Table 1.
Baseline Patient and Disease Characteristics (Safety Analysis Population)
| Characteristics | Crizotinib |
|||||||
|---|---|---|---|---|---|---|---|---|
| By Country |
By Number of Previous Regimens |
|||||||
| Total (N = 127) | People’s Republic of China (n = 74) | Japan (n = 26) | South Korea or Taiwan (n = 27) | 0 (n = 24) | 1 (n = 53) | 2 (n = 31) | 3 (n = 19) | |
| Median age, y (min, max) | 51.5 (22.8, 79.7) | 49.5 (22.8, 79.7) | 56.3 (30.2, 79.1) | 52.7 (33.8, 73.8) | 57.6 (26.7, 79.7) | 49.1 (22.8, 79.1) | 57.7 (33.8, 76.3) | 50.6 (38.4, 75.4) |
| Sex, n (%) | ||||||||
| Male | 54 (42.5) | 34 (45.9) | 10 (38.5) | 10 (37.0) | 12 (50.0) | 20 (37.7) | 15 (48.4) | 7 (36.8) |
| Female | 73 (57.5) | 40 (54.1) | 16 (61.5) | 17 (63.0) | 12 (50.0) | 33 (62.3) | 16 (51.6) | 12 (63.2) |
| History of smoking, n (%) | 36 (28.3) | 19 (25.7) | 10 (38.5) | 7 (25.9) | 6 (25.0) | 18 (34.0) | 9 (29.0) | 3 (15.8) |
| ECOG PS, n (%) | ||||||||
| 0 | 34 (26.8) | 9 (12.2) | 10 (38.5) | 15 (55.6) | 4 (16.7) | 19 (35.8) | 8 (25.8) | 3 (15.8) |
| 1 | 93 (73.2) | 65 (87.8) | 16 (61.5) | 12 (44.4) | 20 (83.3) | 34 (64.2) | 23 (74.2) | 16 (84.2) |
| Histologic classification, n (%) | ||||||||
| Adenocarcinoma | 124 (97.6) | 71 (95.9) | 26 (100.0) | 27 (100.0) | NA | NA | NA | NA |
| Squamous cell carcinoma | 1 (0.8) | 1 (1.4) | 0 | 0 | ||||
| Other | 2 (1.6) | 2 (2.7) | 0 | 0 | ||||
| Extent of disease, n (%) | ||||||||
| Locally advanced only | 6 (4.7) | 4 (5.4) | 0 | 2 (7.4) | NA | NA | NA | NA |
| Metastatic | 121 (95.3) | 70 (94.6) | 26 (100) | 25 (92.6) | ||||
| Number of previous regimens, n (%) | ||||||||
| 0 | 24 (18.9) | 18 (24.3) | 2 (7.7) | 4 (14.8) | NA | NA | NA | NA |
| 1 | 53 (41.7) | 27 (36.5) | 14 (53.8) | 12 (44.4) | ||||
| 2 | 31 (24.4) | 17 (23.0) | 6 (23.1) | 8 (29.6) | ||||
| 3 | 19 (15.0) | 12 (16.2) | 4 (15.4) | 3 (11.1) | ||||
ECOG PS, Eastern Cooperative Oncology Group performance status; max, maximum; min, minimum; NA, not available.