Journal article
Health-Related Quality of Life in Patients With Progressive Midgut Neuroendocrine Tumors Treated With 177Lu-Dotatate in the Phase III NETTER-1 Trial
Journal of clinical oncology, Vol.36(25), pp.2578-2584
06/07/2018
DOI: 10.1200/JCO.2018.78.5865
PMCID: PMC6366953
PMID: 29878866
Abstract
Purpose Neuroendocrine tumor (NET) progression is associated with deterioration in quality of life (QoL). We assessed the impact of 177 Lu-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 177 Lu-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 177 Lu-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, 177 Lu-Dotatate provides a significant QoL benefit for patients with progressive midgut NETs compared with high-dose octreotide.
Details
- Title: Subtitle
- Health-Related Quality of Life in Patients With Progressive Midgut Neuroendocrine Tumors Treated With 177Lu-Dotatate in the Phase III NETTER-1 Trial
- Creators
- Jonathan Strosberg - The University of Texas MD Anderson Cancer CenterEdward Wolin - The University of Texas MD Anderson Cancer CenterBeth Chasen - The University of Texas MD Anderson Cancer CenterMatthew Kulke - The University of Texas MD Anderson Cancer CenterDavid Bushnell - The University of Texas MD Anderson Cancer CenterMartyn Caplin - The University of Texas MD Anderson Cancer CenterRichard P. Baum - The University of Texas MD Anderson Cancer CenterPamela Kunz - The University of Texas MD Anderson Cancer CenterTimothy Hobday - The University of Texas MD Anderson Cancer CenterAndrew Hendifar - The University of Texas MD Anderson Cancer CenterKjell Oberg - The University of Texas MD Anderson Cancer CenterMaribel Lopera Sierra - The University of Texas MD Anderson Cancer CenterThomas Thevenet - The University of Texas MD Anderson Cancer CenterInes Margalet - The University of Texas MD Anderson Cancer CenterPhilippe Ruszniewski - The University of Texas MD Anderson Cancer CenterEric Krenning - The University of Texas MD Anderson Cancer Center
- Resource Type
- Journal article
- Publication Details
- Journal of clinical oncology, Vol.36(25), pp.2578-2584
- Publisher
- American Society of Clinical Oncology
- DOI
- 10.1200/JCO.2018.78.5865
- PMID
- 29878866
- PMCID
- PMC6366953
- ISSN
- 0732-183X
- eISSN
- 1527-7755
- Alternative title
- Quality of Life Analysis From the Phase III NETTER-1 Trial
- Language
- English
- Date published
- 06/07/2018
- Academic Unit
- Radiology
- Record Identifier
- 9984318712702771
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