Lung Adenocarcinoma Clinical Trial
Official title:
An Open-label Phase II Trial of Gefitinib and Berberine in Patients With Advanced Non-small Cell Lung Cancer and Activating EGFR Mutations
Rationale:
Advanced non-small-cell lung cancer (NSCLC) patients harboring epidermal growth factor
receptor (EGFR) mutations (del19 or L858R) show an impressive progression-free survival
between 9 and 11 months when treated with gefitinib. Combination of gefitinib and berberine
could improve efficacy in lung cancer with EGFR mutation in vivo and vitro. The investigators
hypothesize that progression-free survival could be improved by combination of gefitinib and
berberine.
Strong lipogenic activity and high expression of sterol regulatory element-binding protein 1 (SREBP-1) were found in gefitinib-resistance NSCLC cells. Berberine, an effective suppressor of SREBP1 and lipogenesis regulated through ROS/AMPK pathway, selectively inhibited the growth of gefitinib-resistance NSCLC cells but not that of normal cells. It effectively caused mitochondrial dysfunction, activated reactive oxygen species (ROS)/AMPK pathway and finally suppressed cellular lipogenesis and cell proliferation. Addition of ROS blocker, AMPK inhibitor and palmitic acid significantly reduced the effect of Berberine. In in vivo study, treatment of Berberine led to significant inhibition of mouse tumor xenograft growth. ;
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