Change in Patient-Reported Symptom Control in Patients With Neuroendocrine Tumors Treated With Lanreotide Depot (2017)

Introduction: Lanreotide depot significantly reduced short-acting (rescue) octreotide medication use for carcinoid syndrome symptom control in neuroendocrine tumor (NET) patients, compared to placebo, in the 16-week double-blind (DB) phase of the ELECT study. To further illustrate the effect of lanreotide depot on symptom control, we present post-hoc cumulative distribution data on changes in average combined scores of patient-reported symptoms (diarrhea and/or flushing) in the DB phase. Methods: ELECT consisted of a 16-week DB phase, a 32-week open-label phase, and a long-term open-label extension. The primary endpoint was the mean percentage of days of rescue octreotide use for symptom control in the DB phase. Adults with confirmed NET (known origin) or NET of unknown location with liver metastases and history of carcinoid syndrome were randomized to lanreotide depot 120 mg or placebo every 4 weeks, and all were able to use rescue octreotide as needed for symptom control. The frequency and severity of diarrhea and flushing were captured in daily patient-recorded diaries using an Interactive Voice (Web) Response System. Data were analyzed using analysis of covariance models with country, prior somatostatin analog status, and baseline symptoms as covariates. The average combined score of daily frequency and severity of symptoms/patient/day was calculated by multiplying the frequency (eg, 0=no symptoms) with the respective severity score (1=mild, 2=moderate, 3=severe/missing). Results: A total of 115 patients were randomized to lanreotide depot (n=59) or placebo (n=56). In the DB phase, ≈70% of lanreotide depot-treated patients experienced decreases in average combined scores of daily frequency and severity of diarrhea compared to < 55% of placebo-treated patients (Figure 1). There was a smaller difference when comparing changes in scores for flushing (Figure 2). For diarrhea and/or flushing, ≈75% of lanreotide depot-treated patients experienced decreases compared to < 60% of placebotreated patients (Figure 3). Median changes in scores for diarrhea and/or flushing were -1.46 and -0.57 for lanreotide depot and placebo, respectively.Figure: Cumulative distribution function of the change in average combined score of daily frequency and severity of diarrhea from baseline during the double-blind phase by treatment arm (intention-to-treat population).Figure: Cumulative distribution function of the change in average combined score of daily frequency and severity of flushing from baseline during the double-blind phase by treatment arm (intention-to-treat population).Figure: Cumulative distribution function of the change in average combined score of daily frequency and severity of diarrhea and/or flushing from baseline during the doubleblind phase by treatment arm (intention-to-treat population).Conclusion: The results of this post-hoc analysis confirm the efficacy of lanreotide depot for symptom control in patients with NETs and carcinoid syndrome. The cumulative distribution function of changes in average combined symptom scores further characterizes the effect of lanreotide depot on symptom control in this population.