CHIH-HUNG HSUKang Y.K.Yang T.-S.CHIA-TUNG SHUNYU-YUN SHAOSu W.-C.Sandoval-Tan J.Chiou T.-J.Jin K.CHIUN HSUANN-LII CHENG2020-04-102020-04-1020130030-2414https://www.scopus.com/inward/record.uri?eid=2-s2.0-84879774804&doi=10.1159%2f000350841&partnerID=40&md5=7a2f5a313d6351a3d1064aeec41ae248https://scholars.lib.ntu.edu.tw/handle/123456789/484093Objectives: The bevacizumab/erlotinib combination was reported with high clinical activity for advanced hepatocellular carcinoma (HCC) by a phase II study conducted in the USA. This multicenter study across several Asian countries was to evaluate the safety and efficacy of the combination in this population. Methods: Patients with histology-proven HCC, advanced disease and Child-Pugh class A liver function received bevacizumab 5 mg/kg intravenously every 2 weeks and erlotinib 150 mg/day orally as first-line therapy. The primary end point was progression-free survival at 16 weeks (PFS-16W). The expression of epidermal growth factor receptor (EGFR), phospho-AKT and vascular endothelial growth factor, the microvessel density and the EGFR gene copy number in HCC tissues were correlated with treatment efficacy. Results: Fifty-one patients were enrolled. The PFS-16W was 35.3% (95% CI 22.4-49.9), the median PFS was 2.9 months (95% CI, 1.3-4.4) and the median overall survival was 10.7 months (95% CI, 6.2-15.2). Grade 3/4 toxicities were uncommon, including rash, acne (10% each), diarrhea (6%) and gastrointestinal bleeding (4%). None of the evaluated biomarkers correlated with disease control or PFS. Conclusions: Bevacizumab plus erlotinib showed good tolerability and modest activity in this Asian cohort. Further studies are warranted to identify the predictive biomarkers of this combination. Copyright ? 2013 S. Karger AG, Basel.[SDGs]SDG3bevacizumab; epidermal growth factor receptor; erlotinib; hepatitis B surface antigen; sorafenib; vasculotropin; bevacizumab; epidermal growth factor receptor; erlotinib; protein kinase B; vasculotropin; acne; adult; advanced cancer; alopecia; anemia; article; Asian; capillary density; Child Pugh score; correlation analysis; diarrhea; drug efficacy; drug eruption; drug safety; epistaxis; fatigue; female; gastrointestinal hemorrhage; gene dosage; hand foot syndrome; histopathology; human; hyperbilirubinemia; hypertension; immunohistochemistry; liver cell carcinoma; liver function; lung hemorrhage; major clinical study; male; melena; metastasis; multicenter study; nausea; neutropenia; outcome assessment; overall survival; paronychia; phase 2 clinical trial; priority journal; progression free survival; protein expression; proteinuria; stomach ulcer; stomatitis; treatment response; advanced hepatocellular carcinoma; advanced hepatocellular carcinoma; aged; Article; cancer tissue; disease control; human tissue; leukoencephalopathy; open study; rash; therapy; United States; Adult; Aged; Aged, 80 and over; Antibodies, Monoclonal, Humanized; Antineoplastic Combined Chemotherapy Protocols; Asian Continental Ancestry Group; Carcinoma, Hepatocellular; Disease-Free Survival; Female; Humans; Liver Neoplasms; Male; Middle Aged; Proto-Oncogene Proteins c-akt; Quinazolines; Receptor, Epidermal Growth Factor; Treatment Outcome; Vascular Endothelial Growth Factor Ajournal article10.1159/000350841238385762-s2.0-84879774804