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Immune Checkpoint Inhibitors in High-grade Gastroenteropancreatic Neuroendocrine Neoplasms.
Nicola Fazio1, Anna La Salvia2
1Division of Gastrointestinal Medical Oncology and Neuroendocrine Tumors, European Institute of Oncology, IEO, IRCCS, Milan 20141, Italy.
Endocrine Reviews
|October 9, 2025
Summary
High-grade gastroenteropancreatic neuroendocrine neoplasms (HG-NENs) show promise for immune checkpoint inhibitors (ICIs) due to higher tumor mutational burden. Further research is needed to optimize ICI therapy selection for these challenging cancers.
Area of Science:
- Oncology
- Immunotherapy
- Gastroenteropancreatic Neuroendocrine Neoplasms
Background:
- High-grade gastroenteropancreatic neuroendocrine neoplasms (HG-NENs) include grade 3 neuroendocrine tumors (NETs) and neuroendocrine carcinomas (NECs), presenting distinct clinical management challenges.
- Current first-line therapy for advanced NECs (platinum plus etoposide) is not optimal for G3 NETs, where other treatments show limited efficacy.
- HG-NENs possess biological characteristics like higher tumor mutational burden (TMB), increased PD-1/PD-L1 expression, and greater immune infiltration, suggesting potential suitability for immune checkpoint inhibitors (ICIs).
Purpose of the Study:
- To provide a comprehensive literature review on the role of immune checkpoint inhibitors (ICIs) in high-grade gastroenteropancreatic neuroendocrine neoplasms (HG-NENs).
- To analyze critical aspects of existing clinical trials involving ICIs in HG-NENs, including patient populations, study designs, and outcomes.
- To identify potential biomarkers for selecting HG-GEP-NENs patients who may benefit from ICI therapy.
Main Methods:
- Systematic literature review of clinical trials investigating immune checkpoint inhibitors (ICIs) in high-grade gastroenteropancreatic neuroendocrine neoplasms (HG-NENs).
- Analysis focused on study populations, trial designs, efficacy and safety results.
- Evaluation of potential predictive biomarkers for ICI response in HG-NENs.
Main Results:
- Limited clinical trials have explored ICIs in HG-NENs, necessitating a comprehensive overview of current data.
- Analysis of study populations, designs, and results is crucial for understanding ICI efficacy and safety in this context.
- Identification of biomarkers is essential for patient stratification and optimizing ICI therapy selection in HG-NENs.
Conclusions:
- High-grade gastroenteropancreatic neuroendocrine neoplasms (HG-NENs) present a rationale for exploring immune checkpoint inhibitors (ICIs) due to their immunogenic profile.
- A thorough analysis of existing literature is required to assess the efficacy and safety of ICIs in HG-NENs.
- Further research focusing on biomarker discovery is critical for personalized ICI treatment strategies in HG-NEN patients.
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