China News Service, Beijing, September 13th (Reporter Li Yanan) A prospective, one-arm observational study evaluating the treatment of Epton in Chinese glioblastoma (GBM) patients with tumor electric field treatment was recently published in the Chinese Medical Doctor Association Brain Gel It was announced at the 4th Annual Meeting of the Professional Committee on Glioma and the 4th China Glioma Academic Conference.
The study published for the first time the efficacy data of tumor electric field therapy applied to the Chinese population in the real world.
Glioblastoma is the most common and aggressive adult brain tumor, with the highest mortality rate except pancreatic cancer.
As the most common malignant tumor of the nervous system, glioblastoma progresses very rapidly and is easy to relapse. The recurrence rate of patients is as high as 100%, and the five-year survival rate is less than 5%. It is considered the most difficult neurosurgical treatment. One of refractory tumors.
In August 2019, Epdun was awarded the "Innovative Medical Device Qualification Certification", becoming the first innovative treatment approved for glioblastoma in mainland China in 15 years.
This real-world study was jointly initiated by Mainland China and Hong Kong, China. It is the first domestic research on electric field therapy for tumors in a Chinese population jointly conducted by the two places.
The study enrolled 44 patients from Mainland China at the Hong Kong Anjian Cancer Treatment Center, including 29 in the newly-onset GBM group and 15 in the recurrent GBM group.
The results of the interim analysis of the study showed that the median progression-free survival of new-onset patients was 6.4 months, and the median overall survival had not yet been reached; the median progression-free survival of relapsed patients reached 4.5 months, and the median overall survival was 8.6 months; In terms of safety, the most common adverse reactions are mild to moderate skin irritation, all of which are grade I-II.
Deputy Director of Beijing Institute of Neurosurgery, founder and founder of the Chinese Glioma Genome Atlas Database, and Professor Jiang Tao from Beijing Tiantan Hospital said: "As the first real-world study of electric field therapy for tumors in the Chinese population, it is currently in the stage. This has proven the safety and effectiveness of Chinese patients using tumor electric field therapy. Compared with traditional therapies, the side effects are mainly concentrated on slight and controllable skin adverse reactions. Therefore, this real-world study can be said to be a Chinese glia master The clinical treatment of cell tumors is injected with a dose of cardiotonic. We will continue to follow up and observe long-term data."
In 2019, the National Medical Products Administration released the China Drug Regulatory Scientific Action Plan, which listed "Methodological Research on the Use of Real-World Data for Clinical Evaluation of Medical Devices" as the first batch of research projects to assist drug and medical device R&D and regulatory decision-making .
Professor Zhang Wei, chief physician of the Department of Neurosurgery of Beijing Tiantan Hospital, said: “In order to provide patients with safer and more effective innovative treatment plans, objectively evaluate the application of treatment plans in actual clinical practice, and support national regulatory decisions in the field of medical devices. After the tumor electric field therapy was launched in Hong Kong, we immediately started to carry out the real-world research on the tumor electric field therapy with the Hong Kong Anjian Cancer Treatment Center. The research started in June last year and is the first to date based on Chinese patients receiving tumors. The research on electric field therapy fills the data gap in Chinese glioblastoma patients using tumor electric field therapy, and provides more evidence-based basis for clinicians when choosing innovative treatment options." (End)