Long-Acting Somatostatin Analogue Safety Monitoring Protocol for Outpatients With Neuroendocrine Tumors.

Somatostatin analogues (SSAs) are widely used in the long-term treatment of neuroendocrine tumors (NETs) and have a relatively favorable safety profile. However, SSAs are associated with specific side effects that are important to monitor. Currently, there is no standardized safety monitoring protocol for health-care professionals to use as a reference when initiating patients on long-acting SSAs. With the expansion of SSA use from symptomatic control to include antiproliferative tumor treatment in patients with NETs, it is increasingly important that patients taking these medications are properly monitored. The purpose of this analysis was to develop a comprehensive, practical SSA safety monitoring protocol for patients with NETs in the outpatient setting. This strategy was based on side effect frequencies that were reported and the monitoring parameters used in influential clinical and safety trials. Based on our assessment, we consider monitoring gallbladder imaging, laboratory tests (including blood chemistry, thyroid-stimulating hormone, hemoglobin A1c, and stool studies), vital signs, and physical examinations as the most important parameters when evaluating the safety of long-term SSA therapy. Due to the frequency at which patients experienced diarrhea as a side effect in clinical trials, questions about urgency, frequency, timing, consistency, odor, and color of bowel movements should be asked as part of the follow-up visits every 6 months to help differentiate between drug-induced vs. disease-associated causes. This broad monitoring strategy for patients receiving long-term SSAs was developed specifically for patients with NETs; however, the use of this protocol could be expanded to other indications in the future.