Patient-Reported Symptom Control of Diarrhea and Flushing in Patients with Neuroendocrine Tumors Treated with Lanreotide Depot/Autogel: Results from a Randomized, Placebo-Controlled, Double-Blind and 32-Week Open-Label Study

George A. Fisher, Edward M. Wolin, Nilani Liyanage, Susan Pitman Lowenthal, Beloo Mirakhur, Rodney F. Pommier, Montaser Shaheen, Aaron Vinik, on behalf of the ELECT Study Group

Research output: Contribution to journalArticle

2 Citations (Scopus)

Abstract

Background: In the double-blind (DB) ELECT study, lanreotide depot/autogel significantly reduced versus placebo the need for short-acting octreotide for symptomatic carcinoid syndrome (CS) control in neuroendocrine tumor (NET) patients. Here we present patient-reported symptom data during DB and initial open-label (IOL) treatment. Materials and Methods: Adults with NETs and CS history, with/without prior somatostatin analog use, were randomized to 16 weeks’ DB lanreotide 120 mg subcutaneous or placebo every 4 weeks, followed by 32 weeks’ IOL lanreotide. Patients recorded diarrhea and/or flushing frequency and severity daily by Interactive Voice (Web) Response System for 1 month prior to randomization and throughout the study. Results: Of 115 patients randomized (n = 59 lanreotide, n = 56 placebo), 56 lanreotide and 45 placebo patients enrolled in the IOL phase. During DB treatment, least square (LS) mean percentages of days with moderate/severe diarrhea and/or flushing were significantly lower for lanreotide (23.4%) versus placebo (35.8%; LS mean difference [95% confidence interval]: −12.4 [−20.73 to −4.07]; p =.004). For DB lanreotide patients, average daily composite (frequency × severity) diarrhea scores improved significantly between DB and IOL treatment (mean difference: −0.71 [−1.20 to −0.22]; p =.005), and remained stable for diarrhea and/or flushing. For DB placebo patients, composite scores for diarrhea, flushing, and diarrhea and/or flushing improved significantly between DB and IOL treatment (mean differences: −1.07 [−1.65 to −0.49]; −1.06 [−1.93 to −0.19]; and −2.13 [−3.35 to −0.91]; all p ≤.018). Conclusion: Improved diarrhea and flushing control in CS patients during 16-week lanreotide treatment was sustained during maintenance of lanreotide treatment for the 32-week IOL phase (48 weeks total). Implications for Practice: This study prospectively collected daily patient-reported data on diarrhea and flushing from the ELECT trial to evaluate the direct impact of lanreotide depot on patients’ relief of carcinoid syndrome symptoms. Treatment with lanreotide depot was associated with significant reductions in the percentages of days patients reported symptoms of diarrhea and flushing, as well as reductions in the frequency and severity of daily symptoms compared with placebo during 16 weeks of double-blind treatment. These improvements were sustained for 32 additional weeks of open-label lanreotide treatment (i.e., through week 48 of treatment), resulting in clinically meaningful, long-term symptom reduction.

Original languageEnglish (US)
Pages (from-to)16-24
Number of pages9
JournalOncologist
Volume23
Issue number1
DOIs
StatePublished - Jan 1 2018

Fingerprint

Neuroendocrine Tumors
Diarrhea
Placebos
Carcinoid Tumor
Therapeutics
Least-Squares Analysis
lanreotide
Octreotide
Random Allocation
Somatostatin
Double-Blind Method
History
Maintenance

Keywords

  • Carcinoid syndrome
  • Clinical trial
  • Lanreotide depot/autogel
  • Neuroendocrine tumor
  • Quality of life

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

Cite this

Patient-Reported Symptom Control of Diarrhea and Flushing in Patients with Neuroendocrine Tumors Treated with Lanreotide Depot/Autogel : Results from a Randomized, Placebo-Controlled, Double-Blind and 32-Week Open-Label Study. / Fisher, George A.; Wolin, Edward M.; Liyanage, Nilani; Pitman Lowenthal, Susan; Mirakhur, Beloo; Pommier, Rodney F.; Shaheen, Montaser; Vinik, Aaron; on behalf of the ELECT Study Group.

In: Oncologist, Vol. 23, No. 1, 01.01.2018, p. 16-24.

