【CSCO 2022 Preview】Focusing on patients with RAIR-DTC, Professor Lin Yansong of Peking Union will report the phase III results of donafenib

In recent years, the incidence of thyroid cancer has continued to rise, differentiated thyroid cancer (DTC) is the most common type of thyroid cancer, DTC patients after standardized surgical treatment, selective iodine-131 treatment and thyroid-stimulating hormone (TSH) inhibition first-line standard treatment has a good
prognosis.
However, it is regrettable that after standard treatment, more than 60% of DTC patients will gradually lose iodine intake function, show an iodine-refractory state, and eventually develop into iodine-refractory DTC (RAIR-DTC), and the survival time of such patients is greatly shortened, with a five-year survival rate of less than 20%.

Targeted therapy has opened a new chapter in the treatment of RAIR-DTC, and targeted drugs represented by multi-target TKI drugs can significantly improve the progression-free survival (PFS) of patients with RAIR-DTC, but the problem of toxic side effects of drugs cannot be ignored
.
With the continuous progress of drug research and development, more and more high-efficiency and low-toxicity targeted drugs have been approved for marketing, which provides clinicians with the possibility to optimize the
treatment of thyroid cancer.
Donafenib achieves dose optimization through deuteration technology, which effectively improves the safety of multi-target TKI drugs on the basis of ensuring efficacy, and reduces the incidence of suspension/reduction/termination caused by AE, which is of great significance
for patients to adhere to long-term medication.

On August 12, 2022, according to the official website of China's National Medical Products Administration (NMPA), donafenib tosylate tablets (donafenib) developed by Zejing Pharmaceutical were officially approved for the treatment of patients
with progressive, locally advanced or metastatic radioactive iodine-refractory differentiated thyroid cancer (RAIR-DTC).
。 It is reported that the key study approved for the new indication of donafenib is a multi-center, randomized, double-blind, placebo-controlled phase III clinical trial (DIRECTION study), and the results of the study were reviewed by the Independent Data Monitoring Committee (IDMC) and determined that its efficacy and safety results met expectations
.
In September 2022, Donafeni brought the results of DIRECTION to the 2022 ESMO Conference and was selected for this year's ESMO Preferred Paper Presentation, making China's voice on the international stage
.

The DIRECTION study is led by Professor Lin Yansong of Peking Union Medical College Hospital of the Chinese Academy of Medical Sciences, and at the upcoming 25th National Congress of Clinical Oncology and the 2022 CSCO Annual Conference, Professor Lin Yansong will make a keynote speech at the conference keynote speech, entitled "Multicenter, randomized, double-blind, placebo-controlled phase III clinical study and subgroup analysis results of donafenib tablets in the treatment of locally advanced/metastatic radioactive iodine-refractory differentiated thyroid cancer (DIRECTION)", At that time, Professor Lin will bring us a detailed interpretation of this major progress, please pay attention to
it from all walks of life.

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