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Cancer Biother Radiopharm. 2008 Aug;23(4):477-82. doi: 10.1089/cbr.2008.0486.

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.

Author information

1
Melanoma Unit, Department of General Surgery, N.N. Blokhin Cancer Research Center, Russian Academy of Medical Sciences, Moscow, Russian Federation. info@eso.ru

Erratum in

  • Cancer Biother Radiopharm. 2008 Oct;23(5):669.

Abstract

OBJECTIVE:

The fermented wheat germ extract (FWGE) nutraceutical (Avemar), manufactured under "good manufacturing practice" conditions and, fulfilling the self-affirmed "generally recognized as safe" status in the United States, has been approved as a "dietary food for special medical purposes for cancer patients" in Europe. In this paper, we report the adjuvant use of this nutraceutical in the treatment of high-risk skin melanoma patients.

METHODS:

In a randomized, pilot, phase II clinical trial, the efficacy of dacarbazine (DTIC)-based adjuvant chemotherapy on survival parameters of melanoma patients was compared to that of the same treatment supplemented with a 1-year long administration of FWGE.

RESULTS:

At the end of an additional 7-year-long follow-up period, log-rank analyses (Kaplan-Meier estimates) showed significant differences in both progression-free (PFS) and overall survival (OS) in favor of the FWGE group. Mean PFS: 55.8 months (FWGE group) versus 29.9 months (control group), p = 0.0137. Mean OS: 66.2 months (FWGE group) versus 44.7 months (control group), p = 0.0298.

CONCLUSIONS:

The inclusion of Avemar into the adjuvant protocols of high-risk skin melanoma patients is highly recommended.

PMID:
18771352
DOI:
10.1089/cbr.2008.0486
[Indexed for MEDLINE]

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