Lanreotide depot/autogel (LAN) vs. placebo (PBO) for carcinoid syndrome (CS) in patients with neuroendocrine tumors (NETs): Subgroup analysis of the ELECT study.

Authors

null

Aaron Vinik

Eastern Virginia Medical School, Norfolk, VA

Aaron Vinik , Edward M. Wolin , Helene Audry , Edda Gomez-Panzani , George A. Fisher

Organizations

Eastern Virginia Medical School, Norfolk, VA, University of Kentucky, Lexington, KY, Ipsen, Boulougne-Billancourt, France, Ipsen, Les Ulis, France, Stanford University School of Medicine, Stanford, CA

Research Funding

Pharmaceutical/Biotech Company

Background: ELECT, a large phase 3 study of the long-acting somatostatin analog (SSA) LAN for symptomatic control of CS in NET patients showed significant improvement over PBO in % days with short-acting octreotide use as rescue medication. Here, we investigate reduction in use of rescue medication for LAN vs PBO in subgroups defined by baseline characteristics. Methods: Patients with histologically confirmed NETs and history of CS received double-blind LAN 120 mg (n=59) or PBO (n=56) every 4 wks for 16 wks, with access to short-acting octreotide for breakthrough symptoms (NCT00774930). Least-squares mean differences in % of days rescue octreotide use for LAN vs PBO were calculated by ANCOVA within subgroups. Results: The significant reduction for LAN vs PBO in rescue medication use in the overall population (Table; approximately one-third lower for LAN group relative to PBO group) was generally consistent with reductions favoring LAN over PBO across subgroups, except small subgroups in which CIs were wide (e.g. BMI ≥30). Conclusions: Beneficial effects of LAN for CS symptom control in NET patients are consistent regardless of baseline characteristics. Clinical trial information: NCT00774930

SubgroupShort-acting
octreotide use,
% days*
Treatment difference
(LAN – PBO) [95% CI]*
LANPBO
Overall population (n=115)33.748.5-14.8 [-26.8, -2.8]
Age<65 y (n=78)35.853.2-17.4 [-34.1, -0.6]
≥65 y (n=37)25.845.5-19.7 [-35.5, -3.9]
GenderMale (n=48)36.760.8-24.1 [-45.7, -2.5]
Female (n=67)33.739.1-5.4 [-21.5, 10.7]
BMI<25 (n=41)29.948.5-18.6 [-39.6, 2.3]
>25 to <30 (n=50)30.952.7-21.8 [-39.6, -4.1]
≥30 (n=21)37.431.65.8 [-32.4, 44.0]
Race/ethnicityCaucasian (n=96)34.248.7-14.5 [-27.6, -1.4]
Other (n=19)21.946.6-24.8 [-70.4, 21.0]
RegionUS (n=40)19.630.2-10.7 [-32.5, 11.2]
Ex-US (n=75)39.555.8-16.3 [-31.6, -1.0]
Prior SSANo (n=51)25.344.3-18.9 [-37.0, -0.9]
Yes (n=64)33.944.2-10.3 [-26.5, 5.9]
Time since diagnosis<1 y (n=41)39.153.3-14.2 [-36.3, 7.9]
≥1 y (n=74)28.838.3-9.5 [-24.4, 5.4]

*LS mean, from subgroup ANCOVAs containing treatment, stratification factor(s) and baseline parameters (octreotide, diarrhea and flushing events), intent-to-treat population.

Disclaimer

This material on this page is ©2024 American Society of Clinical Oncology, all rights reserved. Licensing available upon request. For more information, please contact licensing@asco.org

Abstract Details

Meeting

2015 ASCO Annual Meeting

Session Type

Poster Session

Session Title

Gastrointestinal (Noncolorectal) Cancer

Track

Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary

Sub Track

Neuroendocrine/Carcinoid

Clinical Trial Registration Number

NCT00774930

Citation

J Clin Oncol 33, 2015 (suppl; abstr 4103)

DOI

10.1200/jco.2015.33.15_suppl.4103

Abstract #

4103

Poster Bd #

214

Abstract Disclosures