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.
RCT Entities:
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 cancerpatients" in Europe. In this paper, we report the adjuvant use of this nutraceutical in the treatment of high-risk skin melanomapatients. METHODS: In a randomized, pilot, phase II clinical trial, the efficacy of dacarbazine (DTIC)-based adjuvant chemotherapy on survival parameters of melanomapatients 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 melanomapatients is highly recommended.
Authors: Patricia L Judson; Entidhar Al Sawah; Douglas C Marchion; Yin Xiong; Elona Bicaku; Nadim Bou Zgheib; Hye Sook Chon; Xiaomang B Stickles; Ardeshir Hakam; Robert M Wenham; Sachin M Apte; Jesus Gonzalez-Bosquet; Dung-Tsa Chen; Johnathan M Lancaster Journal: Int J Gynecol Cancer Date: 2012-07 Impact factor: 3.437
Authors: Gustavo A Barisone; Robert T O'Donnell; Yunpeng Ma; Mastewal W Abuhay; Kathleen Lundeberg; Sonia Gowda; Joseph M Tuscano Journal: PLoS One Date: 2018-01-05 Impact factor: 3.240