38994
document
A randomized , phase II trial of two dose schedules of carboplatin/paclitaxel/cetuximab in stage IIIB/IV non-small-cell lung cancer ( NSCLC ) . BACKGROUND This trial investigated the efficacy and safety of weekly cetuximab combined with two different schedules of paclitaxel/carboplatin for stage IIIB/IV non-small-cell lung cancer ( NSCLC ) . METHODS A total of 168 patients with previously untreated stage IIIB/IV NSCLC were randomized to arm A , cetuximab ( 400 mg/m ( 2 ) day 1 followed by weekly 250 mg/m ( 2 ) ) + paclitaxel ( Taxol ) ( 225 mg/m ( 2 ) ) /carboplatin ( AUC6 ) day 1 every 3 weeks or arm B , same cetuximab regimen plus paclitaxel ( 100 mg/m ( 2 ) ) days 1 , 8 , and 15 every 3 weeks and carboplatin ( AUC6 ) day 1 every 4 weeks . Treatment continued for a four-cycle maximum . Patients with a complete response , partial response , or stable disease after four cycles could receive cetuximab 250 mg/m ( 2 ) /week until disease progression or unacceptable toxicity . The primary end point was to evaluate progression-free survival ( PFS ) . RESULTS Median PFS was 4.7 and 4.3 months for arms A and B , respectively ( 6-month PFS , 27.3 % versus 30.9 % ) . Median overall survival was 11.4 versus 9.8 months for arms A and B , respectively ; estimated 1-year survival , 47.7 % versus 39.3 % ; and objective response rate , 29.6 % versus 25 % . The regimen was well tolerated with rash and hematologic toxicity being most common . CONCLUSIONS This study did not meet the prespecified benchmark of 35 % 6-month PFS rate ; both combination schedules of cetuximab plus paclitaxel/carboplatin were feasible and equivalent for treating advanced NSCLC .
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Intervention_Pharmacological
carboplatin/paclitaxel/cetuximab
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Intervention_Pharmacological
cetuximab combined with two different schedules of paclitaxel/carboplatin
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Intervention_Pharmacological
cetuximab
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Intervention_Pharmacological
paclitaxel
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Intervention_Pharmacological
mg/m ( 2 ) ) /carboplatin ( AUC6 )
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Intervention_Pharmacological
cetuximab regimen plus paclitaxel
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Intervention_Pharmacological
and carboplatin
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Intervention_Pharmacological
cetuximab
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Intervention_Pharmacological
cetuximab plus paclitaxel/carboplatin
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Outcome_Other
efficacy and safety
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Outcome_Physical
disease progression or unacceptable toxicity
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Outcome_Mortality
progression-free survival ( PFS )
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Outcome_Physical
PFS
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Outcome_Mortality
Median overall survival
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Outcome_Other
tolerated
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Outcome_Physical
rash and hematologic toxicity
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Participant_Condition
non-small-cell lung cancer
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Participant_Condition
stage IIIB/IV non-small-cell lung cancer ( NSCLC )
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Participant_Sample-size
168 patients
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Participant_Condition
advanced NSCLC