Efficacy and safety of the combination of pravastatin and sorafenib for the treatment of advanced hepatocellular carcinoma (ESTAHEP clinical trial)

Riaño, I. ; Martín, L. ; Varela, M. ; Serrano, T. (Universidad de Zaragoza) ; Núñez, O. ; Mínguez, B. ; Rodrigues, P.M. ; Perugorria, M.J. ; Banales, J.M. ; Arenas, J.I.

Resumen: Pravastatin has demonstrated anti-tumor activity in preclinical and clinical studies. This multicentric randomized double-blind placebo-controlled phase II study (NCT01418729) investigated the efficacy and safety of sorafenib + pravastatin combination on the overall survival (OS) and time to progression (TTP) of patients with advanced hepatocellular carcinoma (aHCC). A total of 31 patients were randomized. Median OS did not differ between both groups (12.4 months for the sorafenib + pravastatin group vs. 11.6 months for the control group). Of note, however, the radiological TTP was higher in patients treated with sorafenib + pravastatin than in the control group (9.9 months vs. 3.2 months; p = 0.008). Considering all the study population, the presence of portal vein thrombosis (PVT) was associated with worse OS, being lower in patients with PVT compared to patients without PVT (6.3 months vs. 14.8 months; p = 0.026). Data also showed a decrease in OS in patients with vascular invasion (VI) compared to patients who did not present it (6.3 months vs. 14.8 months; p = 0.041). The group of patients without dermatological events (DE) showed lower OS (6.9 months vs. 14.5 months; p = 0.049). In conclusion, combination of sorafenib + pravastatin was safe and well-tolerated, prolonging the TTP of patients with aHCC but not improving the OS compared to sorafenib + placebo. The absence of PVT and VI and the development of DE are positive prognostic factors of sorafenib response.

Idioma: Inglés

DOI: 10.3390/cancers12071900

Año: 2020

Publicado en: Cancers 12, 7 (2020), 1900 1-15
ISSN: 2072-6694

Factor impacto JCR: 6.639 (2020)

Categ. JCR: ONCOLOGY rank: 51 / 242 = 0.211 (2020) - Q1 - T1

Factor impacto SCIMAGO: 1.818 - Oncology (Q1) - Cancer Research (Q1)

Financiación: info:eu-repo/grantAgreement/ES/MSCBS/EC10-201

Tipo y forma: Article (Published version)

Área (Departamento): Area Medicina (Dpto. Medicina, Psiqu. y Derm.)