Theodore W. Laetsch, MD

Theodore W. Laetsch, MD, an attending physician with the Cancer Center at Children’s hospital of Philadelphia discusses what was evaluated in various trials examining larotrectinib (Vitrakvi) in patients with TRK fusion positive thyroid cancer.

While larotrectinib has demonstrated efficacy in both adults and children with TRK-fusion cancers, questions regarding whether an increase in fractures are associated with the agent remain.

To examine whether or not larotrectinib changed the risk of fractures in this patient population, data from 3 trials, the adult phase 1 trial (NCT02122913) of larotrectinib with general patients, with or without the presence of a TRK fusion, the pediatric SCOUT study (NCT02637687), and the adult and adolescent phase 2 NAVIGATE (NCT02576431) trial, were observed.

Results concluded the rate of fractures from these 3 studies to be around 7% of patients, ultimately not demonstrating any evidence for larotrectinib to increase the risk.

 We evaluated the rate of fractures in patients treated on those 3 clinical trials and found that the rate of fractures was really quite low, approximately 7% for the entire cohort of patients, which is in keeping with the expectations for patients with advanced cancer enrolled on such trials, and not clearly showing any evidence that the rate of fractures is increased with larotrectinib treatment.

I think it's important to highlight that we are continuing to gather additional safety data, that these trials are ongoing. And especially in children that are growing, it's important to continue to gather this data, but certainly we were happy to see these results.

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Theodore W. Laetsch, MD, discusses various trials examining larotrectinib in patients with TRK fusion positive thyroid cancer.


Theodore W. Laetsch, MD | Authors

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Larotrectinib Does Not Increase Risk of Fractures for Thyroid Cancer