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 .
Vinorelbine plus gemcitabine followed by docetaxel versus carboplatin plus paclitaxel in patients with advanced non-small-cell lung cancer: a randomised, open-label, phase III study.
BACKGROUND Platinum-containing two-drug combinations improve survival and cancer-related symptoms in patients with advanced non-small-cell lung cancer ( NSCLC ) . However , survival benefit is modest and platinum-containing regimens cause substantial toxic effects . We did a prospect i ve r and omised open-label phase III study to compare an experimental platinum-free , triplet , sequential regimen of vinorelbine plus gemcitabine followed by docetaxel with the st and ard platinum-containing , doublet regimen paclitaxel plus carboplatin in patients with advanced NSCLC . METHODS Between March , 2001 , and April , 2005 , patients with stage IIIB ( positive pleural effusion ) or IV NSCLC , performance status 0 to 1 , and adequate organ function , were r and omly assigned to experimental treatment or to st and ard treatment . R and omisation was done central ly by use of a dynamic balancing algorithm . Patients were stratified by weight loss , lactate dehydrogenase concentration , and disease stage . Patients in the experimental group were scheduled to receive intravenous vinorelbine ( 25 mg/m(2 ) ) plus gemcitabine ( 1000 mg/m(2 ) ) on days 1 and 8 every 21 days for three cycles , followed by intravenous docetaxel ( 60 mg/m(2 ) ) on day 1 every 21 days for three cycles . Patients in the st and ard group were scheduled to receive intravenous paclitaxel ( 225 mg/m(2 ) ) plus carboplatin ( area under the curve=6 ) for 3 h on day 1 , every 21 days for six cycles . The primary endpoint was overall survival , and secondary endpoints were progression-free survival , response , and toxic effects . Analyses were by intention to treat . This trial is registered with Clinical Trials.gov , number NCT00079287 . FINDINGS Of the 401 patients enrolled and r and omised in the trial , five patients in the experimental group and three in the st and ard group were ineligible for analysis ; thus 196 patients in the experimental group and 197 in the st and ard group were included in analyses . Patient characteristics were well-balanced between the two groups with regard to major prognostic factors . Median overall survival was 13.6 months ( range 12.0 - 16.4 ) in the experimental group versus 14.1 months ( 11.9 - 17.5 ) in the st and ard group ( p=0.97 ) . 49 of 196 patients ( 25 % ) in the experimental group had a partial response compared with 73 of 197 patients ( 37 % ) in the st and ard group ( p=0.012 ) . There were no complete responses . Median progression-free survival was 5.5 months ( 95 % CI 4.9 - 6.3 ) in the experimental group compared with 5.8 months ( 5.3 - 6.1 ) in the st and ard group ( p=0.74 ) . The incidence of grade 3 and 4 neutropenia , neuropathy , arthralgia , and myalgia was lower in the experimental group than in the st and ard group , although the incidence of pulmonary toxic effects was higher . INTERPRETATION Although platinum-containing regimens remain the st and ard treatment for advanced NSCLC , non-platinum regimens could provide equivalent efficacy with a different toxicity profile
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 .