SPINET Trial Could Alter Practice for Patients With Lung NETs

Excerpt:

“Since its FDA approval in 2014, the somatostatin analog lanreotide (Somatuline Depot) has been creating fresh options for select patients with gastroenteropancreatic neuroendocrine tumors (NETs), given the significant improvement in progression-free survival (PFS) demonstrated in this population.

“Now, investigators are examining the potential that the agent could have in patients with lung NETs—an area that is greatly lacking in research— in a potentially practice-changing clinical trial that seeks to determine the role of the synthetic growth inhibitory hormone in patients with the rare tumor type. Thus far, no prospective trials specifically for patients with lung NETs have been reported, researchers have noted.”

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Video: Efficacy of Lanreotide for the Treatment of Neuroendocrine Tumors

“Martyn E. Caplin, professor, lead clinician, Neuroendocrine Unit at the Royal Free Hospital, London, discusses the efficacy of lanreotide for the treatment of patients with neuroendocrine tumors, as shown in clinical trials such as the CLARINET study.”

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Pancreatic Neuroendocrine Tumors: A Lesser Threat than Adenocarcinomas, but Still Hard to Treat


Pancreatic neuroendocrine tumors (PNETs) constitute only about 3% to 5% of all pancreatic cancers. Compared to the most common pancreatic cancer—adenocarcinoma (aka exocrine tumors), PNETs have a longer disease course and better prognosis; the 5-year survival rate is 42% for PNETs, but only about 5% to 6% for adenocarcinomas. When PNETs are localized, they can usually be removed by surgery. However, PNETs tend to metastasize, most often to the liver, and present a formidable treatment challenge at this stage. Continue reading…


Hormone-Mimicking Drugs Are Used To Treat Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs)


Neuroendocrine tumors (NETs) can arise wherever neuroendocrine (hormone-producing) cells are found—which is in most organs. Most NETs (65%-70%) are gastroenteropancreatic, or GEP, arising in different gastrointestinal organs. GEP-NETs are most commonly found in the small bowel (including the appendix), stomach, and rectum. Still, NETs in general are rare, which complicates the development of new treatments and identification of the genetic drivers of these cancers. Treatment of GEP-NETs is clearly an unmet medical need, and is now even more urgent because their incidence has been on the rise in the last 20 years. Continue reading…


FDA Grants Priority Review to Lanreotide Injection for Gastroenteropancreatic Neuroendocrine Tumors

Editor’s note: In the U.S., a drug must be approved by the U.S. Food and Drug Administration (FDA) in order for it to be prescribed to patients with specific diseases. Particularly promising drugs might be granted Priority Review, meaning that the FDA agrees to work with the drug manufacturer to accelerate the approval process. The FDA recently granted priority review to a drug meant to treat a subset of pancreatic cancer tumors known as gastroenteropancreatic neuroendocrine tumors. The drug is called lanreotide (aka Somatuline Depot). The FDA’s decision was based on promising results for the lanreotide in a clinical trial that tested it in volunteer patients.

“The U.S. Food and Drug Administration (FDA) has accepted and granted priority review to Ipsen’s supplemental New Drug Application (sNDA) for the somatostatin analog lanreotide (Somatuline Depot) 120 mg injection in the treatment of gastroenteropancreatic neuroendocrine tumors. The FDA designates priority review status to drug candidates that have the potential to offer a significant improvement in treatment compared to currently approved options. A decision is expected in early 2015.

“In the United States, lanreotide is indicated for the long-term treatment of patients with acromegaly who have had an inadequate response to or cannot be treated with surgery and/or radiotherapy. The active substance in the drug is lanreotide acetate, a somatostatin analog that inhibits the secretion of several endocrine, exocrine, and paracrine amines and peptides.

“ ‘[Lanreotide] is the first and only somatostatin analog to demonstrate a statistically significant improvement in progression-free survival in patients with gastroenteropancreatic neuroendocrine tumors in a large, multinational clinical trial,’ said Cynthia Schwalm, President and CEO of Ipsen North America.”


OncoBriefs: Local Tx for mRCC, Cervical Ca Prevention (CME/CE)

Editor’s note: This article describes three separate new findings in cancer research. The first is relevant for people with metastatic renal cell carcinoma (mRCC). Researchers have found that image-guided local ablation of tumors still has an important treatment role, even though there have been recent improvements in mRCC drugs. The second finding concerns people with metastatic neuroendocrine tumors (NETS). A clinical trial with volunteer patients found promising results for patients treated with the new drug lanreotide (aka Somatuline). The third finding has to do with preventing cervical cancer in women at high risk for the disease. The women involved in the study had high-grade cervical intraepithelial neoplasia (CIN 2/3), and were treated with surgical removal of the squamocolumnar junction (SCJ). These women had only low-grade recurrences, suggesting that removing SCJ cells might help prevent cervical cancer.

“More than 80% of patients with metastatic renal cell carcinoma (mRCC) remained alive without disease progression 3 years after image-guided local ablation of tumors, a retrospective study showed.

“Six of 76 evaluable tumors recurred an average of 1.6 years from treatment. Local ablation represents a “relatively safe procedure with acceptable local control rates,” authors concluded in an article published in the August issue of the Journal of Urology. A summary of the article leads off this edition of OncoBriefs, which also examines a somatostatin derivative for neurendocrine tumors and a surgical approach to cervical cancer prevention.”


Lanreotide Improves Survival with Enteropancreatic Tumors

The gist: A clinical trial with volunteer patients tested the effectiveness of a drug called lanreotide for people with grade 1 or 2 metastatic enteropancreatic neuroendocrine tumors. The researchers found that, compared to taking a “fake” placebo drug, lanreotide increased the amount of time patients lived without their disease worsening. However, lanreotide did not improve overall survival or quality of life.

“Lanreotide significantly improves survival among patients with metastatic enteropancreatic neuroendocrine tumors (grade 1 or 2), according to a study published in the July 17 issue of the New England Journal of Medicine.

“Martyn E. Caplin, D.M., from Royal Free Hospital in London, and colleagues conducted a multinational study of patients with advanced, well-differentiated or moderately-differentiated, nonfunctioning, somatostatin receptor-positive neuroendocrine tumors (grade 1 or 2 that originated in the pancreas, midgut, or hindgut, or were of unknown origin) and documented disease-progression status. Participants were randomly assigned to receive an extended-release aqueous-gel formulation of lanreotide at a dose of 120 mg (101 patients) or placebo (103 patients) once every 28 days for 96 weeks.

“The researchers found that, compared to placebo, lanreotide was associated with significantly prolonged progression-free survival (P placebo group. In predefined subgroups, the therapeutic effect was generally consistent with that found in the overall population. Groups were similar in quality of life and overall survival. Diarrhea was the most common treatment-related adverse event (26 percent of the lanreotide group versus 9 percent of the placebo group).”