Efficacy of lanreotide 30 mg as symptomatic treatment in patients with inoperable bowel obstruction due to peritoneal carcinomatosis: A randomized double-blind, placebo-controlled study.
242 Background: Somatostatin analogues in previous open label studies improved symptoms due to bowel obstruction in patients with peritoneal carcinomatosis. This study assessed the efficacy and safety of lanreotide microparticles 30 mg as treatment of clinical symptoms in inoperable patients. Methods: Eighty cancer patients with inoperable digestive obstruction of malignant origin (mean age 62.3 years, 82.5% female) were randomized to receive one intramuscular injection either of lanreotide microparticles 30 mg (N=43) or placebo (N=37). The primary location of cancer was mostly genital (ovary 37.5%, uterus 13.8%) or digestive (colon 16.3%, stomach 11.3%, pancreas 6.3%). Most patients were fed by central parenteral route (80%) and were severely impaired (63.8% ECOG 3 or 4). The primary endpoint was the response rate at day 7 (responders defined as patients with ≤ 1 vomiting episode per day or no vomiting recurrence after removal of the NGT, for at least 3 consecutive days) assessed in a diary card in the intention to treat (ITT) population. Per protocol (PP) population mainly excludes concomitant treatment and inclusion criteria deviations defined during a blinded data review meeting. Results: In the ITT analysis, 41.9% of lanreotide 30mg treated patients were responders versus 29.7% for placebo. This difference was not statistically significant (odds ratio (OR) = 1.75 (95% CI [0.68; 4.49], p = 0.24, logistic regression). The predefinedPP (n= 49) sub group analysis did show a statistically and clinically significantly higher response rate in the lanreotide group (OR 3.60 (95% CI [1.03, 12.62], p = 0.045). There was no significant difference between the 2 treatment groups in secondary efficacy endpoints assessment but there were significant differences in favor of lanreotide in well-being using a visual analogue scale at D3 (p = 0.04), D6 (p = 0.04) and D7 (p = 0.01). No drug-related serious adverse event (SAE) or unexpected event was reported. Conclusions: Lanreotide 30 mg may decrease clinical symptoms and improve well-being in patients with inoperable bowel obstruction due to peritoneal carcinomatosis. [Table: see text]