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

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

Research output: Contribution to journalArticle

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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. Conclusion: Lanreotide depot/autogel is effective for the control of CS symptoms in patients (SSA-naïve or experienced) with NETs. Abbreviations: 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.

Original languageEnglish (US)
Pages (from-to)1068-1080
Number of pages13
JournalEndocrine Practice
Volume22
Issue number9
DOIs
StatePublished - Sep 1 2016
Externally publishedYes

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Carcinoid Tumor
Octreotide
Placebos
Safety
Neuroendocrine Tumors
Somatostatin
Confidence Intervals
Therapeutics
lanreotide
Diarrhea
Body Mass Index
Odds Ratio
Quality of Life

ASJC Scopus subject areas

  • Endocrinology, Diabetes and Metabolism
  • Endocrinology

Cite this

Evaluation of Lanreotide Depot/Autogel Efficacy and Safety As A Carcinoid Syndrome Treatment (Elect) : A Randomized, Double-Blind, Placebo-Controlled Trial. / Vinik, Aaron I.; Wolin, Edward M.; Liyanage, Nilani; Gomez-Panzani, Edda; Fisher, George A.

In: Endocrine Practice, Vol. 22, No. 9, 01.09.2016, p. 1068-1080.

Research output: Contribution to journalArticle

Vinik, Aaron I. ; Wolin, Edward M. ; Liyanage, Nilani ; Gomez-Panzani, Edda ; Fisher, George A. / Evaluation of Lanreotide Depot/Autogel Efficacy and Safety As A Carcinoid Syndrome Treatment (Elect) : A Randomized, Double-Blind, Placebo-Controlled Trial. In: Endocrine Practice. 2016 ; Vol. 22, No. 9. pp. 1068-1080.
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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. Conclusion: Lanreotide depot/autogel is effective for the control of CS symptoms in patients (SSA-na{\"i}ve or experienced) with NETs. Abbreviations: 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.",
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N2 - 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. Conclusion: Lanreotide depot/autogel is effective for the control of CS symptoms in patients (SSA-naïve or experienced) with NETs. Abbreviations: 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.

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