Relative risk analysis of safety profile of lanreotide autogel/depot vs. placebo in patients with pancreatic and intestinal neuroendocrine tumours
Abstract
Background: In the CLARINET study (NCT00353496), progression-free survival (PFS) of patients with metastatic pancreatic and intestinal neuroendocrine tumours (NETs) was significantly increased with lanreotide Autogel (Depot in USA) 120mg vs placebo (hazard ratio [HR] for progressive disease [PD]/death 0.47 [95% confidence interval CI: 0.30, 0.73]). We now present detailed analysis of the safety and tolerability data from CLARINET evaluating the relative risk of adverse events.
Methods: Patients with metastatic grade 1/2 (Ki-67 =5% of patients in either group were calculated post hoc for lanreotide vs. placebo. Results: The overall incidence of adverse events was similar for lanreotide- and placebo-treated patients (88% vs 90%).
The most common adverse events were gastrointestinal disorders, which occurred in 67% of the lanreotide-treated group vs. 63% of the placebo-treated group (RR 1.1 [0.9, 1.3]). Of these, diarrhoea was the most common individual adverse event (35% vs 35%; RR 1.0 [0.7, 1.4]).
None of the adverse events occurring in >=5% of either group were statistically significantly different between the lanreotide and placebo treated patients when based on the RRs although the CIs for the RRs were wide in several cases (lower limit of CIs were <=1). The most frequent adverse events in either group are shown in the Table.
Conclusions: No new safety signals for lanreotide were identified in the CLARINET study supporting its favourable benefit-risk profile in patients with pancreatic and intestinal NETs.