Treatment with everolimus in the RADIANT-3 trial was associated with a median overall survival of 44 months among patients with advanced, progressive pancreatic neuroendocrine tumors (NET), according to an analysis published in the Journal of Clinical Oncology.1
Investigators randomly assigned 410 patients with advanced, progressive, low- or intermediate-grade pancreatic NET to receive everolimus or placebo. Crossover from placebo to open-label everolimus was permitted after patients experienced disease progression. Median progression-free survival was 6.4 months longer with everolimus.
Among the 225 patients treated who received open-label everolimus, median overall survival was 44 months (95% CI, 35.6-51.8), versus 37.7 months (95% CI, 29.1-45.8) for those who received placebo. This finding was not statistically significant.
The most frequently reported adverse events were stomatitis, rash, and diarrhea.
Elevated baseline chromogranin A, neuron-specific enolase, placental growth factor, and soluble vascular endothelial growth factor receptor 1 levels were prognostic factors for poor overall survival.
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Despite the non-significance in median overall survival between the 2 arms, 44 months is the longest overall survival reported in a phase 3 trial in this patient population. The authors hypothesize that crossover from placebo to open-label everolimus likely diminished the median overall survival results of patients who received everolimus.
- Yao JC, Pavel M, Lombard-Bohas C, et al. Everolimus for the treatment of advanced pancreatic neuroendocrine tumors: overall survival and circulating biomarkers from the randomized, phase III RADIANT-3 study. J Clin Oncol. 2016 Sep 12. doi: 10.1200/JCO.2016.68.0702 [Epub ahead of print]