A new targeted drug, oxytinib (AZD929 1), was listed in the United States as early as 20 15438+0 1, also known as the third-generation targeted therapeutic drug. It is found that this drug can effectively overcome the drug resistance of the first generation of targeted drugs (Iressa, Trocquer, etc.). ) and has a good effect on patients with brain metastasis.
It is precisely because of the excellent therapeutic effect of oxytinib after the failure of the first generation of targeted drugs that it is an urgent problem to directly apply oxytinib to mutant patients to study whether it can achieve better curative effect and prolong the total survival time of patients. In this context, a large-scale phase III clinical trial, FLAURA, came into being.
How is the FLAURA study done?
FLAURA is a phase III, double-blind, randomized controlled and global multicenter study. * * * 556 patients from 29 countries were recruited, 279 patients received oxitinib treatment and 277 patients received so-called standard treatment (gefitinib or erlotinib treatment). For humanitarian reasons, patients with drug-resistant EGFR T790M mutation after the first generation of targeted drugs can enter the oxitinib group for further treatment. The results showed that oxitinib not only prolonged the time to control tumor growth, but also prolonged the overall survival of patients, making it the first drug to prolong the survival of patients with advanced mutation for more than 3 years. The results were published twice in the famous New England Journal of Medicine.
First, first-line use of oxitinib has an excellent effect on overall survival (OS) and progression-free survival (PFS)!
Esmo flora research published the results of progression-free survival (PFS) in 20 17. The median PFS of the oxitinib group and the control group were 65438 08.9 months and 65438 00.2 months, respectively (HR = 0.46；; P < 0.0001). In the same year, NCCN guidelines recommended oxitinib as the first-line treatment for advanced EGFR mutation non-small cell lung cancer.
Therefore, if the patient has EGFR mutation and the first-generation targeted drugs are used in the first line, the tumor may progress in about 10 months. At this time, it is necessary to detect the mechanism of drug resistance and then change the treatment plan. However, if oxytinib is directly used as the first-line treatment, the time of tumor progression can be delayed by nearly 9 months or even more than one year!
In addition, the overall survival (OS) of the FLAURA study was published in 20 19ESMO. The median OS of the oxitinib group and the control group were 38.6m and 365,438 0.8m, respectively (HR = 0.8, p=0.046). That is to say, the total survival time of patients with advanced EGFR mutation treated with oxitinib is nearly 40 months, and the median survival time of patients with advanced EGFR mutation treated with single drug is more than 3 years, which further establishes the position of oxitinib in first-line treatment.
Second, it has the strongest ability to enter the brain and is the first choice for patients with brain metastasis of EGFR.
The FLAURA study subgroup analyzed patients with brain metastases. Compared with the standard first-generation targeted drug therapy group, oxitinib reduced the risk of brain metastasis by 53% and increased the survival time of patients with brain metastasis without brain progress. The study also found that the number of patients with new brain metastasis in the oxitinib group was significantly lower than that in the standard treatment group, suggesting that oxitinib can effectively reduce the risk of brain metastasis in patients during treatment, and can play a role in preventing metastasis as soon as possible. First choice is oxitinib.
Third, the incidence of adverse reactions is the lowest, and the quality of life of patients has been significantly improved.
Oxitinib selectively inhibits mutation active sites, including EGFR mutation L858R, exon 19 deletion mutation and EGFR T790M mutation, but it has low affinity for normal physiological EGFR, so the incidence of side effects including rash and diarrhea is low, which can relieve the pain of patients with weak health and greatly improve the quality of life of patients.
4. All guidelines unanimously recommend oxitinib as the first-line treatment for EGFR mutation positive non-small cell lung cancer.
At present, the first-line treatment of oxitinib has been approved in more than 70 countries and regions such as the United States, the European Union and Japan, and it has been listed as the first-line treatment drug for advanced EGFR mutation non-small cell lung cancer by the guidelines of the National Comprehensive Cancer Network (NCCN), the European Society of Oncology (ESMO), the Pan-Asian Lung Cancer Guidelines and the Japanese Lung Cancer Guidelines.
Fortunately, on August 30th, 20th19th, China Pharmaceutical Products Supervision and Administration (NMPA) officially approved the use of oxitinib as the first-line treatment for EGFR mutation positive non-small cell lung cancer! Lung cancer patients have one more choice of first-line medication, which may mean better quality of life and longer survival time for some patients!
I believe that oxytinib can give us more time and benefit more patients!