EVALUATION OF LANREOTIDE DEPOT/AUTOGEL EFFICACY AND SAFETY AS A CARCINOID SYNDROME TREATMENT (ELECT): A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL
Abstract
OBJECTIVE: To evaluate the efficacy and safety of lanreotide depot/autogel 120mg for the control of carcinoid syndrome (CS) symptoms in patients with neuroendocrine tumors (NETs).
METHODS: This was a 16-week, randomized, double-blind, phase-3 trial (Clinicaltrials.gov: NCT00774930). Patients with/without prior somatostatin analog (SSA) use were randomized to lanreotide depot/autogel 120mg or placebo every 4 weeks, with access to short-acting octreotide as rescue medication. The primary endpoint was the percentage of days in which short-acting octreotide was used, which was assessed from daily diaries using an analysis of covariance (ANCOVA) including the stratification variables, baseline short-acting octreotide use and frequency of diarrhea/flushing. The proportions of patients experiencing treatment success was a supportive analysis. Adverse events were recorded at all visits.
RESULTS: 115 patients were enrolled (lanreotide, n=59; placebo, n=56). The adjusted mean [95% CI] percentage days with rescue octreotide use (primary endpoint) was significantly lower in the lanreotide (33.7 [25.0, 42.4]%) vs the placebo group (48.5 [39.6, 57.4]%), representing an absolute difference of -14.8% ([95% CI: -26.8, -2.8] p=0.017). The odds ratio of full/partial treatment success (≤3 days shortacting octreotide use weeks 12-15) was significantly greater with lanreotide than placebo (2.4 [95% CI: 1.1, 5.3]; p=0.036). No new safety concerns were identified, and lanreotide was well tolerated.
CONCLUSION: Lanreotide is effective for the control of CS symptoms in patients (SSA-naïve or experienced) with NETs.
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