438PD - Improved Time to Quality of Life Deterioration in Patients with Progressive Midgut Neuroendocrine Tumors Treated with 177Lu-DOTATATE: the NETTER-1...

Date 11 September 2017
Event ESMO 2017 Congress
Session Endocrine and neuroendocrine tumours
Topics Neuroendocrine Cancers
Endocrine Cancers
Presenter Jonathan Strosberg
Citation Annals of Oncology (2017) 28 (suppl_5): v142-v157. 10.1093/annonc/mdx368
Authors J. Strosberg1, E.M. Wolin2, B. Chasen3, M.H. Kulke4, D. Bushnell5, M. Caplin6, R.P. Baum7, P. Kunz8, T. Hobday9, A. Hendifar10, K. Öberg11, M. Lopera Sierra12, P. Ruszniewski13, E. Krenning14
  • 1Gi Oncology, H. Lee Moffitt Cancer Center University of South Florida, 33612 - Tampa/US
  • 2., Montefiore Einstein Center for Cancer Care, New York/US
  • 3Nuclear Medicine, The University of Texas MD Anderson Cancer Center, 7 - Houston/US
  • 4Gastrointestinal Cancer, Dana-Farber Cancer Institute, Boston/US
  • 5Nuclear Medicine, University of Iowa, Iowa/US
  • 6Neuroendocrine Tumour Unit, Royal Free Hospital, London/GB
  • 7Nuclear Medicine, Zentralklinik Bad Berka GmbH, 99437 - Bad Berka/DE
  • 8Oncology, Stanford University Medical Center, Stanford/US
  • 9Oncology, Mayo Clinic, 55905 - Rochester/US
  • 10Oncology, Cedars-Sinai Medical Center, 90048 - Los Angeles/US
  • 11Endocrine Oncology, University Hospital, Uppsala University, Uppsala/SE
  • 12Medical, Advanced Accelerator Applications, 10118 - New York/US
  • 13Oncology, Hôpital Beaujon, 92110 - Clichy/FR
  • 14Oncology, Erasmus Medical Center, Rotterdam/NL

Abstract

Background

Neuroendocrine tumor (NET) progression is associated with deterioration in quality of life (QoL). We assessed the impact of 177Lu-DOTATATE treatment on the time to clinically relevant change (deterioration) in health-related QoL (HRQoL). The NETTER-1 trial is an international phase III study in patients with progressive, somatostatin receptor positive midgut NET. Patients were randomized to receive treatment with 177Lu-DOTATATE versus high-dose (60 mg) Octreotide LAR (Oct). EORTC questionnaires QLQC-30 and G.I.NET-21 were assessed during the trial to determine the impact of treatment on HRQoL.

Methods

231 patients completed EORTC QLQC-30 and G.I.NET-21 questionnaires at baseline and every 12 weeks thereafter until tumor progression centrally confirmed. QoL scores were converted to a 100-point scale according to EORTC instructions and individual changes from baseline scores were assessed. Time to QoL deterioration (TTD) was defined as the time from randomization to the first QoL deterioration ≥10 points for each patient in the corresponding domain scale. This magnitude of variation was considered clinically relevant. All analyses were conducted on the ITT population.

Results

TTD was significantly longer in the 177Lu-DOTATATE arm (N = 117) vs the control arm (N = 114) for the following domains: global health status (hazard ratio (HR) 0.406; p = 0.0006), physical functioning (HR 0.518; p = 0.0147), role functioning (HR 0.580; p = 0.0298), fatigue (HR 0.621; p = 0.0297), pain (HR 0.566; p = 0.0247), diarrhea (HR 0.473; p = 0.0107), disease related worries (HR 0.572; p = 0.0176) and body image (HR 0.425; p = 0.0058). In the other domains TTD did not reach statistical significance between the arms. Differences in median TTD were clinically significant in several domains: 28.8 months vs. 6.1 months for global health status, and 25.2 months vs. 11.5 months for physical functioning.

Conclusions

This analysis from the NETTER-1 Phase III study demonstrates that 177Lu-DOTATATE provides a significant quality of life benefit for patients with progressive midgut NETs compared to high-dose octreotide, in addition to the meaningful increase in progression-free survival already reported.

Clinical trial identification

NCT01578239

Legal entity responsible for the study

NETTER-1 study group and Advanced Accelerator Applications

Funding

Advanced Accelerator Applications

Disclosure

M. Lopera Sierra: Advanced Accelerator Applications Chief Medical Officer E. Krenning: Stock ownership. All other authors have declared no conflicts of interest.