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[Efficacy of gefitinib on advanced non-small cell lung cancer in expanded access program (EAP)]
1State Key Laboratory of Oncology in South China, Guangzhou, Guangdong, 510060, P. R. China.
Background & Objective:
Gefitinib is a selective inhibitor of epidermal growth factor receptor (EGFR) tyrosine kinase, and has been used in treating advanced non-small cell lung cancer (NSCLC). This study was to evaluate the efficacy of Gefitinib on advanced NSCLC, and observe adverse events.
Methods:
An open labeled, expanded access program (EAP) was conducted. Pathologically confirmed advanced NSCLC patients who had progressed after systemic chemotherapy or was not suitable for systemic chemotherapy were eligible for this program. Gefitinib (250 mg) was orally administered daily till disease progression or intolerable adverse events developed.
Results:
From Sep. 2002 to Mar. 2005, 120 patients were enrolled, and 103 of them were assessable for response. The objective response rate was 18.4% (19/103). The disease control rate was 51.5% (53/103). The median survival time was 6 months (0.5-33 months). Adverse events were generally mild (grade I or II), including skin rash (30.1%), dry skin (12.6%), and diarrhea (25.2%). Two (1.9%) patients developed grade III elevation of serum glutamate pyruvate transaminase (SGPT). No grade IV adverse event occurred.
Conclusion:
Gefitinib is effective in treating advanced NSCLC, and the adverse events are mild.
Insights
Gefitinib effectively treats advanced non-small cell lung cancer (NSCLC) with mild side effects. This study found an 18.4% objective response rate and manageable adverse events in NSCLC patients.
Area of Science:
- Oncology
- Pharmacology
- Medical Research
Background:
- Gefitinib is a targeted therapy inhibiting epidermal growth factor receptor (EGFR) tyrosine kinase.
- It is utilized in advanced non-small cell lung cancer (NSCLC) treatment.
- Previous treatments may include systemic chemotherapy.
Purpose of the Study:
- To assess the efficacy of Gefitinib in advanced NSCLC patients.
- To monitor and document adverse events associated with Gefitinib treatment.
Main Methods:
- An open-label, expanded access program (EAP) was implemented.
- Eligible patients had pathologically confirmed advanced NSCLC, with progression post-chemotherapy or unsuitability for it.
- Gefitinib was administered orally at 250 mg daily until disease progression or adverse events.
Main Results:
- 120 patients were enrolled; 103 were assessable for response.
- Objective response rate was 18.4% (19/103), with a disease control rate of 51.5% (53/103).
- Median survival time was 6 months; common adverse events included rash (30.1%) and diarrhea (25.2%), mostly mild (Grade I/II).
Conclusions:
- Gefitinib demonstrates efficacy in treating advanced NSCLC.
- The observed adverse events were generally mild and manageable.
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