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
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.
N Engl J Med 2014