Document Type : Original Article
Authors
1
Clinical Pharmacy Department, Ain Shams University Specialized Hospital, Cairo, Egypt
2
Tropical Medicine, Faculty of Medicine, Ain Shams University, Cairo 11566, Egypt
3
Pharmacology and Therapeutics Department, Faculty of Medicine, Ain Shams University, Cairo, Egypt
4
Department of Pharmacology and Toxicology, Faculty of Pharmacy, Ain Shams University, Cairo 11566, Egypt
Abstract
Background:Transarterial chemoembolization(TACE)is the most widely used treatment worldwide for intermediate unresectable hepatocellular carcinoma(HCC).New systemic therapies have shown survival benefits but looking ahead to the future of systemic therapies is necessary to overcome low response rates, relatively high toxicity.
Aim:The present study aimed to assess efficacy& safety of viscum album in Egyptian patients with intermediate Barcelona Clinic Liver Cancer (BCLC) stage HCC compared to TACE.
Patients and methods:Forty-five naïve intermediate HCC patients were enrolled in this prospective open label study. Patients were randomly assigned into 3 groups,viscum Group I,TACE/Viscum Group II and TACE Group III.Viscum has been prepared as an injectable aqueous solution containing one milliliter of viscum.Two viscum ampoules per week were subcutaneously administered for 8 weeks.All patients underwent laboratory investigations including liver function tests to assess deterioration in liver functions and triphasic spiral computed tomography to assess radiological response according to modified response evaluation criteria in solid tumors (mRECIST).
Results:In all cases, chronic hepatitis C virus infection was the cause of liver disease.Stable disease was achieved in all patients.Toxicity,primarily in the form of local reaction&fever,was generally mild &well tolerated.No discontinuation or toxic deaths associated with drugs were observed.In HCC patients, serum levels of vascular endothelial cell growth factor(VEGF)&Tumour necrosis factor alpha(TNF-α)were significantly elevated,whereas levels of Transforming growth factor-B(TGF-β)were lower compared to pretreatment values.
Conclusion:In patients with intermediate HCC,Viscum Album is a secure treatment.For efficacy elucidation,Further randomized controlled trials with large numbers of patients are recommended.Treatment with TACE&viscum is associated with modulation of HCC patients with serum angiogenic,inflammatory cytokines.
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