New England Journal of Medicine· 2017Q1
Phase 3 Trial of <sup>177</sup> Lu-Dotatate for Midgut Neuroendocrine Tumors
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- Q1SCImago
- 2017year
Short summary
<sup>177</sup>Lu-Dotatate significantly improved progression-free survival (PFS) in patients with advanced midgut neuroendocrine tumors, extending it to a median of 40.2 months versus 10.8 months with octreotide LAR alone (hazard ratio for progression or death, 0.21).
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Key points
- <sup>177</sup>Lu-Dotatate extended median progression-free survival to 40.2 months vs. 10.8 months for octreotide LAR (HR 0.21).
- Objective response rate was 16% with <sup>177</sup>Lu-Dotatate compared to 2% with octreotide LAR.
- No renal toxic effects were observed with <sup>177</sup>Lu-Dotatate during the study period.
- The trial included 231 patients with advanced, progressive, somatostatin-receptor-positive midgut neuroendocrine tumors.
AI-generated from the title and abstract; the full text is not read.
Abstract
BACKGROUND: Lu)-Dotatate in patients with advanced, progressive, somatostatin-receptor-positive midgut neuroendocrine tumors. METHODS: Lu-Dotatate group) or octreotide LAR alone (113 patients) administered intramuscularly at a dose of 60 mg every 4 weeks (control group). The primary end point was progression-free survival. Secondary end points included the objective response rate, overall survival, safety, and the side-effect profile. The final analysis of overall survival will be conducted in the future as specified in the protocol; a prespecified interim analysis of overall survival was conducted and is reported here. RESULTS: Lu-Dotatate group as compared with no patients in the control group, with no evidence of renal toxic effects during the observed time frame. CONCLUSIONS: Lu-Dotatate group. (Funded by Advanced Accelerator Applications; NETTER-1 ClinicalTrials.gov number, NCT01578239 ; EudraCT number 2011-005049-11 .).
The authors' abstract, as published at the source. New England Journal of Medicine, 2017 · DOI ↗
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Field: Epidemiology
EpidemiologyMedicine