Both Afinitor (everolimus) and octreotide are FDA approved for neuroendocrine cancer. The phase III RADIANT-2 trial conducted in 429 patients with advanced neuroendocrine tumors (NETs) previously established that the addition of everolimus to long-acting octreotide led to a clinically meaningful 5.1-month delay in disease progression compared with octreotide alone. However, this value just missed the prespecified boundary for statistical significance (prespecified p value ≤ 0.0246; actual p value = 0.026).
Closer inspection of the data revealed that more patients with a poor prognosis were randomly assigned to the experimental arm versus the control arm, potentially attenuating the observed benefit of everolimus. Future studies will attempt to confirm the benefit of combining these two drugs.
Pavel ME, Hainsworth JD, Baudin E, Peeters M, Hörsch D, Winkler RE, Klimovsky J, Lebwohl D, Jehl V, Wolin EM, Oberg K, Van Cutsem E, Yao JC; RADIANT-2 Study Group.Everolimus plus octreotide long-acting repeatable for the treatment of advanced neuroendocrine tumours associated with carcinoid syndrome (RADIANT-2): a randomised, placebo-controlled, phase 3 study.Lancet. 2011 Dec 10;378(9808):2005-12. doi: 10.1016/S0140-6736(11)61742-X. Epub 2011 Nov 25.
Everolimus is beneficial
Octreotide is beneficial