Background: Lung cancer is the leading cause of cancer deaths in most countries. In patients with metastases, such as the brain, the 1-year survival is 10% and most of these patients die in 1-3 months. Data from large phase II trials of non-small cell lung cancer (NSCLC) suggested that the histologic subtype of adenocarcinoma may be a prognostic factor for patients treated with gefitinib. To evaluate the efficacy of gefitinib in palliative therapy for advanced patients with adenocarcinoma and brain metastases, we conducted a phase II study.
Patients and methods: Eligible patients had histologically confirmed adenocarcinoma and brain metastases confirmed with radiological studies. All eligible patients had undergone chemotherapy previously. From December 2003 to December 2004, 40 patients received 250mg doses of gefitinib daily. The symptomatic response, survival, and toxicity were recorded.
Results: The overall objective response rate was 32% with a disease control rate of 77%. Altogether, 45% of the patients experienced symptom improvement. The median progression-free survival and overall survival were 9.0 months and 15.0 months, respectively. Gefitinib was well-tolerated, with cutaneous reactions as the most frequent toxicity.
Conclusions: Our data suggest that gefitinib has promising activity in palliative therapy for patients with advanced lung adenocarcinoma and brain metastasis.