420PD - NETTER-1 phase III in patients with midgut neuroendocrine tumors treated with 177Lu-dotatate: Efficacy, safety, QoL results and subgroup analysis

Date 10 October 2016
Event ESMO 2016 Congress
Session Endocrine and neuroendocrine tumours
Topics Neuroendocrine Tumours
Presenter Jonathan Strosberg
Citation Annals of Oncology (2016) 27 (6): 136-148. 10.1093/annonc/mdw369
Authors J. Strosberg1, E. Wolin2, B. Chasen3, M. Kulke4, D. Bushnell5, M. Caplin6, R. Baum7, P.L. Kunz8, T. Hobday9, A. Hendifar10, K. Oberg11, M. Lopera Sierra12, D. Kwekkeboom13, P. Ruszniewski14, E. Krenning15
  • 1Oncology, H. Lee Moffitt Cancer Center University of South Florida, FL 33612 - Tampa/US
  • 2Oncology, University of Kentucky, NY 10461-2601 - Lexington/US
  • 3Nuclear Medicine, University of Texas Health Science Center, 77030 - Houston/US
  • 4Medical Oncology, Dana-Farber Cancer Institute, 02215 - Boston/US
  • 5Division Of Nuclear Medicine, University of Iowa, 52242 - Iowa City/US
  • 6Gastroenterology, Neuroendocrine Tumour Unit, Royal Free Hospital School of Medicine, NW3 2QG - London/GB
  • 7Nuclear Medicine, Zentralklinik Bad Berka GmbH, 99437. - Bad Berka/DE
  • 8Oncology, Stanford University Medical Center, CA94305 - Stanford/US
  • 9Oncology, Mayo Clinic, 55905 - Rochester/US
  • 10Oncology, Cedars-Sinai Medical Center, 90048 - Los Angeles/US
  • 11Endocrine Oncology, University Hospital Uppsala Akademiska Sjukhuset, 751 85 - Uppsala/SE
  • 12-, Advanced Accelerator Applications, 10118 - New York/US
  • 13Nuclear Medicine Department, Erasmus University Medical Center, 3015 - Rotterdam/NL
  • 14Gastroenterology, Hôpital Beaujon, 92110 - Clichy/FR
  • 15Oncology, Erasmus University Medical Center, 3015 - Rotterdam/NL

Abstract

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.