(ChemotherapyAdvisor) – Use of the somatostatin analog lanreotide is safe and has some efficacy in the symptomatic treatment of patients with inoperable bowel obstruction due to peritoneal carcinomatosis, investigators reported in the Journal of Clinical Oncology online October 29.
“This study shows that it is feasible to overcome many of the methodologic challenges inherent in conducting randomized controlled trials in this setting and should spur further study,” noted Pascale Mariani, MD, Institut Curie, Paris, France, and colleagues. “It is important to note that trial participants benefit from clinical research, particularly from enhanced medical care.”
The phase 3 trial randomly assigned 80 patients from 22 European hospitals to one 30mg injection of lanreotide microparticles (n=43) or placebo (n=37) in a 10-day, double-blind, parallel-group phase; after the 10 days, patients could enter an open-label lanreotide-only phase. Patients had peritoneal carcinomatosis, inoperable malignant digestive obstruction, and two or more vomiting episodes per day or nasogastric tube and had been treated with intravenous corticosteroids and proton pump inhibitors.
Primary end point was patients who responded on day 7, defined as ≥3 consecutive days of one or fewer episodes of vomiting per day or no vomiting recurrence after removal of the nasogastric tube.
In the lanreotide arm, 41.9% of patients responded vs 29.7% in the placebo arm. While this difference was not statistically significant for the intent-to-treat population on the basis of diary cards (primary analysis; OR 1.75; 95% CI, 0.68–4.49; P=0.24), it was for the corresponding supportive per protocol analysis (57.7% vs 30.4% P<0.05) and intent-to-treat analysis on the basis of investigators’ assessments (50.0% vs 28.6%; P<0.05).
“Improvements in well-being were significantly greater with lanreotide on days 3, 6, and 7,” they found. Two mild/moderate treatment-emergent adverse events were considered related to lanreotide.
“Additional research in the challenging circumstances of palliative care is welcome,” the investigators concluded. “However, on the basis of this randomized controlled trial, the body of evidence in similar fragile patient populations, and the lack of effective therapeutic options, lanreotide is a feasible second-line symptomatic treatment option after corticosteroids for inoperable bowel obstruction due to peritoneal carcinomatosis.”
An accompanying editorial noted, “…patients receiving lanreotide reported a modest benefit compared with those who did not (the primary analysis) while the investigators’ assessment was that they clearly did better (the secondary analysis). This disparity is a cautionary note that we sometimes do not help our patients as much as we might think, and that in palliative care research the primary end points should always be patient derived.”