Research output: Contribution to journalArticle

Fisher, George A. ; Wolin, Edward M. ; Liyanage, Nilani ; Pitman Lowenthal, Susan ; Mirakhur, Beloo ; Pommier, Rodney F. ; Shaheen, Montaser ; Vinik, Aaron ; on behalf of the ELECT Study Group. / Patient-Reported Symptom Control of Diarrhea and Flushing in Patients with Neuroendocrine Tumors Treated with Lanreotide Depot/Autogel : Results from a Randomized, Placebo-Controlled, Double-Blind and 32-Week Open-Label Study. In: Oncologist. 2018 ; Vol. 23, No. 1. pp. 16-24.
@article{cbc2bd4719434cf6aadf1ab75005bae7,
title = "Patient-Reported Symptom Control of Diarrhea and Flushing in Patients with Neuroendocrine Tumors Treated with Lanreotide Depot/Autogel: Results from a Randomized, Placebo-Controlled, Double-Blind and 32-Week Open-Label Study",
abstract = "Background: In the double-blind (DB) ELECT study, lanreotide depot/autogel significantly reduced versus placebo the need for short-acting octreotide for symptomatic carcinoid syndrome (CS) control in neuroendocrine tumor (NET) patients. Here we present patient-reported symptom data during DB and initial open-label (IOL) treatment. Materials and Methods: Adults with NETs and CS history, with/without prior somatostatin analog use, were randomized to 16 weeks’ DB lanreotide 120 mg subcutaneous or placebo every 4 weeks, followed by 32 weeks’ IOL lanreotide. Patients recorded diarrhea and/or flushing frequency and severity daily by Interactive Voice (Web) Response System for 1 month prior to randomization and throughout the study. Results: Of 115 patients randomized (n = 59 lanreotide, n = 56 placebo), 56 lanreotide and 45 placebo patients enrolled in the IOL phase. During DB treatment, least square (LS) mean percentages of days with moderate/severe diarrhea and/or flushing were significantly lower for lanreotide (23.4{\%}) versus placebo (35.8{\%}; LS mean difference [95{\%} confidence interval]: −12.4 [−20.73 to −4.07]; p =.004). For DB lanreotide patients, average daily composite (frequency × severity) diarrhea scores improved significantly between DB and IOL treatment (mean difference: −0.71 [−1.20 to −0.22]; p =.005), and remained stable for diarrhea and/or flushing. For DB placebo patients, composite scores for diarrhea, flushing, and diarrhea and/or flushing improved significantly between DB and IOL treatment (mean differences: −1.07 [−1.65 to −0.49]; −1.06 [−1.93 to −0.19]; and −2.13 [−3.35 to −0.91]; all p ≤.018). Conclusion: Improved diarrhea and flushing control in CS patients during 16-week lanreotide treatment was sustained during maintenance of lanreotide treatment for the 32-week IOL phase (48 weeks total). Implications for Practice: This study prospectively collected daily patient-reported data on diarrhea and flushing from the ELECT trial to evaluate the direct impact of lanreotide depot on patients’ relief of carcinoid syndrome symptoms. Treatment with lanreotide depot was associated with significant reductions in the percentages of days patients reported symptoms of diarrhea and flushing, as well as reductions in the frequency and severity of daily symptoms compared with placebo during 16 weeks of double-blind treatment. These improvements were sustained for 32 additional weeks of open-label lanreotide treatment (i.e., through week 48 of treatment), resulting in clinically meaningful, long-term symptom reduction.",
keywords = "Carcinoid syndrome, Clinical trial, Lanreotide depot/autogel, Neuroendocrine tumor, Quality of life",
author = "Fisher, {George A.} and Wolin, {Edward M.} and Nilani Liyanage and {Pitman Lowenthal}, Susan and Beloo Mirakhur and Pommier, {Rodney F.} and Montaser Shaheen and Aaron Vinik and {on behalf of the ELECT Study Group}",
year = "2018",
month = "1",
day = "1",
doi = "10.1634/theoncologist.2017-0284",
language = "English (US)",
volume = "23",
pages = "16--24",
journal = "Oncologist",
issn = "1083-7159",
publisher = "AlphaMed Press",
number = "1",

}

TY - JOUR

T1 - Patient-Reported Symptom Control of Diarrhea and Flushing in Patients with Neuroendocrine Tumors Treated with Lanreotide Depot/Autogel

T2 - Results from a Randomized, Placebo-Controlled, Double-Blind and 32-Week Open-Label Study

AU - Fisher, George A.

AU - Wolin, Edward M.

AU - Liyanage, Nilani

AU - Pitman Lowenthal, Susan

AU - Mirakhur, Beloo

AU - Pommier, Rodney F.

