CT, computed tomography
ECOG PS, Eastern Cooperative Oncology Group Performance Status
HCC, hepatocellular carcinoma
HR, hazard ratio
Hepatocellular carcinoma
ITT, intention-to-treat
Local ablation
MRI, magnetic resonance imaging
MWA, microwave ablation
PP, per protocol
RFA, radiofrequency ablation
RFS, relapse-free survival
SIRT, selective internal radiation therapy
SORAMIC, SORAfenib in combination with local MICro-therapy guided by gadolinium-EOB-DTPA-enhanced MRI
Sorafenib
TTR, time-to-recurrence
Time-to-recurrence
Journal
JHEP reports : innovation in hepatology
ISSN: 2589-5559
Titre abrégé: JHEP Rep
Pays: Netherlands
ID NLM: 101761237
Informations de publication
Date de publication:
May 2023
May 2023
Historique:
received:
22
07
2022
revised:
22
12
2022
accepted:
17
01
2023
entrez:
27
3
2023
pubmed:
28
3
2023
medline:
28
3
2023
Statut:
epublish
Résumé
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. 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 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; 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. 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. EudraCT 2009-012576-27, NCT01126645.
Sections du résumé
Background & Aims
UNASSIGNED
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
UNASSIGNED
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
Results
UNASSIGNED
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;
Conclusions
UNASSIGNED
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
UNASSIGNED
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.
Clinical trial number
UNASSIGNED
EudraCT 2009-012576-27, NCT01126645.
Identifiants
pubmed: 36968218
doi: 10.1016/j.jhepr.2023.100699
pii: S2589-5559(23)00030-7
pmc: PMC10031000
doi:
Banques de données
ClinicalTrials.gov
['NCT01126645']
Types de publication
Journal Article
Langues
eng
Pagination
100699Informations de copyright
© 2023 The Author(s).
Déclaration de conflit d'intérêts
MS: Personal fees: Bayer, Sirtex. OÖ: Honoraria: Bayer. PM: Grants: Bayer, Sirtex. TB: Grants/research support: Abbvie, BMS, Gilead, MSD/Merck, Humedics, Intercept, Merz, Novartis, Sequana Medical. Honoraria or consultation fees: Abbvie, Alexion, Bayer, Gilead, Eisai, Humedics, Intercept, Ipsen, Janssen, MSD/Merck, Novartis, Roche, Sequana Medical, SIRTEX, SOBI, and Shionogi. ENdT: Consultant fees: AstraZeneca, Bayer, BMS, EISAI, Eli Lilly & Co, Pfizer, IPSEN, and Roche. Travel fees: Arqule, Astrazeneca, BMS, Bayer, Celsion, and Roche and lecture honoraria from BMS and Falk. Grants: Arqule, AstraZeneca, BMS, Bayer, Eli Lilly, and Roche. BS: Consultancy fees: Adaptimmune, Astra Zeneca, Bayer, BMS, Boston Scientific, BTG, Eisai, Eli Lilly, H3 Biomedicine, Ipsen, Novartis, Merck, Roche, Sirtex Medical and Terumo. Speaker fees: Astra Zeneca, Bayer, BMS, BTG, Eli Lilly, Ipsen, Novartis, Merck, Roche, Sirtex Medical and Terumo. Grants (to Institution): BMS and Sirtex Medical. MP: Grants: Sirtex, Bayer; Personal fees: Sirtex. JR: Grants: Sirtex, Bayer; Personal fees: Sirtex, Bayer. Please refer to the accompanying ICMJE disclosure forms for further details.
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