LANREOTIDE THERAPY in CARCINOID SYNDROME

PROSPECTIVE ANALYSIS of PATIENT-REPORTED SYMPTOMS in PATIENTS RESPONSIVE to PRIOR OCTREOTIDE THERAPY and PATIENTS NAÏVE to SOMATOSTATIN ANALOGUE THERAPY in the ELECT PHASE 3 STUDY

George A. Fisher, Edward M. Wolin, Nilani Liyanage, Susan Pitman Lowenthal, Beloo Mirakhur, Rodney Pommier, Montaser Shaheen, Aaron I. Vinik

    Research output: Contribution to journalArticle

    2 Citations (Scopus)

    Abstract

    Objective: This ELECT prospective analysis examined lanreotide depot/autogel for carcinoid syndrome (CS) symptom control in patients with neuroendocrine tumors (NETs) who were responsive to prior octreotide (prior octreotide group) compared with patients who were naïve to prior somatostatin analogue treatment (de novo group). Methods: Adults with histopathologically confirmed NET and stable CS (diarrhea and/or flushing) were randomized to subcutaneous (SC) lanreotide 120 mg or placebo every 4 weeks for 16 weeks. Patients reported diarrhea and/or flushing symptom severity and frequency and short-acting SC octreotide rescue therapy daily using an Interactive Voice/Web Response System. To evaluate the efficacy of lanreotide compared with placebo, the novel primary endpoint of patient-determined use of SC octreotide rescue therapy for breakthrough symptoms was used as a surrogate for symptom control. Clinically meaningful patient-reported treatment benefit was examined using daily patient-reported symptoms of diarrhea and flushing. Results: Of the 115 randomized patients, 51 (n = 26 lanreotide, n = 25 placebo) were octreotide-naïve (de novo) and 64 (n = 33 lanreotide; n = 31 placebo) received prior octreotide. Lanreotide versus placebo patients had a lower mean percentage of days of SC octreotide rescue therapy in de novo and prior octreotide groups (least squares LS mean difference-19.1, P =.0477 and-6.9, P =.4332, respectively). The mean percentage of days with moderate/severe diarrhea and/or flushing was lower in lanreotide versus placebo patients in de novo and prior octreotide groups (LS mean difference-14.6, P =.0140 and-10.9, P =.0746, respectively). The transition from octreotide to lanreotide was generally well-tolerated. Conclusion: Improvement in CS symptoms occurred with lanreotide treatment, regardless of prior octreotide use.

    Original languageEnglish (US)
    Pages (from-to)243-255
    Number of pages13
    JournalEndocrine Practice
    Volume24
    Issue number3
    DOIs
    StatePublished - Mar 1 2018

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    Octreotide
    Carcinoid Tumor
    Placebos
    Diarrhea
    Neuroendocrine Tumors
    Therapeutics
    lanreotide
    Somatostatin
    Least-Squares Analysis

    ASJC Scopus subject areas

    • Endocrinology, Diabetes and Metabolism
    • Endocrinology

    Cite this

    LANREOTIDE THERAPY in CARCINOID SYNDROME : PROSPECTIVE ANALYSIS of PATIENT-REPORTED SYMPTOMS in PATIENTS RESPONSIVE to PRIOR OCTREOTIDE THERAPY and PATIENTS NAÏVE to SOMATOSTATIN ANALOGUE THERAPY in the ELECT PHASE 3 STUDY. / Fisher, George A.; Wolin, Edward M.; Liyanage, Nilani; Lowenthal, Susan Pitman; Mirakhur, Beloo; Pommier, Rodney; Shaheen, Montaser; Vinik, Aaron I.

    In: Endocrine Practice, Vol. 24, No. 3, 01.03.2018, p. 243-255.

    Research output: Contribution to journalArticle

    Fisher, George A. ; Wolin, Edward M. ; Liyanage, Nilani ; Lowenthal, Susan Pitman ; Mirakhur, Beloo ; Pommier, Rodney ; Shaheen, Montaser ; Vinik, Aaron I. / LANREOTIDE THERAPY in CARCINOID SYNDROME : PROSPECTIVE ANALYSIS of PATIENT-REPORTED SYMPTOMS in PATIENTS RESPONSIVE to PRIOR OCTREOTIDE THERAPY and PATIENTS NAÏVE to SOMATOSTATIN ANALOGUE THERAPY in the ELECT PHASE 3 STUDY. In: Endocrine Practice. 2018 ; Vol. 24, No. 3. pp. 243-255.
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    abstract = "Objective: This ELECT prospective analysis examined lanreotide depot/autogel for carcinoid syndrome (CS) symptom control in patients with neuroendocrine tumors (NETs) who were responsive to prior octreotide (prior octreotide group) compared with patients who were na{\"i}ve to prior somatostatin analogue treatment (de novo group). Methods: Adults with histopathologically confirmed NET and stable CS (diarrhea and/or flushing) were randomized to subcutaneous (SC) lanreotide 120 mg or placebo every 4 weeks for 16 weeks. Patients reported diarrhea and/or flushing symptom severity and frequency and short-acting SC octreotide rescue therapy daily using an Interactive Voice/Web Response System. To evaluate the efficacy of lanreotide compared with placebo, the novel primary endpoint of patient-determined use of SC octreotide rescue therapy for breakthrough symptoms was used as a surrogate for symptom control. Clinically meaningful patient-reported treatment benefit was examined using daily patient-reported symptoms of diarrhea and flushing. Results: Of the 115 randomized patients, 51 (n = 26 lanreotide, n = 25 placebo) were octreotide-na{\"i}ve (de novo) and 64 (n = 33 lanreotide; n = 31 placebo) received prior octreotide. Lanreotide versus placebo patients had a lower mean percentage of days of SC octreotide rescue therapy in de novo and prior octreotide groups (least squares LS mean difference-19.1, P =.0477 and-6.9, P =.4332, respectively). The mean percentage of days with moderate/severe diarrhea and/or flushing was lower in lanreotide versus placebo patients in de novo and prior octreotide groups (LS mean difference-14.6, P =.0140 and-10.9, P =.0746, respectively). The transition from octreotide to lanreotide was generally well-tolerated. Conclusion: Improvement in CS symptoms occurred with lanreotide treatment, regardless of prior octreotide use.",
    author = "Fisher, {George A.} and Wolin, {Edward M.} and Nilani Liyanage and Lowenthal, {Susan Pitman} and Beloo Mirakhur and Rodney Pommier and Montaser Shaheen and Vinik, {Aaron I.}",
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    T1 - LANREOTIDE THERAPY in CARCINOID SYNDROME

