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<p>This spotlight depicts the route to Peptide Receptor Radionuclide Therapy (PRRT) for Neuroendocrine Tumors (NETs) in the early 2000s which revolutionized the care of patients with neuroendocrine tumors, as ideated by the nuclear medicine team at the IRCCS European Institute of Oncology (IEO). Significant clinical responses, in fact, were yelded after high doses of labeled somatostatin analogs by Prof. E. Krenning and DJ Kwekkeboom. Though, many challenges had to be faced to reach standardization with authority requests. The NETTER protocol reported the efficacy and safety of 177Lu-DOTATATE, and the Data Safety Monitorig Board (2014) transferred all patients to the active arm due to overwhelming evidence of efficacy. The median PFS was not reached compared to the control arm! Then, finally submitting the dossier to FDA, some technological difficulties had to be overcome. Then Lu-177-oxodotreotide was approved by FDA and then in Europe by EMA and in Italy by AIFA on spring 2019. New indications, such as in NETTER-2, new peptides and various radionuclides are now investigated, in order to make PRRT available for everyone.</p>

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The experience of a nuclear physician in developing a radiopharmaceutical: from Lu-177-oxodotreotide and beyond

  • 期刊论文

  • 发表日期：

    2025年3月16日

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  • Maribel Lopera Sierra,
  • Stefano Buono,
  • Laura Travascio,
  • Giovanni Tesoriere,
  • Paola Santoro,
  • Sara Pacella,
  • Chiara Maria Grana

摘要

This spotlight depicts the route to Peptide Receptor Radionuclide Therapy (PRRT) for Neuroendocrine Tumors (NETs) in the early 2000s which revolutionized the care of patients with neuroendocrine tumors, as ideated by the nuclear medicine team at the IRCCS European Institute of Oncology (IEO). Significant clinical responses, in fact, were yelded after high doses of labeled somatostatin analogs by Prof. E. Krenning and DJ Kwekkeboom. Though, many challenges had to be faced to reach standardization with authority requests. The NETTER protocol reported the efficacy and safety of 177Lu-DOTATATE, and the Data Safety Monitorig Board (2014) transferred all patients to the active arm due to overwhelming evidence of efficacy. The median PFS was not reached compared to the control arm! Then, finally submitting the dossier to FDA, some technological difficulties had to be overcome. Then Lu-177-oxodotreotide was approved by FDA and then in Europe by EMA and in Italy by AIFA on spring 2019. New indications, such as in NETTER-2, new peptides and various radionuclides are now investigated, in order to make PRRT available for everyone.