In the third-line setting , for patients who have not received erlotinib or gefitinib , treatment with erlotinib is recommended .
There are insufficient data to recommend routine third-line cytotoxic therapy .
Purpose To provide evidence -based recommendations to up date the American Society of Clinical Oncology guideline on systemic therapy for stage IV non – small-cell lung cancer ( NSCLC ) .
Results This guideline up date reflects changes in evidence since the previous guideline .
Randomized, placebo-controlled phase III study of docetaxel plus carboplatin with celecoxib and cyclooxygenase-2 expression as a biomarker for patients with advanced non-small-cell lung cancer: the NVALT-4 study.
PURPOSE Cyclooxygenase-2 ( COX-2 ) protein expression in patients with non-small-cell lung cancer ( NSCLC ) may be not only a prognostic marker but also predictive for COX-2 inhibition . We hypothesized that COX-2 expression is associated with shorter survival and that celecoxib , being a potent COX-2 inhibitor , increases tumor response and survival . PATIENTS AND METHODS A phase III study was performed in patients with stage IIIb/IV NSCLC who had pathologic confirmation , no prior chemotherapy , Eastern Cooperative Oncology Group performance status of 0 to 2 , and adequate organ function . Treatment consisted of docetaxel and carboplatin every 3 weeks for five cycles . Patients were r and omly assigned to receive celecoxib 400 mg or placebo twice daily . COX-2 expression on tumor cells was detected by immunohistochemistry . Primary end point was overall survival ( OS ) . RESULTS From July 2003 to December 2007 , 561 patients were r and omly assigned .  Toxicity was mild , and no increase in cardiovascular events was observed . Tumor response was 38 % in the celecoxib arm and 30 % in the placebo arm ( P = .08 ) . Median progression-free survival was 4.5 months ( 95 % CI , 4.0 to 4.8 ) for the celecoxib arm and 4.0 months ( 95 % CI , 3.6 to 4.9 ) for the placebo arm ( hazard ratio [ HR ] , 0.8 ; 95 % CI , 0.6 to 1.1 ; P = .25 ) . Median OS was 8.2 months ( 95 % CI , 7.5 to 8.8 ) for both treatment arms ( HR , 0.9 ; 95 % CI , 0.6 to 1.2 ; P = .32 ) . COX-2 expression did not independently predict survival . Benefit from celecoxib , restricted to patients with low COX-2 expression , was not significant when adjusted for prognostic factors . CONCLUSION In advanced NSCLC , celecoxib does not improve survival . In this study , COX-2 expression was not a prognostic biomarker and had no predictive value when celecoxib was added to chemotherapy
In the third-line setting , for patients who have not received erlotinib or gefitinib , treatment with erlotinib is recommended .
There are insufficient data to recommend routine third-line cytotoxic therapy .
Purpose To provide evidence -based recommendations to up date the American Society of Clinical Oncology guideline on systemic therapy for stage IV non – small-cell lung cancer ( NSCLC ) .
Results This guideline up date reflects changes in evidence since the previous guideline .