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Reuters Health Information: Lanreotide slows progression of neuroendocrine tumors

Lanreotide slows progression of neuroendocrine tumors

Last Updated: 2014-07-16

By Gene Emery

NEW YORK (Reuters Health) - Lanreotide slows the progression of metastatic enteropancreatic neuroendocrine tumors, but not without tripling the likelihood of diarrhea, according a new trial in 204 people with the rare form of cancer.

"The risk of disease progression within 96 weeks after the first dose of the study drug was reduced by 53%," said the research team, led by Dr. Martyn Caplin of the Royal Free Hospital in London.

The manufacturer, Ipsen, paid for the study, known as CLARINET. The findings are published in the July 17 New England Journal of Medicine.

Ipsen spokesman Abhi Basu, in an email to Reuters Health, declined to discuss the price of the drug because its use against neuroendocrine tumors remains investigational.

However, the 120-mg dose used in the new study was approved in the U.S. for acromegaly in 2007.

Neuroendocrine tumors (NETs), often marked by excessive hormone production, arise in about 5 out of 100,000 people in the U.S. each year and are typically inoperable because they have spread by the time they have been diagnosed. The doctor's job is usually to relieve symptoms.

In the study, all tumors were somatostatin receptor-positive and advanced but "nonfunctioning"; 96% of the patients had stable disease at baseline. The patients were from 12 European countries, the U.S. and India.

"These were 'non-functioning' tumors meaning they did not secrete hormones causing symptoms such as diarrhea or flushing, as in carcinoid syndrome. The latter would be considered a 'functioning tumor,'" Dr. Caplin told Reuters Health by email. "They still have the ability to grow and non-functioning NETs are much more common than functioning NETs hence the importance of the CLARINET study."

A placebo or 120 mg of the extended-release drug was given once every 28 days by deep subcutaneous injection for up to 24 doses.

The researchers estimated a 24-month progression-free survival of 33.0% with placebo and 65.1% with lanreotide.

"Perhaps what was surprising was to see such impressive results in patients with grade 2 neuroendocrine tumors and in patients who have >25% of their liver replaced by tumor metastases," Dr. Caplin said.

The drug did not increase the survival rate or improve the quality of life, however. Two patients in each group died.

Rates of drug-related diarrhea were 26% in the treatment group and 9% with placebo. The diarrhea largely accounted for the fact that 50% of the lanreotide recipients had some type of adverse event compared to 28% of placebo recipients.

"Few patients in either group, however, withdrew because of adverse events," the researchers reported.

The researchers are continuing to study the durability of the results, they said.

SOURCE: http://bit.ly/1mG0CYi

N Engl J Med 2014

 
 
 
 
                               
 
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