On December 16, 2021, “Apatinib vs Placebo in Patients with Locally Advanced or Metastatic, Radioactive Iodine-Refractory Differentiated Thyroid Cancer”, the phase III multi-center, randomized, double-blind, placebo-controlled phase III clinical study (REALITY) conducted by 20-plus hospitals in China under the leadership of Professor Lin Yansong from PUMCH and Professor Qin Shukui from Jinling Hospital, Medical School of Nanjing University, was published in full on the internationally prestigious “JAMA Oncology” (IF=31.777).

To seek accessible and effective drugs and treatment strategies for patients, Professor Lin Yansong’s team took the lead in conducting researches on the treatment of radioactive iodine-refractory differentiated thyroid cancer (RAIR-DTC). In 2013, the team revealed the characteristics of high expression of integrin receptors and abundant blood supply in RAIR-DTC lesions. In 2016, the team initiated a phase II clinical study of apatinib in the treatment of RAIR-DTC. The results of the study showed that the median progression-free survival of patients in the apatinib group exceeded 18 months with the objective response rate and disease control rate reaching 80% and 95% respectively; the research results were presented in the 2019 Annual Meeting of the American Thyroid Association and published in a Q1 journal of the industry, receiving widespread attention from peers.

In 2018, the team launched the REALITY study, a phase III clinical study of apatinib in the treatment of RAIR-DTC. The 500 mg dose with less side effects and equivalent efficacy was used as the experimental group dose, and strict eligibility criteria were adopted. With the unremitting efforts of 21 research centers across China, the REALITY study lasted 3 years and enrolled 92 patients. The results of the study showed that the median progression-free survival of the experimental group (apatinib group) and the placebo group in the phase III study were 22.2 months and 4 months respectively; the median overall survival was not reached and 30 months respectively; the objective response rates were 54.3% and 2.2%, and the disease control rates were 95.7% and 58.7% respectively; Apatinib can reduce the risk of death by 58%, and the dosage is overall safe and tolerated in patients. Therefore, apatinib is recommended as a new standard of care for RAIR-DTC patients. Based on the excellent research results, the Chinese Society of Clinical Oncology (CSCO) Differentiated Thyroid Cancer Diagnosis and Treatment Guidelines 2021 recommends apatinib for patients with locally advanced/ metastatic RAIR-DTC.

The PUMCH-led REALITY research was published on the internationally prestigious journal “JAMA Oncology”

Journalist: Hong Chengwei

Picture: The Lin Yansong team

Translator: Liu Haiyan

Editor: Pan Qingqing and Wang Yao