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Randomized open-label non-comparative multicenter phase II trial of sequential erlotinib and docetaxel versus docetaxel alone in patients with non-small-cell lung cancer after failure of first-line chemotherapy : GFPC 10.02 study . BACKGROUND Concomitant administration of erlotinib with standard chemotherapy does not appear to improve survival among patients with non-small-cell lung cancer ( NSCLC ) , but preliminary studies suggest that sequential administration might be effective . OBJECTIVE To assess the efficacy and tolerability of second-line sequential administration of erlotinib and docetaxel in advanced NSCLC . METHODS In an open-label phase II trial , patients with advanced NSCLC , EGFR wild-type or unknown , PS 0-2 , in whom initial cisplatin-based chemotherapy had failed were randomized to sequential erlotinib 150 mg/d ( day 2-16 ) +docetaxel ( 75 mg/m ( 2 ) d1 ) ( arm ED ) or docetaxel ( 75 mg/m ( 2 ) d1 ) alone ( arm D ) ( 21-day cycle ) . The primary endpoint was the progression-free survival rate at 15 weeks ( PFS 15 ) . Secondary endpoints included PFS , overall survival ( OS ) , the overall response rate ( ORR ) and tolerability . Based on a Simon optimal two-stage design , the ED strategy was rejected if the primary endpoint was below 33/66 patients at the end of the two Simon stages . RESULTS 147 patients were randomized ( median age : 60±8 years , PS 0/1/2 : 44/83/20 patients ; males : 78 % ) . The ED strategy was rejected , with only 18 of 73 patients achieving PFS15 in arm ED at the end of stage 2 and 17 of 74 patients in arm D. In arms ED and D , respectively , median PFS was 2.2 and 2.5 months and median OS was 6.5 and 8.3 months . CONCLUSION Sequential erlotinib and docetaxel was not more effective than docetaxel alone as second-line treatment for advanced NSCLC with wild-type or unknown EGFR status .
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Intervention_Pharmacological
erlotinib and docetaxel versus docetaxel alone
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Intervention_Physical
Concomitant administration of erlotinib with standard chemotherapy
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Intervention_Pharmacological
erlotinib and docetaxel
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Intervention_Pharmacological
sequential erlotinib 150 mg/d ( day 2-16 ) +docetaxel ( 75 mg/m ( 2 ) d1 ) ( arm ED )
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Intervention_Pharmacological
docetaxel ( 75 mg/m ( 2 ) d1 ) alone
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Intervention_Physical
ED
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Outcome_Mortality
survival
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Outcome_Other
efficacy and tolerability
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Outcome_Mortality
progression-free survival rate
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Outcome_Mortality
PFS
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Outcome_Mortality
overall survival ( OS ) ,
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Outcome_Mental
overall response rate ( ORR
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Outcome_Other
tolerability
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Participant_Condition
non-small-cell lung cancer
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Participant_Condition
non-small-cell lung cancer ( NSCLC )
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Participant_Condition
advanced NSCLC
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Participant_Sample-size
147
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Participant_Age
60±8 years ,
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Participant_Sex
males