Health Problem: Gastroenteropancreatic neuroendocrine tumors (GEP-NETs) are a rare and heterogeneous group of neoplasms derived from neuroendocrine cells within the gastrointestinal tract and pancreas, where curative surgery options are limited. GEP-NETs are estimated to affect approximately 3 individuals per 100,000 people per year.

Technology Description: Lutetium Lu 177 dotatate is a radiolabeled somatostatin analog that is administered intravenously. The drug is able to bind and enter tumor cells through somatostatin receptors; once internalized, it emits a cytotoxic dose of beta radiation. This provides a targeted approach to destroy cancerous neuroendocrine cells.

Controversy: Lutetium Lu 177 dotatate is a radiopharmaceutical that upon administration releases harmful levels of beta radiation that can cause severe toxicity. This exposure may be a concern for providers and family members as well as patients. The benefits of lutetium Lu 177 dotatate must therefore be weighed against the risks of adverse events. There is remaining uncertainty about optimal treatment parameters (i.e., whether lutetium Lu 177 dotatate is most effective when used alone or in combination with other treatments) and patient selection criteria.

Key Questions:

  • Is Lutathera effective in treating somatostatin receptor–positive GEP-NETs?

  • How does Lutathera compare with alternative treatments for GEP-NETs?

  • Is Lutathera safe for treatment of GEP-NETs?

  • Have definitive patient selection criteria been identified for treatment with Lutathera in patients with GEP-NETs?

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