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.
Artamonova E, Demidov L, Kharkevitch G, Manziuk L, Pirogova N. 2008 Cancer Biotherapy Radiopharmaceuticals Vol23.4:(5):669
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.
Original publication:
(pdf)
Reproduced by kind permission of
Biropharma Kft.
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