Efficacy and safety of viscum fraxini-2 in advanced hepatocellular carcinoma: a phase II study

Ebrahim, Mohamed A.; El-Hadaad, Hend Ahmed; Alemam, Omyma A.; Keshta, Salah A.

doi:10.1007/s10330-010-0629-y

Cited by 3 publications

(8 citation statements)

References 22 publications

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“…Major risk factors for HCC were HCV [5] or alcohol [2] related cirrhosis. All but 1 patient had undergone previous treatments including sorafenib [9], TACE [5], EBRT [5], chemotherapy [3], RFA [1], and hepatic arterial infusion [1]. Patients had a range of Child-Pugh classifications: A = 4, B = 6, C = 2.…”

Section: Resultsmentioning

confidence: 99%

“…SD was reported in all three clinical trials including 35% in a phase II study of stage IV melanoma treated with aviscumine. The most relevant clinical data to this case series comes from a prospective non-randomized clinical trial of a specific ME named VF-2 for advanced HCC [9], which reported an objective response rate of 20% (including 2 CRs) and SD rate of 33% among 120 patients.…”

Section: Discussionmentioning

confidence: 99%

“…Although some cohort and retrospective studies have indicated possible anticancer activity, studies from prospective clinical trials have been more mixed. With regard to HCC, investigators in Egypt have conducted a prospective non-randomized clinical trial of mistletoe therapy (viscum fraxini-2, VF-2) for advanced patients not eligible to pursue other treatments [9]. They demonstrated a combined partial response (PR)/complete response (CR) rate of 20% and stable disease (SD) rate of 33% in this study of 120 patients.…”

Section: Introductionmentioning

confidence: 90%

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Mistletoe Extract Viscum Fraxini-2 for Treatment of Advanced Hepatocellular Carcinoma: A Case Series

et al. 2021

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Background: Hepatocellular carcinoma (HCC) is the fourth leading cause of death from cancer worldwide, and for advanced HCC the prognosis is poor. Preliminary studies indicate mistletoe extracts may have anticancer activity for HCC. Methods: A prospective observational case series of advanced HCC patients that chose to take a mistletoe extract called viscum fraxini-2 (VF-2) alone for treatment. Time on treatment, imaging, and laboratory values were collected for descriptive analyses. Results: A total of 12 patients with advanced HCC enrolled onto the protocol, and 10 patients had data available for evaluation. The majority were male (10/12) with a median age of 64 (SD 11). Most patients had received sorafenib therapy (9/12) and had varying Child-Pugh classes (A-4, B-6, C-2). Treatment with VF-2 ranged from 1 to 36 weeks with a mean of 12.3 weeks (SD 12). Six patients received 8 weeks of treatment, and 3 patients received 12 or more weeks of treatment. For patients that received at least 4 weeks of treatment, the average AFP value stabilized during the first 4 weeks of treatment. Two patients experienced an AFP decrease of >30%, approximately 37 and 40% decreases at the nadir. One patient had stable disease of 9 months. Major side effects were fever, fatigue, rash, and local injection site reaction of swelling, redness, and tenderness. Conclusion: This case series of advanced HCC indicates that mistletoe extract VF-2 may have potential biological activity against HCC for selected patients. Research is needed to identify the active compound and predictive markers of response.

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Section: Resultsmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 90%

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Mistletoe Extract Viscum Fraxini-2 for Treatment of Advanced Hepatocellular Carcinoma: A Case Series

et al. 2021

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“…VAE have also been studied in treatment of HCC [14][15][16][17][18][19][20][21][22]. To our knowledge, our case presented here documents for the first time a prompt and durable tumour response under intravenous delivery of VAE.…”

Section: Introductionmentioning

confidence: 81%

“…For all types of VAE treatment of HCC, single cases [14][15][16], case reviews [17][18][19][20], and 2 phase II studies [21,22] document favourable tumour responses, improvement of serum AFP and transaminases, and found survival advantages. Ismail et al [19] found that VAE had no significant tumour effect nor prevented recurrence postresection.…”

