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Efficacy and Safety Results from a Phase 2, Randomized, Double-Blind Study of Enzalutamide Versus Placebo in Advanced Hepatocellular Carcinoma

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Abstract
Background and Objective Hepatocellular carcinoma (HCC) is the fourth leading cause of cancer-related mortality worldwide. Despite recent advances, more effective therapeutic options for patients with advanced HCC are still required. The aim of this Phase 2, multicenter, multinational, randomized, double-blind, placebo-controlled study (NCT02528643) was to investigate the potential benefit of enzalutamide in the treatment of patients with advanced HCC. Methods Patients aged >= 18 years diagnosed with advanced HCC (Barcelona Clinic Liver Cancer stage B or C and Child-Pugh class A at screening who had progressed on, or were intolerant to, sorafenib or other anti-vascular endothelial growth factor therapies) were randomized 2:1 to receive either enzalutamide 160 mg daily or placebo. The primary endpoint was overall survival (OS); secondary endpoints included progression-free survival (PFS) and safety. Results In total, 165 patients were randomized to enzalutamide (n = 110) or placebo (n = 55). The hazard ratio (HR) (95% confidence interval [CI]) for OS was 1.15 (0.774-1.696) and median OS was 7.8 months and 7.7 months for enzalutamide and placebo, respectively. The HR (95% CI) for PFS was 1.04 (0.732-1.474) and median PFS was 2.2 months and 1.9 months for enzalutamide and placebo, respectively. The overall frequency of treatment-emergent adverse events (TEAEs) was broadly similar between the groups: 105 (98.1%) enzalutamide patients experienced >= 1 TEAEs compared with 49 (89.1%) placebo patients. Conclusions The results of this study indicate that enzalutamide does not provide a benefit in patients with advanced HCC. No unexpected safety findings were observed in the trial. ClinicalTrials.gov identifier NCT02528643.
Author(s)
류백렬박숙련Beatriz LopezBruno DanieleDaniel H. PalmerDebashis SarkerHo Yeong LimJoyce SteinbergLorenza Rimassa
Issued Date
2021
Type
Article
Keyword
Cancer therapiesconfidence intervalsHepatitisInternal MedicineLiver cancerMalesMedical prognosisMedicineMedicine & Public healthMastasisMortalityNCTNCT02528643Original Research ArticlePatientsPharmacology/ToxicologyPharmacotherapyProstate cancerVascular endothelial growth factor
DOI
10.1007/s40261-021-01063-0
URI
https://oak.ulsan.ac.kr/handle/2021.oak/8324
https://ulsan-primo.hosted.exlibrisgroup.com/primo-explore/fulldisplay?docid=TN_cdi_proquest_miscellaneous_2558454468&context=PC&vid=ULSAN&lang=ko_KR&search_scope=default_scope&adaptor=primo_central_multiple_fe&tab=default_tab&query=any,contains,Efficacy%20and%20Safety%20Results%20from%20a%20Phase%202,%20Randomized,%20Double-Blind%20Study%20of%20Enzalutamide%20Versus%20Placebo%20in%20Advanced%20Hepatocellular%20Carcinoma&pcAvailability=true
Publisher
CLINICAL DRUG INVESTIGATION
Location
뉴질랜드
Language
한국어
ISSN
1173-2563
Citation Volume
41
Citation Number
9
Citation Start Page
795
Citation End Page
808
Appears in Collections:
Medicine > Medicine
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