The somatostatin analog lanreotide (Somatuline) reduced the frequency of vomiting for patients with inoperable malignant bowel obstruction (MBO) in what presenter Pascale Mariani, MD, at the Institut Curie in Paris, France, called the first randomized, doubleblind, placebo-controlled study on palliative care in this patient population. “We showed that lanreotide may reduce the frequency of vomiting and allow for nasogastric tube [NGT] removal, which makes hospital discharge possible,” said Mariani, who presented the findings.
Investigators at 22 European centers enrolled symptomatic patients with inoperable MBO who were experiencing ≥2 vomiting episodes per day or had an NGT. Most patients were severely impaired; 63.8% had an ECOG performance status of 3 or 4, and 80% were fed by central parenteral route. Patients were randomly assigned to receive 1 injection with 30 mg of lanreotide microparticles (n = 43) or placebo (n = 37). The trial’s primary end point was response rate (RR), defined as the proportion of patients at 7 days who, for 3 consecutive days, recorded ≤1 episode of vomiting or no vomiting after NGT removal.
In the intent-to-treat (ITT) population, RR was 41.9% for patients injected with lanreotide compared with 29.7% for those given placebo, a difference that was not significant (odds ratio [OR], 1.75; 95% confidence interval [CI], 0.68- 4.49; P = .24). A per protocol analysis found a statistically significant benefit associated with lanreotide use, with an RR of 57.7% in the treatment arm versus 30.4% in the control group (OR, 3.60; 95% CI, 1.03-12.62; P = .045). Mariani said investigator assessment of data for the ITT population also found a significant difference in RR between the groups, favoring lanreotide over placebo (50.0% vs 28.6%, respectively; P = .0481). By day 7, the frequency of vomiting had declined by a median of 2.3 episodes for patients in the lanreotide group and 1.3 episodes for patients in the placebo arm (P = .4510).
On most secondary end points, no significant differences were observed be - tween the groups. The mean number of days without vomiting and the mean change in episodes of nausea from baseline to day 7 were similar, as was the decline in the abdominal pain score. Well-being, which investigators assessed on day 7 using a visual analog scale, was the only secondary end point that significantly favored lanreotide. Patients treated with lanreotide experienced significant im provement in well-being, which declined for patients given placebo.
Mariani said treatment-emergent adverse events were similar in both groups and as expected for patients with inoperable MBO. None of the serious adverse events appeared to be treatment-related.
Robert S. Krouse, MD, a surgery professor at the University of Arizona and staff general and oncologic surgeon at Southern Arizona VA Health Care System in Tuscon, discussed the findings at the session. He observed how challenging it is to treat MBO, which occurs in approximately onequarter of patients with colorectal cancer and half of patients with ovarian cancer. “There is no defined algorithm for the management of these patients,” said Krouse, but he noted that somatostatin analogs are the standard of care, with multiple studies showing some benefit with octreotide (Sandostatin LAR) use. “This study suggests that lanreotide may also have a role in the treatment algorithm for MBO.”
Krouse said medical treatment is often preferred to surgery even for patients with operable MBO because nearly 20% “just get postoperative pain without benefit.” The patients who undergo surgery have higher risks of morbidity and mortality and worse quality of life and up to 50% experience recurrence. Krouse said nearly one-third of patients with MBO benefit from nonsurgical interventions such as nasogastric compression and symptom management