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Consensus report of the 2021 National Cancer Institute neuroendocrine tumor clinical trials planning meeting
Simron Singh1, Thomas A Hope2, Emily B Bergsland3
1Department of Medicine, Sunnybrook Health Sciences Centre, Odette Cancer Center, University of Toronto, Toronto, ON, Canada.
Abstract:
Important progress has been made over the last decade in the classification, imaging, and treatment of neuroendocrine neoplasm (NENs), with several new agents approved for use. Although the treatment options available for patients with well-differentiated neuroendocrine tumors (NETs) have greatly expanded, the rapidly changing landscape has presented several unanswered questions about how best to optimize, sequence, and individualize therapy. Perhaps the most important development over the last decade has been the approval of 177Lu-DOTATATE for treatment of gastroenteropancreatic-NETs, raising questions around optimal sequencing of peptide receptor radionuclide therapy (PRRT) relative to other therapeutic options, the role of re-treatment with PRRT, and whether PRRT can be further optimized through use of dosimetry among other approaches. The NET Task Force of the National Cancer Institute GI Steering Committee convened a clinical trial planning meeting in 2021 with multidisciplinary experts from academia, the federal government, industry, and patient advocates to develop NET clinical trials in the era of PRRT. Key clinical trial recommendations for development included 1) PRRT re-treatment, 2) PRRT and immunotherapy combinations, 3) PRRT and DNA damage repair inhibitor combinations, 4) treatment for liver-dominant disease, 5) treatment for PRRT-resistant disease, and 6) dosimetry-modified PRRT.
Insights
Recent advancements in neuroendocrine neoplasm (NEN) treatment include new approvals and peptide receptor radionuclide therapy (PRRT). Further research is needed to optimize sequencing, re-treatment, and combinations for neuroendocrine tumors (NETs).
Area of Science:
- Oncology
- Nuclear Medicine
- Medical Imaging
Background:
- Significant progress in neuroendocrine neoplasm (NEN) classification, imaging, and treatment over the past decade.
- Expansion of therapeutic options for well-differentiated neuroendocrine tumors (NETs) presents challenges in optimizing and individualizing care.
- Approval of 177Lu-DOTATATE for gastroenteropancreatic-NETs necessitates further investigation into its optimal use.
Purpose of the Study:
- To address unanswered questions regarding the optimization, sequencing, and individualization of therapy for neuroendocrine tumors (NETs).
- To guide the development of future clinical trials for NETs in the era of peptide receptor radionuclide therapy (PRRT).
Main Methods:
- Convening of a multidisciplinary NET Task Force meeting in 2021.
- Inclusion of experts from academia, government, industry, and patient advocacy groups.
- Focus on developing clinical trial recommendations for NETs.
Main Results:
- Key clinical trial recommendations for NETs include PRRT re-treatment strategies.
- Exploration of combinations of PRRT with immunotherapy and DNA damage repair inhibitors.
- Addressing treatment for liver-dominant disease and PRRT-resistant disease, alongside dosimetry-modified PRRT.
Conclusions:
- The evolving landscape of NET treatment requires strategic clinical trial planning.
- Further research is essential to optimize PRRT and combination therapies for improved patient outcomes.
- Future trials should focus on re-treatment, novel combinations, and personalized approaches for NET management.
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