Dr. Wolin on the Safety of Lutathera in Advanced NETs

Edward Wolin, MD, senior faculty, hematologist-oncologist, and director of the Center for Carcinoid and Neuroendocrine Tumors at Mount Sinai, discusses the safety profile of Lutathera (lutetium Lu 177 dotatate) in patients with advanced neuroendocrine tumors (NETs).

In the US Expanded Access Program trial, investigators assessed the long-term toxicity of Lutathera in patients with advanced, somatostatin receptor–positive NETs. The trial had an average follow-up of 130.8 days at the time of data analysis presented during the 2020 NANETs Virtual Symposium.

Results showed that the most commonly reported toxicities with the agent were mild, says Wolin. Severe toxicities of grade 3 or 4 were extremely uncommon, with few patients experiencing life-threatening toxicities. The most common grade 1 or 2 toxicities included nausea, which occurred in 93% of patients, and vomiting, which was reported in 41% patients. However, in almost all cases, these toxicities were not caused by the the study drug; rather, they were linked with the amino acids that were used to protect patients' kidneys, according to Wolin.

At one point on the trial, many patients switched from the initial amino acid regimen to a new amnio acid regimen, which was found to protect the kidneys equally well without nausea, adds Wolin. The other toxicities that were reported included fatigue, in 28% of patients, and thrombocytopenia, in 18% of patients. Only 1% of patients experienced severe treatment-related toxicities. It was very rare for patients to experience carcinoid crisis (0.3%) or severe vomiting that lead to dehydration (0.3%), concludes Wolin.