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Prospective phase II study of gefitinib in non-small cell lung cancer with epidermal growth factor receptor gene
Kenji Sugio1, Hidetaka Uramoto, Takamitsu Onitsuka
1Second Department of Surgery, School of Medicine, University of Occupational and Environmental Health, 1-1 Iseigaoka, Yahatanishi-ku, Kitakyushu 807-8555, Japan. kensugio@med.uoeh-u.ac.jp
Background:
This study prospectively assessed the efficacy of gefitinib and the survival benefit for non-small cell lung cancer (NSCLC) patients with epidermal growth factor receptor (EGFR) mutations.
Method:
Patients with either recurrent disease after undergoing surgery or advanced NSCLC disease (IIIB or IV) which demonstrated EGFR mutations were eligible for this study. EGFR mutations in exons 19-21 were examined. The patients with EGFR mutations were enrolled in this study after obtaining their informed consent a second time, and they were thereafter treated with gefitinib.
Results:
EGFR mutations were detected in 20 of 48 patients with NSCLC, and 19 patients were enrolled onto this study and treated with gefitinib. Seven patients had an exon 19 deletion, 10 had L858R, 1 had both, and 1 had an exon 19 deletion and G796A. The overall response rate was 63.2%, and the disease control rate was 89.5%. In patients with an exon 19 del and L858R, the response rates were 71.4% and 60.0%, respectively. The median progression-free survival time was 7.1 months, and the median survival time was 20.0 months. No life-threatening toxicity was observed. Four of five acquired resistant tumors showed an acquired T790M mutation.
Conclusions:
EGFR mutations in exons 19 or 21 are considered to be a good predictor of the efficacy of gefitinib.
Insights
Gefitinib demonstrated significant efficacy and survival benefits in non-small cell lung cancer (NSCLC) patients with specific epidermal growth factor receptor (EGFR) mutations. These EGFR mutations in exons 19 or 21 predict a positive response to gefitinib treatment.
Area of Science:
- Medical Oncology
- Genetics
- Pulmonology
Background:
- Non-small cell lung cancer (NSCLC) is a leading cause of cancer mortality.
- Epidermal growth factor receptor (EGFR) mutations are key drivers in a subset of NSCLC.
- Targeted therapies like gefitinib offer improved outcomes for patients with specific EGFR mutations.
Purpose of the Study:
- To prospectively evaluate the efficacy of gefitinib in NSCLC patients with EGFR mutations.
- To assess the survival benefit associated with gefitinib treatment in this patient cohort.
- To identify EGFR mutation status as a predictive biomarker for gefitinib response.
Main Methods:
- Prospective study of advanced or recurrent NSCLC patients with confirmed EGFR mutations (exons 19-21).
- Informed consent obtained for gefitinib treatment.
- EGFR mutation analysis performed using established methods.
Main Results:
- 19 of 48 NSCLC patients with EGFR mutations were enrolled and treated with gefitinib.
- Overall response rate was 63.2%; disease control rate was 89.5%.
- Median progression-free survival was 7.1 months; median overall survival was 20.0 months. Acquired T790M mutation observed in resistant tumors.
Conclusions:
- EGFR mutations in exons 19 or 21 are strong predictors of gefitinib efficacy in NSCLC.
- Gefitinib provides significant clinical benefit and survival advantage in selected NSCLC patients.
- Further research into acquired resistance mechanisms, such as T790M, is warranted.
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