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

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 greater than or equal to 3 stools/ day and/ or greater than or equal to 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 fi rst 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. Copyright (C) 2004 S. Karger AG, Basel.