Tarceva is FDA approved after standard chemo has failed. It is being studied for first line therapy of lung cancer instead of chemotherapy. This drug has been studied primarily in stage IV, when it has spread but recently it has been also studied, for maintenance, once treatment with chemotherapy had stopped. Studies, such as the Saturn trial, have been encouraging for maintenance and suggest prolongation of PFS but not overall survival. On April 16, 2010, the U. S. Food and Drug Administration (FDA) approved erlotinib (Tarceva) tablets for maintenance treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose disease has not progressed after four cycles of platinum-based first-line chemotherapy. NICE in 2011 did not recommend routine use of erlotinib for maintenance, because the independent Appraisal Committee felt that there was too much uncertainty about the amount of extra time or overall survival gain expected from the treatment and that based on the evidence available erlotinib was not considered value for money. On the other hand, in the USA Erlotinib is recommended as an option in the NCCN Guidelines® for maintenance therapy in advanced non-small cell lung cancer (NSCLC) based on the results of the SATURN trial.
A meta-analysis in 2013 concluded that maintenance therapy with erlotinib or gefitinib produces a significant PFS and OS benefit for unselected patients with advanced NSCLC compared with placebo or observation. This was true in both EGFR + and negative patients. As such, Tarceva maintenance is supported despite the absence of EGFR receptor testing.
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PLOS Published: March 21, 2013 • http://dx.doi.org/10.1371/journal.pone.0059314
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