Phase 1 Clinical Trial of Trametes versicolor in Women with Breast Cancer

Abstract

Introduction. Orally administered preparations from the Trametes versicolor (Tv) mushroom have been hypothesized to improve immune response in women with breast cancer after standard chemotherapy and radiotherapy. Methods. A phase I, two-center, dose escalation study was done to determine the maximum tolerated dose of a Tv preparation when taken daily in divided doses for 6 weeks after recent completion of radiotherapy. Eleven participants were recruited and nine women completed the study. Each cohort was comprised of three participants given one of three doses of Tv (3, 6, or 9 grams). Immune data was collected pre- and postradiation, at 3 on-treatment time points and after a 3-week washout. Results. Nine adverse events were reported (7 mild, 1 moderate, and 1 severe), suggesting that Tv was well tolerated. Immunological results indicated trends in (1) increased lymphocyte counts at 6 and 9 grams/day; (2) increased natural killer cell functional activity at 6 grams/day; (3) dose-related increases in CD8+ T cells and CD19+ B cells , but not CD4+ T cells or CD16+56+ NK cells. Conclusion. These findings show that up to 9 grams/day of a Tv preparation is safe and tolerable in women with breast cancer in the postprimary treatment setting. This Tv preparation may improve immune status in immunocompromised breast cancer patients following standard primary oncologic treatment.

Antiproliferative Activity of Kenyan Trametes versicolor Aqueous Extract on Selected Cancer and Normal Cell Lines

“…In another study done by Cheong-Yip et al [36], ethanolwater extract of T. versicolor exhibited significant antiproliferative activity on three human breast cancer cell lines (MDA-MB-231, MCF-7 and T-47D) in a dose-dependent manner in vitro. Carolyn achieved similar findings et al [37] in a clinical trial on women with breast cancer where oral preparations of T. versicolor administered to the subjects showed significant antiproliferative activity.…”

Anticancer potential of Trametes versicolor (L.) Lloyd and Auriporia aurea (Peck) Ryvarden mycelia in rat Guerin’s carcinoma.

“…T. versicolor anticancer activity was investigated in many studies and reported in many reviews (in experimental cancer models and clinical trials) [2,5,[12][13][14][15]. The majority of reviews and studies are related to the activity of the extracts from this fungus [12,16].…”

“…Another important question was the method adopted for mushroom preparations processing. The most common forms of mushroom preparations are extracts [2] and powders (suspensions) [5]. However the comparative studies regarding the effectiveness of certain substances (fractions isolated from the fungus) or mushroom powder (complex of biologically active substances) application are not well presented in the literature.…”

Medicinal properties of fungi occurring on Betula sp. trees. A review

“…Owing to its effect on the immune system, the YZP protein is able to suppress inflammation, which is a desirable phenomenon in cancer treatment [50]. An extract of T. versicolor was shown to be a safe immunostimulant which can support chemotherapy and improve patient's condition generally [51]. The anti-tumor effect in breast cancer is attributed to the PSP and PSK (Krestin) polysaccharopeptides, which act on the immune system and mediators of inflammation [19].…”