Table 1.
Study | Design | Patients (n) | Histology | EGFR mutation | Afatinib dose | Control arm | Results |
---|---|---|---|---|---|---|---|
LUX-Lung 548 | Phase III | 1,154 | Adenocarcinoma/squamous cell carcinoma | Not required | Part A: 50 mg/d Part B: 40 mg/d + paclitaxel |
Part A: none Part B: investigator’s choice |
PFS: 5.6 versus 2.8 months (P=0.003) (analysis of 202 patients) |
LUX-Lung 835 | Phase III | 795 | Squamous cell carcinoma | Not required | 40 mg/d | Erlotinib | PFS: 2.4 versus 1.9 months (P=0.042) |
LUX-Lung 8, VeriStrat evaluation7 | Retrospective | 795 | Squamous cell carcinoma | Not required | 40 mg/d | Erlotinib | 675 were classified: VS-G: 412, VS-P: 263 OS in VS-G Afatinib versus erlotinib: HR 0.79, 95% CI: 0.63–0.98 OS in VS-P Afatinib versus erlotinib: HR 0.90, 95% CI 0.70–1.16 OS in VS-G versus VS-P patients in overall VS-classified population: HR 0.41, 95% CI 0.35–0.49 |
LUX-Lung 8, symptoms and QoL61 | Prospective | 795 | Squamous cell carcinoma | Not required | 40 mg/d | Erlotinib | Questionnaire compliance: Afatinib, 77.3–99% Erlotinib, 68.7–99% Improved scores for GHS/QoL (P=0.041): Afatinib: 36% Erlotinib: 28%; Improved scores for cough (P=0.029) Afatinib: 43% Erlotinib 35% |
Abbreviations: CI, confidence interval; EGFR, epidermal growth factor receptor; GHS, global health status; HR, hazard ratio; OS, overall survival; PFS, progression-free survival; QoL, quality of life; SqCC, squamous cell carcinoma; VS-G, VeriStrat-good; VS-P, VeriStrat-poor.