BACKGROUNDTo explore the efficacy of gefitinib to non small cell lung cancer (NSCLC) patients irrespective of their performance status, number of prior treatment regimens and the presence of brain metastasis.

METHODSA total of 76 patients were enrolled.

RESULTSFor all enrolled patients, the disease control rate was 63.2% (95% CI, 52.1%-74.3%) with a median progression-free survival of 5.0 months (95% CI, 3.5-6.6 months) and median overall survival of 9.9 months (95% CI, 4.9-14.8 months). Fifty seven patients had measurable lesions and the objective response rate was 33.3% (95% CI, 20.7%-46.0%). Twenty one patients had simultaneously assessable intracranial and extracranial lesions, 17 of them (81.0%) showed comparable tumor response. There was no survival difference between the patients with and without metastatic brain disease. Most drug-related adverse events were mild. Intolerable toxicities happened in 5 patients, 4 of them were interstitial pneumonia (5.8%)

CONCLUSIONSGefitinib is active in patients with brain metastasis from NSCLC. It is feasible to conduct randomized trials to identify the role of gefitinib alone or in combination with other modality in the treatment of NSCLC patients who have metastatic brain lesion(s).