Annals of Oncology 15:1042-1047, 2004
© 2004 European Society for Medical Oncology
Gefitinib in patients with brain metastases from non-small-cell lung cancer: a prospective trial
Background: Brain metastases are a common occurrence in patients with non-small-cell lung cancer (NSCLC). Whole-brain radiotherapy (WBRT) is the standard therapy; more aggressive approaches such as surgery or radiosurgery are indicated in a subset of patients only. The role of systemic treatments remains controversial. Gefitinib is an oral, highly tolerable, specific inhibitor of epidermal growth factor receptor-associated tyrosine kinase, which has shown activity in chemotherapy pre-treated NSCLC. The aim of this study was to evaluate the activity and safety of gefitinib in NSCLC patients with brain metastases.Patients and methods: From January 2001 to May 2003, 41 consecutive NSCLC patients with measurable brain metastases were treated with gefitinib, given orally at daily dose of 250 mg. Thirty-seven patients had received previous chemotherapy and 18 patients had been treated previously with WBRT, completed at least 3 months before entering the trial.
Results: A partial response (PR) was observed in four patients (10%), with stable disease (SD) in seven cases, for an overall disease control (DC) rate (DC=PR+SD) of 27% (95% confidence interval 13% to 40%). Median duration of PR was 13.5 months. Median progression-free survival (PFS) of the whole population was 3 months. DC rate was higher in patients pre-treated with WBRT (P=0.05) and with adenocarcinoma histological type (P=0.08); adenocarcinoma patients had also a longer PFS (P=0.04). Toxicity was mild and consisted of grade 1/2 skin toxicity and diarrhoea, occurring in 24% and 10% of patients, respectively.
Conclusions: Gefitinib can be active on brain disease in NSCLC patients. Since the results of standard therapy for brain metastases in this clinical setting are particularly disappointing, gefitinib appears to be a possible new treatment option.
1 Department of Oncology, Scientific Institute San Raffaele, Milan; 2 Division of Medical Oncology, Bellaria Hospital, Bologna, Italy
*Correspondence to: Dr G. L. Ceresoli, Department of Oncology, Scientific Institute San Raffaele, Via Olgettina, 60, 20123 Milano, Italy. Tel: +39-02-26432514; Fax: +39-02-26437625; Email: ceresoli.giovanni{at}hsr.it
Key words: brain metastases, gefitinib, non-small-cell lung cancer
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