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Frontline gefitinib in advanced non-small cell lung cancer: Meta-analysis of published randomized trials
1Oncology Center of Excellence, International Medical Center, Jeddah, Saudi Arabia. ezzibrahim@imc.med.sa
Objective:
Gefitinib, a small molecule tyrosine kinase inhibitor, showed a substantial effect as a salvage treatment for patients with advanced non-small cell lung cancer (NSCLC) who had failed prior chemotherapy. Subsequent phase III trials in previously untreated patients have failed to demonstrate such benefit. It was later reported that gefitinib had a positive outcome when used in selected population.
Rational:
The inconsistent results and the lack published meta-analysis that systematically examined the overall efficacy of gefitinib in the frontline setting in such patients, have prompted the current meta-analysis.
Methods:
We selected for analysis only those randomized, peer-reviewed clinical studies where the efficacy of gefitinib-based therapy (GBT) was investigated in chemotherapy naïve patients with locally advanced or metastatic NSCLC. We also included studies where patients were randomized between gefitinib vs. placebo or none after initial chemoradiation or chemotherapy induction offered to all included patients.
Results:
We identified seven eligible studies involving 2,646 and 1,939 patients randomized to GBT and to control arms, respectively. In mostly unselected population, GBT was not associated with higher objective response rate (ORR), progression-free survival (PFS) (hazard ratio [HR] = 0.97, 95% CI: 0.78-1.20, P = 0.78), or overall survival (OS) (HR = 1.04, 95% CI: 0.95-1.13, P = 0.45) as compared with control interventions. In a fraction of patients with known EGFR mutation status, GBT showed significantly higher ORR among patients with mutant EGFR (odds ratio [OR] = 2.81, 95% CI: 1.71-4.62, P < 0.0001); however, EGFR mutation was not associated with better PFS or OS with GBT. Nevertheless, patients receiving GBT experienced significant improvement in quality of life as compared with those in the control arms.
Conclusion:
We conclude that GBT cannot be recommended for frontline management of patients with advanced NSCLC in unselected patient population.
Insights
Gefitinib-based therapy (GBT) showed no survival benefit for advanced non-small cell lung cancer (NSCLC) patients in frontline treatment. While effective in EGFR-mutated patients, GBT is not recommended for unselected NSCLC populations.
Area of Science:
- Oncology
- Pharmacology
Background:
- Gefitinib, a tyrosine kinase inhibitor, showed promise in salvage therapy for advanced non-small cell lung cancer (NSCLC) but failed in previously untreated patients.
- Inconsistent results and lack of meta-analyses prompted an investigation into gefitinib's efficacy in the frontline setting.
Purpose of the Study:
- To systematically evaluate the efficacy of gefitinib-based therapy (GBT) in chemotherapy-naive patients with advanced non-small cell lung cancer (NSCLC).
- To analyze GBT's impact on objective response rate (ORR), progression-free survival (PFS), and overall survival (OS) in an unselected NSCLC population.
Main Methods:
- A meta-analysis of randomized, peer-reviewed clinical studies investigating GBT in chemotherapy-naive advanced or metastatic NSCLC patients.
- Included studies compared GBT versus placebo or no intervention after initial chemoradiation or chemotherapy.
Main Results:
- Seven studies with 2,646 patients on GBT and 1,939 on control were analyzed.
- GBT did not improve ORR, PFS, or OS in the overall unselected NSCLC population.
- In a subset with known EGFR mutation status, GBT significantly increased ORR (OR = 2.81), but not PFS or OS.
Conclusions:
- Gefitinib-based therapy (GBT) is not recommended for the frontline management of advanced non-small cell lung cancer (NSCLC) in unselected patients.
- While showing a benefit in EGFR-mutated patients, overall survival benefits were not observed in the general NSCLC population.
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