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.














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