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Apatinib vs placebo in patients with locally advanced or metastatic thyroid cancer

JAMA Dec 22, 2021

Lin Y, Qin S, Li Z, et al. - Apatinib, a highly selective vascular endothelial growth factor (VEGFR-2) inhibitor, might serve as a new therapeutic choice for radioactive iodine–refractory differentiated thyroid cancer (RAIR-DTC).

  • This is a phase 3 randomized clinical trial of 92 eligible participants (REALITY trial) for testing apatinib in patients with progressive locally advanced or metastatic RAIR-DTC.

  • Patients were randomized (1:1) to apatinib, 500 mg/d, or placebo.

  • A significant improvement in progression-free survival (PFS) and overall survival was achieved with apatinib vs placebo.

  • In the apatinib group, median PFS, confirmed objective response rate and disease control rate were 22.2 months, 54.3%, and 95.7%, respectively; vs 4.5 months, 2.2%, and 58.7% in the placebo group.

  • Hypertension was documented as the most common grade 3 or higher-level adverse event.

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