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Medline ® Abstract for Reference 27

of 'Pulmonary toxicity associated with antineoplastic therapy: Molecularly targeted agents'

27
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Erlotinib in advanced non-small cell lung cancer: efficacy and safety findings of the global phase IV Tarceva Lung Cancer Survival Treatment study.
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Reck M, van Zandwijk N, Gridelli C, Baliko Z, Rischin D, Allan S, Krzakowski M, Heigener D
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J Thorac Oncol. 2010;5(10):1616.
 
INTRODUCTION: Erlotinib 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).
METHODS: Patients 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.
RESULTS: The 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 AEsdefined 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%).
CONCLUSIONS: These data confirm the favorable efficacy and safety profile of erlotinib in a large heterogeneous non-small cell lung cancer population.
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Department of Thoracic Oncology, Hospital Grosshansdorf, Grosshansdorf, Germany. dr.martin.reck@web.de
PMID