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document
Gefitinib plus best supportive care in previously treated patients with refractory advanced non-small-cell lung cancer : results from a randomised , placebo-controlled , multicentre study ( Iressa Survival Evaluation in Lung Cancer ) . BACKGROUND This placebo-controlled phase III study investigated the effect on survival of gefitinib as second-line or third-line treatment for patients with locally advanced or metastatic non-small-cell lung cancer . METHODS 1692 patients who were refractory to or intolerant of their latest chemotherapy regimen were randomly assigned in a ratio of two to one either gefitinib ( 250 mg/day ) or placebo , plus best supportive care . The primary endpoint was survival in the overall population of patients and those with adenocarcinoma . The primary analysis of the population for survival was by intention to treat . This study has been submitted for registration with ClinicalTrials.gov , number 1839IL/709 . FINDINGS 1129 patients were assigned gefitinib and 563 placebo . At median follow-up of 7.2 months , median survival did not differ significantly between the groups in the overall population ( 5.6 months for gefitinib and 5.1 months for placebo ; hazard ratio 0.89 [ 95 % CI 0.77-1.02 ] , p=0.087 ) or among the 812 patients with adenocarcinoma ( 6.3 months vs 5.4 months ; 0.84 [ 0.68-1.03 ] , p=0.089 ) . Preplanned subgroup analyses showed significantly longer survival in the gefitinib group than the placebo group for never-smokers ( n=375 ; 0.67 [ 0.49-0.92 ] , p=0.012 ; median survival 8.9 vs 6.1 months ) and patients of Asian origin ( n=342 ; 0.66 [ 0.48-0.91 ] , p=0.01 ; median survival 9.5 vs 5.5 months ) . Gefitinib was well tolerated , as in previous studies . INTERPRETATION Treatment with gefitinib was not associated with significant improvement in survival in either coprimary population . There was pronounced heterogeneity in survival outcomes between groups of patients , with some evidence of benefit among never-smokers and patients of Asian origin .
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Intervention_Pharmacological
Gefitinib
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Intervention_Other
best supportive care
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Intervention_Control
placebo-controlled
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Intervention_Pharmacological
gefitinib
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Intervention_Pharmacological
gefitinib
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Intervention_Control
placebo
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Intervention_Pharmacological
gefitinib
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Outcome_Other
effect on survival
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Outcome_Mortality
survival
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Outcome_Mortality
survival
24389
Outcome_Mortality
median survival
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Outcome_Mortality
survival
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Outcome_Mortality
median survival
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Outcome_Mortality
median survival
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Outcome_Other
tolerated
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Outcome_Mortality
survival
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Outcome_Mortality
survival
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Participant_Condition
refractory advanced non-small-cell lung cancer :
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Participant_Condition
locally advanced or metastatic non-small-cell lung cancer
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Participant_Sample-size
1692
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Participant_Condition
refractory to or intolerant of their latest chemotherapy regimen
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Participant_Sample-size
1129
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Participant_Sample-size
563
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Participant_Sample-size
812