AU - Shaheen, Montaser

AU - Vinik, Aaron

AU - on behalf of the ELECT Study Group

PY - 2018/1/1

Y1 - 2018/1/1

N2 - Background: In the double-blind (DB) ELECT study, lanreotide depot/autogel significantly reduced versus placebo the need for short-acting octreotide for symptomatic carcinoid syndrome (CS) control in neuroendocrine tumor (NET) patients. Here we present patient-reported symptom data during DB and initial open-label (IOL) treatment. Materials and Methods: Adults with NETs and CS history, with/without prior somatostatin analog use, were randomized to 16 weeks’ DB lanreotide 120 mg subcutaneous or placebo every 4 weeks, followed by 32 weeks’ IOL lanreotide. Patients recorded diarrhea and/or flushing frequency and severity daily by Interactive Voice (Web) Response System for 1 month prior to randomization and throughout the study. Results: Of 115 patients randomized (n = 59 lanreotide, n = 56 placebo), 56 lanreotide and 45 placebo patients enrolled in the IOL phase. During DB treatment, least square (LS) mean percentages of days with moderate/severe diarrhea and/or flushing were significantly lower for lanreotide (23.4%) versus placebo (35.8%; LS mean difference [95% confidence interval]: −12.4 [−20.73 to −4.07]; p =.004). For DB lanreotide patients, average daily composite (frequency × severity) diarrhea scores improved significantly between DB and IOL treatment (mean difference: −0.71 [−1.20 to −0.22]; p =.005), and remained stable for diarrhea and/or flushing. For DB placebo patients, composite scores for diarrhea, flushing, and diarrhea and/or flushing improved significantly between DB and IOL treatment (mean differences: −1.07 [−1.65 to −0.49]; −1.06 [−1.93 to −0.19]; and −2.13 [−3.35 to −0.91]; all p ≤.018). Conclusion: Improved diarrhea and flushing control in CS patients during 16-week lanreotide treatment was sustained during maintenance of lanreotide treatment for the 32-week IOL phase (48 weeks total). Implications for Practice: This study prospectively collected daily patient-reported data on diarrhea and flushing from the ELECT trial to evaluate the direct impact of lanreotide depot on patients’ relief of carcinoid syndrome symptoms. Treatment with lanreotide depot was associated with significant reductions in the percentages of days patients reported symptoms of diarrhea and flushing, as well as reductions in the frequency and severity of daily symptoms compared with placebo during 16 weeks of double-blind treatment. These improvements were sustained for 32 additional weeks of open-label lanreotide treatment (i.e., through week 48 of treatment), resulting in clinically meaningful, long-term symptom reduction.

AB - Background: In the double-blind (DB) ELECT study, lanreotide depot/autogel significantly reduced versus placebo the need for short-acting octreotide for symptomatic carcinoid syndrome (CS) control in neuroendocrine tumor (NET) patients. Here we present patient-reported symptom data during DB and initial open-label (IOL) treatment. Materials and Methods: Adults with NETs and CS history, with/without prior somatostatin analog use, were randomized to 16 weeks’ DB lanreotide 120 mg subcutaneous or placebo every 4 weeks, followed by 32 weeks’ IOL lanreotide. Patients recorded diarrhea and/or flushing frequency and severity daily by Interactive Voice (Web) Response System for 1 month prior to randomization and throughout the study. Results: Of 115 patients randomized (n = 59 lanreotide, n = 56 placebo), 56 lanreotide and 45 placebo patients enrolled in the IOL phase. During DB treatment, least square (LS) mean percentages of days with moderate/severe diarrhea and/or flushing were significantly lower for lanreotide (23.4%) versus placebo (35.8%; LS mean difference [95% confidence interval]: −12.4 [−20.73 to −4.07]; p =.004). For DB lanreotide patients, average daily composite (frequency × severity) diarrhea scores improved significantly between DB and IOL treatment (mean difference: −0.71 [−1.20 to −0.22]; p =.005), and remained stable for diarrhea and/or flushing. For DB placebo patients, composite scores for diarrhea, flushing, and diarrhea and/or flushing improved significantly between DB and IOL treatment (mean differences: −1.07 [−1.65 to −0.49]; −1.06 [−1.93 to −0.19]; and −2.13 [−3.35 to −0.91]; all p ≤.018). Conclusion: Improved diarrhea and flushing control in CS patients during 16-week lanreotide treatment was sustained during maintenance of lanreotide treatment for the 32-week IOL phase (48 weeks total). Implications for Practice: This study prospectively collected daily patient-reported data on diarrhea and flushing from the ELECT trial to evaluate the direct impact of lanreotide depot on patients’ relief of carcinoid syndrome symptoms. Treatment with lanreotide depot was associated with significant reductions in the percentages of days patients reported symptoms of diarrhea and flushing, as well as reductions in the frequency and severity of daily symptoms compared with placebo during 16 weeks of double-blind treatment. These improvements were sustained for 32 additional weeks of open-label lanreotide treatment (i.e., through week 48 of treatment), resulting in clinically meaningful, long-term symptom reduction.

KW - Carcinoid syndrome

KW - Clinical trial

KW - Lanreotide depot/autogel

KW - Neuroendocrine tumor

KW - Quality of life

UR - http://www.scopus.com/inward/record.url?scp=85040347850&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85040347850&partnerID=8YFLogxK

U2 - 10.1634/theoncologist.2017-0284

DO - 10.1634/theoncologist.2017-0284

M3 - Article

AN - SCOPUS:85040347850

VL - 23

SP - 16

EP - 24

JO - Oncologist

JF - Oncologist

SN - 1083-7159

IS - 1

ER -