    T2 - PROSPECTIVE ANALYSIS of PATIENT-REPORTED SYMPTOMS in PATIENTS RESPONSIVE to PRIOR OCTREOTIDE THERAPY and PATIENTS NAÏVE to SOMATOSTATIN ANALOGUE THERAPY in the ELECT PHASE 3 STUDY

    AU - Fisher, George A.

    AU - Wolin, Edward M.

    AU - Liyanage, Nilani

    AU - Lowenthal, Susan Pitman

    AU - Mirakhur, Beloo

    AU - Pommier, Rodney

    AU - Shaheen, Montaser

    AU - Vinik, Aaron I.

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    N2 - Objective: This ELECT prospective analysis examined lanreotide depot/autogel for carcinoid syndrome (CS) symptom control in patients with neuroendocrine tumors (NETs) who were responsive to prior octreotide (prior octreotide group) compared with patients who were naïve to prior somatostatin analogue treatment (de novo group). Methods: Adults with histopathologically confirmed NET and stable CS (diarrhea and/or flushing) were randomized to subcutaneous (SC) lanreotide 120 mg or placebo every 4 weeks for 16 weeks. Patients reported diarrhea and/or flushing symptom severity and frequency and short-acting SC octreotide rescue therapy daily using an Interactive Voice/Web Response System. To evaluate the efficacy of lanreotide compared with placebo, the novel primary endpoint of patient-determined use of SC octreotide rescue therapy for breakthrough symptoms was used as a surrogate for symptom control. Clinically meaningful patient-reported treatment benefit was examined using daily patient-reported symptoms of diarrhea and flushing. Results: Of the 115 randomized patients, 51 (n = 26 lanreotide, n = 25 placebo) were octreotide-naïve (de novo) and 64 (n = 33 lanreotide; n = 31 placebo) received prior octreotide. Lanreotide versus placebo patients had a lower mean percentage of days of SC octreotide rescue therapy in de novo and prior octreotide groups (least squares LS mean difference-19.1, P =.0477 and-6.9, P =.4332, respectively). The mean percentage of days with moderate/severe diarrhea and/or flushing was lower in lanreotide versus placebo patients in de novo and prior octreotide groups (LS mean difference-14.6, P =.0140 and-10.9, P =.0746, respectively). The transition from octreotide to lanreotide was generally well-tolerated. Conclusion: Improvement in CS symptoms occurred with lanreotide treatment, regardless of prior octreotide use.

    AB - Objective: This ELECT prospective analysis examined lanreotide depot/autogel for carcinoid syndrome (CS) symptom control in patients with neuroendocrine tumors (NETs) who were responsive to prior octreotide (prior octreotide group) compared with patients who were naïve to prior somatostatin analogue treatment (de novo group). Methods: Adults with histopathologically confirmed NET and stable CS (diarrhea and/or flushing) were randomized to subcutaneous (SC) lanreotide 120 mg or placebo every 4 weeks for 16 weeks. Patients reported diarrhea and/or flushing symptom severity and frequency and short-acting SC octreotide rescue therapy daily using an Interactive Voice/Web Response System. To evaluate the efficacy of lanreotide compared with placebo, the novel primary endpoint of patient-determined use of SC octreotide rescue therapy for breakthrough symptoms was used as a surrogate for symptom control. Clinically meaningful patient-reported treatment benefit was examined using daily patient-reported symptoms of diarrhea and flushing. Results: Of the 115 randomized patients, 51 (n = 26 lanreotide, n = 25 placebo) were octreotide-naïve (de novo) and 64 (n = 33 lanreotide; n = 31 placebo) received prior octreotide. Lanreotide versus placebo patients had a lower mean percentage of days of SC octreotide rescue therapy in de novo and prior octreotide groups (least squares LS mean difference-19.1, P =.0477 and-6.9, P =.4332, respectively). The mean percentage of days with moderate/severe diarrhea and/or flushing was lower in lanreotide versus placebo patients in de novo and prior octreotide groups (LS mean difference-14.6, P =.0140 and-10.9, P =.0746, respectively). The transition from octreotide to lanreotide was generally well-tolerated. Conclusion: Improvement in CS symptoms occurred with lanreotide treatment, regardless of prior octreotide use.

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