Rapid and Sustained Relief from the Symptoms of Carcinoid Syndrome: Results from an Open 6-Month Study of the 28-Day Prolonged-Release Formulation of Lanreotide

Abstract

This 6-month, open, non-controlled, multicenter, dose-titration study evaluated the efficacy and safety of 28-day prolonged-release (PR) lanreotide in the treatment of carcinoid syndrome. Eligible patients had a carcinoid tumor with ≧3 stools/day and/or ≧1 moderate/severe flushing episodes/day. Six treatments of 28-day PR lanreotide were administered by deep subcutaneous injection. The dose for the first two injections was 90 mg. Subsequent doses could be titrated (60, 90, 120 mg) according to symptom response. Seventy-one patients were treated. Flushing decreased from a mean of 3.0 at baseline to 2.3 on day 1, and 2.0 on day 2, with a daily mean of 2.1 for the first week post-treatment (p < 0.05). Diarrhea decreased from a mean of 5.0 at baseline to 4.3 on day 1 (p < 0.05), and 4.5 on day 2, with a daily mean of 4.4 for the first week post-treatment (p < 0.001). Symptom frequency decreased further after the second and third injections, and reached a plateau after the fourth injection. By month 6, flushing and diarrhea had significantly decreased from baseline by a mean of 1.3 and 1.1 episodes/day, respectively (both p ≤ 0.001); 65% of patients with flushing as the target symptom and 18% of diarrhea-target patients achieved ≧50% reduction from baseline. Median urinary 5-hydroxyindoleacetic acid and chromogranin A levels decreased by 24 and 38%, respectively. Treatment was well tolerated. 28-day PR lanreotide was effective in reducing the symptoms and biochemical markers associated with carcinoid syndrome.

Lanreotide autogel every 6 weeks compared with Lanreotide microparticles every 3 weeks in patients with well differentiated neuroendocrine tumors

“…4,5,16 Chromogranins are markers of secretory activity because they are released from NET at the same time as amines and peptide hormones. Therefore, the reduction in circulating levels can parallel a decline in hormone secretion and symptom severity or frequency, although declining tumor markers do not necessarily reflect a loss of tumor mass.…”

“…Lanreotide Autogel TM (Lan ATG) (Ipsen, Paris, France) is injected every 4 weeks at a dose of 60 mg, 90 mg, or 120 mg 4 ; whereas lanreotide microparticles (Lan MP) (Ipsen) at a dose of 30 mg are injected every 7 to 14 days or every 14 to 28 days for the 60-mg dose (available only in some markets). [5][6][7][8] Therapeutic equivalence has been demonstrated between Lan ATG and Lan MP in the control of hormone hypersecretion in patients with acromegaly.…”

“…9,10 Recent studies also have suggested that Lan ATG at a dose of 120 mg is as effective for controlling acromegaly when injected every 4 to 8 weeks as Lan MP every 7 to 14 days. 11 However, both equivalence between the lanreotide formulations and the use of a dosing interval for Lan ATG extended beyond 4 weeks have yet to be investigated in NET. Therefore, the objective of the current study was to assess the equivalence between Lan ATG at a dose of 120 mg every 6 weeks and Lan MP at a dose of 60 mg every 3 weeks in patients with NET.…”

TNM staging of midgut and hindgut (neuro) endocrine tumors: a consensus proposal including a grading system

“…Based on recognized differences in morphology, function and clinical behavior [1,2,21,30], the current WHO classification provides a prognosis-oriented definition of gastroenteropancreatic neuroendocrine tumors (GEP-NETs) [3,5,8,12,13,34].…”

MANAGEMENT OF ENDOCRINE DISEASE: Flushing: current concepts

“…This treatment significantly reduces plasma CgA levels, especially in patients with classical midgut NETs, probably reflecting an inhibition of both hormone synthesis and release from the tumour cells. Studies on long-acting analogues demonstrate a symptomatic response rate of 70% (50) in patients with the carcinoid syndrome, and referring specifically to flushing, a response rate of 50-60% (51,52). Since the goal of improving symptom control is a common reason for somatostatin analogue dose escalation, Strosberg et al have recently evaluated the effects of above-standard dose of octreotide LAR in a multicentre study, concluding that the resolution or improvement of flushing after dose escalation can be observed in 80% of patients (53).…”