A Randomized Phase IIb Trial of myo-Inositol in Smokers with Bronchial Dysplasia.

Cancer prevention research (Philadelphia, Pa.), 2016; doi:10.1158/1940-6207.CAPR-15-0254

Authors: Lam Stephen, Mandrekar Sumithra J, Gesthalter Yaron, Allen Ziegler Katie L, Seisler Drew K et al.(20)

Affiliation: British Columbia Cancer Agency, Integrative Oncology, British Columbia Cancer Agency; Mayo Clinic College of Medicine; Boston University School of Medicine; Mayo Clinic, Biostatistics, Mayo Clinic; Biomedical Statistics and Informatics, Rochester, NY, United States (show more (20))

Abstract: Previous preclinical studies and a phase I clinical trial suggested myo-inositol may be a safe and effective lung cancer chemopreventive agent. We conducted a randomized, double blind, placebo-controlled, phase IIb study to determine the chemopreventive effects of myo-inositol in smokers with bronchial dysplasia. Smokers with >/= 1 site of dysplasia identified by autofluorescence bronchoscopy-directed biopsy were randomly assigned to receive oral placebo or myo-inositol, 9 g once/day for two weeks, and then twice/day for 6 months. The primary endpoint was change in dysplasia rate after six months of intervention on a per participant basis. Other trial endpoints reported herein include Ki-67 labeling index, blood and bronchoalveolar lavage fluid (BAL) levels of pro-inflammatory, oxidant/anti-oxidant biomarkers, and an airway epithelial gene-expression signature for phosphatidylinositol 3-kinase (PI3K) activity. Seventy four (n=38 myo-inositol, n=36 placebo) participants with a baseline and 6-month bronchoscopy were included in all efficacy analyses. The complete response and the progressive disease rates were 26.3% versus 13.9% and 47.4% versus 33.3%, respectively, in the myo-inositol and placebo arms (p=0.76). Compared with placebo, myo-inositol intervention significantly reduced IL-6 levels in BAL over 6 months (p=0.03). Among those who had a complete response in the myo-inositol arm, there was a significant decrease in a gene-expression signature reflective of PI3K activation within the cytologically-normal bronchial airway epithelium (p=0.002). The heterogeneous response to myo-inositol suggests a targeted therapy approach based on molecular alterations is needed in future clinical trials to determine the efficacy of myo-inositol as a chemopreventive agent.

Related patents


Map of newest papers for: inositol myo

The top research papers for the subject are placed on the map. Studies form clusters based on semantic relation.

Size of the point represents relevance of the paper.

You can pan and zoom the graph using mouse and mouse wheel.

Right click on the paper to:

  • a) open the paper
  • b) to open first author’s resume page.

Left click on keyword to add it to search.

Sign up to create your own map!