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Abstract
Preclinical studies have established that the Ganoderma lucidum polysaccharide (GLPS) fractions have potent anti‐tumor activity, which has been associated with the immuno‐stimulating effects of GLPS. However, it is unclear whether GLPS has immuno‐modulating effects in humans in vivo. This study aimed to investigate the effects of Ganopoly®, the polysaccharides fractions extracted from G. lucidum, on the immune function of advanced‐stage cancer patients. Thirty‐four advance‐stage cancer patients were entered onto this study, and treated with 1800 mg Ganopoly®, three times daily orally before meals for 12 weeks. Immune parameters (cytokines, T cell subsets, mitotic response to phytohemagglutinin (PHA) and natural killer (NK) activity) were compared between baseline and after 12‐week treatment. Thirty patients are assessable for their immune functions. Treatment of Ganopoly® for 12 weeks resulted in a significant (P < 0.05) increase in the mean plasma concentrations of interleukin (IL‐2), IL‐6, and interferon (IFN)‐γ, whereas the levels of IL‐1 and tumor necrosis factor (TNF‐α) were significantly (P < 0.05) decreased. A marked variability among patients with advanced‐stage cancer was observed in the numbers of each lymphocyte subset at baseline. The mean absolute number of CD56+ cells was significantly (P < 0.05) increased after 12‐week treatment of Ganopoly®, whereas the numbers of CD3+, CD4+, and CD8+ were just marginally increased compared to baseline levels, with the CD4:CD8 T cell ratios unchanged. PHA responses after 12‐week treatment with Ganopoly® were enhanced in most patients, when compared to pretreatment baselines (P < 0.05). In addition, Ganopoly® treatment resulted in a significant increase (P < 0.05) in the mean NK activity compared to baselines (34.5 ± 11.8% vs 26.6 ± 8.3%). The present study indicates that Ganopoly® enhanced the immune responses in patients with advanced‐stage cancer. Clinical evaluations of response and toxicity are ongoing.