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Maitake mushroom extract in myelodysplastic syndromes (MDS): a phase II study.

  • 2014-10-29
  • Cancer immunology, immunotherapy : CII 64(2)
    • Kathleen M Wesa
    • Susanna Cunningham-Rundles
    • Virginia M Klimek
    • Emily Vertosick
    • Marci I Coleton
    • K Simon Yeung
    • Hong Lin
    • Stephen Nimer
    • Barrie R Cassileth

Study Design

Type
Clinical Trial
Sample size
n = 21
Population
Myelodysplastic syndromes patients with International Prognostic Scoring System Low- and Intermediate-1-risk disease
Methods
phase II trial, oral Maitake extract at 3 mg/kg twice daily for 12 weeks
Blinding
Open-label
Duration
12 weeks
Funding
Unclear

Background

Myelodysplastic syndromes (MDS) are characterized by ineffective erythropoiesis with dysplastic bone marrow leading to peripheral cytopenia, risk of infection, and progression to acute myelogenous leukemia. Maitake mushroom beta-glucan, a dietary supplement, stimulates hematopoietic progenitor cell differentiation, granulocyte colony-stimulating factor production, and recovery of peripheral blood leukocytes after bone marrow injury. This phase II trial examined the effects of Maitake on innate immune function in MDS.

Methods

Myelodysplastic syndromes patients with International Prognostic Scoring System Low- and Intermediate-1-risk disease received oral Maitake extract at 3 mg/kg twice daily for 12 weeks. Primary endpoints included neutrophil count and function tested as endogenous or stimulated neutrophil production of reactive oxygen species (ROS) by flow cytometry compared with age-matched healthy controls (HC). ROS activators were Escherichia coli, phorbol ester, and the bacterial peptide N-formylmethionyl-leucyl-phenylalanine (fMLP). Complete blood counts, chemistry panels, iron studies, and monocyte function were evaluated.

Results

Of 21 patients enrolled, 18 completed the study and were evaluable. Maitake increased endogenous (basal) neutrophil (p = 0.005) and monocyte function (p = 0.021). Pre-treatment monocyte response to E. coli was reduced in MDS patients compared with HC (p = 0.002) and increased (p = 0.0004) after treatment. fMLP-stimulated ROS production response also increased (p = 0.03). Asymptomatic eosinophilia occurred in 4 patients (p = 0.014). Other changes in albumin, hemoglobin, and total protein were not clinically relevant.

Conclusions

Maitake was well tolerated. Enhanced in vitro neutrophil and monocyte function following treatment demonstrate that Maitake has beneficial immunomodulatory potential in MDS. Further study is warranted.

Research Insights

  • Maitake→Improved Monocyte Function

    Maitake increased endogenous (basal) neutrophil (p = 0.005) and monocyte function (p = 0.021).

    Effect
    Beneficial
    Effect size
    Moderate
    Dose
    3 mg/kg twice daily
  • Maitake→Improved Neutrophil Function

    Maitake increased endogenous (basal) neutrophil (p = 0.005) and monocyte function (p = 0.021).

    Effect
    Beneficial
    Effect size
    Moderate
    Dose
    3 mg/kg twice daily
  • Maitake→Increased Eosinophil Count

    Asymptomatic eosinophilia occurred in 4 patients (p = 0.014).

    Effect
    Neutral
    Effect size
    Small
    Dose
    3 mg/kg twice daily
  • Maitake→Increased Reactive Oxygen Species Response

    Pre-treatment monocyte response to E. coli was reduced in MDS patients compared with HC (p = 0.002) and increased (p = 0.0004) after treatment. fMLP-stimulated ROS production response also increased (p = 0.03).

    Effect
    Beneficial
    Effect size
    Moderate
    Dose
    3 mg/kg twice daily
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