A phase II study of Lenvatinib and Everolimus in advanced well-differentiated extra pancreatic neuroendocrine tumors

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Introduction: Data suggest that combined inhibition of VEGF and FGF is an effective antiangiogenic strategy and that concomitant inhibition of the mTOR pathway may be further synergistic.

Aim(s): The primary objective of this phase II trial was objective response rate (ORR) and secondary objectives included progression-free survival (PFS) & safety.

Materials and methods: In a single institution phase II trial, pts with advanced, progressive extra pancreatic neuroendocrine tumors (epNET) were treated with lenvatinib (L), a VEGF & FGF inhibitor, and the mTOR inhibitor everolimus (E) mg in 28 d cycles, c with re-staging every 3c. The trial was initiated at L 18 mg and E 5 mg po d but after the first 3 pts having G3 AEs, L was reduced to 14. With a 2-stage design where H0 is ORR <5% and H1 is ORR >= 20% up to 32 pts were needed for type 1 & 2 error = 10%.

Conference:

Presenting Author: Dasari A

Authors: Dasari A, Qiao W, Halperin D, Stanietzky N, Surabhi V,

Keywords: Extrapancreatic NET, Lenvatinib, Everolimus, Phase II,