New treatment option for nonfunctional neuroendocrine tumours
(Vienna, 28 October 2015) The results of the international, multicenter, Phase 3 RADIANT-4 study clearly demonstrate the efficacy of the agent everolimus in treating nonfunctional neuroendocrine tumours of lung or gastrointestinal origin. Progression-free survival of patients was successfully extended by seven months and the risk of progression of the disease fell by 52%. Everolimus was well tolerated and side-effects were consistent with the known profile. The Comprehensive Cancer Center (CCC) of MedUni Vienna and Vienna General Hospital was represented in the study by Markus Raderer of the University Department of Internal Medicine I.
Everolimus is an agent that blocks the mTOR receptor in the cell interior. mTOR (mammalian target of rapamycin) is an enzyme that controls cell survival, growth, division and mobility. It is part of the signalling system in the body and the start of a cascade of signalling pathways. Overactivity of these signalling pathways can contribute significantly to the development and progression of certain types of cancer, such as advanced, nonfunctional neuroendocrine tumours, for example. If mTOR is inhibited, tumour growth is slowed down.
Everolimus is already approved for treating advanced neuroendocrine tumours (NET) of the pancreas. Up until now no suitable data has been available about the use of everolimus for advanced, nonfunctional neuroendocrine tumours of lung or gastrointestinal origin. The RADIANT-4 study therefore investigated the efficacy and safety of everolimus for this indication. The results were presented at the European Cancer Congress 2015 in Vienna.
Sensible treatment option
Markus Raderer, oncologist at the University Department of Internal Medicine I at MedUni Vienna and Vienna General Hospital, Deputy Director of the CCC unit for NeuroEndocrine Tumours (CCC-NET) and co-author of the study, says: "So far, treatment options have been very limited, especially for NET of the lung. This is also the case for NET of the small intestine, if somatostatin analogues fail. The results of our approval study show that the period of progression-free survival can be extended by 7.1 months compared with placebo and the risk of progression of the disease can be reduced by 52%. Since everolimus is also known to be safe, it can potentially be used effectively in everyday clinical practice. Especially for NET of the lung, I believe this represents major therapeutic progress, because, hitherto, there has not been any properly established treatment option for this condition."
About the study
RADIANT-4 was the first large-scale, international, placebo-controlled, Phase 3 study conducted with patients with advanced, nonfunctional neuroendocrine tumours to investigate the use of everolimus in this patient population. 302 patients were enrolled in the study. Their average age was 63 and 53% of participants were women.
“Everolimus in Advanced Nonfunctional Neuroendocrine Tumors (NET) of Lung or Gastrointestinal (GI) Origin: Efficacy and Safety Results from the Placebo-Controlled, Double-blind, Multicenter, Phase 3 RADIANT-4 Study”
J. Yao, N. Fazio, S. Singh, R. Buzzoni, C. Carnaghi, E. Wolin, J. Tomasek, M. Raderer, H. Lahner, M. Voi, L. Pacaud, N. Rouyrre, C. Sachs, J. Valle, G. Delle Fave, E. Van Cutsem, M.E.T. Tesselaar, Y. Shimada, D.Y. Oh, J. Strosberg, M. Kulke, M. Pavel for the RAD001 in Advanced Neuroendocrine Tumors, Fourth Trial (RADIANT-4) Study Group