Clinical efficacy of erlotinib in patients previously treated for advanced non-small cell lung cancer

Background and objective: Erlotinib is one of the standard second/third line treatments for patients with advanced non-small cell lung cancer (NSCLC). This study investigated the efficacy of erlotinib in a Chinese population with advanced NSCLC and compared the predictive value of serum vascular endothelial growth factor (VEGF) and transforming growth factor (TGF)-alpha for the efficacy of erlotinib. Methods: Patients with advanced, previously treated NSCLC received 150 mg of erlotinib once daily orally until disease progression or intolerable toxicity. Serum levels of VEGF and TGF-alpha were measured by ELISA at baseline and 1 month after treatment commenced. Results: There were 112 patients enrolled during the period October 2005 to February 2008 and followed until July 2008. Serum samples were available in 50 patients. Tumour response to erlotinib was partial in 35.7% of patients and 41.1% of patients had stable disease. The severity of skin rash (P < 0.001) had a significant positive correlation with the response to erlotinib. Median progression-free survival (PFS) and overall survival were 6.3 months and 12.5 months, respectively. After erlotinib treatment, serum VEGF levels did not change significantly, while serum TGF-alpha levels increased in patients who had partial response (P = 0.075) or stable disease (P = 0.055), but not in patients with progressive disease (P = 0.155). In patients with measurable serum TGF-alpha levels at baseline the PFS and median survival were 5 and 9.9 months respectively, and in patients with no measurable TGF-alpha at baseline the PFS and median survival were 11 and 21 months, respectively. Overall survival was significantly longer in patients with negative baseline serum TGF-alpha (P = 0.002). Conclusions: Oral erlotinib was effective as a second/third line treatment for patients with advanced NSCLC. Baseline serum TGF-alpha levels may be a predictor for the efficacy of erlotinib treatment.