Multicentre prospective phase II trial of gefitinib for advanced non-small cell lung cancer with epidermal growth factor receptor mutations: results of the West Japan Thoracic Oncology Group trial (WJTOG0403)
2008

Gefitinib for Advanced Lung Cancer with EGFR Mutations

Sample size: 118 publication 10 minutes Evidence: high

Author Information

Author(s): Tamura K, Okamoto I, Kashii T, Negoro S, Hirashima T, Kudoh S, Ichinose Y, Ebi N, Shibata K, Nishimura T, Katakami N, Sawa T, Shimizu E, Fukuoka J, Satoh T, Fukuoka M

Primary Institution: National Cancer Center Hospital

Hypothesis

The study aims to evaluate the efficacy of gefitinib and the feasibility of screening for EGFR mutations in patients with advanced non-small cell lung cancer.

Conclusion

Gefitinib chemotherapy was highly effective in patients with advanced NSCLC harboring EGFR mutations, with a 75% overall response rate.

Supporting Evidence

  • The overall response rate was 75%, and the disease control rate was 96%.
  • The median progression-free survival was 11.5 months.
  • EGFR mutations were detected in 32 out of 117 patients screened.

Takeaway

This study shows that a medicine called gefitinib can help people with a specific type of lung cancer that has a certain gene change, making them feel better.

Methodology

Patients were screened for EGFR mutations and those with mutations received gefitinib; response rates and survival were evaluated.

Potential Biases

Potential selection bias due to the eligibility criteria and the specific patient population studied.

Limitations

The study had a relatively short observation period and was conducted at multiple institutions in a specific region, which may not represent broader clinical practice.

Participant Demographics

The median age of participants was 68 years, with 64% female, 96% having adenocarcinoma, and 68% being never smokers.

Statistical Information

P-Value

p<0.001

Confidence Interval

95% CI: 57.6–91.0%

Statistical Significance

p<0.05

Digital Object Identifier (DOI)

10.1038/sj.bjc.6604249

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