• J Thorac Oncol · Oct 2010

    Multicenter Study

    Efficacy and safety of erlotinib in 1242 East/South-East Asian patients with advanced non-small cell lung cancer.

    • Tony Mok, Yi-long Wu, Joseph Siu-kie Au, Caicun Zhou, Li Zhang, Reury-Perng Perng, and Keunchil Park.
    • Department of Oncology, Prince of Wales Hospital, Hong Kong, China.
    • J Thorac Oncol. 2010 Oct 1;5(10):1609-15.

    IntroductionErlotinib is an epidermal growth factor receptor tyrosine kinase inhibitor that significantly increases survival for patients with previously treated advanced non-small cell lung cancer. Epidermal growth factor receptor tyrosine kinase inhibitors have been reported to be particularly effective in Asian patients and may have a distinct safety profile in this population compared with non-Asian patients. We report safety and efficacy data from a subpopulation of East/South-East (E/SE) Asian patients enrolled in a global, open-label, phase IV trial of erlotinib (Tarceva Lung Cancer Survival Treatment study).MethodsPatients who had previously failed on chemotherapy or radiotherapy, or were unsuitable for these treatments, were treated with oral erlotinib (150 mg/d) until disease progression or unacceptable toxicity.ResultsBest response data were available for 1118 E/SE Asian and 4276 non-E/SE Asian patients. The overall response rates were 27% versus 10%, respectively (p < 0.0001). The disease control rates were 78% versus 66%, respectively (p < 0.0001). Survival data were available for 1242 E/SE Asian and 5338 non-E/SE Asian patients. The median progression-free survival times were 5.78 months versus 2.92 months, respectively (hazard ratio = 0.66, p < 0.0001). The median overall survival times were 14.7 months versus 6.8 months, respectively (hazard ratio = 0.57, p < 0.0001). One-year survival rates were 58.3% and 32.7%, respectively. Safety data were available for 1242 E/SE Asian patients. Seventeen percent of these patients experienced one or more erlotinib-related adverse event (AE) (other than the most frequently occurring AEs prespecified in the protocol) and 2% experienced an erlotinib-related serious AE. Dose reductions were reported for 171 (14%) patients.ConclusionErlotinib is an effective and well-tolerated treatment for Asian patients with advanced non-small cell lung cancer.

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