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 .
PARAMOUNT: Final overall survival results of the phase III study of maintenance pemetrexed versus placebo immediately after induction treatment with pemetrexed plus cisplatin for advanced nonsquamous non-small-cell lung cancer.
PURPOSE In the phase III PARAMOUNT trial , pemetrexed continuation maintenance therapy reduced the risk of disease progression versus placebo ( hazard ratio [ HR ] , 0.62 ; 95 % CI , 0.49 to 0.79 ; P < .001 ) . Here we report final overall survival ( OS ) and up date d safety data . PATIENTS AND METHODS In all , 939 patients with advanced nonsquamous non-small-cell lung cancer ( NSCLC ) received four cycles of pemetrexed-cisplatin induction therapy ;  then , 539 patients with no disease progression and Eastern Cooperative Oncology Group performance status 0 or 1 were r and omly assigned ( 2:1 ) to maintenance pemetrexed ( 500 mg/m(2 ) on day 1 of 21-day cycles ; n = 359 ) or placebo ( n = 180 ) . Log-rank test compared OS between arms as measured from r and om assignment ( α = .0498 ) . RESULTS The mean number of maintenance cycles was 7.9 ( range , one to 44 ) for pemetrexed and 5.0 ( range , one to 38 ) for placebo . After 397 deaths  ( pemetrexed , 71 % ; placebo , 78 % ) and a median follow-up of 24.3 months for alive patients ( 95 % CI , 23.2 to 25.1 months ) , pemetrexed therapy result ed in a statistically significant 22 % reduction in the risk of death ( HR , 0.78 ; 95 % CI , 0.64 to 0.96 ; P = .0195 ; median OS : pemetrexed , 13.9 months ; placebo , 11.0 months ) . Survival on pemetrexed was consistently improved for all patient subgroups , including induction response : complete/partial responders ( n = 234 ) OS HR , 0.81 ; 95 % CI , 0.59 to 1.11 and stable disease ( n = 285 ) OS HR , 0.76 ; 95 % CI , 0.57 to 1.01 ) . Postdiscontinuation therapy use was similar : pemetrexed , 64 % ; placebo , 72 % . No new safety findings emerged . Drug-related grade 3 to 4 anemia , fatigue , and neutropenia were significantly higher in pemetrexed-treated patients . CONCLUSION Pemetrexed continuation maintenance therapy is well-tolerated and offers superior OS compared with placebo , further demonstrating that it is an efficacious treatment strategy for patients with advanced nonsquamous NSCLC and good performance status who did not progress during pemetrexed-cisplatin induction therapy
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 .