scholarly journals A Phase II Trial of Bevacizumab with Capecitabine in Progressive, Metastatic Well-Differentiated Digestive Endocrine Tumors (Better Study)

2012 ◽  
Vol 23 ◽  
pp. ix378
Author(s):  
T.A. Walter ◽  
E. Baudin ◽  
J.E. Kurtz ◽  
P. Ruszniewski ◽  
L. Bengrine-Lefevre ◽  
...  
Keyword(s):  
Phase Ii ◽  
Phase Ii Trial ◽  
Endocrine Tumors ◽  
Well Differentiated

Efficacy and safety of bevacizumab combined with chemotherapy in the treatment of patients with metastatic well-differentiated duodeno-pancreatic endocrine tumors (BETTER study).

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 4036-4036 ◽  
Author(s):  
Michel Ducreux ◽  
Jean-François Seitz ◽  
Denis Smith ◽  
Dermot O'Toole ◽  
Céline Lepère ◽  
...  
Keyword(s):  
Phase Ii ◽  
Phase Ii Trial ◽  
Phase Iii ◽  
Tumor Control ◽  
Endocrine Tumors ◽  
Efficacy And Safety ◽  
Ki 67 ◽  
Pancreatic Net ◽  
Well Differentiated ◽  
Ecog Ps

4036 Background: Gastrointestinal neuroendocrine tumors (NET) overexpress vascular endothelial growth factor (VEGF), thus we hypothesized that Bevacizumab (Bv), a monoclonal antibody targeting VEGF in combination with chemotherapy may show an activity in duodeno-pancreatic NET. Methods: This multicenter, open-label, non-randomized, two- group phase II trial assessed in one group the efficacy and safety of Bv (7.5 mg/kg IV on day 1, every 3 weeks), combined with 5-FU/streptozotocin (stz): 5-FU 400 mg/m²/d; Stz 500 mg/m²/d IV, d1-5/ every 42 days, during a minimum of 6 months in patients (pts) with progressive, metastatic, well-differentiated duodeno-pancreatic NET (WHO 2000), not previously treated with chemotherapy, ECOG PS ≤2 and Ki 67 index < 15%. Primary endpoint was progression-free survival (PFS). Secondary endpoints were overall survival (OS), response rate, safety and quality of life. Study duration was 24 months. Results: In the ITT population, 34 pts were enrolled, 22 (64.7%) were men, median age 55.3 years (37.0-77.6), 33 (97.1%) pts had ECOG-PS 0/1. Most metastases were in the liver 33 (97.1%) pts or lymph nodes 14 (41.2%) pts. Ki-67 proliferative index was 0-2% in 8 (25%) pts, 3-4% in 5 (15.6%), 5-9% in 6 (18.8%), 10-14% in 12 (37.5%) and 15% in 1(3.1%) pt. Median treatment duration was 14.0 months; median number of cycles was 10. At 24 months, median PFS was 23.7 months [95%CI: 14.5; not reached] based on 18 events. PFS rate at 18 months was 62%. Tumor control rate was 100% (n= 34) including partial response in 19 (55.9%) pts and stable disease in 15 (44.1%) pts. Survival rate at 24 months was 88%. Median OS was not reached, 5 patients died. CTC grade 3/4 Adverse Events (AEs) occurred in 23 (67.6%) of pts, mainly digestive 5 (14.7%) pts. G3/4 Bv targeted AEs were hypertension in 7 (20.6%) pts and thromboembolism in 4 (11.8%). Conclusions: Efficacy data in this phase II trial assessing a novel approach with Bv and 5-FU/stz in duodeno-pancreatic NET is encouraging and the toxicity profile is acceptable. Results suggest that Bv may have a place in the treatment of pancreatic NET and warrant further investigation in a phase III trial.

scholarly journals Chromogranin A: From Laboratory to Clinical Aspects of Patients with Neuroendocrine Tumors

2018 ◽  
Vol 2018 ◽  
pp. 1-12 ◽  
Author(s):  
Paola Di Giacinto ◽  
Francesca Rota ◽  
Laura Rizza ◽  
Davide Campana ◽  
Andrea Isidori ◽  
...  
Keyword(s):  
Neuroendocrine Tumors ◽  
Phase Ii ◽  
Chromogranin A ◽  
Carcinoid Syndrome ◽  
Phase Ii Trial ◽  
Randomized Study ◽  
Clinical Aspects ◽  
Clinical Activity ◽  
Octreotide Lar ◽  
Well Differentiated

