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 .
A double-blind, randomised, placebo-controlled phase III intergroup study of gefitinib in patients with advanced NSCLC, non-progressing after first line platinum-based chemotherapy (EORTC 08021/ILCP 01/03).
BACKGROUND EORTC study 08021/ILCP 01/03 evaluated the role of consolidation gefitinib , an oral tyrosine kinase inhibitor ( TKI ) , administered in patients with advanced non-small cell lung cancer ( NSCLC ) , not progressing following st and ard 1st-line chemotherapy . METHODS Patients with advanced NSCLC , not-progressing after four cycles of platinum-based chemotherapy  , were r and omised to receive either gefitinib 250mg/d or matched placebo until progression or unacceptable toxicity . The primary end-point was overall survival ( OS ) . Secondary end-points were progression-free survival ( PFS ) and toxicity . The study was powered to detect a 28 % increase in OS from a median of 11 - 14.1months ( HR=0.78 ) and planned to r and omise 598 patients to observe 514 deaths . RESULTS After inclusion of 173 patients , the trial was prematurely closed due to low accrual . Baseline characteristics for gefitinib ( n=86 ) and placebo ( n=87 ) arms were well balanced . After a median follow up of 41months , the difference in median OS in the gefitinib and placebo arms was not statistically significant ( 10.9 and 9.4months , HR 0.83 [ 95 % confidence interval ( 95 % CI ) 0.60 - 1.15 ] ; p=0.2 ) . The difference in median PFS significantly favoured gefitinib ( 4.1 and 2.9months , HR=0.61 , [ 95 % CI 0.45 , 0.83 ] ) , p=0.0015 ) . Adverse events reported in more than 10 % of patients were rash ( 47 % with gefitinib versus 13 % with placebo ) and diarrhoea ( 34 % with gefitinib versus13 % with placebo ) . CONCLUSIONS Despite its premature closure , this trial confirms previous evidence that consolidation gefitinib is safe and improves PFS . However , no difference in OS was observed in this study ( NCT00091156 )
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 .