Symptomatic Treatment With Lanreotide Microparticles in Inoperable Bowel Obstruction Resulting From Peritoneal Carcinomatosis: A Randomized, Double-Blind, Placebo-Controlled Phase III Study

• Published in: Journal of clinical oncology Vol. 30; no. 35; pp. 4337 - 4343
• Main Authors: MARIANI, Pascale, BLUMBERG, Joelle, LANDAU, Alain, LEBRUN-JEZEKOVA, Daniela, BOTTON, Estelle, BEATRIX, Olivier, MAYEUR, Didier, HERVE, Robert, MAISONOBE, Pascal, CHAUVENET, Laure
• Format: Journal Article
• Language: English
• Published: Alexandria, VA American Society of Clinical Oncology 10.12.2012
• Subjects: Adult; Antineoplastic Agents - administration & dosage; Antineoplastic Agents - adverse effects; Biological and medical sciences; Double-Blind Method; Female; Gastroenterology. Liver. Pancreas. Abdomen; Humans; Intestinal Obstruction - drug therapy; Intestinal Obstruction - etiology; Male; Medical sciences; Other diseases. Semiology; Particle Size; Peptides, Cyclic - administration & dosage; Peptides, Cyclic - adverse effects; Peritoneal Neoplasms - complications; Peritoneal Neoplasms - drug therapy; Placebos; Somatostatin - administration & dosage; Somatostatin - adverse effects; Somatostatin - analogs & derivatives; Stomach. Duodenum. Small intestine. Colon. Rectum. Anus; Tumors; Phase III trial; Peptides; Intestine occlusion; Malignant tumor; Octapeptide; Randomization; Cancerology; Treatment; Abdominal disease; Lanreotide; Peritoneal carcinomatosis; Placebo; Digestive diseases; Intestinal disease; Microparticle; Cancer
• ISSN: 0732-183X; 1527-7755
• DOI: 10.1200/JCO.2011.40.5712

To investigate the somatostatin analog lanreotide as symptomatic treatment for inoperable bowel obstruction due to peritoneal carcinomatosis. In all, 80 patients with peritoneal carcinomatosis, inoperable malignant digestive obstruction, and two or more vomiting episodes per day or nasogastric tube (NGT) who were previously treated with intravenous corticosteroids and proton pump inhibitors were randomly assigned to one 30-mg injection of lanreotide microparticles (n = 43) or placebo (n = 37) in a 10-day, double-blind, parallel-group phase. The primary end point was the proportion of patients responding on day 7 (one or fewer episodes of vomiting per day or no vomiting recurrence after NGT removal [for ≥ 3 consecutive days in both cases]). Vomiting frequency/NGT secretion volumes, nausea, abdominal pain, well-being, and safety were also assessed. Patients could then enter an open-label lanreotide-only phase. The study was conducted at 22 European hospitals. More patients receiving lanreotide than placebo were responders; this difference was not statistically significant for the intent-to-treat (ITT) population on the basis of diary cards (primary analysis; 41.9% [18 of 43] v 29.7% [11 of 37], respectively; odds ratio, 1.75; 95% CI, 0.68 to 4.49; P = .24) but was statistically significant for the corresponding supportive per protocol analysis (57.7% [15 of 26] v 30.4% [seven of 23]; P < .05) and ITT analysis, on the basis of investigators' assessments (50.0% [19 of 38] v 28.6% [10 of 35]; P < .05). Improvements in well-being were significantly greater with lanreotide on days 3, 6, and 7. No significant differences were observed for other secondary end points. Only two (mild/moderate) treatment-emergent adverse events were considered related to lanreotide. These results show that lanreotide has some efficacy and is safe in the symptomatic treatment of patients with inoperable bowel obstruction due to peritoneal carcinomatosis.