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.
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.
Demidov
Lev V
LV
Melanoma Unit, Department of General Surgery, N.N. Blokhin Cancer Research Center, Russian Academy of Medical Sciences, Moscow, Russian Federation. info@eso.ru
Manziuk
Ljudmila V
LV
Kharkevitch
Galina Y
GY
Pirogova
Nina A
NA
Artamonova
Elena V
EV
D000293:Adolescent; D000328:Adult; D000368:Aged; D017024:Chemotherapy, Adjuvant / Q000379:methods; D003606:Dacarbazine / Q000009:adverse effects / Q000627:therapeutic use; D019587:Dietary Supplements; D004359:Drug Therapy, Combination; D005260:Female; D005285:Fermentation; D005500:Follow-Up Studies; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008545:Melanoma / Q000188:drug therapy* / Q000473:pathology; D008875:Middle Aged; D010865:Pilot Projects; D010936:Plant Extracts / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D012878:Skin Neoplasms / Q000188:drug therapy* / Q000473:pathology; D016896:Treatment Outcome; D014908:Triticum / Q000737:chemistry* / Q000378:metabolism
D010936:Plant Extracts; D003606:Dacarbazine