Somatostatin analogues are commonly used to treat symptoms associated with hormone hypersecretion in neuroendocrine tumors.
However, data on their antitumor effects are limited.
Dr Martyn Caplin and colleagues conducted a randomized, double-blind, placebo-controlled, multinational study of the somatostatin analogue lanreotide in patients with advanced, well-differentiated or moderately differentiated, nonfunctioning, somatostatin receptor–positive neuroendocrine tumors of grade 1 or 2, and documented disease-progression status.
The tumors originated in the pancreas, midgut, or hindgut or were of unknown origin.
Patients were randomly assigned to receive an extended-release aqueous-gel formulation of lanreotide at a dose of 120 mg or placebo once every 28 days for 96 weeks.
The team's primary end point was progression-free survival, defined as the time to disease progression or death.
|The estimated rate of progression-free survival at 24 months was 65% in the lanreotide group|
|New England Journal of Medicine|
Secondary end points included overall survival, quality of life, and safety.
The research team observed that most patients had no tumor progression in the 3 to 6 months before randomization, and 33% had hepatic tumor volumes greater than 25%.
Lanreotide, as compared with placebo, was associated with significantly prolonged progression-free survival.
The team found that the estimated rates of progression-free survival at 24 months were 65% in the lanreotide group, and 33% in the placebo group.
The therapeutic effect in predefined subgroups was generally consistent with that in the overall population, with the exception of small subgroups in which confidence intervals were wide.
The researchers noted no significant between-group differences in quality of life or overall survival.
The most common treatment-related adverse event was diarrhea.
Dr Caplin's team concludes, "Lanreotide was associated with significantly prolonged progression-free survival among patients with metastatic enteropancreatic neuroendocrine tumors of grade 1 or 2."