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Longer term efficacy of lanreotide autogel/depot (LAN) for symptomatic treatment of carcinoid syndrome (CS) in neuroendocrine tumor (NET) patients from the ELECT open label study

Date

08 Oct 2016

Session

Poster Display

Presenters

George Fisher Jr

Citation

Annals of Oncology (2016) 27 (6): 136-148. 10.1093/annonc/mdw369

Authors

G.A. Fisher Jr1, E. Wolin2, P.L. Kunz1, N. Liyanage3, B. Mirakhur4, S. Pitman Lowenthal4, R.F. Pommier5, M. Shaheen6, A. Vinik7

Author affiliations

  • 1 School Of Medicine, Stanford University, 94305 - Stanford/US
  • 2 Medical Oncology, Montifiore Einstein Center for Cancer Care, Bronx/US
  • 3 -, Ipsen Biopharmaceuticals, Inc., Boulogne-Billancourt/FR
  • 4 -, Ipsen Biopharmaceuticals, Inc., Basking Ridge/US
  • 5 Surgical Oncology, Oregon Health Science University, Portland/US
  • 6 Cancer Center, University of New Mexico, Albuquerque/US
  • 7 -, Eastern Virginia Medical School, Norfolk/US
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Resources

Abstract 4163

Background

In ELECT, LAN significantly reduced the need for short-acting octreotide rescue medication for symptomatic control of CS in NET patients vs placebo (PBO) in the 16-wk double-blind (DB) phase (primary result). Here we compare patient-reported symptoms in the DB vs 32-wk initial open-label phase (IOL).

Methods

Adults with histopathologically confirmed NET and history of CS with/without prior somatostatin analog (SSA) use were randomized to DB LAN 120 mg or PBO every 4 wks for 16 wks followed by a 32-wk IOL on LAN. Patients recorded daily the frequency and severity of diarrhea and/or flushing by Interactive Voice (Web) Response System for 1 month pre-randomization through IOL. Mean composite symptom scores (frequency x severity) in DB vs IOL were analyzed posthoc. Analysis of covariance models (ANCOVA) were used for these analyses with baseline symptoms, prior SSA, and country as factors. Urinary 5-hydroxyindoleacetic acid (u5HIAA) values were log transformed.

Results

Of 115 randomized (n = 59 LAN, n = 56 PBO), 56 LAN- and 45 PBO-treated patients, switched to LAN, were available for IOL analysis. Among patients initially on LAN, composite diarrhea scores improved significantly from DB to IOL (mean difference 0.7, 95% CI: 0.22, 1.20; p = 0.005) and were not significantly different for flushing (mean difference -0.2, 95% CI: -1.25, 0.80) or diarrhea and flushing (mean difference 0.5, 95% CI: -0.69, 1.67). As expected, the mean difference in composite scores for diarrhea (1.1, 95% CI: 0.49, 1.65), flushing (1.1, 95% CI: 0.19, 1.93), and diarrhea / flushing (2.1, 95% CI: 0.91, 3.35) reflected significant improvement from DB to IOL for patients initially on PBO (P-values

Conclusions

Improved control of diarrhea and flushing in CS patients during initial 16 wks of LAN was sustained through wk 48 of this phase 3 study.

Clinical trial identification

EudraCT 2010-019066-92; NCT00774930

Legal entity responsible for the study

George A. Fisher, Jr.

Funding

This study was funded by Ipsen Biopharmaceuticals, Inc., Basking Ridge, NJ

Disclosure

G.A. Fisher Jr: Consulting—Ipsen; Research funding, Ipsen.

E. Wolin: Consulting or Advisory Role – Celgene; Ipsen; Novartis; Pfizer; Research Funding – Ipsen (Inst); Novartis (Inst); Pfizer (Inst).

P.L. Kunz: Research funding from Genentech, Merck, Advanced Accelerator Applications, Lexicon, Oxigene; Advisor for Ipsen, Novartis.

N. Liyanage, B. Mirakhur, S. Pitman Lowenthal: Employee Ipsen Biopharmaceuticals, Inc.

A. Vinik: Consulting or Advisory Role – Isis Pharmaceuticals; Merck Co., Inc.; Neurometrix; Pamlab; Pfizer; Speakers' Bureau – Merck Co., Inc.; Pamlab; Research Funding – Daiichi Sankyo; Impeto Medical; Intarcia Therapeutics; Pfizer; Tercica; ViroMed.

All other authors have declared no conflicts of interest.

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