Tarceva is FDA approved after standard chemo has failed or for maintenance after treatment of advanced or metastatic disease. It is not currently FDA approved as first line therapy even for stage IV. TARCEVA (erlotinib) monotherapy is indicated for the maintenance treatment of patients with locally advanced or metastatic non-small cell lung cancer whose disease has not progressed after four cycles of platinum-based first-line chemotherapy. However, I believe that a patient treated for locally advanced disease (stage IIIB), and who then became metastatic, would be included in the indication for Tarceva.
The FDA does not absolutely require EGFR positivity. This is the FDA indication: “TARCEVA monotherapy is indicated for the maintenance treatment of patients with locally advanced or metastatic non-small cell lung cancer whose disease has not progressed after four cycles of platinum-based first-line chemotherapy”. However, recently emerging is the approach in which all lung cancers are tested for EGFR and ALK and those positive for etiher of these mutations are treated with Tarceva or Xalkori respectively in first line. Some researchers call it “genotype directed therapy”.
Tarceva is now recommended by NCCN for first line therapy for a poor performance status with an EGFR activating mutation. In the event that EGFR was not performed, older literature, from before EGFR was available still supports the use of Tarceva in first line.
Researchers did find that certain subsets of patients were most likely to respond to erlotinib: Asians; women; patients with adenocarcinoma; and those who had never smoked. EGFR + patients have more response than EGFR negative patients but this difference was not absolute. These results confirmed those of numerous other studies. However, it is generally accepted that these factors alone do not indicate Tarceva therapy. These factors be surrogates for EGFR positivity.
In older studies that were performed without routine EGFR testing, Erlotinib (Tarceva®) prolonged survival in patients with advanced non-small cell lung cancer who had progressed after standard chemotherapy. The median survival among patients who took erlotinib was 6.7 months compared to 4.7 months for those on placebo. At one year, 31 percent of the patients taking erlotinib were still alive compared to 22 percent of those taking the placebo. There was another phase II study suggesting effectiveness front line. In an 80-patient phase 2 study, presented at the European Respiratory Society meeting, there were no complete responses among 69 evaluable patients. But 41 of the 69 patients with Stage IIIB or IV disease had a partial response (eight) or had stable disease.
In conclusion, recently routine EGFR testing became available and decisions are being made incorporating EGFR results. Older standards are appropriate when EGFR is not available.
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