Apatinib showed substantial therapeutic advantages in both extended Progression Free Survival (PFS) and overall survival with a tolerable safety profile in patients with progressive locally advanced or metastatic RAIR-DTC in a new research led by Yansong Lin and colleagues. At the predetermined intermediate analysis, the REALITY study fulfilled its primary end goal of PFS.
The findings of this study was published in the Journal of American Medical Association on 16th December, 2021.
Radioactive iodine–refractory differentiated thyroid cancer (RAIR-DTC) patients have a dismal prognosis and few therapy choices. As a result, the goal of this research was to evaluate the effectiveness and safety of apatinib, a highly selective vascular endothelial growth factor (VEGFR-2) inhibitor, in patients with locally progressed or metastatic RAIR-DTC.
This randomized, double-blind, placebo-controlled phase 3 trial was conducted in 92 patients with progressive locally advanced or metastatic RAIR-DTC at 21 sites in China between February 17, 2017 and March 2, 2020, with the data cutoff date for this analysis being March 25, 2020. Patients were randomized at random (1:1) to receive apatinib, 500 mg/d, or a placebo. Patients who experienced progression while on placebo were permitted to switch to apatinib. for this research The primary endpoint was PFS as determined by the investigator. Overall survival, objective response rate (ORR), disease control rate (DCR), length of response, time to objective response, and safety were secondary end goals. To assess effectiveness, intention-to-treat analyses were used.
The key findings are:
1. The trial comprised 92 patients, 56 of whom were women (60.9%); the mean (SD) age at baseline was 55.7 (10.6) years.
2. Patients were randomly assigned to either the apatinib (n = 46) or placebo (n = 46) groups. The median period of follow-up was 18.1 months (IQR, 12.7-22.2).
3. The median PFS for apatinib was 22.2 months compared to 4.5 months for placebo. The verified ORR in the apatinib group was 54.3%, and the DCR was 95.7%, compared to an ORR of 2.2% and a DCR of 58.7% in the placebo group.
4. The median overall survival for apatinib was not obtained, however it was 29.9 months for placebo.
5. The most prevalent treatment-related side effects in the apatinib group were hypertension (16 [34.8%]), hand-foot syndrome (8 [17.4%]), proteinuria (7 [15.2%]), and diarrhea (7 [15.2%]), none of which occurred in the placebo group.
In conclusion, Apatinib showed substantial therapeutic advantages in terms of both longer PFS and OS with a tolerable safety profile in patients with progressive locally progressed or metastatic RAIR-DTC in this randomized clinical study. For individuals with RAIR-DTC, apatinib should be investigated as a novel therapy option.
Reference:
Lin Y, Qin S, Li Z, et al. Apatinib vs Placebo in Patients With Locally Advanced or Metastatic, Radioactive Iodine–Refractory Differentiated Thyroid Cancer: The REALITY Randomized Clinical Trial. JAMA Oncol. Published online December 16, 2021. doi:10.1001/jamaoncol.2021.6268