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. 2017 Nov 27;9:147–157. doi: 10.2147/CPAA.S112715

Table 1.

Afatinib evaluations in lung SqCC in cited studies

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.