| Summary: | The prognostic role of diabetes mellitus (DM) in advanced enteropancreatic neuroendocrine tumors (NETs) is unclear. Progression free survival (PFS) was assessed in post-hoc analyses of the 96-week, phase III, double-blind, placebo-controlled CLARINET study of lanreotide 120 mg in patients with advanced non-functional enteropancreatic NETs with DM (with/without metformin) and without DM. Of 204 patients, there were 79 with DM (lanreotide, <i>n =</i> 42 {metformin, <i>n =</i> 14}; placebo, <i>n =</i> 37 {metformin, <i>n =</i> 10}) and 125 without DM (lanreotide, <i>n =</i> 59; placebo, <i>n =</i> 66). Median PFS was 96.0 and 98.0 weeks with and without DM, respectively (hazard ratio 1.20 {95% confidence interval 0.79 to 1.82}; <i>p</i> = 0.380). No difference in PFS was observed in lanreotide-treated patients with/without DM (<i>p</i> = 0.8476). In the placebo group, median PFS was numerically shorter with versus without DM (<i>p</i> = 0.052) and was significantly longer in patients with DM and metformin (85.7 weeks) versus without metformin (38.7 weeks; <i>p</i> = 0.009). Multivariable Cox analyses showed that DM at baseline was not associated with PFS (<i>p</i> = 0.079); lanreotide was significantly associated with lower disease progression risk (<i>p</i> = 0.017). Lanreotide efficacy was confirmed in patients with advanced enteropancreatic NETs, regardless of diabetic status; DM was not a negative prognostic factor. A potential antitumor effect of metformin was observed in patients receiving placebo.
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