Efficacy and Safety of the Combination of Pravastatin and Sorafenib for the Treatment of Advanced Hepatocellular Carcinoma (ESTAHEP Clinical Trial)
Riaño, Ioana (Biodonostia Osasun Ikerketako Institutura (País Basc))
Martín, Leticia (Biodonostia Osasun Ikerketako Institutura (País Basc))
Varela Calvo, Maria (Hospital Universitario Central de Asturias)
Serrano, Trinidad (Hospital Clínico Universitario "Lozano Blesa" de Zaragoza)
Núñez, Oscar (Hospital Universitario Infanta Sofía (San Sebastián de los Reyes))
Mínguez Rosique, Beatriz (Hospital Universitari Vall d'Hebron. Institut de Recerca)
Rodrigues, Pedro M. (Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas)
Perugorria, Maria J. (Universidad del País Vasco)
Banales, Jesus (Basque Foundation for Science)
Arenas, Joaquín (Biodonostia Osasun Ikerketako Institutura (País Basc))
Universitat Autònoma de Barcelona

Data:	2020
Resum:	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.
Ajuts:	Ministerio de Economía y Competitividad PI15/01132 Instituto de Salud Carlos III PI18/01075
Drets:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, fins i tot amb finalitats comercials, sempre i quan es reconegui l'autoria de l'obra original.
Llengua:	Anglès
Document:	Article ; recerca ; Versió publicada
Matèria:	Hepatocellular carcinoma ; Sorafenib ; Pravastatin ; Randomized clinical trial ; Overall survival ; Time to progression ; Prognostic factors
Publicat a:	Cancers, Vol. 12 (july 2020) , ISSN 2072-6694

DOI: 10.3390/cancers12071900
PMID: 32674461

15 p, 2.2 MB

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