scholarly journals SUNitinib and EVOfosfamide ( TH ‐302) in systemic treatment‐naïve patients with G1 / G2 metastatic pancreatic neuroendocrine tumors, the GETNE ‐1408 trial

2021 ◽  
Author(s):  
Enrique Grande ◽  
Cristina Rodriguez‐Antona ◽  
Carlos López ◽  
Teresa Alonso‐Gordoa ◽  
Marta Benavent ◽  
...  
Keyword(s):  
Neuroendocrine Tumors ◽  
Systemic Treatment ◽  
Pancreatic Neuroendocrine Tumors ◽  
Treatment Naïve

Systemic treatment of pancreatic neuroendocrine tumors

2019 ◽  
Vol 23 (2) ◽  
pp. 48-58
Author(s):  
Landon L. Chan ◽  
Stephen L. Chan
Keyword(s):  
Neuroendocrine Tumors ◽  
Systemic Treatment ◽  
Pancreatic Neuroendocrine Tumors

The efficacy and safety of sunitinib in patients with advanced well-differentiated pancreatic neuroendocrine tumors.

2017 ◽  
Vol 35 (4_suppl) ◽  
pp. 380-380 ◽  
Author(s):  
Eric Raymond ◽  
Matthew H. Kulke ◽  
Shukui Qin ◽  
Michael Schenker ◽  
Antonio Cubillo ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Neuroendocrine Tumors ◽  
Phase Iii ◽  
Pancreatic Neuroendocrine Tumors ◽  
Pivotal Phase ◽  
Treatment Naïve ◽  
Phase Iii Study ◽  
Previously Treated Patients ◽  
Previously Treated ◽  
Well Differentiated

380 Background: Sunitinib was approved by the FDA in 2011 for treatment of progressive, well-differentiated, advanced pancreatic neuroendocrine tumors (pNETs) based on a pivotal phase III study (NCT00428597) that showed a significant increase in progression-free survival (PFS) over placebo following early study termination. Subsequently, the FDA requested a post-approval study to support these findings. Methods: In this open-label, phase IV clinical trial (NCT01525550), patients with progressive, well-differentiated, unresectable advanced/metastatic pNETs received continuous sunitinib 37.5 mg once daily. Eligibility criteria were similar to the phase III study. Primary endpoint was investigator-assessed PFS per RECIST 1.0. This study is ongoing. Results: Sixty one treatment-naïve and 45 previously treated patients with progressive pNETs were treated with sunitinib: mean age, 54.6 years; males, 59.4%; white, 63.2%; ECOG PS 0, 65.1% or PS 1, 34.0%; and prior somatostatin analog, 48.1% (treatment-naïve, 39.3%; previously treated, 60.0%). At the data cutoff date, 82 (77%) patients discontinued treatment, mainly due to disease progression (46%). Median duration of treatment was ~11.9 months. Investigator-assessed median PFS (mPFS) was 13.2 months (95% CI, 10.9–16.7) in the overall population, with comparable mPFS in treatment-naïve and previously treated patients (13.2 vs 13.0 months). mPFS per independent radiologic review was 11.1 months (95% CI, 7.4–16.6). Objective response rate (ORR) per RECIST was 24.5%: 21.3% in treatment-naïve and 28.9% in previously treated patients. Median overall survival, although not yet mature, was 37.8 months. Treatment-emergent, all-causality adverse events (AEs) reported by ≥ 20% of all patients included neutropenia, diarrhea, leukopenia, fatigue, hand–foot syndrome, hypertension, abdominal pain, dysgeusia, and nausea. Most common grade 3/4 AEs were neutropenia (22%) and diarrhea (9%). Conclusions: The mPFS of 13.2 months and ORR of 24.5% observed in this study support the outcomes of the pivotal phase III study of sunitinib in pNETs and confirm its activity in this setting. AEs were consistent with known safety profile of sunitinib. Clinical trial information: NCT01525550.

Optimal strategy of systemic treatment for unresectable pancreatic neuroendocrine tumors based upon opinion of Japanese experts

Pancreatology ◽  
2020 ◽  
Vol 20 (5) ◽  
pp. 944-950
Author(s):  
Masafumi Ikeda ◽  
Chigusa Morizane ◽  
Susumu Hijioka ◽  
Shigemi Matsumoto ◽  
Tsuyoshi Konishi ◽  
...  
Keyword(s):  
Neuroendocrine Tumors ◽  
Optimal Strategy ◽  
Systemic Treatment ◽  
Pancreatic Neuroendocrine Tumors

Proposal of a two-step dynamic prognostic stratification for stage IV sporadic pancreatic neuroendocrine tumors

2016 ◽  
Author(s):  
Vincenzo Marotta ◽  
Thomas Walter ◽  
Cao Christine Do ◽  
Salvatore Tafuto ◽  
Vincenzo Montesarchio ◽  
...  
Keyword(s):  
Neuroendocrine Tumors ◽  
Stage Iv ◽  
Pancreatic Neuroendocrine Tumors ◽  
Prognostic Stratification

Pre-operative Diagnosis of Pancreatic Neuroendocrine Tumors with Endoscopic Ultrasonography and Computed Tomography in a Large Series

2016 ◽  
Vol 25 (3) ◽  
pp. 317-321 ◽  
Author(s):  
Raffaele Manta ◽  
Elisabetta Nardi ◽  
Nico Pagano ◽  
Claudio Ricci ◽  
Mariano Sica ◽  
...  
Keyword(s):  
Computed Tomography ◽  
Neuroendocrine Tumors ◽  
Endoscopic Ultrasonography ◽  
Fine Needle Aspiration ◽  
Chromogranin A ◽  
Needle Aspiration ◽  
Large Series ◽  
Tumor Diameter ◽  
Pancreatic Neuroendocrine Tumors ◽  
Fine Needle

Background & Aims: Diagnosis of pancreatic neuroendocrine tumors (p-NETs) is frequently challenging. We describe a large series of patients with p-NETs in whom both pre-operative Computed Tomography (CT) and Endoscopic Ultrasonography (EUS) were performed. Methods: This was a retrospective analysis of prospectively collected sporadic p-NET cases. All patients underwent both standard multidetector CT study and EUS with fine-needle aspiration (FNA). The final histological diagnosis was achieved on a post-surgical specimen. Chromogranin A (CgA) levels were measured. Results: A total of 80 patients (mean age: 58 ± 14.2 years; males: 42) were enrolled. The diameter of functioning was significantly lower than that of non-functioning p-NETs (11.2 ± 8.5 mm vs 19.8 ± 12.2 mm; P = 0.0004). The CgA levels were more frequently elevated in non-functioning than functioning pNET patients (71.4% vs 46.9%; P = 0.049). Overall, the CT study detected the lesion in 51 (63.7%) cases, being negative in 26 (68.4%) patients with a tumor ≤10 mm, and in a further 3 (15%) cases with a tumor diameter ≤20 mm. CT overlooked the pancreatic lesion more frequently in patients with functioning than non-functioning p-NETs (46.5% vs 24.3%; P = 0.002). EUS allowed a more precise pre-operative tumor measurement, with an overall incorrect dimension in only 9 (11.2%) patients. Of note, the EUS-guided FNA suspected the neuroendocrine nature of tumor in all cases. Conclusions: Data of this large case series would suggest that the EUS should be included in the diagnostic work-up in all patients with a suspected p-NET, even when the CT study was negative for a primary lesion in the pancreas.– . Abbrevations: CgA: chromogranin A; EUS: Endoscopic Ultrasonography; FNA: fine-needle aspiration; p-NETs: pancreatic neuroendocrine tumors.

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