Adjuvant Fermented Wheat Germ Extract (Avemar™) Nutraceutical Improves Survival of High-Risk Skin Melanoma Patients: A Randomized, Pilot, Phase II Clinical Study with a 7-Year Follow-Up

2008 ◽  
Vol 23 (4) ◽  
pp. 477-482 ◽  
Author(s):  
Lev V. Demidov ◽  
Ljudmila V. Manziuk ◽  
Galina Y. Kharkevitch ◽  
Nina A. Pirogova ◽  
Elena V. Artamonova
2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 9049-9049
Author(s):  
H. Gogas ◽  
Y. Metaxas ◽  
A. Polyzos ◽  
M. Mantzourani ◽  
A. Antoniadis ◽  
...  

9049 Background: Attempts to identify patients who benefit from adjuvant treatment of interferon alfa-2b (IFN) have been disappointing. Interleukin-10 polymorphisms have been implicated with the prognosis of patients with advanced melanoma and associated with response to biochemotherapy. Several polymorphisms have been found within the IL-10 gene. We evaluated three IL-10 Single Nucleotide Polymorphisms (SNPs) in high-risk melanoma patients enrolled in a study of two regimens of high-dose IFN and compared the distribution of SNPs found in healthy controls. Methods: We genotyped DNA from peripheral blood of 280 stage IIb, IIc and III melanoma patients and 288 healthy controls for 592 C/A, 819 C/T and 1082 G/A with PCR and pyrosequencing technology (Biotage, Uppsala, Sweden). Results: At a median follow up of 56.3 months (95% CI 47.4–63.7), 147 patients have recurred and 94 have died. The median DFS was 53 months and the median OS 86 months. There were no statistically significant differences in the incidence of IL-10 polymorphisms between the melanoma patients and healthy controls. The incidence of these polymorphisms is presented in table . RFS and OS did not differ significantly between the alleles of these polymorphisms (p=0.88 and p=0.55 for 592 C/A, p=0.84 and p=0.68 for 819 C/T and p=0.26 and p=0.30 for 1082 G/A respectively). Conclusions: No SNP studied was correlated with improved RFS and OS in this high-risk group of melanoma patients. [Table: see text] [Table: see text]


2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e20014-e20014
Author(s):  
Z. Chi ◽  
C. Cui ◽  
X. Yuan ◽  
L. Si ◽  
X. Sheng ◽  
...  

e20014 Background: To investigate the efficacy and safety of hepatic intra-arterial infusion of cisplatin, fotemustine combined with systemic dacarbazine for the treatment of melanoma patients with liver metastasis. Methods: From 2005.7 to 2008.7, thirty-six melanoma patients with liver metastatic were enrolled. Systemic dacarbazine (250mg/m2 d1–5) and intra-arterial hepatic (i.a.h.) of cisplatin (75mg/m2 d6) and fotemustine (100mg/m2 d7) were given repeated for 4-weeks. Response, progress free survival(PFS), and toxicity were analyzed. Results: 27 of the 36 patients were evaluable, with mean cycle 2.16±1.19, one achieved CR, one PR and seven SD. The disease control rate was 33.3% (9/27) with a median PFS of 3.5 months (95% CI 3.45–7.02months), overall survival of 7.5 months (95 CI 6.87–11.06 months, following to 2008.8). The Grade 3/4 toxicity was mainly myelosuppression, with occurrence rates of 40.7% (10/27). Conclusions: Intra-arterial hepatic chemotherapy show its efficacy and may prolong PFS in melanoma patients with liver metastasis. No significant financial relationships to disclose.


2013 ◽  
Vol 2013 ◽  
pp. 1-9 ◽  
Author(s):  
Cheng-Jeng Tai ◽  
Wen-Ching Wang ◽  
Chien-Kai Wang ◽  
Chih-Hsiung Wu ◽  
Mei-Due Yang ◽  
...  

Hepatocellular carcinoma (HCC) is one of the most common causes of cancer-related death worldwide. Due to the difficulties of early diagnosis, curative treatments are not available for most patients. Palliative treatments such as chemotherapy are often associated with low response rate, strong adverse effects and limited clinical benefits for patients. The alternative approaches such as fermented wheat germ extract (FWGE) with anti-tumor efficacy may provide improvements in the clinical outcome of current therapy for HCC. This study aimed to clarify antitumor efficacy of FWGE and the combination drug effect of FWGE with chemotherapeutic agents, cisplatin and 5-fluorouracil (5-Fu) in human HCC cells, HepG2, Hep3B, and HepJ5. The present study indicated that FWGE exhibited potential to suppress HepG2, Hep3B, and HepJ5 cells, with the half maximal inhibitory concentrations (IC50) of FWGE were 0.494, 0.371 and 1.524 mg/mL, respectively. FWGE also induced Poly (Adenosine diphosphate ribose) polymerase (PARP) associated cell death in Hep3B cells. Moreover, the FWGE treatment further enhanced the cytotoxicity of cisplatin in all tested HCC cells, and cytotoxicity of 5-Fu in a synergistic manner in HepJ5 cells. Collectively, the results identified the anti-tumor efficacy of FWGE in HCC cells and suggested that FWGE can be used as a supplement to effectively improve the tumor suppression efficiency of cisplatin and 5-Fu in HCC cells.


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