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 naive 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.
Highlights
Hepatocellular carcinoma (HCC) is an aggressive tumor, considered the world's third most prevalent malignancy with a very poor prognosis, making it the fourth leading cause of cancer-related deaths [1]
The baseline alpha-fetoprotein levels were different, it was significantly higher in the transarterial chemoembolization (TACE) group as compared to the other groups (>200 ng/mL) AFP change to predict the prognosis after may be impossible in this study
AFP change after therapies has been proved to correlate the survival of primary HCC patients
Summary
Hepatocellular carcinoma (HCC) is an aggressive tumor, considered the world's third most prevalent malignancy with a very poor prognosis, making it the fourth leading cause of cancer-related deaths [1]. Transarterial chemoembolization (TACE) is recommended for selected patients who are not appropriate for such interventions but have the liver-confined disease, preserved liver function, and good performance status [3]. A single agent's activity is limited, with only a few drugs showing a response rate of >10%. Combination chemotherapy has proven disappointing because compared to a single agent; additional drugs have resulted in increased toxicity without any increased efficacy. In the management of HCC patients, developing effective treatment modalities is crucial. TACE is still one of the common modalities in the treatment of patients with unresectable intermediate-stage hepatocellular carcinoma. Residual viable HCC is not uncommon following TACE, leading to poor overall survival after TACE alone [5]
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