Afatinib is a selective, orally
bioavailable, irreversible ErbB family blocker of EGFR (ErbB1), HER2 (ErbB2),
and ErbB4．
対象
308 participants with the exon 19 deletion
or the exon 21 L858R mutation
chemotherapy-naïve patients
Afatinib群と標準治療群（PTX+PEM）に割り付けた．
Afatinib: 40 mg daily
PTX+PEM: pemetrexed 500 mg/m2 plus
cisplatin 75 mg/m2 every 21 days for up
to 6 cycles
65% of the cohort was female, 72% was
Asian, 68% had never smoked, 49% had the exon 19 deletion, 40% had the exon 21
L858R mutation, and 11% had other mutations
結果
8ヵ月の追跡期間中央値で
標準治療群と比較し、afatinib群は4ヵ月以上疾患進行を遅延させる（中央値、11.1対6.9ヵ月;
HR 0.58; 95% CI,0.43～0.78; P = .0004).
PFSはafatinib群で著明に延長した (13.6 vs 6.9 months; HR, 0.47; 95% CI, 0.34 to 0.65; P < .0001).
objective response rate：
56% vs. 23%; P < .0001
significant delay in the time to
deterioration of cancer-related symptoms of cough HR, (0.60; P = .0072) and
dyspnea (HR, 0.68; P = .0145).
afatinibによる最も頻度の高い有害事象は、下痢（95%）、発疹（62%）と爪周囲炎（57%）であった．
標準的治療で、最も頻度が高い有害事象は、嘔気（66%）、食欲不振（53%）と嘔吐（42%）であった．
