Patient Related Outcome Measures (Oct 2019)
A Patient-Reported Outcomes Analysis Of Lanreotide In The Treatment Of NETs Patients With Carcinoid Syndrome: Evidence From The ELECT Trial
Abstract
Koenraad Blot,1 Luc Duchateau,2 Benedicte Lescrauwaet,3 Nilani Liyanage,4 David Ray,5 Beloo Mirakhur,5 Aaron I Vinik6 1Alacrita Consulting Ltd, London, UK; 2Department of Comparative Physiology and Biometrics, Faculty of Veterinary Medicine, Ghent University, Ghent, Belgium; 3Xintera Bvba, Ghent, Belgium; 4Ipsen Pharma France, Paris, France; 5Ipsen Biopharmaceuticals, Basking Ridge, NJ, USA; 6Eastern Virginia Medical School, Norfolk, VA, USACorrespondence: Koenraad BlotAlacrita Consulting Ltd, 2 Royal College Street, London NW1 0NH, UKTel +32 472 846 377Email [email protected]: The purpose of this analysis of patient-reported outcomes from the ELECT (Evaluation of Lanreotide Depot/Autogel Efficacy and Safety as a Carcinoid Syndrome Treatment) trial (NCT00774930) was to explore the effect of lanreotide on symptoms of carcinoid syndrome. Specifically, this post hoc analysis was designed to identify the most important patient-reported outcomes for patients in ELECT.Methods: The post hoc analysis of ELECT, a placebo-controlled study of lanreotide in patients with neuroendocrine tumors, evaluated patient-reported outcomes during the double-blind phase of the trial, specifically daily diarrhea and flushing symptoms, octreotide rescue use, and the EORTC QLQ-C30 and QLQ-GINET21 questionnaires at baseline and week 12. Principal component (PC) analysis was applied on baseline data to identify independent variable clusters and clinically meaningful summary measures that highly correlated to these PCs. From those, the minimum clinical important differences were derived so to perform a responder analysis.Results: The three largest PCs captured 42.9% of the variation among baseline variables. The C30 summary score (C30-SS), diarrhea burden, and flushing burden were highly correlated with PC1, PC2, and PC3, respectively. Lanreotide patients were more likely to experience an improvement on the C30-SS (risk ratio [RR] 2.42; P=0.023), diarrhea burden (RR 2.85; P=0.005), and flushing burden (RR 1.39; P=0.31) compared to placebo patients. Lanreotide-treated patients have a higher probability of being a responder on at least one of the three domains of C30-SS, diarrhea burden, or flushing burden compared to placebo patients (RR 1.48; P=0.06).Conclusion: The higher response rates in the diarrhea burden are consistent with the previously reported effects of lanreotide on octreotide rescue medication use, while the findings of a greater efficacy of lanreotide vs placebo in the quality-of-life domains represent a novel aspect in the benefits of lanreotide.Trial registration: ClinicalTrials.gov identifier: NCT00774930.Keywords: lanreotide, patient-reported outcomes, neuroendocrine tumors, NETs
