Randomized phase II study of platinum-based chemotherapy plus controlled diet with or without metformin in patients with advanced non-small cell lung cancer

ObjectivesAccumulating evidence indicates anti-diabetic drug metformin has anti-cancer effect by controlling cancer metabolism. We evaluated whether addition of to chemotherapy improved survival lung patients.Materials and methodsThis randomized phase II study enrolled 164 patients with chemo-native, EGFR-ALK wild-type, stage IIIB/IV non-small-cell (NSCLC). Patients were receive either (1000 mg twice daily) or alone every 3 weeks for six cycles. The received gemcitabine mg/m2) on days 1 8 carboplatin (5 area under the curve) day 1. Exploratory studies included serum metabolic panels, positron-emission tomography (PET) imaging, genetic mutation tests metabolism-related genes.ResultsMetformin group showed no significant difference in risk progression death compared control (progression: hazard ratio [HR] = 1.01 [95% confidence interval (CI) 0.72 − 1.42], P 0.935; death: HR 0.95 CI 0.67–1.34], 0.757). Squamous cell carcinoma (SqCC) had significantly higher fluorodeoxyglucose (FDG) uptake baseline PET image than non-SqCC NSCLC (P 0.004). In SqCC high FDG uptake, decreased 0.31 0.12−0.78], 0.013; 0.42 0.18–0.94], 0.035). HDL-cholesterol level was increased after treatment 0.011). benefit hyperinsulinemia whose insulin treatment.ConclusionsAddition provided unselected patients. However, it selected showing uptake. It suggests shows synergistic anti-tumor tumor which are highly dependent glucose