title: Rationale of a relaunch of gefitinib in Caucasian non-small cell lung cancer patients.
abstract: In 2002 results of two-phase II studies with the new epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) gefitinib showed not only promising efficacy in second and third line non-small cell lung cancer (NSCLC) therapies but also an excellent tolerability. Since then, thousands of patients have been treated in one of the largest expanded access programs ever performed and the successful application in daily routine led to a preliminary approval of the drug by the U.S. Food and Drug Administration in 2003. In the light of the negative results of a subsequent phase III trial comparing gefitinib with best supportive care, the approval was withdrawn. In 2009 gefitinib was relaunched for Caucasian patients in the US and Europe based on new data and on the re-interpretation of previous studies. The approval is now recommended exclusively for patients with an activating EGFR mutation. For the first time in lung cancer, molecular work-up is of clinical relevance and will change the diagnostic and therapeutic algorithms. The present review summarizes these data, presents the rationale for this development and proposes a diagnostic work-up.
authors.affiliation: Medical University Innsbruck, Department of Internal Medicine V, Hematology and Oncology, Anichstrasse 35, 6020 Innsbruck, Austria. andreas.pircher@i-med.ac.at
authors.forename: Andreas
authors.initials: A
authors.lastname: Pircher
authors.forename: Ferdinand
authors.initials: F
authors.lastname: Ploner
authors.forename: Helmut
authors.initials: H
authors.lastname: Popper
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Hilbe
mesh_terms: D002289:Carcinoma, Non-Small-Cell Lung / Q000175:diagnosis / Q000188:drug therapy* / Q000235:genetics / Q000473:pathology; D002986:Clinical Trials as Topic; D017277:Drug Approval; D055088:Early Detection of Cancer; D066246:ErbB Receptors / Q000235:genetics / Q000378:metabolism; D005060:Europe; D000077156:Gefitinib; D006801:Humans; D008175:Lung Neoplasms / Q000175:diagnosis / Q000188:drug therapy* / Q000235:genetics / Q000473:pathology; D009154:Mutation / Q000235:genetics; D018579:Patient Selection; D017410:Practice Guidelines as Topic; D047428:Protein Kinase Inhibitors / Q000627:therapeutic use*; D011799:Quinazolines / Q000627:therapeutic use*; D014481:United States; D044465:White People
chemical_list: D047428:Protein Kinase Inhibitors; D011799:Quinazolines; C512478:EGFR protein, human; D066246:ErbB Receptors; D000077156:Gefitinib