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Lung cancer research has incorporated molecular medicine into the management of this disease during the last 5 years. Several novel tumorigenesis pathways associated with lung cancer development and proliferation have been discovered and further developed as targets. The idea behind this is to deliver individualized therapy for each patient based on his/her tumor phenotype, which may involve the overexpression or lack of certain proteins, receptors, mutations and other factors. To date, many of these characteristics have been shown to have a potential role as prognostic or predictive biomarkers, with most of the available data being obtained from retrospective analyses, various laboratory platforms, and data sets used for comparison. However, well-designed prospective randomized clinical trials are underway to validate the significance and future role of these novel biomarkers, allowing us to sort out the best personalized management for an individual with lung cancer diagnosis. Nevertheless, one of these features, the EGF receptor (EGFR) gene mutation, has emerged as a prognostic and strongly predictive biomarker when EGFR inhibition is used as a therapy for tumors that harbor the mutation. Our article displays the most recently developed data related to this biomarker and what have we learned based on the analyses of clinical trials that have studied different agents in the clinical arena.

For many decades, the use of chemotherapy as second-line therapy in non-small-cell lung cancer relied upon disease progression. Several studies have shown that four to six cycles of chemotherapy administered as front-line therapy treatment offers a survival advantage to patients; however, further chemotherapy beyond this initial treatment was more associated with side effects and no benefit in survival. Until 2009, second-line treatment for lung cancer was well established for three therapeutic agents: docetaxel, pemetrexed and erlotinib. Currently, the timeframe to use these agents has been challenged by two large randomized clinical trials in which pemetrexed (JMEN trial) and erlotinib (Sequential Tarceva in Unresectable NSCLC [SATURN] trial) were used as 'maintenance' therapy and shown to impact progression-free survival and overall survival. This review focuses on the actual dilemma that medical oncologists face in clinical practice in terms of when and to whom maintenance therapy should be applied or if the 'watch and wait' approach prior to start second-line therapy is still advisable.