(Thyroid Cancer) Is Apatinib Effective?

On December 16, 2021, Yansong Lin et al. of Peking Union Medical College Hospital published in the medical journal JAMA Oncology the efficacy and safety results of Apatinib in the REALITY Phase 3 clinical trial for patients with locally advanced or differentiated thyroid cancer resistant to radioiodine therapy.

This Phase 3 clinical trial was a double-blind, randomized controlled trial enrolling locally advanced or differentiated thyroid cancer patients resistant to radioiodine therapy (N=92), divided into the Apatinib group (once daily, 500 mg, N=46) and the placebo group (N=46). The primary endpoint was progression-free survival, and secondary endpoints included overall survival, objective response rate, duration of response, disease control rate, and safety.

In this trial, the median patient age was 55.7 years, with females comprising 60.9% (N=56). Results at a median follow-up of 18.1 months were as follows.

The median primary endpoint progression-free survival was: Apatinib group 22.2 months / placebo group 4.5 months. The Apatinib group showed a significant 74% improvement in risk of death (progression-free survival) compared to the placebo group.

Secondary endpoint objective response rates were: Apatinib group 54.3% / placebo group 2.2%. Disease control rates were: Apatinib group 95.7% / placebo group 58.7%.

Median overall survival was: Apatinib group not reached / placebo group 29.9 months. The Apatinib group showed a 58% reduction in risk of death (overall survival) compared to the placebo group.

Regarding safety, Grade 3 or higher adverse events in the Apatinib group included hypertension 34.8% (N=16), hand-foot syndrome 17.4% (N=8), proteinuria 15.2% (N=7), and diarrhea 15.2% (N=7).

Based on the REALITY trial results, Yansong Lin et al. concluded that in locally advanced or differentiated thyroid cancer patients resistant to radioiodine therapy, Apatinib monotherapy showed significant improvement in progression-free survival compared to placebo, with overall survival also improved and adverse events manageable.

Source: https://jamanetwork.com/journals/jamaoncology/fullarticle/2786815

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