Non-small cell lung cancer (NSCLC) represents a major challenge to oncologists because of its dismal outcomes. Conventional cytotoxic therapies for advanced disease have been unsatisfactory with modest efficacy and high toxicities. The last decade witnessed the introduction of many novel agents with enhanced efficacy and more manageable safety profile than conventional therapies. Gemcitabine is one of these novel agents which was introduced in the mid 1990's in the US/Europe and has been available in Japan since 1999. Due to its unique profile of great efficacy, mild toxicities and combinability with other agents, gemcitabine and its combination have been widely accepted as one of the standard regimens for the treatment of advanced NSCLC. There were multiple clinical trials demonstrated the superiority of gemcitabine or its combination over conventional therapies, especially in terms of increased response, prolonged survival, and quality of life enhancement for these patients. The current review presents an overview of all the randomized clinical trials of gemcitabine and its combination for advanced NSCLC published over the last decade.
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