Table 1. Clinical characteristics and comparison of patient groups according to afatinib treatment in the first 6 months.
| Characteristic | Afatinib-treated patients in the first 6 months | P-value | ||
|---|---|---|---|---|
| All (n = 140) | 40 mg (n = 81) | < 40 mg (n = 59) | ||
| Age (years), median (range) | 61 (28–87) | 61 (28–82) | 63 (33–87) | |
| Sex, n (%) | 0.060 | |||
| M | 53 (37.9) | 36 (44.4) | 17 (28.8) | |
| F | 87 (62.1) | 45 (55.6) | 42 (71.2) | |
| Smoking status, n (%) | 0.450 | |||
| Never smoked | 98 (70.0) | 54 (66.7) | 44 (74.6) | |
| Ex-smokera | 19 (13.6) | 11 (13.6) | 8 (13.5) | |
| Current smoker | 23 (16.4) | 16 (19.7) | 7 (11.9) | |
| BMI, mean (SD)b | 23.4 (3.2) | 23.8 (3.2) | 22.8 (3.1) | 0.058 |
| BSA, mean (SD)c | 1.62(0.14) | 1.65(0.17) | 1.58(0.14) | 0.067 |
| Weight loss at diagnosis, n(%) | 0.661 | |||
| ≤10.0% | 109 (77.9) | 62 (76.5) | 47 (79.7) | |
| > 10.0%d | 31 (22.1) | 19 (23.5) | 12 (20.3) | |
| Baseline ECOG PS, n(%) | 0.527 | |||
| 0–1 | 129 (92.1) | 76 (93.8) | 53 (89.8) | |
| 2–4 | 11 (7.9) | 5 (6.2) | 6 (10.2) | |
| cStage at screening, n(%) | > 0.999 | |||
| Stage IIIB | 4 (2.9) | 2 (2.5) | 2 (3.4) | |
| Stage IV | 136 (97.1) | 79 (97.5) | 57 (96.6) | |
| Metastatic site at screening, n(%) | ||||
| Lung | 73 (52.1) | 39 (48.1) | 34 (57.6) | 0.268 |
| Bone | 48 (34.3) | 29 (35.8) | 19 (32.2) | 0.658 |
| Brain | 42 (30.0) | 24 (29.6) | 18 (30.5) | 0.911 |
| Liver | 12 (8.6) | 7 (8.6) | 5 (8.5) | 0.972 |
| Adrenal glands | 9 (6.4) | 4 (4.9) | 5 (8.5) | 0.493 |
| Other | 15 (10.7) | 7 (8.6) | 8 (13.6) | 0.353 |
| EGFR mutation status,n (%) | 0.006* | |||
| Group 1 (classical mutation[s]) | 108 (77.1) | 70 (86.4) | 38 (64.4) | |
| 19DEL | 81 (57.9) | 50 (61.7) | 31 (52.5) | |
| p.L858R | 24 (17.1) | 18 (22.3) | 6 (10.2) | |
| p.L858R and 19DEL | 3 (2.1) | 2 (2.5) | 1 (1.7) | |
| Group 2 (complex mutation with classical mutation) | 6 (4.3) | 3 (3.7) | 3 (5.1) | |
| p.L858R and p.T790M | 4 (2.9) | 2 (2.5) | 2 (3.4) | |
| Other | 2 (1.4) | 1 (1.2) | 1 (1.7) | |
| Group 3 (Rare mutation with or without complex mutation) | 26 (18.6) | 8 (9.9) | 18 (30.5) | |
| p.L861Q | 10 (7.1) | 1 (1.2) | 9 (15.2) | |
| p.G719A | 6 (4.3) | 3 (3.7) | 3 (5.1) | |
| 20-INS | 4 (2.9) | 0 (0.0) | 4 (6.8) | |
| p.G719A and p.T790M/Other | 6 (4.3) | 4 (4.9) | 2 (3.4) | |
* P < 0.05
aCeased smoking > 1 year before diagnosis
bBMI = body weight (kg)/body height (m)2
cBSA= [body Height (cm) x body weight (kg)/ 3600 ]½
dSignificant weight loss of >10.0% within 6 months of diagnosis
BMI, body mass index; BSA, body surface area; cStage, clinical stage; DEL, deletion; ECOG, Eastern Cooperative Oncology Group; F, female; INS, insertion; M, male; PS, performance status; SD, standard deviation