A Patient-Reported Outcomes Analysis Of Lanreotide In The Treatment Of NETs Patients With Carcinoid Syndrome: Evidence From The ELECT Trial

Koenraad Blot, Luc Duchateau, Benedicte Lescrauwaet, Nilani Liyanage, David Ray, Beloo Mirakhur, Aaron I Vinik, Koenraad Blot, Luc Duchateau, Benedicte Lescrauwaet, Nilani Liyanage, David Ray, Beloo Mirakhur, Aaron I Vinik

Abstract

Purpose: 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: NETs; lanreotide; neuroendocrine tumors; patient-reported outcomes.

Conflict of interest statement

David Ray, Beloo Mirakhur, and Nilani Liyanage were paid employees of Ipsen Biopharmaceuticals, Inc. Luc Duchateau was financially supported by Ipsen to perform the analysis. Benedicte Lescrauwaet is an employee of Xintera Bvba. The authors report no other conflicts of interest in this work.

© 2019 Blot et al.

Figures

Figure 1
Figure 1
Response to treatment for (A) the C30-SS from baseline to week 12, (B) the diarrhea burden from baseline to week 12, and (C) the flushing burden from baseline to week 12. Abbreviations: C30-SS, European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ) C30 summary score; MCID, minimal clinically important difference.

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