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Table 1 Patient characteristics

From: Efficacy and safety of afatinib in Chinese patients with EGFR-mutated metastatic non-small-cell lung cancer (NSCLC) previously responsive to first-generation tyrosine-kinase inhibitors (TKI) and chemotherapy: comparison with historical cohort using erlotinib

  Afatinib (n = 25) (%) Erlotinib (n = 28) (%) p-value
Age (range) 63 (42–85) 59 (36–80) 0.59
Sex (male/female) 11/14 10/18 0.54
ECOG    
  0 1 (4.0) 0 (0.0) 0.01
  1 12 (48.0) 24 (85.7)
  2 12 (48.0) 4 (14.3)
  0/1 vs. 2 13 (52.0) vs. 12 (48.0) 24 (85.7) vs. 4 (14.3) 0.008
Smoking status    0.88
  Never smokers 22 (88.0) 25 (89.3)
  Current or past smokers 3 (12.0) 3 (10.7)
Histology    0.31
  Adenocarcinoma 23 (92.0) 28 (100.0)
  Squamous cell carcinoma 1 (4.0) 0 (0.0)
  Bronchoalveolar carcinoma 1 (4.0) 0 (0.0)
Initial EGFR mutation status at diagnosis    0.79
  exon 18 mutation 0 1
  exon 19 deletion 11 13
  exon 19 substitution mutation 1 1
   L858R 8 10
   L861Q 0 2
  double mutations 1 1
EGFR mutation status with re-biopsy before afatinib or erlotinib    
T790M alone 4 unknown NA
Brain metastasis before afatinib or erlotinib 6 (24.0) 13 (46.4) 0.09
1st TKI therapy    NA
  Gefitinib 14 (56.0) 28 (100)  
  Erlotinib 11 (44.0) 0 (0)  
Median duration of therapy (months, range) 14.5 (3.52–40.64) 9.2 (2.63–24.61) 0.02
 Median Time to progression (months range) 13.9 (0.66–40.15) 9.1 (2.52–24.57) 0.14
 Best response    0.42
  CR 1 (4.0) 1 (3.6)
  PR 23 (92.0) 23 (82.1)
  SD 0 (0.0) 3 (10.7)
  PD 1 (4.0) 1 (3.6)
Number of lines of prior chemotherapy before afatinib or erlotinib    0.08
  1 14 (56.0) 22 (78.6)
  2 11 (44.0) 6 (21.4)
First-line chemotherapy before afatinib or erlotinib 25 (100) 28 (100) 0.88
   Pemetrexed + cisplatin 3 (12.0) 6 (21.4)
   Pemetrexed + carboplatin 9 (36.0) 7 (25.0)
   Paclitaxel + carboplatin 4 (16.0) 4 (14.3)
   Gemcitabine + carboplatin 5 (20.0) 5 (17.9)
   Carboplatin 2 (8.0) 2 (7.1)
   Pemetrexed 2 (8.0) 4 (14.3)
 Median duration of therapy (months, range) 3.50 (0.69–17.97) 2.96 (0.66–17.02) 0.85
 Median time to progression (months, range) 3.35 (0.69–17.97) 3.48 (0.85–16.95) 0.76
Second-line chemotherapy before afatinib or erlotinib 11 (44.0) 6 (21.4) 0.08
   Pemetrexed + carboplatin 1 (4.0) 0 (0.0)
   Paclitaxel + carboplatin 2 (8.0) 2 (7.1)
   Gemcitabine + carboplatin 5 (20.0) 4 (14.3)
   Docetaxel 1 (4.0) 0 (0.0)
   Vinorelbine 1 (4.0) 0 (0.0)
   Pemetrexed 1 (4.0) 0 (0.0)
Median duration of therapy (months, range) 2.30 (0.66–9.63) 2.92 (0.69–4.34) 0.91
Median time to progression (months, range) 3.09 (0.66–10.28) 3.25 (0.72–4.44) 0.74
Median time interval between 1st TKI therapy and afatinib or erlotinib (months, range) 8.38 (2.30–54.28) 6.39 (2.56–20.07) 0.15
Median time interval between last chemotherapy and afatinib or erlotinib (months, range) 2.79 (0.46–34.28) 2.58 (0.23–17.05) 0.49
  1. Abbreviations: CR complete response, EGFR epidermal growth factor receptor, NA not applicable, PD progressive disease, PR partial response, SD stable disease, TKI tyrosine-kinase inhibitor