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International Journal of Medicinal Mushrooms

Impact factor: 1.357

ISSN Print: 1521-9437
ISSN Online: 1940-4344

International Journal of Medicinal Mushrooms

DOI: 10.1615/IntJMedMushr.v4.i3.30
8 pages

A Phase I/II Study of a Ganoderma lucidum (Curt.: Fr.) P. Karst. Extract (Ganopofy) in Patients with Advanced Cancer

Yihuai Gao
Institute of Food, Nutrition and Human Health, Massey University; Landcare Research, Private Bag 92170, Auckland, New Zealand
Shufeng Zhou
Division of Pharmacy, School of Life Sciences, Faculty of Science, Queensland University of Technology, Australia; Department of Pharmacy, Faculty of Science, National University of Singapore; University of South Florida FL 33612, USA
Guoliang Chen
Division of Traditional Chinese Medicine, New Zealand Institute of Natural Medicines, Auckland, New Zealand
Xihu Dai
Department of Internal Medicine, Fuzhou General Hospital of Nanjing Military Region of the Peoples' Liberation Army, Fuzhou, R.P. China
Jingxian Ye
Department of Integrated Medicine. Hospital of Fujian University of Traditional Chinese Medicine, Fuzhou, R.P. China

ABSTRACT

In vitro and animal studies have established that the polysaccharide fractions of Ganoderma lucidum have potential antitumor activity and inhibitory effect on tumor metastasis. Ganopoly (crude polysaccharide fractions extracted from G. lucidum by patented technique, kindly provided by Encore International Ltd., Auckland, NZ) has demonstrated immunomodulating and tumor inhibitory effects in in vitro and mouse models. A clinical trial was conducted to evaluate the efficacy and safety of Ganopoly in patients with advanced cancer. One hundred and forty-three patients with advanced, previously treated cancer were enrolled. Eligibility criteria included confirmation of diagnosis, objectively measurable disease, Eastern Cooperative Oncology Group performance status of 0 to 2, life expectancy of 12 weeks or greater, no recent or concomitant anticancer therapy, and informed consent. Patients underwent evaluation of the extent of disease, quality of life, hematologic, biochemical, and selected immune function studies at baseline and after 6 and 12 weeks of Ganopoly therapy. Standard criteria were used to evaluate adverse events and response. Ganopoly was given orally at 1800 mg three times daily. Twenty-seven patients were not assessable for response and toxicity because they were lost to follow-up or refused further therapy before 12 weeks of treatment. Of the 100 fully assessable patients, 46 patients (32.2%) had progressive disease (PD) before or at the 6-week evaluation point (range, 5 days—6 weeks). Sixteen patients (11.2%) developed PD between 6 and 12 weeks of therapy. No objective (partial or complete) responses were observed, but 38 of 143 patients (26.6%) had stable disease (SD) for 12 weeks or more (range, 12-50 weeks). There was no significant change in the FACT-G scores in 85 assessable patients. However, palliative effects on cancer-related symptoms, such as sweating and insomnia, have been observed in many patients. In the group of patients with SD, FACT-G scores improved in 23 patients, were unchanged in 5 patients, and declined in 1 patient. Within this group, the median change from the baseline score to the 6- and 12-week score was +7.6 and +10.3 score, both statistically significant (P < 0.05). No significant changes of the selected immune function parameters were observed in 75 assessable patients. However, in the group of 32 patients with SD for 12 weeks or more, Ganopoly significantly increased lymphocyte mitogenic reactivity to concanavalin A and phytohemagglutinin by 28 ± 7.3% (P < 0.05) and significantly enhanced natural killer cell activity by 25 ± 5.9% (P < 0.05). Five adverse events (grade 1) were recorded, 3 of which were gastrointestinal (nausea, 2; diarrhea, 1). The results indicate that Ganopoly may have an adjunct role in the treatment of patients with advanced cancer, although objective responses were not observed in this study.