Late Toxicities Burden in Patients with RAI-resistant Differentiate Thyroid Cancer (DTC) on Therapy with Lenvatinib

  • Background: Lenvatinib is approved for patients with RAI-resistant DTC. Whether the rate and the timing of acute toxicities is very well known, the definition and the burden of late toxicities have to be clarified yet.

    Methods: We reviewed data from January 2015 to December 2018 on RAI-resistant DTC patients. Median duration of lenvatinib from SELECT trial was 13.8 months and accordingly we selected as late toxicities only those appeared after at least one year of lenvatinib treatment. AEs were described according to CTCAE 4.0.

    Results: 72 RAI-resistant DTC patients on TKIs were evaluated and, among them, 25 were treated with lenvatinib. Female/Male 17/8, with a median age of 65 years (43-84). The median time of treatment duration was 12 months (12-44). The median time to develop any AEs was 1 month. The most common were G2 hypertension in 13/25 patients (52%) with G3 in 7/13; G1 diarrhea in 7/25 patients (28%) with G2 in 4/7 patients and G2 fatigue in 4/25 patients (16%). After 12 months of treatment, all patients had at least one dose reduction. New and late hypertension occurred in 7/25 pts, cardiovascular toxicities in 6/25 (QTc prolongation 2/5, q-wave 1/5), proteinuria in 3/25 and fatigue in 2/25. All toxicities were G2. Prolonged diarrhea G1 was observed in 7/25 patients.

    Conclusions: The late toxicities burden of patients on lenvatinib was 72%. Cardiovascular (52%) and proteinuria (12%) were the most common late toxicities. A continuing active monitoring of side effects is mandatory even after prolonged lenvatinib exposure.


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