title: 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 120 mg 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 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.
  
  
  RESULTS
  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.
  
  
  CONCLUSIONS
  Lanreotide depot/autogel is effective for the control of CS symptoms in patients (SSA-naïve or experienced) with NETs.
  
  
  BACKGROUND
  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.
authors.forename: Aaron I
authors.initials: AI
authors.lastname: Vinik
authors.forename: Edward M
authors.initials: EM
authors.lastname: Wolin
authors.forename: Nilani
authors.initials: N
authors.lastname: Liyanage
authors.forename: Edda
authors.initials: E
authors.lastname: Gomez-Panzani
authors.forename: George A
authors.initials: GA
authors.lastname: Fisher
mesh_terms: D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects; D002276:Carcinoid Tumor / Q000150:complications / Q000188:drug therapy*; D004311:Double-Blind Method; D004339:Drug Compounding; D005260:Female; D005782:Gels; D006801:Humans; D008297:Male; D008303:Malignant Carcinoid Syndrome / Q000188:drug therapy*; D008875:Middle Aged; D018358:Neuroendocrine Tumors / Q000150:complications / Q000188:drug therapy*; D015282:Octreotide / Q000008:administration & dosage / Q000009:adverse effects; D010456:Peptides, Cyclic / Q000008:administration & dosage* / Q000009:adverse effects*; D010919:Placebos; D013004:Somatostatin / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D005782:Gels; D010456:Peptides, Cyclic; D010919:Placebos; C060347:lanreotide; D013004:Somatostatin; D015282:Octreotide