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Afatinib versus gefitinib in patients with EGFR mutation-positive advanced non-small-cell lung cancer: overall survival data from the phase IIb LUX-Lung 7 trial

View Article: PubMed Central - PubMed

ABSTRACT

Background: In LUX-Lung 7, the irreversible ErbB family blocker, afatinib, significantly improved progression-free survival (PFS), time-to-treatment failure (TTF) and objective response rate (ORR) versus gefitinib in patients with epidermal growth factor receptor (EGFR) mutation-positive non-small-cell lung cancer (NSCLC). Here, we present primary analysis of mature overall survival (OS) data.

Patients and methods: LUX-Lung 7 assessed afatinib 40 mg/day versus gefitinib 250 mg/day in treatment-naïve patients with stage IIIb/IV NSCLC and a common EGFR mutation (exon 19 deletion/L858R). Primary OS analysis was planned after ∼213 OS events and ≥32-month follow-up. OS was analysed by a Cox proportional hazards model, stratified by EGFR mutation type and baseline brain metastases.

Results: Two-hundred and twenty-six OS events had occurred at the data cut-off (8 April 2016). After a median follow-up of 42.6 months, median OS (afatinib versus gefitinib) was 27.9 versus 24.5 months [hazard ratio (HR) = 0.86, 95% confidence interval (CI) 0.66‒1.12, P = 0.2580]. Prespecified subgroup analyses showed similar OS trends (afatinib versus gefitinib) in patients with exon 19 deletion (30.7 versus 26.4 months; HR, 0.83, 95% CI 0.58‒1.17, P = 0.2841) and L858R (25.0 versus 21.2 months; HR 0.91, 95% CI 0.62‒1.36, P = 0.6585) mutations. Most patients (afatinib, 72.6%; gefitinib, 76.8%) had at least one subsequent systemic anti-cancer treatment following discontinuation of afatinib/gefitinib; 20 (13.7%) and 23 (15.2%) patients received a third-generation EGFR tyrosine kinase inhibitor. Updated PFS (independent review), TTF and ORR data were significantly improved with afatinib.

Conclusion: In LUX-Lung 7, there was no significant difference in OS with afatinib versus gefitinib. Updated PFS (independent review), TTF and ORR data were significantly improved with afatinib.

Clinicaltrials.gov identifier: NCT01466660.

No MeSH data available.


Overall survival in patients subsequently treated with a third-generation EGFR TKI following discontinuation of study treatment. CI, confidence interval; EGFR, epidermal growth factor receptor; HR, hazard ratio; TKIs, tyrosine kinase inhibitors.
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mdw611-F3: Overall survival in patients subsequently treated with a third-generation EGFR TKI following discontinuation of study treatment. CI, confidence interval; EGFR, epidermal growth factor receptor; HR, hazard ratio; TKIs, tyrosine kinase inhibitors.

Mentions: In a post-hoc analysis, median OS with afatinib versus gefitinib in patients who received a third-generation EGFR TKI following discontinuation of study treatment was ‘not evaluable’ versus 46.0 months (HR 0.51, 95% CI 0.17‒1.52, P = 0.22; Figure 3).Figure 3


Afatinib versus gefitinib in patients with EGFR mutation-positive advanced non-small-cell lung cancer: overall survival data from the phase IIb LUX-Lung 7 trial
Overall survival in patients subsequently treated with a third-generation EGFR TKI following discontinuation of study treatment. CI, confidence interval; EGFR, epidermal growth factor receptor; HR, hazard ratio; TKIs, tyrosine kinase inhibitors.
© Copyright Policy - cc-by-nc
Related In: Results  -  Collection

License
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getmorefigures.php?uid=PMC5391700&req=5

mdw611-F3: Overall survival in patients subsequently treated with a third-generation EGFR TKI following discontinuation of study treatment. CI, confidence interval; EGFR, epidermal growth factor receptor; HR, hazard ratio; TKIs, tyrosine kinase inhibitors.
Mentions: In a post-hoc analysis, median OS with afatinib versus gefitinib in patients who received a third-generation EGFR TKI following discontinuation of study treatment was ‘not evaluable’ versus 46.0 months (HR 0.51, 95% CI 0.17‒1.52, P = 0.22; Figure 3).Figure 3

View Article: PubMed Central - PubMed

ABSTRACT

Background: In LUX-Lung 7, the irreversible ErbB family blocker, afatinib, significantly improved progression-free survival (PFS), time-to-treatment failure (TTF) and objective response rate (ORR) versus gefitinib in patients with epidermal growth factor receptor (EGFR) mutation-positive non-small-cell lung cancer (NSCLC). Here, we present primary analysis of mature overall survival (OS) data.

Patients and methods: LUX-Lung 7 assessed afatinib 40 mg/day versus gefitinib 250 mg/day in treatment-naïve patients with stage IIIb/IV NSCLC and a common EGFR mutation (exon 19 deletion/L858R). Primary OS analysis was planned after ∼213 OS events and ≥32-month follow-up. OS was analysed by a Cox proportional hazards model, stratified by EGFR mutation type and baseline brain metastases.

Results: Two-hundred and twenty-six OS events had occurred at the data cut-off (8 April 2016). After a median follow-up of 42.6 months, median OS (afatinib versus gefitinib) was 27.9 versus 24.5 months [hazard ratio (HR) = 0.86, 95% confidence interval (CI) 0.66‒1.12, P = 0.2580]. Prespecified subgroup analyses showed similar OS trends (afatinib versus gefitinib) in patients with exon 19 deletion (30.7 versus 26.4 months; HR, 0.83, 95% CI 0.58‒1.17, P = 0.2841) and L858R (25.0 versus 21.2 months; HR 0.91, 95% CI 0.62‒1.36, P = 0.6585) mutations. Most patients (afatinib, 72.6%; gefitinib, 76.8%) had at least one subsequent systemic anti-cancer treatment following discontinuation of afatinib/gefitinib; 20 (13.7%) and 23 (15.2%) patients received a third-generation EGFR tyrosine kinase inhibitor. Updated PFS (independent review), TTF and ORR data were significantly improved with afatinib.

Conclusion: In LUX-Lung 7, there was no significant difference in OS with afatinib versus gefitinib. Updated PFS (independent review), TTF and ORR data were significantly improved with afatinib.

Clinicaltrials.gov identifier: NCT01466660.

No MeSH data available.