Everolimus Survival Benefit Suggested in Updated NET Trial Results

Excerpt:

“Patients with nonfunctioning neuroendocrine tumors (NETs) of lung or gastrointestinal (GI) origin continued to live longer when treated with the mammalian target of rapamycin (mTOR) inhibitor everolimus (Afinitor) than with placebo, ongoing follow-up in a randomized trial has shown.

“A second planned interim analysis of the RADIANT-4 trial showed a 27% reduction in the estimated risk of death for patients who received everolimus compared with placebo. However, the difference did not meet the statistical threshold for overall survival (OS) significance.

“As previously reported, the trial met the primary endpoint of progression-free survival (PFS), and a first interim survival analysis showed a trend in favor of the everolimus arm. Follow-up for survival will continue, James C. Yao, MD, a professor at The University of Texas MD Anderson Cancer Center, reported at the 2016 ASCO Annual Meeting.”

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Blood Test Predicts Success of Neuroendocrine Cancer Therapy

Excerpt:

“Malignant neuroendocrine tumors (NETs) are relatively rare, notoriously difficult to treat, and associated with poor long-term survival. According to research presented at the 2016 Annual Meeting of the Society of Nuclear Medicine and Molecular Imaging (SNMMI), an investigative blood test could predict how patients will respond to peptide receptor radionuclide therapy (PRRT) before they commit to a course of treatment.

“Cancerous NETs can develop in a variety of places where hormone signaling occurs between nerve cells and organs of the endocrine system, but the most common origins of these tumors are in the gastrointestinal tract, the lungs and the pancreas. These cancers sneak up on oncologists due to their rarity and the fact that symptoms such as flushing, diarrhea and sweating are often regarded as unrelated to disease and part of normal life events. Most cases are not caught until these tumors have already spread to other organs, making them difficult to treat with conventional means. A targeted treatment established in the early 2000s called peptide receptor radionuclide therapy (PRRT) zeros in on active peptide receptors that are over-expressed on the surface of NETs. The injected drug binds specifically to these receptors and knocks out tumors by irradiating them with a powerful dose of short-range radioactive material while sparing healthy tissues nearby.”

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A Better Way to Diagnose and Manage Neuroendocrine Tumors

Excerpt:

“A recent study reported in the May issue of The Journal of Nuclear Medicine demonstrates that Ga-68 DOTATATE PET/CT scans are superior to In-111 pentetreotide scans, the current imaging standard in the United States for detecting neuroendocrine tumors (NETS), and could significantly impact treatment management.

“NETS occur mostly in the respiratory and digestive tracts and are usually slow-growing. They can be difficult to diagnose, and many treatment options exist. It’s therefore critical to delineate the extent of disease accurately for proper management. While the incidence of NETS is relatively low, with 2.5-5 cases per 100,000 in the United States, data from the National Cancer Institute show a five-fold increase worldwide from 1973 to 2004. NETS can be malignant and, although they comprise less than two percent of gastrointestinal cancers, they are more prevalent than stomach and pancreatic cancers combined.”

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Clinical Trial Versus Standard Protocol: Why and How to Enroll in a Trial


My job at Cancer Commons is to help cancer patients better understand and make decisions about their treatment. Through our Ask Cancer Commons service, I also strive to inform patients about new drugs in trials that they can discuss with their oncologists. Sometimes, I explain the rationale behind a patient’s current or upcoming treatment, and sometimes I try to convince patients to actually get treated, rather than hope that a vegetarian diet and herbal supplements will cure their metastatic disease. Continue reading…


CHMP Recommends Approval of Everolimus for GI, Lung NETs

Excerpt:

“Everolimus (Afinitor) has received a positive recommendation from the EMA’s Committee for Medicinal Products for Human Use (CHMP) as a treatment for patients with progressive, unresectable or metastatic, well-differentiated nonfunctional gastrointestinal (GI) or lung neuroendocrine tumors (NETs).

“The positive opinion suggests the mTOR inhibitor everolimus is likely to be approved in this setting when the European Commission issues its final decision.

“CHMP based its recommendation on data from the phase III RADIANT-4 trial. In the study, median progression-free survival (PFS) was 11 months with everolimus versus 3.9 months with placebo, representing a 52% reduction in the risk of progression or death (HR, 0.48; 95% CI, 0.35-0.67; P <.00001).”

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FDA Approval Sought for Telotristat Etiprate for Carcinoid Syndrome

Excerpt:

“A new drug application (NDA) has been submitted to the FDA for telotristat etiprate as a treatment for carcinoid syndrome in patients with metastatic neuroendocrine tumors (NETs), according to a statement from the drug’s developer, Lexicon Pharmaceuticals.

“The application was based on data from two phase III trials, both of which demonstrated significant reductions in the frequency of daily bowel movements with telotristat etiprate versus placebo. In the first study, TELESTAR, telotristat etiprate reduced daily bowel movements by up to 35%. In the second study, TELECAST, there was also a significant reduction in bowel movements (P ≤.004), although the exact data were not yet released.

“The FDA will review the NDA within 60 days of submission, at which point the agency will assign a review deadline under the Prescription Drug User Fee Act. Lexicon requested a priority review for the NDA, which would provide a 6-month deadline if the designation is granted.”

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New Treatments for Gastrointestinal Neuroendocrine Tumors


Neuroendocrine tumors of the digestive system (GI-NETs) can arise in different parts of the digestive tract. GI-NETs originating in the ileum, duodenum, and appendix are known as midgut NETs, and tumors of the stomach, colon, and rectum are non-midgut NETs. Many of these tumors are functional; that is, they produce a variety of hormonal substances that cause serious, debilitating symptoms. Continue reading…


Another Indication OK'd for Afinitor

“Everolimus (Afinitor) is now approved for treating inoperable, locally advanced or metastatic neuroendocrine tumors of gastrointestinal or lung origin, the FDA said Friday.

“The agency further specified that the tumors should be ‘progressive, well-differentiated [and] non-functional.’

“Approval was based primarily on a 302-patient trial comparing everolimus with placebo, both in combination with best supportive care. Median progression-free survival was 11 months in the active-drug arm compared with 3.9 months for placebo. However, in an interim analysis, there was no difference in overall survival, and response rates (i.e., achieving significant tumor shrinkage) were 2% with everolimus and 1% with placebo.”


Expert Discusses Emerging Treatments, Immunotherapy Potential in pNETs

“Several recent studies have shown promise for the treatment of pancreatic NETs (pNETs). In the phase II CALGB-80701, which investigated the addition of bevacizumab (Avastin) to a treatment paradigm of everolimus and octreotide (Sandostatin) LAR in patients with locally advanced or metastatic pNETs, bevacizumab extended progression-free survival (PFS) by more than 3 months compared with everolimus and octreotide LAR alone.

“Response rate was also higher in the bevacizumab arm, with a 31% response to everolimus plus bevacizumab versus a 12% response in the control arm. Toxicity, however, was significantly higher in the bevacizumab arm.”