Recently, a randomized trial (EURTAC study) comparing the efficacy of erlotinib with chemotherapy in Europe showed that erlotinib, the first-line drug, can activate epidermal growth factor receptor (EGFR) compared with chemotherapy. Patients with advanced non-small cell lung cancer (NSCLC) nearly double their non-deteriorating survival time. This study was the first phase III study of erlotinib in such patients.
Erlotinib has been shown to be an ideally effective drug for the sequential maintenance therapy of advanced lung cancer following first-line platinum-induced chemotherapy. The European Agency for Drug Control (EMA) and the U.S. Food and Drug Administration (FDA) both approve their use in patients with advanced or metastatic NSCLC (with or without EGFR mutations) for immediate use after the first (first-line) chemotherapy to ensure disease Controllable (maintenance therapy) can also be used in patients who have undergone treatment failure after a previous chemotherapy regimen (second- or third-line) has progressed.
The incidence of EGFR-positive mutations in NSCLC is usually 10% in lung cancer patients in Western countries, and about 30% in lung cancer patients in Asia.
The EURTAC study was designed and bided by the Spanish Lung Cancer Group (SLCG) and conducted with researchers from France or Italy. In this study, from February 2007 to January 2011, a total of 1275 patients were screened for the presence or absence of EGFR activating mutations, and 174 patients with EGFR-activated NSCLC were randomized to erlotinib or platinum-based chemotherapy. The primary endpoint of the study was the disease-free progression of life (PFS) assessed by the investigator, and the secondary end points included response rates, overall survival (OS), and safety characteristics.
The results of the study showed that patients with EGFR-activated NSCLC treated with erlotinib as the initial treatment drug nearly doubled their non-proliferative survival time compared with those receiving platinum-based chemotherapy (median progression-free survival or PFS: 9.7 months vs. 5.2 months), the risk of lung cancer progression was reduced by 63% (hazard ratio = 0.37, p < 0.0001; a hazard ratio less than 1 means a reduced risk of progression, and a p-value less than 0.05 means statistically significant ). The safety of erlotinib is similar to that of previous NSCLC studies.
Hal Barron M, Chief Medical Officer, Roche Global Product Development. D. Said: "There are now two studies showing that erlotinib, as a first-line treatment for advanced lung cancer with EGFR mutation positive, can prolong the patient's progression-free survival compared with standard chemotherapy, which provides individualized treatment for patients with advanced lung cancer. The basis."
Accordingly, Roche has filed an application with EMA requesting the expansion of erlotinib's indications in the European Union, including first-line treatment of NSCLC patients with advanced EGFR-activating mutations. Currently, the FDA is also discussing a proposal that includes the use of comparative diagnostic tests to help identify patients with EGFR activation mutations that are suitable for erlotinib.
Erlotinib has been shown to be an ideally effective drug for the sequential maintenance therapy of advanced lung cancer following first-line platinum-induced chemotherapy. The European Agency for Drug Control (EMA) and the U.S. Food and Drug Administration (FDA) both approve their use in patients with advanced or metastatic NSCLC (with or without EGFR mutations) for immediate use after the first (first-line) chemotherapy to ensure disease Controllable (maintenance therapy) can also be used in patients who have undergone treatment failure after a previous chemotherapy regimen (second- or third-line) has progressed.
The incidence of EGFR-positive mutations in NSCLC is usually 10% in lung cancer patients in Western countries, and about 30% in lung cancer patients in Asia.
The EURTAC study was designed and bided by the Spanish Lung Cancer Group (SLCG) and conducted with researchers from France or Italy. In this study, from February 2007 to January 2011, a total of 1275 patients were screened for the presence or absence of EGFR activating mutations, and 174 patients with EGFR-activated NSCLC were randomized to erlotinib or platinum-based chemotherapy. The primary endpoint of the study was the disease-free progression of life (PFS) assessed by the investigator, and the secondary end points included response rates, overall survival (OS), and safety characteristics.
The results of the study showed that patients with EGFR-activated NSCLC treated with erlotinib as the initial treatment drug nearly doubled their non-proliferative survival time compared with those receiving platinum-based chemotherapy (median progression-free survival or PFS: 9.7 months vs. 5.2 months), the risk of lung cancer progression was reduced by 63% (hazard ratio = 0.37, p < 0.0001; a hazard ratio less than 1 means a reduced risk of progression, and a p-value less than 0.05 means statistically significant ). The safety of erlotinib is similar to that of previous NSCLC studies.
Hal Barron M, Chief Medical Officer, Roche Global Product Development. D. Said: "There are now two studies showing that erlotinib, as a first-line treatment for advanced lung cancer with EGFR mutation positive, can prolong the patient's progression-free survival compared with standard chemotherapy, which provides individualized treatment for patients with advanced lung cancer. The basis."
Accordingly, Roche has filed an application with EMA requesting the expansion of erlotinib's indications in the European Union, including first-line treatment of NSCLC patients with advanced EGFR-activating mutations. Currently, the FDA is also discussing a proposal that includes the use of comparative diagnostic tests to help identify patients with EGFR activation mutations that are suitable for erlotinib.
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