A long acting somatostatin analogue.
Approved for Neuroendocrine Tumors.
Trade name Somatuline.
For the treatment of patients with unresectable, well or moderately differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors (NETs).
it is used in the management of acromegaly and symptoms caused by neuroendocrine tumors, most notably carcinoid syndrome.
A depot injection, is already marketed for the long-term treatment of acromegaly.
Improved progression-free survival in the CLARINET trial, a multicenter, international, randomized placebo-controlled study.
Shown to delay tumor growth in patients with mostly stable, advanced enteropancreatic neuroendocrine tumors.
Approved for the treatment of carcinoid syndrome of NETs.
Reduces number of days that patients experience diarrhea and flushing associated with carcinoid syndrome.
The most common adverse reactions in lanreotide-treated patients were abdominal pain, musculoskeletal pain, vomiting, headache, injection-site reaction, hyperglycemia, hypertension, and cholelithiasis.
The most common serious adverse reaction in the lanreotide group was vomiting (4%).
Treatment with the somatostatin analogue lanreotide halves the risk for progression and death in patients with nonfunctioning neuroendocrine enteropancreatic tumors, according to results from a phase III study (CLARINET).
In the above study individualized to lanreotide achieved a progression-free survival of 66%, compared with 22% for placebo, within 96 weeks of treatment representing a 53% reduction in the risk for progression and death.
CLARINET a multicenter, randomized, double blind, placebo-controlled trial involving 204 patients with nonfunctioning GEP-NETs. A total of 101 patients were randomized to Lanreotide vs placebo.
Of the 113 patients, 55% had NETs arising outside the pancreas.
Study patient’s tumors were unresectable, well or moderately differentiated, and locally advanced or metastatic.
Lanreotide given intramuscularly 120 mg every 28 days, and 102 patients were randomized to a matching placebo.
The median PFS was not reached with lanreotide; it was 18 months with placebo, with no difference in overall survival.
The effect of active treatment very pronounced in patients with NETs involving the midgut. although a significant benefit was seen in patients with pancreatic tumors.
The most common side effects are diarrhea 26%, abdominal pain 14% and cholelithiasis 10%.