Table 1.
Baseline characteristics according to whether patients treated with dacomitinib experienced a grade ≥2 skin-related adverse event.
| Grade ≥2 skin-related AE (n = 164) | No grade ≥2 skin-related AE (n = 63) | |
|---|---|---|
| Age, median (range), years | 62.0 (28–87) | 61.5 (28–81) |
| <65, n (%) | 94 (57.3) | 39 (61.9) |
| ≥65, n (%) | 70 (42.7) | 24 (38.1) |
| Sex, n (%) | ||
| Female | 113 (68.9) | 33 (52.4) |
| Male | 51 (31.1) | 30 (47.6) |
| Race, n (%) | ||
| Asian | 126 (76.8) | 44 (69.8) |
| Chinese | 74 (45.1) | 40 (63.5) |
| Japanese | 38 (23.2) | 2 (3.2) |
| Other East Asian | 14 (8.5) | 2 (3.2) |
| White | 38 (23.2) | 18 (28.6) |
| Black | 0 | 1 (1.6) |
| ECOG performance status, n (%) | ||
| 0 | 62 (37.8) | 13 (20.6) |
| 1 | 102 (62.2) | 50 (79.4) |
| Disease stage at screening, n (%) | ||
| Stage IIIB | 14 (8.5) | 3 (4.8) |
| Stage IV | 145 (88.4) | 58 (92.1) |
| Unknowna | 5 (3.0) | 2 (3.2) |
| Smoking status, n (%) | ||
| Never smoked | 111 (67.7) | 36 (57.1) |
| Former smoker | 44 (26.8) | 21 (33.3) |
| Current smoker | 9 (5.5) | 6 (9.5) |
| Type of EGFR mutationb, n (%) | ||
| Exon19 deletionc | 98 (59.8) | 36 (57.1) |
| Leu858Arg | 66 (40.2) | 27 (42.9) |
a
Newly diagnosed with stage IV disease at the time of study entry.
b
EGFR mutations (at randomization) were identified from tumor specimens.
c
At randomization, no patients in the dacomitinib group had the Thr790Met mutation.
AE: Adverse event; ECOG: Eastern Cooperative Oncology Group; EGFR: Epidermal growth factor receptor.