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Special Announcement (August 30, 2011): The US Food and Drug Administration (FDA) announced its approval of crizotinib for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) that is positive for a rearrangement in the anaplastic lymphoma kinase (ALK) gene as detected by an FDA-approved test on August 26, 2011, based on two single-arm trials. When the data supporting this approval are fully published in peer-reviewed journals the ASCO NSCLC Guideline Update Committee will consider them in the context of this guideline.
Important note: The recommendations for the use of EGFR mutation testing for patients with stage IV NSCLC who are candidates for EGFR tyrosine-kinase therapy have been updated since the publication of this guideline (Recommendation D1). The new guidance is now reflected in a Provisional Clinical Opinion (PCO) on EGFR testing in NSCLC.
To provide updated recommendations for the treatment of patients with stage IV non-small cell lung cancer.
A literature search identified relevant randomized trials. An Update Committee reviewed the literature and made updated recommendations. Recent results from phase III clinical trials have demonstrated that in patients with stage IV NSCLC who have received four cycles of first-line chemotherapy and whose disease has not progressed, an immediate switch to alternative, single-agent chemotherapy can extend progression-free survival and, in some cases, overall survival. Because of limitations in the data, delayed treatment with a second-line agent after disease progression is also acceptable.
162 publications met the inclusion criteria for the 2009 update. For the recent focused update, seven randomized controlled trials of carboxyaminoimidazole, docetaxel, erlotinib, gefitinib, gemcitabine, and pemetrexed have evaluated outcomes in patients who received an immediate, non–cross resistant alternative therapy (switch maintenance) after first-line therapy.
Recommendations were based on treatment strategies that improve overall survival. Treatments which improve only progression-free survival prompted scrutiny of toxicity and quality of life. In patients with stage IV NSCLC, first-line cytotoxic chemotherapy should be stopped at disease progression or after four cycles in patients whose disease is stable but not responding to treatment. Two-drug cytotoxic combinations should be administered for no more than six cycles. For those with stable disease or response after four cycles, immediate treatment with an alternative, single-agent chemotherapy such as pemetrexed in patients with nonsquamous histology, docetaxel in unselected patients, or erlotinib in unselected patients may be considered. Limitations of this data are such that a break from cytotoxic chemotherapy after a fixed course is also acceptable, with initiation of second-line chemotherapy at disease progression*. Bevacizumab is recommended with carboplatin-paclitaxel, except for those with certain clinical characteristics. Cetuximab is recommended with cisplatin-vinorelbine for patients with EGFR-positive tumors by immunohistochemistry. Docetaxel, erlotinib, gefitinib, or pemetrexed are recommended as second-line therapy. Erlotinib is recommended third-line therapy for patients who have not received prior erlotinib or gefitinib. Data are insufficient to recommend the routine third-line use of cytotoxic drugs. Data are insufficient to recommend routine use of molecular markers to select chemotherapy.
*Indicates a change from the 2009 Recommendaion
The clinical practice guidelines and other guidance published herein are provided by the American Society of Clinical Oncology, Inc. ("ASCO") to assist practitioners in clinical decision making. The information therein should not be relied upon as being complete or accurate, nor should it be considered as inclusive of all proper treatments or methods of care or as a statement of the standard of care. With the rapid development of scientific knowledge, new evidence may emerge between the time information is developed and when it is published or read. The information is not continually updated and may not reflect the most recent evidence. The information addresses only the topics specifically identified therein and is not applicable to other interventions, diseases, or stages of diseases. This information does not mandate any particular course of medical care. Further, the information is not intended to substitute for the independent professional judgment of the treating physician, as the information does not account for individual variation among patients. Recommendations reflect high, moderate or low confidence that the recommendation reflects the net effect of a given course of action. The use of words like "must," "must not," "should," and "should not" indicate that a course of action is recommended or not recommended for either most or many patients, but there is latitude for the treating physician to select other courses of action in individual cases. In all cases, the selected course of action should be considered by the treating physician in the context of treating the individual patient. Use of the information is voluntary. ASCO provides this information on an "as is" basis, and makes no warranty, express or implied, regarding the information. ASCO specifically disclaims any warranties of merchantability or fitness for a particular use or purpose. ASCO assumes no responsibility for any injury or damage to persons or property arising out of or related to any use of this information or for any errors or omissions.