Lanreotide shows promise in patients with pancreatic neuroendocrine tumors

Lanreotide demonstrated antitumor activity with a manageable safety profile in patients with pancreatic neuroendocrine tumors, according to a subgroup analysis of the CLARINET study presented at the Gastrointestinal Cancers Symposium.

The randomized, double blind CLARINET study included patients with metastatic grade 1 or grade 2 (Ki-67 <10%) non-functioning enteropancreatic neuroendocrine tumors. Patients underwent first-line treatment with 120 mg lanreotide (Somatuline Depot, Ipsen), a somatostatin analog, or placebo every 4 weeks for 96 weeks. Lanreotide was administered by deep subcutaneous injection.

Alexandria T. Phan

Previously released results showed lanreotide significantly prolonged PFS (HR for death=0.47; 95% CI, 0.3-0.73).

In the current analysis, Alexandria T. Phan, MD, an oncologist at Houston Methodist Hospital, and colleagues attempted to better characterize treatment effects in the subgroup of 91 patients with pancreatic neuroendocrine tumors. In this subgroup, 42 patients received lanreotide and 49 received placebo.

The mean age of the patients was 64 years in both arms. Overall, 37% had hepatic tumor loads >25%, and 95% had stable disease. Thirty-eight percent of patients had undergone prior surgery on their tumor, and 77% had received no prior treatment.

At the conclusion of treatment, median PFS was not reached in the lanreotide arm vs. 12.1 months (95% CI, 9.4-18.3) in the placebo arm (HR for progression/death=0.58; 95% CI, 0.32-1.04). In the first planned analysis in an open-label extension study, median PFS in the lanreotide arm was 29.7 months (95% CI, 12-32.4).

Researchers reported 88% of patients in each arm experienced adverse events. The most common adverse event was diarrhea, which occurred in 43% of patients in the lanreotide arm and 37% of patients in the placebo arm.

Treatment-related adverse events occurred in 55% of patients assigned lanreotide and 24% of those assigned placebo. Serious adverse events occurred in 29% of patients assigned lanreotide and 43% of those assigned placebo. Three patients — two assigned lanreotide and one assigned placebo — experienced treatment-related serious adverse events.

Two patients in each treatment group withdrew due to adverse events.

“The evidence in [this subgroup] suggesting antitumor effects with lanreotide, together with the favorable long-term safety profile, support a positive benefit–risk profile for lanreotide as a first-line treatment for pancreatic neuroendocrine tumors,” Phan and colleagues wrote.

For more information:

Phan AT. Abstract #233. Presented at: 2015 Gastrointestinal Cancers Symposium; Jan. 15-17, 2015; San Francisco.

Disclosure: The researchers report research funding from, consultant/advisory roles with, honoraria from, speakers’ bureau roles with and employment relationships with Bayer, Celgene, Ipsen, Keocyt, Lexicon, Novartis, Pfizer and Roche.