First update on overall survival, progression-free survival, and health-related time-to-deterioration quality of life from the NETTER-1 study: 177Lu-Dotatate vs. high dose octreotide in progressive midgut neuroendocrine tumors.

Authors

null

Jonathan R. Strosberg

H. Lee Moffitt Cancer Center & Research Institute, Tampa, FL

Jonathan R. Strosberg , Edward M. Wolin , Beth A. Chasen , Matthew H. Kulke , David L Bushnell Jr., Martyn E. Caplin , Richard P. Baum , Timothy J. Hobday , Andrew Eugene Hendifar , Maribel Lopera Sierra , Kjell E. Oberg , Philippe B. Ruszniewski , Eric Krenning

Organizations

H. Lee Moffitt Cancer Center & Research Institute, Tampa, FL, Montefiore Einstein Center for Cancer Care, Bronx, NY, Department of Nuclear Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX, Boston University/Boston Medical Center, Boston, MA, University of Iowa, Iowa City, IA, Neuroendocrine Tumour Unit, Royal Free Hospital, London, United Kingdom, Zentralklinik, Bad Berka, Germany, Bad Berka, Germany, Mayo Clinic, Rochester, MN, Samuel Oschin Comprehensive Cancer Institute, Cedars-Sinai Medical Center, Los Angeles, CA, Advanced Accelerator Applications, New York, NY, Uppsala University Hospital, Uppsala, Sweden, Beaujon Hospital, Clichy, France, Erasmus MC, Rotterdam, Netherlands

Research Funding

Pharmaceutical/Biotech Company

Background: The final per-protocol statistical analysis (cut–off date 24 July 2015) of PFS, the primary endpoint of the NETTER-1 study, showed a significant difference (p < 0.0001) between the treatment arms. Supplemental updated analysis was requested by regulatory authorities for registration purposes. Quality of life (QoL) was analysed one year later, with a cut-off date of 30 June 2016 for time to clinically relevant deterioration (TTD) in health-related QoL (HRQoL). Methods: Overall survival (OS) and PFS were evaluated using Kaplan Meier methodology. HRQoL analysis was based on EORTC QLQC-30 and G.I.NET-21 questionnaires, completed at baseline and every 12 weeks thereafter. TTD was defined as the time from randomization to the first QoL deterioration ≥10 points for each patient in the corresponding domain scale. First OS regulatory update cut-off date was 30 June 2016. Results: At this first update, median OS was 27.4 months in Oct arm and still not reached in Lu arm. PFS at this date showed 30 events in the Lu arm and 78 in the Oct arm (HR: 0.21 CI: 0.14 0.33; p < 0.0001). HRQoL TTD was significantly longer in the Lu arm vs. the Oct arm for global health status (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). Conclusions: This supplemental analysis from the NETTER-1 Phase III study confirms the clinically and statistically meaningful PFS benefit, and still suggests a survival benefit with 177Lu-dotatate. It also demonstrates that 177Lu-dotatate provides a significant quality of life benefit for patients compared to high-dose octreotide. Clinical trial information: NCT01578239

Disclaimer

This material on this page is ©2024 American Society of Clinical Oncology, all rights reserved. Licensing available upon request. For more information, please contact licensing@asco.org

Abstract Details

Meeting

2018 ASCO Annual Meeting

Session Type

Poster Session

Session Title

Gastrointestinal (Noncolorectal) Cancer

Track

Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary

Sub Track

Neuroendocrine/Carcinoid

Clinical Trial Registration Number

NCT01578239

Citation

J Clin Oncol 36, 2018 (suppl; abstr 4099)

DOI

10.1200/JCO.2018.36.15_suppl.4099

Abstract #

4099

Poster Bd #

288

Abstract Disclosures