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document
Gefitinib versus placebo in completely resected non-small-cell lung cancer : results of the NCIC CTG BR19 study . PURPOSE Survival of patients with completely resected non-small-cell lung cancer ( NSCLC ) is unsatisfactory , and in 2002 , the benefit of adjuvant chemotherapy was not established . This phase III study assessed the impact of postoperative adjuvant gefitinib on overall survival ( OS ) . PATIENTS AND METHODS Patients with completely resected ( stage IB , II , or IIIA ) NSCLC stratified by stage , histology , sex , postoperative radiotherapy , and chemotherapy were randomly assigned ( 1:1 ) to receive gefitinib 250 mg per day or placebo for 2 years . Study end points were OS , disease-free survival ( DFS ) , and toxicity . RESULTS As a result of early closure , 503 of 1,242 planned patients were randomly assigned ( 251 to gefitinib and 252 to placebo ) . Baseline factors were balanced between the arms . With a median of 4.7 years of follow-up ( range , 0.1 to 6.3 years ) , there was no difference in OS ( hazard ratio [ HR ] , 1.24 ; 95 % CI , 0.94 to 1.64 ; P = .14 ) or DFS ( HR , 1.22 ; 95 % CI , 0.93 to 1.61 ; P = .15 ) between the arms . Exploratory analyses demonstrated no DFS ( HR , 1.28 ; 95 % CI , 0.92 to 1.76 ; P = .14 ) or OS benefit ( HR , 1.24 ; 95 % CI , 0.90 to 1.71 ; P = .18 ) from gefitinib for 344 patients with epidermal growth factor receptor ( EGFR ) wild-type tumors . Similarly , there was no DFS ( HR , 1.84 ; 95 % CI , 0.44 to 7.73 ; P = .395 ) or OS benefit ( HR , 3.16 ; 95 % CI , 0.61 to 16.45 ; P = .15 ) from gefitinib for the 15 patients with EGFR mutation-positive tumors . Adverse events were those expected with an EGFR inhibitor . Serious adverse events occurred in ≤ 5 % of patients , except infection , fatigue , and pain . One patient in each arm had fatal pneumonitis . CONCLUSION Although the trial closed prematurely and definitive statements regarding the efficacy of adjuvant gefitinib can not be made , these results indicate that it is unlikely to be of benefit .
61015
Intervention_Pharmacological
Gefitinib
61016
Intervention_Control
placebo
61017
Intervention_Pharmacological
gefitinib
61018
Intervention_Pharmacological
gefitinib 250 mg per day or placebo
61019
Intervention_Pharmacological
gefitinib
61020
Intervention_Control
placebo
61021
Intervention_Pharmacological
gefitinib
61022
Intervention_Pharmacological
gefitinib
61023
Outcome_Mortality
overall survival ( OS ) .
61024
Outcome_Mortality
OS
61025
Outcome_Mortality
disease-free survival ( DFS )
61026
Outcome_Other
toxicity
61027
Outcome_Mortality
OS
61028
Outcome_Mortality
DFS
61029
Outcome_Mortality
DFS
61030
Outcome_Mortality
OS benefit
61031
Outcome_Mortality
DFS
61032
Outcome_Mortality
OS
61033
Outcome_Adverse-effects
Adverse events
61034
Outcome_Adverse-effects
Serious adverse events
61035
Participant_Condition
completely resected non-small-cell lung cancer ( NSCLC )
61036
Participant_Sample-size
503 of 1,242
61037
Participant_Sample-size
344 patients