Journal Article

Evaluation of Lanreotide Depot/Autogel Efficacy and Safety as a Carcinoid Syndrome Treatment (Elect): A Randomized, Double-Blind, Placebo-Controlled Trial

Gomez-Panzani, Edda, Liyanage, Nilani, Wolin, Edward M., Vinik, Aaron I., Fisher, George A.

2016

Overview

To evaluate the efficacy and safety of lanreotide depot/autogel 120 mg for the control of carcinoid syndrome (CS) symptoms in patients with neuroendocrine tumors (NETs). 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 120 mg 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 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. A total of 115 patients were enrolled (lanreotide, n = 59; placebo, n = 56). The adjusted mean (95% confidence interval [CI]) percentage of days with rescue octreotide use (primary endpoint) was significantly lower in the lanreotide (33.7%; 95% CI, 25.0%-42.4%) versus the placebo group (48.5%; 95% CI, 39.6%-57.4%), representing an absolute difference of -14.8% (95% CI, -26.8% to -2.8%; P = .017). The odds ratio of full/partial treatment success (≤3 days short-acting octreotide use weeks 12 to 15) was significantly greater with lanreotide than placebo (2.4; 95% CI, 1.1-5.3; P = .036). No new safety concerns were identified, and lanreotide was well tolerated. Lanreotide depot/autogel is effective for the control of CS symptoms in patients (SSA-naïve or experienced) with NETs. AE = adverse event BMI = body mass index CS = carcinoid syndrome ELECT = Evaluating Lanreotide Efficacy and safety as a Carcinoid-syndrome Treatment HRQoL = health-related quality of life LTOLE = long-term open-label extension NET = neuroendocrine tumor OL = open label SSA = somatostatin analog.

• Publisher: Elsevier Limited
• Subject: Aged / Antineoplastic Agents - administration & dosage / Antineoplastic Agents - adverse effects / Carcinoid Tumor - complications / Carcinoid Tumor - drug therapy / Double-Blind Method / Drug Compounding / Female / Gels / Humans / Male / Malignant Carcinoid Syndrome - drug therapy / Middle Aged / Neuroendocrine Tumors - complications / Neuroendocrine Tumors - drug therapy / Octreotide - administration & dosage / Octreotide - adverse effects / Peptides, Cyclic - administration & dosage / Peptides, Cyclic - adverse effects / Placebos / Somatostatin - administration & dosage / Somatostatin - adverse effects / Somatostatin - analogs & derivatives / Treatment Outcome