Abstract 1186MO
Background
Surgical resection of Nonfunctioning Pancreatic Neuroendocrine Tumor (NF-PanNET) is curative in most of the cases. Neoadjuvant treatments in patients with resectable NF-PanNET at high-risk of recurrence have never been investigated. Aim of this study was to test the safety and efficacy of neoadjuvant PRRT with 177Lu-DOTATATE followed by surgery in patients with resectable high-risk NF-PanNET.
Methods
This was a multi-center single-arm phase 2 trial. Treatment was PRRT with 177Lu-DOTATATE (Lutathera) followed by surgery in patients with high-risk of recurrence resectable NF-PanNET. “High-risk NF-PanNET” was defined by the presence of at least one of the following: tumor size > 4 cm, nearby organ/s invasion, Ki67 >10%, vascular invasion, single liver metastasis, nodal involvement. Primary endpoints were postoperative morbidity and mortality. Secondary endpoint was the rate of objective radiological response.
Results
Thirty-one patients were enrolled in the study. Twenty-six (84%) tolerated 4 cycles of 177Lu-DOTATATE whereas 4 patients did not complete 4 cycles for adverse events. One patient voluntary interrupted treatment after 2 cycles. A partial radiological response was observed in 17 patients (59%) whereas no disease progression occurred. Two patients refused to undergo surgery after 177Lu-DOTATATE. Eventually, 29 patients underwent surgery after a median period of 281 days (261.5–309 days) from the enrollment. Resection of NF-PanNET was achieved in 28 patients (96.5%) whereas one patient underwent exploratory laparotomy. Pancreaticoduodenectomy (n= 11) and distal pancreatectomy (n= 11) were the most frequent operations. At final histology, the majority of patients had a NF-PanNET G2 (n= 16) and a nodal involvement (N1) was present in the 52% of cases. There was no postoperative mortality. Severe postoperative complications occurred in the 24% of patients and postoperative pancreatic fistula was the most frequent complication after surgery (34%).
Conclusions
Neoadjuvant PRRT with 177Lu-DOTATATE followed by surgery for NF-PanNET is safe and effective demonstrating evidence of a high rate-of radiological response.
Clinical trial identification
NCT04385992.
Editorial acknowledgement
Legal entity responsible for the study
Massimo Falconi.
Funding
Advanced Accelerator Applications (a Novartis company).
Disclosure
All authors have declared no conflicts of interest.
Resources from the same session
2211MO - Uncovering the mechanisms of persistent disease in RET-altered thyroid cancers: Insights from patient-derived xenograft models treated with selective RET inhibitors
Presenter: Alejandro Garcia Alvarez
Session: Mini oral session - NETs and endocrine tumours
Resources:
Abstract
Slides
Webcast
1183MO - Molecular characterization of rectal neuroendocrine tumors (NETs) with unfavorable prognosis by multiomics analysis: A multicenter retrospective cohort study (GARNET)
Presenter: Taro Shibuki
Session: Mini oral session - NETs and endocrine tumours
Resources:
Abstract
Slides
Webcast
Invited Discussant 2211MO and 1183MO
Presenter: Mauro Cives
Session: Mini oral session - NETs and endocrine tumours
Resources:
Slides
Webcast
1184MO - Safety and efficacy of everolimus (EVE) as second-line treatment in neuroendocrine neoplasms G3 (NEN G3): An AIO phase II study (EVINEC)
Presenter: Marianne Pavel
Session: Mini oral session - NETs and endocrine tumours
Resources:
Abstract
Slides
Webcast
1185MO - Activity and safety of avelumab alone or in combination with cabozantinib in patients with advanced high grade neuroendocrine neoplasias (NEN G3) progressing after chemotherapy. The phase II, open-label, multicenter AVENEC and CABOAVENEC trials
Presenter: Matthias M. Weber
Session: Mini oral session - NETs and endocrine tumours
Resources:
Abstract
Slides
Webcast
725MO - Phase I trial of the DLL3/CD3 IgG-like T cell engager BI 764532 in patients (pts) with DLL3-positive (+) tumours: Focus on neuroendocrine carcinomas
Presenter: Valentina Gambardella
Session: Mini oral session - NETs and endocrine tumours
Resources:
Abstract
Slides
Webcast
Invited Discussant 1184MO, 1185MO and 725MO
Presenter: Sara De Dosso
Session: Mini oral session - NETs and endocrine tumours
Resources:
Slides
Webcast
2212MO - Major secondary outcomes in the multicentre noninferiority randomised trial IoN: Is ablative radioiodine necessary for low-risk differentiated thyroid cancer patients?
Presenter: Allan Hackshaw
Session: Mini oral session - NETs and endocrine tumours
Resources:
Abstract
Slides
Webcast
1187MO - Does the ENDOCAN-COMETE network improves the survival of adrenocortical carcinomas in France?
Presenter: Rossella Libe
Session: Mini oral session - NETs and endocrine tumours
Resources:
Abstract
Slides
Webcast
Invited Discussant 1186MO, 2212MO and 1187MO
Presenter: Jaydira Del Rivero
Session: Mini oral session - NETs and endocrine tumours
Resources:
Slides
Webcast