Section: Discussionmentioning

confidence: 99%

Complete, Durable Remission of Advanced Hepatocellular Carcinoma under Treatment with <b><i>Viscum album</i></b> Extracts: A Case Report

Orange¹,

Poidimani²,

Crosignani³

et al. 2022

Complement Med Res

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BACKGROUND Hepatocellular carcinoma (HCC) is the 3rd leading cause of cancer deaths. Early stage disease is treated with curative intent, but most patients present with advanced HCC, which carries a poor prognosis. Viscum album extracts (VAE) are used by cancer patients as an adjunct treatment or palliation. CASE PRESENTATION A 51-year old female presented with relapsing multifocal HCC. She declined palliative treatment and commenced intravenous VAE treatment in conjunction with intravenous hepato-protective L-ornithine L-aspartate (LOLA). She experienced a significant improvement of life-quality and performance status. After 3 months a significant regression was noted on computerised tomography and α-fetoprotein was in normal range. Imaging 11 months later confirmed a complete regression. The VAE and LOLA treatment continues to date. The patient had no other cancer-directed therapy. The regression is sustained for 5 years at publication, confirmed by regular imaging and serology. The patient is experiencing an unrestricted quality of life. CONCLUSION Complete regression of advanced HCC is rare. Responses of HCC to VAE treatment have been reported before. However, this is the first documented case with a complete and durable regression of an HCC under treatment with VAE. Further studies should evaluate VAE treatment in HCC, especially when administered in forms as reported here.

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Systematic analysis of mistletoe prescriptions in clinical studies

Staupe

Buentzel

Keinki

et al. 2022

J Cancer Res Clin Oncol

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Purpose Mistletoe treatment is discussed controversial as a complementary treatment for cancer patients. Aim of this systematic analysis is to assess the concept of mistletoe treatment in the clinical studies with respect to indication, type of mistletoe preparation, treatment schedule, aim of treatment, and assessment of treatment results. Methods In the period from August to December 2020, the following databases were systematically searched: Medline, Embase, Cochrane Central Register of Controlled Trials (CENTRAL), PsycINFO, CINAHL, and “Science Citation Index Expanded” (Web of Science). We assessed all studies for study types, methods, endpoints and mistletoe preparations including their ways of application, host trees and dosage schedules. Results The search concerning mistletoe therapy revealed 3296 hits. Of these, 102 publications and at total of 19.441 patients were included. We included several study types investigating the application of mistletoe in different groups of participants (cancer patients of any type of cancer were included as well as studies conducted with healthy volunteers and pediatric patients). The most common types of cancer were breast cancer, pancreatic cancer, colorectal cancer and malignant melanoma. Randomized controlled studies, cohort studies and case reports make up most of the included studies. A huge variety was observed concerning type and composition of mistletoe extracts (differing pharmaceutical companies and host trees), ways of applications and dosage schedules. Administration varied e. g. between using mistletoe extract as sole treatment and as concomitant therapy to cancer treatment. As the analysis of all studies shows, there is no relationship between mistletoe preparation used, host tree and dosage, and cancer type. Conclusions Our research was not able to deviate transparent rules or guidelines with respect to mistletoe treatment in cancer care.

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Efficacy and safety of viscum fraxini-2 in advanced hepatocellular carcinoma: a phase II study

Cited by 3 publications

References 22 publications

Mistletoe Extract Viscum Fraxini-2 for Treatment of Advanced Hepatocellular Carcinoma: A Case Series

Mistletoe Extract Viscum Fraxini-2 for Treatment of Advanced Hepatocellular Carcinoma: A Case Series

Complete, Durable Remission of Advanced Hepatocellular Carcinoma under Treatment with <b><i>Viscum album</i></b> Extracts: A Case Report

Systematic analysis of mistletoe prescriptions in clinical studies

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