|The following article features coverage from the 2017 American Society of Clinical Oncology Annual Meeting in Chicago, Illinois. Click here to read more of Oncology Nurse Advisor‘s conference coverage.|
CHICAGO — Lanreotide depot/autogel treatment improves control of carcinoid syndrome symptoms in patients with neuroendocrine tumors, including patients who were previously responsive to octreotide therapy, according to new data presented at the 2017 American Society of Clinical Oncology (ASCO) Annual Meeting.
The data are from a subanalysis of the randomized, double-blind, phase 3 ELECT (Evaluating Lanreotide Efficacy and safety as a Carcinoid-syndrome Treatment) trial, which randomized 115 patients to receive 120 mg lanreotide depot/autogel every 4 weeks for 16 weeks or placebo. The primary study demonstrated that lanreotide, a somatostatin analog, significantly decreased the percentage of days that short-acting octreotide rescue medication was used for symptomatic control of carcinoid syndrome compared with placebo (Endocr Pract 2016;22:1068-1080).
“In this [new] study, we validate and extend the findings of that trial using patient-reported outcomes obtained from 32,345 daily diary entries recorded by patients over 52 weeks,” said lead investigator George A. Fisher, MD, PhD, of Stanford University School of Medicine in Stanford, California. “We found that lanreotide had a significant impact on diarrhea and flushing symptoms of carcinoid syndrome and an associated decrease in levels of urinary 5-hydroxyindoleacetic acid. Patient compliance with daily entries was outstanding and adds clinical context to the primary end point of number of rescue octreotide shots administered.”
Dr Fisher added, “Patient-reported outcomes have been underutilized in clinical trials yet have the potential to define and refine the day-to-day impact of a therapeutic intervention on symptoms associated with a disease or treatment.”
Carcinoid syndrome is characterized by flushing, diarrhea, abdominal pain, and bronchospasm. It occurs with symptomatic neuroendocrine tumors due to the release of serotonin and other vasoactive amines into the systemic circulation. Urinary 5-hydroxyindoleacetic acid, the main metabolite of serotonin, is used to determine patients’ serotonin levels.
Of the 115 patients in the primary study, 51 were octreotide naïve (de novo) and 64 were treated previously with octreotide.
Dr Fisher and his collaborators showed that lanreotide improved patient-reported symptom control in all patients, including those previously responsive to conventional octreotide therapy and who transitioned to lanreotide therapy. A greater proportion of lanreotide patients than placebo recipients had complete or partial treatment response in both the de novo and prior octreotide groups (34.6% vs 20% and 57.6% vs 35.5%, respectively). The investigators observed complete response in a higher percentage of prior octreotide patients receiving lanreotide than in de novo patients, possibly because their symptoms were controlled on octreotide prior to study randomization.
In both the de novo and prior octreotide groups, lanreotide-treated patients had a lower percentage of days of short-acting octreotide use as rescue therapy compared with placebo recipients. The least squares (LS) mean treatment difference for lanreotide vs placebo was −19.07 (95% CI, −37.9, −0.2; P =.0477) for the de novo patients and −6.86 (95% CI, −24.3, 10.5; P =.4332) for the prior octreotide group.
In the de novo group, the LS mean percentage of days in which patients experienced moderate or severe flushing was lower in lanreotide-treated patients than placebo recipients (−8.6% (95% CI, −17.05, −0.06; P =.0486). The mean percentage of days in which patients experienced moderate or severe diarrhea also was lower in the lanreotide patients (−8.9; 95% CI, −18.36, −0.58; P =.0650).
In the prior octreotide group, the mean percentage of days of moderate or severe flushing was lower in the lanreotide group than the placebo recipients (−7.9; 95% CI, −17.75, 2.01; P =.1162). The mean percentage of days with moderate or severe diarrhea also was lower in the lanreotide patients (−8.4; 95% CI, −18.61, 1.75; P =.1027).
Read more of Oncology Nurse Advisor‘s coverage of the 2017 American Society of Clinical Oncology Annual Meeting by visiting the conference page.
1. Fisher GA, Pommier RF, Wolin EM, et al. Lanreotide depot (LAN) for symptomatic control of carcinoid syndrome (CS) in neuroendocrine tumor (NET) patients previously responsive to octreotide (OCT): subanalysis of patient-reported symptoms from the phase 3 ELECT study. Poster presentation at: 2017 American Society of Clinical Oncology Annual Meeting; June 2-6, 2017; Chicago, IL.