David G. Pfister, David H. Johnson, Christopher G. Azzoli, William Sause, Thomas J. Smith, Sherman Baker Jr, Jemi Olak, Diane Stover, John R. Strawn, Andrew T. Turrisi, Mark R. Somerfield


FDA has approved new labeling for gefitinib (Iressa) that states the medicine should be used only in cancer patients who have already taken the medicine and whose doctor believes it is helping them. New patients should not be given Iressa because in a large study Iressa did not make people live longer. There are other medicines for non-small cell lung cancer (NSCLC) that have shown an ability to make people live longer.


For the 2003 update, a methodology similar to that applied in the original ASCO practice guidelines for treatment of unresectable NSCLC was used. Pertinent information published from 1996 through March 2003 was reviewed. The MEDLINE database (1996 through October 2002; National Library of Medicine, Bethesda, MD) was searched to identify relevant information from the published literature for this update. A series of searches was conducted using the medical subject headings, "carcinoma, non–small-cell lung," "diagnostic imaging," "neoplasm staging," "mediastinoscopy," "bone neoplasms," "brain neoplasms," "liver neoplasms," "adrenal gland neoplasms," "non–small-cell lung cancer," "radionuclide imaging," "bisphosphonates," "radiotherapy," "smoking," "chemoprevention," and the text words "chemotherapy," "bone scan," "PET," and "zoledronic acid." These terms were combined with the study design–related subject headings or text words "meta-analysis" and "randomized controlled trial." Search results were limited to human studies and English-language articles. The Cochrane Library was searched in October 2002 using the phrase "lung cancer." Directed searches based on the bibliographies of primary articles were also performed. Randomized trials published in the literature since October 2002, as well as data presented at ASCO Annual Meetings, were added to the evidence for these guidelines at the discretion of members of the Expert Panel.

The entire update committee met once to discuss strategy and assign responsibilities for the update. A writing committee subsequently met to further review the literature searches, collate different sections of the update, and refine the manuscript. A draft update was circulated to the full Expert Panel for review and approval. The final document was also reviewed by ASCO's Health Services Research Committee and the ASCO Board of Directors.

Each recommendation from the 1997 guideline is listed below, and is followed by an updated (2003) recommendation, if applicable. "No change" is indicated if a particular recommendation has not been revised. A summary of the evidence follows thereafter. In order to preserve the framework of the 1997 guideline, information and recommendations regarding major topics, such as fluorodeoxyglucose positron emission tomography (FDG-PET), have been divided and distributed to the appropriate section of the text.



ASCO’s practice guidelines and technology assessments reflect expert consensus based on clinical evidence and literature available at the time they are written, and are intended to assist physicians in clinical decision-making and identify questions and settings for further research.  Due to the rapid flow of scientific information in oncology, new evidence may have emerged since the time a guideline or assessment was submitted for publication.  Guidelines and assessments are not continually updated and may not reflect the most recent evidence.  Guidelines and assessments cannot account for individual variation among patients, and cannot be considered inclusive of all proper methods of care or exclusive of other treatments.  It is the responsibility of the treating physician or other health care provider, relying on independent experience and knowledge of the patient, to determine the best course of treatment for the patient.  Accordingly, adherence to any guideline or assessment is voluntary, with the ultimate determination regarding its application to be made by the physician in light of each patient's individual circumstances.  ASCO guidelines and assessments describe the use of procedures and therapies in clinical practice and cannot be assumed to apply to the use of these interventions in the context of clinical trials.  ASCO assumes no responsibility for any injury or damage to persons or property arising out of or related to any use of ASCO’s guidelines or assessments, or to any errors or omissions.