Gefitinib blocks the signaling through the EGFR and is only effective in cancers with mutated and overactive EGFR. It was initially approved by the FDA in 2003 as a third-line therapy for patients with advanced NSCLC, but it is now approved as initial therapy for advanced NSCLC with an EGFR mutation.
Key Findings
The median time to recurrence (disease-free survival) was 28.7 months for patients who received gefinitib and 18 months for those who received chemotherapy. There were 76 patient deaths (34.2% of all enrollees) during the trial period; 41 occurred in the gefinitib group and 35 in the chemotherapy group.
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Far fewer patients experienced severe side effects with gefitinib (12%) than with chemotherapy (48%). The most common serious side effect in the gefitinib group was elevated liver enzymes, whereas patients in the chemotherapy group had more severe quality of life concerns, including vomiting, nausea, low blood counts, and anemia.
Next Steps
As the researchers have a tissue repository from the surgically removed lung tumors, they plan to perform a comprehensive biomarker analysis looking for other potential biomarkers for gefitinib response or resistance, in addition to EGFR. Dr. Wu stated that a fuller analysis of treatment outcomes is also planned.
This study received funding from Chinese Thoracic Oncology Group (CTONG) and AstraZeneca China.
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