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A Practical Guide for the Production and PET/CT Imaging of 68Ga-DOTATATE for Neuroendocrine Tumors in Daily Clinical Practice
Published on: April 17, 2019
Neoadjuvant 177Lu-DOTATATE for non-functioning pancreatic neuroendocrine tumours (NEOLUPANET): multicentre phase II
Stefano Partelli1,2, Luca Landoni3, Mirco Bartolomei4
1School of Medicine, Vita-Salute San Raffaele University, Milan, Italy.
Background:
Resection of non-functioning pancreatic neuroendocrine tumours (NF-PanNETs) is curative in most patients. The potential benefits of neoadjuvant treatments have, however, never been explored. The primary aim of this study was to evaluate the safety of neoadjuvant 177Lu-labelled DOTA0-octreotate (177Lu-DOTATATE) followed by surgery in patients with NF-PanNETs.
Methods:
NEOLUPANET was a multicentre, single-arm, phase II trial of patients with sporadic, resectable or potentially resectable NF-PanNETs at high-risk of recurrence; those with positive 68Ga-labelled DOTA PET were eligible. All patients were candidates for neoadjuvant 177Lu-DOTATATE followed by surgery. A sample size of 30 patients was calculated to test postoperative complication rates against predefined cut-offs. The primary endpoint was safety, reflected by postoperative morbidity and mortality within 90 days. Secondary endpoints included rate of objective radiological response and quality of life.
Results:
From March 2020 to February 2023, 31 patients were enrolled, of whom 26 completed 4 cycles of 177Lu-DOTATATE. A partial radiological response was observed in 18 of 31 patients, and 13 patients had stable disease. Disease progression was not observed. Twenty-four R0 resections and 4 R1 resections were performed in 29 patients who underwent surgery. One tumour was unresectable owing to vascular involvement. There was no postoperative death. Postoperative complications occurred in 21 of 29 patients. Severe complications were observed in seven patients. Quality of life remained stable after 177Lu-DOTATATE and decreased after surgery.
Conclusion:
Neoadjuvant treatment with 177Lu-DOTATATE is safe and effective for patients with NF-PanNETs.
Insights
Neoadjuvant 177Lu-DOTATATE treatment before surgery is safe for non-functioning pancreatic neuroendocrine tumors (NF-PanNETs). This approach showed radiological response and was well-tolerated, offering a new option for patients.
Area of Science:
- Oncology
- Nuclear Medicine
- Surgical Oncology
Background:
- Non-functioning pancreatic neuroendocrine tumors (NF-PanNETs) are often curable with resection.
- Neoadjuvant treatment benefits for NF-PanNETs remain unexplored.
- This study investigates the safety of neoadjuvant 177Lu-DOTATATE followed by surgery for NF-PanNETs.
Purpose of the Study:
- To evaluate the safety and efficacy of neoadjuvant 177Lu-DOTATATE in patients with NF-PanNETs.
- To assess postoperative complications and radiological response rates.
- To explore the impact on patient quality of life.
Main Methods:
- A multicenter, single-arm, phase II trial (NEOLUPANET) enrolled patients with resectable NF-PanNETs at high risk of recurrence.
- Patients received neoadjuvant 177Lu-DOTATATE followed by surgery.
- Primary endpoint was safety (postoperative morbidity/mortality within 90 days); secondary endpoints included radiological response and quality of life.
Main Results:
- 31 patients enrolled; 26 completed treatment. Partial radiological response in 18/31, stable disease in 13/31. No disease progression.
- 29 patients underwent surgery with 24 R0 and 4 R1 resections. No postoperative deaths.
- 21/29 patients had postoperative complications; 7 had severe complications. Quality of life remained stable post-treatment but decreased post-surgery.
Conclusions:
- Neoadjuvant 177Lu-DOTATATE is a safe and effective treatment option for NF-PanNETs.
- The treatment demonstrated radiological benefits and was generally well-tolerated.
- Further research may establish this as a standard neoadjuvant approach.

