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 .
Phase III trial comparing vinflunine with docetaxel in second-line advanced non-small-cell lung cancer previously treated with platinum-containing chemotherapy.
PURPOSE To compare vinflunine ( VFL ) to docetaxel in patients with stage IIIB/IV non-small-cell lung cancer ( NSCLC ) who have experienced treatment failure with first-line platinum-based chemotherapy . PATIENTS AND METHODS R and omized , multicenter , phase III study , 551 patients received either vinflunine 320 mg/m(2 ) or docetaxel 75 mg/m(2 ) every 21 days until disease progression or serious toxicity . The primary end point was progression-free survival ( PFS ) . The noninferiority analysis was based on a 10 % difference ( types I/II error rates : 5%/20 % ) . Secondary end points included response rate ( ORR ) , response duration , overall survival ( OS ) , clinical benefit , quality of life ( QOL ) , and safety . RESULTS Median PFS was 2.3 months for each arm ( HR , 1.004 ; 95 % CI , 0.841 to 1.199 ) . ORR , stable disease , median OS , were 4.4 % versus 5.5 % , 36.0 % versus 39.6 % , 6.7 versus 7.2 months ( HR , 0.973 ; 95 % CI , 0.805 to 1.176 ) , respectively . No significant difference in patient benefit and QOL ( Functional Assessment of Cancer Therapy-Lung ) . No unexpected adverse events were observed . Grade higher than 0 ( vinflunine v docetaxel ) anemia ( 82.1 % v 79.8 % ) , neutropenia ( 49.3 v 39.02 % ) , thrombocytopenia ( 30.6 % v 14.3 % ) , febrile neutropenia ( 3.3 % v 4.7 % ) , constipation ( 39.2 % v 11.7 % ) , fatigue ( 36.6 % v 33.9 % ) , injection site reaction ( 31.9 % v 0.7 % ) , nausea ( 26.7 % v 23.7 % ) , vomiting ( 23.8 % v 14.2 % ) , alopecia ( 19.8 % v 35.4 % ) , stomatis ( 19.4 % v 12.4 % ) , abdominal pain ( 20.1 % v 3.6 % ) , myalgia ( 14.7 % v 6.6 % ) , peripheral neuropathy ( 10.7 % v 15.0 % ) , arthralgia ( 7.0 % v 7.7 % ) , diarrhea ( 6.2 % v 12.4 % ) , edema ( 1.5 % v 5.4 % ) , and nail disorders ( 1.1 % v 5;1 % ) were observed . CONCLUSION This noninferiority phase III study showed similar efficacy end points for vinflunine and docetaxel . Despite higher rates of some adverse effects ( anemia , abdominal pain , constipation , fatigue ) the overall toxicity profile of vinflunine was manageable . Therefore , VFL may be another option in the second-line treatment of patients with advanced NSCLC
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 .