A phase II study of single-agent gefitinib as first-line therapy in patients with stage IV non-small-cell lung cancer
2006

Gefitinib for Stage IV Lung Cancer

Sample size: 34 publication Evidence: moderate

Author Information

Author(s): R Suzuki, Y Hasegawa, K Baba, H Saka, H Saito, H Taniguchi, M Yamamoto, S Matsumoto, K Kato, T Oishi, K Imaizumi, K Shimokata

Primary Institution: Nagoya University Hospital

Hypothesis

The study aimed to evaluate the efficacy and tolerability of gefitinib in Japanese patients with previously untreated stage IV non-small-cell lung cancer.

Conclusion

Gefitinib is active and well tolerated in chemonaive Japanese patients with advanced non-small-cell lung cancer.

Supporting Evidence

  • The objective response rate was 26.5%.
  • Adverse events were generally mild, with no pulmonary toxicity observed.
  • The median survival time was 14.1 months.

Takeaway

This study tested a medicine called gefitinib on people with a type of lung cancer, and it helped some of them feel better without making them very sick.

Methodology

This was a multi-institutional phase II study where gefitinib was given to patients until disease progression or severe toxicity occurred.

Potential Biases

Potential bias due to the single-arm design and lack of a control group.

Limitations

The study had a small sample size and was limited to Japanese patients, which may affect the generalizability of the results.

Participant Demographics

34 patients, median age 64 years, 21 men and 13 women, all with stage IV non-small-cell lung cancer.

Statistical Information

P-Value

0.0057

Confidence Interval

95% CI, 11.7–41.3%

Statistical Significance

p<0.05

Digital Object Identifier (DOI)

10.1038/sj.bjc.6603159

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