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http://dx.doi.org/10.1056/NEJMc1701616DOI Listing

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Article Synopsis
  • This study investigates how specific quantitative measurements from SSTR-PET imaging and clinical biomarkers affect the progression-free survival (PFS) and overall survival (OS) of neuroendocrine tumor (NET) patients undergoing peptide receptor radionuclide therapy (PRRT).
  • A total of 91 NET patients were analyzed, revealing that larger tumor volumes, especially in bones and the liver, correlate with shorter survival times, and that tumors with low SSTR uptake negatively impact patient outcomes.
  • Elevated levels of the biomarkers chromogranin A and alkaline phosphatase were linked to worse survival, as well as a higher number of previous treatments and tumor origin, with midgut tumors associated with better PFS compared to pancreatic or unknown primary tumors.
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Peptide receptor radionuclide therapy(PRRT)is a pioneer drug in the rapid development of radio-theranostics, and a paradigm-shifting approach to treat neuroendocrine tumor( NET). The NETTER-1 trial for NETs of the midgut is currently the only global phase Ⅲ prospective clinical trial demonstrating the efficacy and safety of PRRT. In Japan, phase Ⅰ and Ⅰ/Ⅱ trials for lung and gastroenteropancreatic NETs were also conducted, and regulatory approval was granted in June of 2021.

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Background: The present prospective phase 1/2 study aimed to elucidate the efficacy and safety of Lu-DOTATATE (four cycles of 7.4 GBq) in Japanese patients with unresectable, progressive neuroendocrine tumors (NETs).

Methods: From April 2018 to October 2020, 15 patients with advanced NETs (five midgut, eight pancreatic, and two lung NETs) were enrolled.

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Background: The primary analysis of the phase 3 NETTER-1 trial showed significant improvement in progression-free survival with Lu-Dotatate plus long-acting octreotide versus high-dose long-acting octreotide alone in patients with advanced midgut neuroendocrine tumours. Here, we report the prespecified final analysis of overall survival and long-term safety results.

Methods: This open-label, randomised, phase 3 trial enrolled patients from 41 sites in eight countries across Europe and the USA.

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