Abstract 3586
Background
Currently, there are limited therapeutic options for patients with advanced midgut neuroendocrine tumors progressing on first-line somatostatin analog therapy.
Methods
NETTER-1 is the first phase III, randomized trial evaluating 177Lu-DOTA0-Tyr3-Octreotate (Lutathera®) in patients with progressive, somatostatin receptor positive midgut NETs. 230 patients were randomized to receive Lutathera 7.4 GBq every 8 weeks (x4 administrations) versus Octreotide LAR 60 mg every 4 weeks. The primary endpoint was PFS (RECIST 1.1). Secondary objectives included ORR, OS, toxicity, and quality of life (QoL) based upon EORTC QLQ-C30 and QLQ-G.I.NET21 questionnaires. Subgroup analysis of PFS was performed to assess impact of potential prognostic factors.
Results
The centrally confirmed disease progressions or deaths were 23 in the Lutathera arm and 68 in the Octreotide LAR 60 mg arm. The median PFS was not reached for Lutathera and was 8.4 months with control, p
Conclusions
The phase III NETTER-1 trial provides evidence for a clinically meaningful and statistically significant increase in PFS, and suggests an OS benefit in patients with advanced midgut NETs treated with Lutathera. Subgroup analysis demonstrates consistent benefit across prognostic factors. The Lutathera safety and QoL profile was found to be favorable.
Clinical trial identification
NCT01578239
Legal entity responsible for the study
Advanced Accelerator Applications
Funding
Advanced Accelerator Applications
Disclosure
J. Strosberg: Ipsen, Novartis, Genentech, Bayer.
E. Wolin: Novartis, Advanced Accelerator Applications.
B. Chasen, A. Hendifar, D. Kwekkeboom, D. Bushnell, M. Lopera Sierra: Advanced Accelerator Applications.
M. Kulke: Novartis Lexicon Ipsen.
M. Caplin: Novartis Pharma, Ipsen Pharma, Lexicon for advisory boards.
K. Oberg: Ipsen Novartis.
P. Ruszniewski: Ipsen Novartis Advanced Accelerator Applications.
E. Krenning: Mallinckrodt SKF Advanced Accelerator Applications.
All other authors have declared no conflicts of interest.
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