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. 2023 Sep 7;115(9):1001-1010.
doi: 10.1093/jnci/djad096.

Consensus report of the 2021 National Cancer Institute neuroendocrine tumor clinical trials planning meeting

Simron Singh  1 , Thomas A Hope  2 , Emily B Bergsland  3 , Lisa Bodei  4 , David L Bushnell  5 , Jennifer A Chan  6 , Beth R Chasen  7 , Aman Chauhan  8 , Satya Das  9 , Arvind Dasari  10 , Jaydira Del Rivero  11 , Ghassan El-Haddad  12 , Karyn A Goodman  13 , Daniel M Halperin  10 , Mark A Lewis  14 , O Wolf Lindwasser  15 , Sten Myrehaug  16 , Nitya P Raj  17 , Diane L Reidy-Lagunes  17 , Heloisa P Soares  18 , Jonathan R Strosberg  19 , Elise C Kohn  20 , Pamela L Kunz  21 ; NET CTPM participants
Collaborators, Affiliations

Consensus report of the 2021 National Cancer Institute neuroendocrine tumor clinical trials planning meeting

Simron Singh et al. J Natl Cancer Inst. .

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.

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Conflict of interest statement

SS: Grants or contracts: AAA/Novartis; Consulting fees: AAA/Novartis, Ipsen; Participation on a Data Safety Monitoring Board or Advisory Board: AAA/Novartis, Ipsen;

TAH: Grants or contracts: GE Healthcare, Philips, Clovis Oncology, AAA/Novartis. Lantheus. Consulting fees: Curium, RayzeBio, ITM, Blue Earth Diagnostics. Participation on a Data Safety Monitoring Board or Advisory Board: Ipsen, Bayer. Leadership role: North American Neuroendocrine Tumor Society. Stock or stock options: RayzeBio.

EBB: Grants or contracts (to institution): Merck. Royalties or licenses: UpToDate. Leadership role: NCCN Neuroendocrine Tumor Panel (unpaid), North American Neuroendocrine Tumor Society (NANETS) Vice President, President, President Emeritus (unpaid).

LB: Grants or contracts: AAA/Novartis. Consulting (nonremunerated): AAA-Novartis, Ipsen, Clovis Oncology, MTTI. Payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events: ITM, Great Point Partners, Iba. Support for attending meetings and/or travel: Great Point Partners. Participation on a Data Safety Monitoring Board: AAA/Novartis (Lu-PSMA-R2). Leadership role: NETRF, ABNM.

DLB: Grants or contracts: University of Iowa NET SPORE (NCI), NIH, RayzeBio.

JAC: Royalties or licenses: UpToDate. Payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events: Ipsen. Participation on a Data Safety Monitoring Board: AAA/Novartis, TerSera, Lexicon, Curium. Leadership role: North American Neuroendocrine Tumor Society (Board of Directors/Officer, unpaid). Stock or stock options: Merck.

BRC: None

AC: Grants or contracts (to institution): BMS, Clovis, Tersera; Consulting fees: Ipsen, Lexicon, ITM, Novartis/AAA, Seneca Therapeutics, Crinetics, Tersera, Curium; Receipt of equipment, materials, drugs, medical writing, gifts or other services: Nanopharmaceutics, EMD Serono.

SD: Consulting fees: Ipsen, Tersera, Novartis/AAA; Employment: AstraZeneca

AD: Grants or contracts (to institution): HutchMed, Eisai, Guardant Health, Natera, Enterome, Novartis, Xencor. Consulting fees: HutchMed, Novartis/AAA, Ipsen, Voluntis. Participation on a Data Safety Monitoring Board or Advisory Board: Oncobay.

JDR: None

GH: Consulting fees: Bayer HealthCare, Boston Scientific Corporation, Canon Medical Systems Corporation, Novartis Pharmaceuticals Corporation, Terumo Medical Corporation. Stock or stock options: Johnson and Johnson.

KAG: Participation on a Data Safety Monitoring Board or Advisory Board: DSMB for SMART Trial funded by Viewray, Advisory board for Phillips Medical. Leadership role: Co-chair of the NCI GI Steering Committee.

DMH: Grants or contracts: Tarveda, Genentech, AAA/Novartis, ITM, RayzeBio, Camurus; Consulting Fees: AAA/Novartis, ITM, Camurus, Amryt, TerSera, Crinetics, Chimeric Therapeutics; Participation on a Data Safety Monitoring Board or Advisory Board: AlphaMedix.

MAL: pending

OWL: None

SM: Grants or contracts (to institution): Ipsen, AAA/Novartis; Consulting fees: AAA/Novartis; Payment or honoraria for lectures, presentations, speakers’ bureaus, manuscript writing or educational events: AAA/Novartis

NPR: Grants or contracts (to institution): ITM, Corcept therapeutics, Xencor Inc; Support for attending meetings and/or travel advisory boards: Ipsen, HRA Pharma, Progenics pharmaceuticals, AAA/Novartis; Participation on a Data Safety Monitoring Board or Advisory Board: Safety monitoring committee for Crinetics Pharmaceuticals.

DLR: Grants or contracts (to institution): Merck, Novartis, Ipsen. Consulting fees: Chiasma, AAA/Novartis. Leadership role: NANETS.

HPS: Consulting fees: Novartis, TerSera, AstraZeneca, Ipsen, Pfizer; Payment or honoraria for lectures, presentations, speakers’ bureaus, manuscript writing or educational events: ITM Isotope Technologies Munich SE. Leadership or fiduciary role in other board, society, committee or advocacy group, paid or unpaid: NANETS Board of Directors, Healing NET Foundation Board of Directors.

JRS: Grants or contracts: Novartis, Merck, ITM. Consulting fees: Tersera. Payment or honoraria for lectures, presentations, speakers’ bureaus, manuscript writing or educational events: Ipsen, Tersera. Support for attending meetings and/or travel: Ipsen.

ECK: None

PLK: Grants or contracts (to institution): AAA/Novartis; Consulting fees: Amgen, Crinetics, Genentech, HutchMed, Ipsen, ITM, Natera, Novartis (Advanced Accelerator Applications), RayzeBio; Leadership or fiduciary role in other board, society, committee or advocacy group, paid or unpaid: NANETS President.

Figures

Figure 1.
Figure 1.
The lifecycle of NET clinical trials. Cap/Tem = capecitabine and temozolomide; EP = etoposide and platinum; fb = followed by; GEP-NET = gastroenteropancreatic neuroendocrine tumor; GI NET = gastrointestinal neuroendocrine tumor; NEC = neuroendocrine carcinoma; Obs = observation; PanNET = pancreatic neuroendocrine tumor; Para/Pheo = paraganglioma and pheochromocytoma; PBO = placebo; Tem = temozolomide.
See this image and copyright information in PMC

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