Lanreotide Autogel-120 mg as First-Line Treatment of Acromegaly
Status:
Completed
Trial end date:
2007-12-01
Target enrollment:
Participant gender:
Summary
Recently, a new formulation of lanreotide, lanreotide Autogel (ATG) 60 mg, 90 mg and 120 mg
was developed in order to further extend the duration of the release of the active
ingredient. The ATG formulation consists of a solution of lanreotide in water with no
additional excipients. ATG was found to have linear pharmacokinetics for the 60 to 120 mg
doses and provided a prolonged dosing interval and good tolerability (1). In some previous
studies, the ATG was demonstrated as effective as the micro-particle lanreotide (2,3) and as
octreotide-LAR in patients with acromegaly (4-7).
Data on the efficacy of ATG in newly diagnosed patients with acromegaly are still lacking.
Similarly, the prevalence and amount of tumor shrinkage after ATG treatment is unknown. This
information is particularly useful in the setting of first-line therapy of acromegaly that is
currently becoming a more frequent approach to the disease (8). It is demonstrated that
approximately 80% of the patients treated with depot somatostatin analogues as first line
have a greater than 20% tumor shrinkage during the first 12 months of treatment (9). A
definition of significant tumor shrinkage was provided in 14 studies (including a total
number of patients of 424) and the results showed that 36.6% (weighted mean percentage) of
patients receiving first-line somatostatin analogues therapy for acromegaly had a significant
reduction in tumor size (10). About 50% of the patients were found to have a greater than 50%
tumor shrinkage within the first year of treatment (10); in this study we found that percent
decrease in IGF-I levels was the major determinant of tumor shrinkage (10).
The current open, prospective study is designed to investigate the prevalence and amount of
tumor shrinkage in newly diagnosed patients with acromegaly treated first-line with ATG.