dc.contributor.author | Berlin, Jordan | |
dc.date.accessioned | 2020-11-03T23:32:45Z | |
dc.date.available | 2020-11-03T23:32:45Z | |
dc.date.issued | 2020-09 | |
dc.identifier.citation | Strosberg, J., Kunz, P. L., Hendifar, A., Yao, J., Bushnell, D., Kulke, M. H., Baum, R. P., Caplin, M., Ruszniewski, P., Delpassand, E., Hobday, T., Verslype, C., Benson, A., Srirajaskanthan, R., Pavel, M., Mora, J., Berlin, J., Grande, E., Reed, N., Seregni, E., … NETTER-1 study group (2020). Impact of liver tumour burden, alkaline phosphatase elevation, and target lesion size on treatment outcomes with 177Lu-Dotatate: an analysis of the NETTER-1 study. European journal of nuclear medicine and molecular imaging, 47(10), 2372–2382. https://doi.org/10.1007/s00259-020-04709-x | en_US |
dc.identifier.issn | 1619-7070 | |
dc.identifier.uri | http://hdl.handle.net/1803/16271 | |
dc.description | Only Vanderbilt University affiliated authors are listed on VUIR. For a full list of authors, access the version of record at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7396396/ | en_US |
dc.description.abstract | Purpose To assess the impact of baseline liver tumour burden, alkaline phosphatase (ALP) elevation, and target lesion size on treatment outcomes with Lu-177-Dotatate. Methods In the phase 3 NETTER-1 trial, patients with advanced, progressive midgut neuroendocrine tumours (NET) were randomised to 177Lu-Dotatate (every 8 weeks, four cycles) plus octreotide long-acting release (LAR) or to octreotide LAR 60 mg. Primary endpoint was progression-free survival (PFS). Analyses of PFS by baseline factors, including liver tumour burden, ALP elevation, and target lesion size, were performed using Kaplan-Meier estimates; hazard ratios (HRs) with corresponding 95% CIs were estimated using Cox regression. Results Significantly prolonged median PFS occurred with Lu-177-Dotatate versus octreotide LAR 60 mg in patients with low (< 25%), moderate (25-50%), and high (> 50%) liver tumour burden (HR 0.187, 0.216, 0.145), and normal or elevated ALP (HR 0.153, 0.177), and in the presence or absence of a large target lesion (diameter > 30 mm; HR, 0.213, 0.063). Within the Lu-177-Dotatate arm, no significant difference in PFS was observed amongst patients with low/moderate/high liver tumour burden (P = 0.7225) or with normal/elevated baseline ALP (P = 0.3532), but absence of a large target lesion was associated with improved PFS (P = 0.0222). Grade 3 and 4 liver function abnormalities were rare and did not appear to be associated with high baseline liver tumour burden. Conclusions Lu-177-Dotatate demonstrated significant prolongation in PFS versus high-dose octreotide LAR in patients with advanced, progressive midgut NET, regardless of baseline liver tumour burden, elevated ALP, or the presence of a large target lesion. : NCT01578239, EudraCT: 2011-005049-11 | en_US |
dc.description.sponsorship | Editorial assistance was provided by Harleigh E. Willmott, PhD, CMPP, and Renee Gordon, PhD, ApotheCom (Yardley, PA). Financial support for medical editorial assistance was provided by Advanced Accelerator Applications, a Novartis company. | en_US |
dc.language.iso | en_US | en_US |
dc.publisher | European Journal of Nuclear Medicine and Molecular Imaging | en_US |
dc.rights | Copyright © The Author(s) 2020
Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. | |
dc.source.uri | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7396396/ | |
dc.subject | Lu-177-Dotatate | en_US |
dc.subject | Liver tumour burden | en_US |
dc.subject | NETTER-1 | en_US |
dc.subject | Neuroendocrine tumour | en_US |
dc.subject | Octreotide | en_US |
dc.title | Impact of liver tumour burden, alkaline phosphatase elevation, and target lesion size on treatment outcomes with Lu-177-Dotatate: an analysis of the NETTER-1 study | en_US |
dc.type | Article | en_US |
dc.identifier.doi | 10.1007/s00259-020-04709-x | |