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 .
First-line erlotinib followed by second-line cisplatin-gemcitabine chemotherapy in advanced non-small-cell lung cancer: the TORCH randomized trial.
PURPOSE Erlotinib prolonged survival of unselected patients with advanced non-small-cell lung cancer ( NSCLC ) who were not eligible for further chemotherapy , and two phase II studies suggested it might be an alternative to first-line chemotherapy . A r and omized phase III trial was design ed to test whether first-line erlotinib followed at progression by cisplatin-gemcitabine was not inferior in terms of survival to the st and ard inverse sequence . PATIENTS AND METHODS Patients with stage IIIB ( with pleural effusion or supraclavicular nodes ) to IV NSCLC and performance status of 0 to 1 were eligible . With a 95 % CI upper limit of 1.25 for the hazard ratio ( HR ) for death , 80 % power , a one-sided α = .025 , and two interim analyses , a sample size of 900 patients was planned . RESULTS At the first planned interim analysis with half the events , the inferiority boundary was crossed , and the Independent Data Monitoring Committee recommended early termination of the study . Seven hundred sixty patients ( median age , 62 years ; range , 27 to 81 years ) had been r and omly assigned . Baseline characteristics were balanced between study arms . As of June 1 , 2011 , median follow-up was 24.3 months , and 536 deaths were recorded ( 263 in the st and ard treatment arm and 273 in the experimental arm ) . Median survival was 11.6 months ( 95 % CI , 10.2 to 13.3 months ) in the st and ard arm and 8.7 months ( 95 % CI , 7.4 to 10.5 months ) in the experimental arm . Adjusted HR of death in the experimental arm was 1.24 ( 95 % CI , 1.04 to 1.47 ) . There was no heterogeneity across sex , smoking habit , histotype , and epidermal growth factor receptor ( EGFR ) mutation . CONCLUSION In unselected patients with advanced NSCLC , first-line erlotinib followed at progression by cisplatin-gemcitabine was significantly inferior in terms of overall survival compared with the st and ard sequence of first-line chemotherapy followed by erlotinib
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 .