A Randomized, Placebo-Controlled, Multicenter Study of Ganoderma lucidum (W.Curt.:Fr.) Lloyd (Aphyllophoromycetideae) Polysaccharides (Ganopoly) in Patients with Advanced Lung Cancer

Preclinical studies have established that the polysaccharide fractions of Ganoderma lucidum (Ling Zhi, reishi mashroom) have potential antitumor activity. Recent clinical studies have demonstrated that G. lucidum polysaccharides enhanced host immune functions (e.g., enhanced natural killer cell activity) in patients with advanced solid tumor, although objective response was not observed. A randomized double-blind, placebo-controlled, multicenter clinical trial was conducted to evaluate the efficacy and safety of the G. lucidum polysaccharides, Ganopoly®, in patients with advanced lung cancer. Sixty-eight patients with histologically confirmed advanced lung cancer were enrolled. Eligibility criteria included con. rmation of diagnosis, objective measurable disease, a Karnofsky performance score і60, life expectancy of 12 weeks or greater, no recent or concomitant anticancer therapy, and informed consent. Patients were evaluated with respect to their extent of disease and quality of life (Karnofsky score), and hematologic and selected immunological and biochemical studies at baseline and after 12 weeks of treatment with oral Ganopoly or placebo at 600 mg three times daily. Patients in both groups were similar with respect to age, sex, treatment history, and lung tumor histology. Treatment with Ganopoly gave stable disease (SD) in 13 (13/37, 35.1%) lung cancer patients at the 12-week evaluation point, which was significantly greater than that of control group (7/31, 22.6%). In 32 assessable cancer patient, treatment of Ganopoly resulted in a significant increase (>10 scores) in the KPS scores in 16 patients (50.0%); 4 patients (14.3%) obtained significant increase in the KPS scores in the control group with 29 assessable patients (p < 0.05); and 9 (28.1%) and 7 (21.9%) patients receiving Ganopoly had unchanged and reduced KPS scores, respectively. Values were 13 (46.4%) and 11 (39.3%) in the control group. Palliative effects on cancer-related symptoms such as fever, cough, weakness, sweating and insomnia have been observed in 43.8.84.4% of cancer patients receiving Ganopoly, but only a small percentage (10.7.42.9%) of cancer patients receiving placebo demonstrated improved cancer-related symptoms. Administration of Ganopoly for 12 weeks resulted in a significant (p < 0.05) increase in lymphocyte mitogenic reactivity to concanavalin A, CD3 percentage, and natural killer cell activity; a marginal increase in the CD4 percentage and CD4/CD8 ratio; but a marginal reduction of CD8. However, all these immune parameters remained unchanged or decreased in the control group. Three episodes of mild toxicity (nausea: 2; insomnia: 1) were recorded in patients receiving Ganopoly, and one episode of toxicity (vomiting) was recorded in the control group. The results indicate that Ganopoly may have an adjunct role in the treatment of patients with advanced lung cancer. Further studies are needed to explore the optimum dosing, efficacy, and safety of Ganopoly when used alone or in combination with chemotherapy/radiotherapy.