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J Clin Oncol. 2018 Sep 1;36(25):2578-2584. doi: 10.1200/JCO.2018.78.5865. Epub 2018 Jun 7.

Health-Related Quality of Life in Patients With Progressive Midgut Neuroendocrine Tumors Treated With 177Lu-Dotatate in the Phase III NETTER-1 Trial.

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1
Jonathan Strosberg, Moffitt Cancer Center, Tampa, FL; Edward Wolin, Montefiore Einstein Center for Cancer Care, Bronx, NY; Beth Chasen, University of Texas MD Anderson Cancer Center, Houston, TX; Matthew Kulke, Dana-Farber Cancer Institute, Boston, MA; David Bushnell, University of Iowa, Iowa City, IA; Martyn Caplin, Royal Free Hospital, London, United Kingdom; Richard P. Baum, Zentralklinik, Bad Berka, Germany; Pamela Kunz, Stanford University Medical Center, Stanford; Andrew Hendifar, Cedars Sinai Medical Center, Los Angeles, CA; Timothy Hobday, Mayo Clinic College of Medicine, Rochester, MN; Kjell Oberg, University Hospital, Uppsala University, Uppsala, Sweden; Maribel Lopera Sierra, Thomas Thevenet, and Ines Margalet, Advanced Accelerator Applications, Geneva, Switzerland; Philippe Ruszniewski, Hopital Beaujon and Paris Diderot University, Clichy, France; and Eric Krenning, Erasmus Medical Center, Rotterdam, Netherlands.

Abstract

Purpose Neuroendocrine tumor (NET) progression is associated with deterioration in quality of life (QoL). We assessed the impact of 177Lu-Dotatate treatment on time to deterioration in health-related QoL. Methods The NETTER-1 trial is an international phase III study in patients with midgut NETs. Patients were randomly assigned to treatment with 177Lu-Dotatate versus high-dose octreotide. European Organisation for Research and Treatment of Cancer quality-of-life questionnaires QLQ C-30 and G.I.NET-21 were assessed during the trial to determine the impact of treatment on health-related QoL. Patients completed the questionnaires at baseline and every 12 weeks until tumor progression. QoL scores were converted to a 100-point scale according to European Organisation for Research and Treatment of Cancer instructions, and individual changes from baseline scores were assessed. Time to QoL deterioration (TTD) was defined as the time from random assignment to the first QoL deterioration ≥ 10 points for each patient in the corresponding domain scale. All analyses were conducted on the intention-to-treat population. Patients with no deterioration were censored at the last QoL assessment date. Results TTD was significantly longer in the 177Lu-Dotatate arm (n = 117) versus the control arm (n = 114) for the following domains: global health status (hazard ratio [HR], 0.406), physical functioning (HR, 0.518), role functioning (HR, 0.580), fatigue (HR, 0.621), pain (HR, 0.566), diarrhea (HR, 0.473), disease-related worries (HR, 0.572), and body image (HR, 0.425). Differences in median TTD were clinically significant in several domains: 28.8 months versus 6.1 months for global health status, and 25.2 months versus 11.5 months for physical functioning. Conclusion This analysis from the NETTER-1 phase III study demonstrates that, in addition to improving progression-free survival, 177Lu-Dotatate provides a significant QoL benefit for patients with progressive midgut NETs compared with high-dose octreotide.

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