Lanreotide depot (LAN) for symptomatic control of carcinoid syndrome (CS) in neuroendocrine tumor (NET) patients previously responsive to octreotide (OCT): Subanalysis of patient-reported symptoms from the phase III elect study.

Authors

null

George A. Fisher Jr.

Stanford University, Stanford, CA

George A. Fisher Jr., Rodney F. Pommier , Edward M. Wolin , Pamela L. Kunz , Nilani Liyanage , Susan W. Pitman Lowenthal , Beloo Mirakhur , Montaser F. Shaheen , Aaron Vinik

Organizations

Stanford University, Stanford, CA, Division of Surgical Oncology, Oregon Health & Science University, Portland, OR, University of Kentucky, Lexington, KY, Stanford University School of Medicine, Stanford, CA, Ipsen Innovation, Les Ulis, France, Ipsen, Basking Ridge, NJ, University of New Mexico Comprehensive Cancer Center, Albuquerque, NM, Eastern Virginia Medical School, Norfolk, VA

Research Funding

Pharmaceutical/Biotech Company

Background: In ELECT, LAN significantly reduced the need for short-acting OCT rescue therapy for symptomatic control of CS in NET patients (pts) vs placebo (PBO) (primary result). Here we present flushing and diarrhea symptom data and biochemical response for pts with or without prior OCT use from ELECT. Methods: Adults with histopathologically-confirmed NET and history of stable CS (diarrhea and/or flushing) who were OCT-naive or responsive to OCT long-acting release (LAR) (≤30 mg q4W) or short-acting OCT (≤600 μg daily) were randomized to LAN 120 mg (SC q4W) or PBO for 16 wks. Pts administered SC OCT if needed and recorded daily frequency and severity of symptoms using Interactive Voice/Web Response System for 1 month pre-randomization and throughout the study. 24-hr urinary 5-hydroxindoleacetic acid (5HIAA) and plasma chromogranin A (CgA) were assessed at baseline and wk 12. Results: Of 115 pts randomized, 51 were OCT-naive and 64 received prior OCT. The least squares (LS) mean percentages of days with moderate/severe diarrhea and/or flushing were lower in both naive and prior OCT LAN pts vs naive and prior OCT PBO pts; LS mean difference (LAN-PBO) was significant in the naive group (Table). By week 12, 5HIAA and CgA levels dropped by ≥30% to normal in 35.3% and 15.8% of naive LAN pts and 28.6% and 4.5% of prior OCT LAN pts; 5HIAA and CgA reductions were seen in 15.4% and 21.4% of naive PBO pts and 5HIAA in 7.1% of prior OCT PBO pts. Conclusions: Pts showed improvement in CS symptoms of flushing and diarrhea and reduction in 5HIAA levels with LAN treatment, indicating efficacy of LAN regardless of prior OCT use. Transition from OCT to LAN was well tolerated among prior OCT pts in ELECT. Clinical trial information: NCT00774930

Percentage of days with moderate/severe diarrhea and/or flushing (ANCOVA, ITT population).

OCT-Naive
Prior OCT
LAN
n = 26
PBO
n = 25
LAN-PBOLAN
n = 33
PBO
n = 31
LAN-PBO
LS Mean
(95% CI)
4.4
(0.00, 16.42)
19.0
(7.09, 30.86)
-14.5
(-26.03, -3.09)
33.0
(24.75, 41.32)
43.9
(35.33, 52.43)
-10.9
(-22.81, 1.11)
P-value0.0140.075

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Abstract Details

Meeting

2017 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 35, 2017 (suppl; abstr 4088)

DOI

10.1200/JCO.2017.35.15_suppl.4088

Abstract #

4088

Poster Bd #

80

Abstract Disclosures