• Martin Reck, Nico van Zandwijk, Cesare Gridelli, Zoltan Baliko, Danny Rischin, Simon Allan, Maciej Krzakowski, and David Heigener.
• Department of Thoracic Oncology, Hospital Grosshansdorf, Grosshansdorf, Germany. dr.martin.reck@web.de
• J Thorac Oncol. 2010 Oct 1;5(10):1616-22.

IntroductionErlotinib is a small molecule inhibitor of epidermal growth factor receptor tyrosine-kinase activity that has been shown to significantly increase survival for patients with previously treated advanced non-small cell lung cancer. Here, we report safety and efficacy data from a large, global, open-label, phase IV trial of erlotinib (Tarceva Lung Cancer Survival Treatment).MethodsPatients who had previously failed on chemotherapy or radiotherapy and were unsuitable for these treatments were treated with oral erlotinib (150 mg/d) until disease progression or unacceptable toxicity.ResultsThe disease control rate was 69% in 5394 patients for whom best response data were available. Survival data were available for 6580 patients. Median progression-free and overall survival times were 3.25 months and 7.9 months, respectively. The 1-year survival rate was 37.7%. Among the 6580 patients included in the safety analysis, 799 (12%) experienced one or more erlotinib-related adverse events (AEs, other than prespecified AEs defined in the protocol), and only 4% experienced an erlotinib-related serious AE. Of the 6580 patients for whom data were available, dose reductions were reported in 1096 (17%), the majority (95%) due to an erlotinib-related AE (most commonly rash 65% or diarrhea 10%). Treatment was discontinued for 337 patients (5%) because of erlotinib-related AEs. Incidence of erlotinib-related rash was investigated as a separate end point. Seventy-one percent of patients for whom data were available experienced erlotinib-related rash; of these, the majority of cases were grade 1/2 (59%).ConclusionsThese data confirm the favorable efficacy and safety profile of erlotinib in a large heterogeneous non-small cell lung cancer population.

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