000095367 001__ 95367
000095367 005__ 20210902121819.0
000095367 0247_ $$2doi$$a10.3390/cancers12071900
000095367 0248_ $$2sideral$$a119167
000095367 037__ $$aART-2020-119167
000095367 041__ $$aeng
000095367 100__ $$aRiaño, I.
000095367 245__ $$aEfficacy and safety of the combination of pravastatin and sorafenib for the treatment of advanced hepatocellular carcinoma (ESTAHEP clinical trial)
000095367 260__ $$c2020
000095367 5060_ $$aAccess copy available to the general public$$fUnrestricted
000095367 5203_ $$aPravastatin 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.
000095367 536__ $$9info:eu-repo/grantAgreement/ES/MSCBS/EC10-201
000095367 540__ $$9info:eu-repo/semantics/openAccess$$aby$$uhttp://creativecommons.org/licenses/by/3.0/es/
000095367 590__ $$a6.639$$b2020
000095367 591__ $$aONCOLOGY$$b51 / 242 = 0.211$$c2020$$dQ1$$eT1
000095367 592__ $$a1.818$$b2020
000095367 593__ $$aOncology$$c2020$$dQ1
000095367 593__ $$aCancer Research$$c2020$$dQ1
000095367 655_4 $$ainfo:eu-repo/semantics/article$$vinfo:eu-repo/semantics/publishedVersion
000095367 700__ $$aMartín, L.
000095367 700__ $$aVarela, M.
000095367 700__ $$0(orcid)0000-0002-7119-2244$$aSerrano, T.$$uUniversidad de Zaragoza
000095367 700__ $$aNúñez, O.
000095367 700__ $$aMínguez, B.
000095367 700__ $$aRodrigues, P.M.
000095367 700__ $$aPerugorria, M.J.
000095367 700__ $$aBanales, J.M.
000095367 700__ $$aArenas, J.I.
000095367 7102_ $$11007$$2610$$aUniversidad de Zaragoza$$bDpto. Medicina, Psiqu. y Derm.$$cArea Medicina
000095367 773__ $$g12, 7 (2020), 1900 1-15$$pCancers$$tCancers$$x2072-6694
000095367 8564_ $$s1364670$$uhttps://zaguan.unizar.es/record/95367/files/texto_completo.pdf$$yVersión publicada
000095367 8564_ $$s486359$$uhttps://zaguan.unizar.es/record/95367/files/texto_completo.jpg?subformat=icon$$xicon$$yVersión publicada
000095367 909CO $$ooai:zaguan.unizar.es:95367$$particulos$$pdriver
000095367 951__ $$a2021-09-02-10:07:02
000095367 980__ $$aARTICLE