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Clinical Trial
. 2017 Feb 1;28(2):270-277.
doi: 10.1093/annonc/mdw611.

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

L Paz-Ares  1 , E-H Tan  2 , K O'Byrne  3 , L Zhang  4 , V Hirsh  5 , M Boyer  6 , J C-H Yang  7 , T Mok  8 , K H Lee  9 , S Lu  10 , Y Shi  11 , D H Lee  12 , J Laskin  13 , D-W Kim  14 , S A Laurie  15 , K Kölbeck  16 , J Fan  17 , N Dodd  18 , A Märten  19 , K Park  20
Affiliations
Clinical Trial

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

L Paz-Ares et al. Ann Oncol. .

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.

Keywords: NSCLC; afatinib; gefitinib; overall survival.

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Figures

Figure 1
Figure 1
Overall survival. Kaplan–Meier curve (A) and forest plot of pre-specified subgroup analyses (B). CI, confidence interval; ECOG, Eastern Cooperative Oncology Group; EGFR, epidermal growth factor receptor; HR, hazard ratio.
Figure 2
Figure 2
Overall survival in patients with common EGFR mutations. Patients with exon 19 deletion (A) and patients with L858R mutation (B). CI, confidence interval; EGFR, epidermal growth factor receptor; HR, hazard ratio.
Figure 3
Figure 3
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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