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The article discusses changes to the American Society of Clinical Oncology (ASCO) clinical practice guideline which covers the use of chemotherapy, biologic therapy, and molecular markers for stage IV non-small-cell lung cancer (NSCLC) in the U.S. It notes that the changes follow several regulatory actions regarding new agents approved by the U.S. Food and Drug Administration (FDA). It mentions that the FDA and the Canadian Agency for Drugs and Technologies in Health have restricted the use of gefitinib in the released guideline.

Lung cancer is one of the most frequent causes of cancer deaths worldwide. Non-small cell lung cancer (NSCLC) accounts for approximately 80% of cases and no curative treatment is available for the advanced stages of disease (stages III and IV), which comprise the majority of cases. Current treatment regimens with standard chemotherapy offer only a limited survival benefit, and, therefore, the development of new therapeutic strategies is needed. Novel chemotherapeutic drugs such as the epothilones, MEN 10755 and S-1 are being studied in patients with advanced stages of disease. Furthermore, a large number of therapies targeted against critical biological abnormalities in NSCLC are being investigated in clinical trials. The latter approach includes inhibition of growth factors, interference with abnormal signal transduction, inhibition of angiogenesis and gene replacement therapy. Promising results have thus far been obtained with some of these therapies. This review describes the role of new therapeutic agents in the treatment of NSCLC. [Copyright &y& Elsevier]

Cytotoxic chemotherapy for advanced non-small cell lung cancer (NSCLC) offers only modest benefits over best supportive care alone by modestly prolonging survival, reducing symptoms, and improving quality of life. Despite the introduction of a number of new agents over the past decade, we have seen no convincing improvements in efficacy and safety with platinum-based regimens. It appears that a plateau has been reached in the development of traditional cytotoxic chemotherapy and a new paradigm is needed. Novel treatment modalities have emerged from advances in the understanding of tumor cell biology. These sophisticated new agents home in on and neutralize specific targets in the biologic pathway of cancer. This “targeted therapy” represents a new generation of anticancer treatment and a chance to revitalize the moribund state of NSCLC treatment. [Copyright &y& Elsevier]