@article{b6a92e5c6445459eb3b737a2ee83ee77,
title = "LANREOTIDE THERAPY in CARCINOID SYNDROME: PROSPECTIVE ANALYSIS of PATIENT-REPORTED SYMPTOMS in PATIENTS RESPONSIVE to PRIOR OCTREOTIDE THERAPY and PATIENTS NA{\"I}VE to SOMATOSTATIN ANALOGUE THERAPY in the ELECT PHASE 3 STUDY",
abstract = "Objective: This ELECT prospective analysis examined lanreotide depot/autogel for carcinoid syndrome (CS) symptom control in patients with neuroendocrine tumors (NETs) who were responsive to prior octreotide (prior octreotide group) compared with patients who were na{\"i}ve to prior somatostatin analogue treatment (de novo group). Methods: Adults with histopathologically confirmed NET and stable CS (diarrhea and/or flushing) were randomized to subcutaneous (SC) lanreotide 120 mg or placebo every 4 weeks for 16 weeks. Patients reported diarrhea and/or flushing symptom severity and frequency and short-acting SC octreotide rescue therapy daily using an Interactive Voice/Web Response System. To evaluate the efficacy of lanreotide compared with placebo, the novel primary endpoint of patient-determined use of SC octreotide rescue therapy for breakthrough symptoms was used as a surrogate for symptom control. Clinically meaningful patient-reported treatment benefit was examined using daily patient-reported symptoms of diarrhea and flushing. Results: Of the 115 randomized patients, 51 (n = 26 lanreotide, n = 25 placebo) were octreotide-na{\"i}ve (de novo) and 64 (n = 33 lanreotide; n = 31 placebo) received prior octreotide. Lanreotide versus placebo patients had a lower mean percentage of days of SC octreotide rescue therapy in de novo and prior octreotide groups (least squares LS mean difference-19.1, P =.0477 and-6.9, P =.4332, respectively). The mean percentage of days with moderate/severe diarrhea and/or flushing was lower in lanreotide versus placebo patients in de novo and prior octreotide groups (LS mean difference-14.6, P =.0140 and-10.9, P =.0746, respectively). The transition from octreotide to lanreotide was generally well-tolerated. Conclusion: Improvement in CS symptoms occurred with lanreotide treatment, regardless of prior octreotide use.",
author = "Fisher, {George A.} and Wolin, {Edward M.} and Nilani Liyanage and Lowenthal, {Susan Pitman} and Beloo Mirakhur and Pommier, {Rodney F.} and Montaser Shaheen and Vinik, {Aaron I.}",
note = "Funding Information: This study and writing support were funded by Ipsen Biopharmaceuticals, Inc. Ipsen provided a full review of the article. The authors wish to thank Lynanne McGuire, PhD, and Sarah Mizne, PharmD, of MedVal Scientific Information Services, LLC, for providing medical writing and editorial assistance. This manuscript was prepared according to the International Society for Medical Publication Professionals{\textquoteright} “Good Publication Practice for Communicating Company-Sponsored Medical Research: the GPP3 Guidelines.” Study procedures conformed to the Declaration of Helsinki, International Conference on Harmonisation Consolidated Guideline on Good Clinical Practice, and all national and local regulatory requirements. All patients provided written informed consent. Funding Information: G.A.F. is a consultant/advisor for and has received research funding from Ipsen and is a consultant/advisor for Genentech/Roche and Merck. E.M.W. is a consultant/ advisor for Ipsen and Advanced Accelerator Application. N.L. is an employee of, owns stock in, and has received travel compensation from Ipsen Innovation. S.P.L. owns stock in Pfizer, is a consultant/advisor for Ipsen, and has received travel compensation from Ipsen. B.M. is an employee of and owns stock in Ipsen. R.F.P. has received honoraria from, is a consultant/advisor to, is a member of a speakers bureau for, and has received reimbursement for travel/accommodation expenses from Novartis Oncology. M.S. has no multiplicity of interest to disclose. A.V. is a consultant/advisor for Merck, Pfizer, Alnylam, Hydra Biosciences, Astellas, Ipsen, and Ionis Pharmaceuticals; is a member of a speakers bureau for Merck & Co., Inc.; and has received research funding from ViroMed, VeroScience, Nestle Health Science-Pamlab, Novo Nordisk, and Matrix Biomed. Publisher Copyright: {\textcopyright} 2018 AACE.",
year = "2018",
month = mar,
doi = "10.4158/EP172000.OR",
language = "English (US)",
volume = "24",
pages = "243--255",
journal = "Endocrine Practice",
issn = "1530-891X",
publisher = "American Association of Clinical Endocrinology",
number = "3",
}