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 .
Quality of life and disease-related symptoms in previously treated Japanese patients with non-small-cell lung cancer: results of a randomized phase III study (V-15-32) of gefitinib versus docetaxel.
BACKGROUND This report describes quality of life ( QoL ) findings of a r and omized study comparing gefitinib with docetaxel in patients with advanced/metastatic pretreated non-small-cell lung cancer . PATIENTS AND METHODS This open-label , phase III study r and omized 490 Japanese patients to gefitinib ( 250 mg/day ) or docetaxel ( 60 mg/m(2)/3 weeks ) , with survival as the primary outcome . Preplanned QoL analyses included Functional Assessment of Cancer Therapy-Lung ( FACT-L ) , Trial Outcome Index ( TOI ) and Lung Cancer Subscale ( LCS ) improvement rates , and mean change from baseline . RESULTS Gefitinib showed statistically significant benefits over docetaxel in QoL improvement rates ( FACT-L 23 % versus 14 % , P = 0.023 ; TOI 21 % versus 9 % , P = 0.002 ) and mean change from baseline score [ mean treatment difference : FACT-L 3.72 points , 95 % confidence interval ( CI ) 0.55 - 6.89 , P = 0.022 ; TOI 4.31 points , 95 % CI 2.13 - 6.49 , P < 0.001 ] , although differences did not meet the clinical ly relevant six-point change . There were no significant differences between treatments in LCS improvement rates ( 23 % versus 20 % , P = 0.562 ) or mean change from baseline score ( 0.63 points , 95 % CI -0.07 to 1.34 , P = 0.077 ) . CONCLUSIONS Gefitinib improved aspects of QoL over docetaxel , with superior objective response rate and a more favorable tolerability profile and no statistically significant difference in overall survival ( although noninferiority was not statistically proven )
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 .