Background. Neuroendocrine tumors (NETs) are characterized by having behavior and prognosis that depend upon tumor histology, primary site, staging, and proliferative index. The symptoms associated with carcinoid syndrome and vasoactive intestinal peptide tumors are treated with octreotide acetate. The PROMID trial assesses the effect of octreotide LAR on the tumor growth in patients with well-differentiated metastatic midgut NETs. The CLARINET trial evaluates the effects of lanreotide in patients with nonfunctional, well-, or moderately differentiated metastatic enteropancreatic NETs. Everolimus has been approved for the treatment of advanced pancreatic NETs (pNETs) based on positive PFS effects, obtained in the treated group. Sunitinib is approved for the treatment of patients with progressive gastrointestinal stromal tumor or intolerance to imatinib, because a randomized study demonstrated that it improves PFS and overall survival in patients with advanced well-differentiated pNETs. In a phase II trial, pasireotide shows efficacy and tolerability in the treatment of patients with advanced NETs, whose symptoms of carcinoid syndrome were resistant to octreotide LAR. An open-label, phase II trial assesses the clinical activity of long-acting repeatable pasireotide in treatment-naive patients with metastatic grade 1 or 2 NETs. Even if the growth of the neoplasm was significantly inhibited, it is still unclear whether its antiproliferative action is greater than that of octreotide and lanreotide. Because new therapeutic options are needed to counter the natural behavior of neuroendocrine tumors, it would also be useful to have a biochemical marker that can be addressed better in the management of these patients. Chromogranin A is currently the most useful biomarker to establish diagnosis and has some utility in predicting disease recurrence, outcome, and efficacy of therapy.

scholarly journals 608P METNET: A phase II trial of metformin in patients with well differentiated neuroendocrine tumours

2020 ◽  
Vol 31 ◽  
pp. S505-S506
Author(s):  
J. Glasberg ◽  
T. Giollo Rivelli ◽  
A. Talans ◽  
R. Mendoza Lopez ◽  
J.E. Bezerra Neto ◽  
...  
Keyword(s):  
Phase Ii ◽  
Neuroendocrine Tumours ◽  
Phase Ii Trial ◽  
Well Differentiated

scholarly journals A Phase II Study of Ibrutinib in Advanced Neuroendocrine Neoplasms

2019 ◽  
Vol 110 (5) ◽  
pp. 377-383 ◽  
Author(s):  
Taymeyah Al-Toubah ◽  
Michael J. Schell ◽  
Mauro Cives ◽  
Jun-Min Zhou ◽  
Heloisa P. Soares ◽  
...  
Keyword(s):  
Phase Ii ◽  
Phase Ii Trial ◽  
Objective Response ◽  
Neuroendocrine Neoplasms ◽  
Prior Therapy ◽  
Progression Of Disease ◽  
Prospective Phase ◽  
Well Differentiated ◽  
Grade 3 ◽  
Unacceptable Toxicity

Background: Ibrutinib is an orally administered inhibitor of Bruton’s tyrosine kinase (Btk). Preclinical data suggest that mast cells are recruited within neuroendocrine neoplasms (NENs) where they stimulate angiogenesis and tumor growth. Ibrutinib inhibits mast cell degranulation and has been associated with regression of tumors in a mouse insulinoma model. Methods: A prospective, phase II trial evaluated patients with advanced gastrointestinal (GI)/lung NENs and pancreatic NENs (pNENs) who had evidence of progression within 12 months of study entry on at least one prior therapy. Patients received ibrutinib 560 mg daily until unacceptable toxicity, progression of disease, or withdrawal of consent. The primary endpoint was objective response rate. Results: Twenty patients were enrolled on protocol from November 2015 to December 2017 (15 advanced GI/lung NENs and 5 pNENs). No patient reached an objective response. Median PFS was 3.0 months. A total of 44 drug-related adverse events (AEs) were captured as probably or definitely associated with ibrutinib. Five patients experienced probably or definitely related grade 3 AEs, and 1 patient experienced a probably related grade 4 AE. Five patients discontinued treatment prior to radiographic assessment. Conclusions: Ibrutinib does not show significant evidence of activity in well-differentiated gastroenteropancreatic and lung NENs.

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