Efficacy and Safety of Lanreotide Autogel in the Treatment of Clinical Symptoms Associated With Inoperable Malignant Intestinal Obstruction: A Prospective Phase II Study
Lionel Duck, Gauthier Demolin, Lionel D'Hondt, Catherine Dopchie, Koen Hendrickx, Beatrice Lannoye, Fabienne Bastin, Dominique Lossignol, Ossama Hamdan, Willem Lybaert, Vincent Vandenhaute, Benjamin Regnault, Vincent De Ruyter, Karen Geboes, Lionel Duck, Gauthier Demolin, Lionel D'Hondt, Catherine Dopchie, Koen Hendrickx, Beatrice Lannoye, Fabienne Bastin, Dominique Lossignol, Ossama Hamdan, Willem Lybaert, Vincent Vandenhaute, Benjamin Regnault, Vincent De Ruyter, Karen Geboes
Abstract
Purpose: Inoperable malignant intestinal obstruction (IMIO) is a severe complication in patients with cancer, usually gastrointestinal or gynecologic in origin. For patients with IMIO, there is a need to relieve symptoms and limit nasogastric tube (NGT) use. Previous studies have suggested the efficacy of somatostatin analogues in relieving obstruction-related symptoms, such as nausea, vomiting, and pain. The purpose of this study was to assess the efficacy of lanreotide autogel 120 mg (LAN 120 mg) in the management of symptoms resulting from IMIO in patients with advanced cancer.
Methods: This single-arm, multicenter study enrolled 52 patients mostly with advanced gastrointestinal or ovarian malignant tumors (35 patients with NGT and 17 patients without NGT). Patients received 1 deep subcutaneous injection of LAN 120 mg. Evaluations were performed on days 7, 14, and 28. The primary end point was the percentage of responding patients before or at day 7. Response was defined as ≤2 vomiting episodes per day (for patients without NGT at baseline) or no vomiting recurrence (after NGT removal) during at least 3 consecutive days at any time point between treatment and day 7. Responders at day 28 were offered a second LAN 120 mg injection and followed up until day 56.
Findings: The proportion of responders in the intention-to-treat population was 24 of 52 (46.2%), which was significantly greater than the reference proportion of 30% (P = 0.0055). Patients without NGT had a higher response (88.2%) than patients with NGT (25.7%) and had a steady trend for clinical improvement that led to sustainable responses. Median time to response was 9 days for the overall population, 3 days for patients without NGT, and 14 days for patients with NGT (P < 0.0001).
Implications: Our study is the first to use long-acting LAN 120 mg in patients with IMIO and suggests an effect in controlling clinical symptoms in patients with and without NGT at baseline. The safety profile of LAN 120 mg was similar to that reported in other indications. ClinicalTrials.gov identifier: NCT02275338.
Keywords: gastrointestinal; intestinal obstruction; intubation; lanreotide; palliative care.
Conflict of interest statement
DISCLOSURES L. Duck served as a consultant for Bayer, received honorarium from Janssen, and received funding from Roche and Teva. B. Lannoye is a former employee of Johnson & Johnson and former employee of Smith & Nephew. O. Hamdan received funding from Novartis. B. Regnault is a current employee of Ipsen. V. De Ruyter is a current employee of Ipsen NV and owns stock in Ipsen. K. Geboes served as a consultant for Roche, Merck, Ipsen, Novartis, Eli Lilly, and Celgene and received funding from Roche, Amgen, Ipsen, Merck, and Novartis. The authors have indicated that they have no other conflicts of interest regarding the content of this article.
Copyright © 2021 Elsevier Inc. All rights reserved.
Source: PubMed