Table 1.
Characteristic | Overall population (N=364)
|
Chinese patients (N=327)
|
||
---|---|---|---|---|
Afatinib (n=242) |
Gem/Cis (n=122) |
Afatinib (n=217) |
Gem/Cis (n=110) |
|
Sex, n (%) | ||||
Female | 155 (64.0) | 83 (68.0) | 136 (62.7) | 76 (69.1) |
Male | 87 (36.0) | 39 (32.0) | 81 (37.3) | 34 (30.9) |
Median age, years (range) | 58 (29–79) | 58 (27–76) | 58 (30–78) | 58 (27–75) |
Race/ethnicity,a n (%) | ||||
Southeast Asian | 14 (5.8) | 10 (8.2) | 0 | 0 |
South Korean | 11 (4.5) | 2 (1.6) | 0 | 0 |
Chinese | 217 (89.7) | 110 (90.2) | 217 (100) | 110 (100) |
ECOG performance status, n (%) | ||||
0 | 48 (19.8) | 41 (33.6) | 44 (20.3) | 40 (36.4) |
1 | 194 (80.2) | 81 (66.4) | 173 (79.7) | 70 (63.6) |
Smoking status, n (%) | ||||
Never smoked | 181 (74.8) | 99 (81.1) | 159 (73.3) | 92 (83.6) |
Other current or ex-smoker | 53 (21.9) | 19 (15.6) | 50 (23.0) | 15 (13.6) |
<15 pack-years and stopped >1 year ago | 8 (3.3) | 4 (3.3) | 8 (3.7) | 3 (2.7) |
Adenocarcinoma stage, n (%) | ||||
IIIB | 16 (6.6) | 6 (4.9) | 13 (6.0) | 6 (5.5) |
IV | 226 (93.4) | 116 (95.1) | 204 (94.0) | 104 (94.5) |
Number of metastatic sites, n (%) | ||||
0 | 5 (2.1) | 1 (0.8) | 3 (1.4) | 1 (0.9) |
1 | 72 (29.8) | 52 (42.6) | 65 (30.0) | 48 (43.6) |
2 | 91 (37.6) | 36 (29.5) | 84 (38.7) | 30 (27.3) |
≥3 | 74 (30.6) | 33 (27.0) | 65 (30.0) | 31 (28.2) |
EGFR mutation, n (%) | ||||
Common mutations | 216 (89.3) | 108 (88.5) | 193 (88.9) | 97 (88.2) |
Del19 | 124 (51.2) | 62 (50.8) | 111 (51.2) | 55 (50.0) |
L858R | 92 (38.0)b | 46 (37.7) | 82 (37.8)b | 42 (38.2) |
Uncommon mutationsc | 26 (10.7) | 14 (11.5) | 24 (11.1) | 13 (11.8) |
Notes:
Available categories within Asian race included Indian subcontinent Asian, Southeast Asian, Japanese, Korean, Taiwanese or Chinese, Asian – other.
Including four patients with both L858R and Del19 mutation.
Including T790M, exon 20 insertions, G719X, S768I, and L861Q, alone or as complex mutations in two or more exons.
Abbreviations: Cis, cisplatin; ECOG, Eastern Cooperative Oncology Group; EGFR, epidermal growth factor receptor; Gem, gemcitabine.