China News Service, Beijing, June 5 (Reporter Li Chun) Shen Lin, deputy dean of Peking University Cancer Hospital, director of the Department of Digestive Oncology, and deputy director of the Beijing Institute of Cancer Prevention and Treatment, said in a media interview in Beijing on the 5th that once The third-line drug treatment fails, and no other drugs are available for the treatment of gastrointestinal stromal tumors, and the listing of fourth-line drugs makes up for this gap.

　　Gastrointestinal stromal tumor (GIST) is a malignant tumor of the digestive tract with an incidence rate second only to gastric cancer and colorectal cancer. It can occur in people of all ages, with an incidence rate of about 10-15 per million, but under 20 years old Of patients are very rare, clinically more common in 50 to 70 years old, mainly middle-aged and elderly patients.

There are approximately 20,000 to 30,000 newly diagnosed patients in my country each year, in addition to an estimated more than 100,000 patients with gastrointestinal stromal tumors undergoing treatment.

　　Gastrointestinal stromal tumors can grow in any part of the digestive tract (including the esophagus, stomach, small intestine, large intestine, rectum, etc.). They mainly occur in the stomach and small intestine. The stomach accounts for 50% to 60% and the small intestine accounts for 20% to 30%. .

Tumors can exist singly or multiple at the same time.

Under normal circumstances, gastrointestinal stromal tumors have no specific clinical manifestations, and early patients are even asymptomatic.

Gastrointestinal bleeding is the most common symptom of gastrointestinal stromal tumors.

In addition, symptoms such as swallowing discomfort, dysphagia, abdominal pain, masses, and gastrointestinal obstruction are also common.

Ascites may occur when gastrointestinal stromal tumors spread to the abdominal cavity, and malignant gastrointestinal stromal tumors may also have symptoms such as weight loss and fever.

　　Shen Lin said that gastrointestinal stromal tumor is a relatively rare disease, and there are almost no symptoms in the early stage, and some symptoms only appear when it grows in a very critical part.

Early patients with gastrointestinal stromal tumors are found through physical examination, and early diagnosis and treatment are the key.

On June 5th, Hu Ningning, vice chairman of the China Primary Health Care Foundation, accepted a mass media interview in Beijing.

Li Chunshe

　　The course of gastrointestinal stromal tumors can be as short as several days and as long as 20 years. Malignant gastrointestinal stromal tumors have a shorter course, mostly within a few months.

The specific pathogenesis of gastrointestinal stromal tumors is not yet clear. About 85% of gastrointestinal stromal tumors have tyrosine kinase receptor gene mutations, and effective pre-administration has not yet been achieved.

　　The current treatment process of gastrointestinal stromal tumors faces many challenges, and malignant gastrointestinal stromal tumors are also considered to be one of the most difficult to treat tumors.

Surgery is the only possible cure for early gastrointestinal stromal tumors.

However, for high-risk patients, more than half of the patients have recurrence or metastasis after surgery, and the recurring tumors grow rapidly and are not sensitive to radiotherapy and chemotherapy.

Although patients can undergo two or repeated operations, it is difficult to improve the survival rate.

　　Although the combined treatment of surgery combined with targeted therapy has significantly improved the prognosis of patients with gastrointestinal stromal tumors, when the first, second, and third-line treatments that have been approved so far have drug resistance, patients with gastrointestinal stromal tumors lack effective treatment Way, facing the dilemma of no medicine available.

Therefore, there is an urgent need for new late-line drugs to effectively treat patients with this disease, further extend the patient's survival period and improve the quality of life.

　　"This tumor is not the same as other tumors. Once it gets out of control, it grows very fast." Shen Lin said that before March this year, there were only one, two and three line treatments, which means that there were only three types of drugs.

After the third-line medication fails, no other medications are available.

"Four-line therapy fills up such a vacancy."

　　On March 31, 2021, the National Medical Products Administration approved a new drug application for repetinib for the treatment of adult patients with advanced gastrointestinal stromal tumors who have received 3 or more kinase inhibitors.

As the first four-line treatment drug for gastrointestinal stromal tumors approved for marketing in Mainland China, this drug fills the gap in the treatment of this disease in China.

　　Gastrointestinal stromal tumor patients will produce huge medical data during long-term treatment, but the data is scattered and heterogeneous, and there are some problems with the completeness and accuracy of the data, which leads to the failure to make full and effective use of the real world in clinical practice. data.

　　On June 5th, the Ruixiang RWD database project, initiated by the China Primary Health Care Foundation and supported by Zai Lab, was officially launched.

The project will collect data from patients with gastrointestinal stromal tumors using repetinib in the real world to establish a drug data database, so that later clinicians can use the database to analyze the efficacy and safety of the drug in the Chinese patient population. Data to provide more evidence-based medical evidence for clinical rational scientific applications.

　　"In fact, we have accumulated a lot of data, but these data lie in the database. They are not excavated and not used for clinical research. In fact, its value and significance are not very great." Vice President of China Primary Health Care Foundation Hu Ningning said that the purpose of carrying out this project is to provide some guarantee for clinical evidence-based medicine and first-line clinical research by experts, and "the significance is still extraordinary."

　　Hu Ningning also said that in order to ensure that the data collected by the project can be used in a reasonable and scientific manner, the Preliminary Insurance Foundation will cooperate with well-known gastrointestinal stromal tumor experts in the country, and a data management committee will be established by multiple experts.

After the database is established, the clinician can submit data analysis requirements to the Preliminary Insurance Foundation. After the data management committee reviews that the requirements are scientific and reasonable, the Preliminary Insurance Foundation will open the data analysis authority for the clinician and perform relevant data analysis. Analysis and research.

　　In addition, by participating in the project, patients can also establish their own medical record files. While consulting their medical records at any time, they can also receive consultations from well-known clinical experts across the country for free. "It has certain value for experts, patients, and clinical research in the future." Hu Ningning said. (Finish)