Table 2.
Baseline demographics and disease characteristics of patients with ALK‐positive NSCLC in crizotinib clinical trials
| PROFILE 100112,a (phase I) | PROFILE 100513,b (phase II) | PROFILE 100710,c (phase III) | ||
|---|---|---|---|---|
| Characteristics | Crizotinib (n = 149) | Crizotinib (n = 261) | Crizotinib (n = 173)d | Chemotherapy (n = 174) |
| Males, no. (%) | 73 (49) | 119 (46) | 75 (43) | 78 (45) |
| Median age, y (range) | 52 (21–86) | 52 (24–82) | 51 (22–81) | 49 (24–85) |
| Race, no. (%) | ||||
| White | 95 (64) | 154 (59) | 90 (52) | 91 (52) |
| Asian | 41 (28) | 94 (36) | 79 (46) | 78 (45) |
| Other | 13 (9) | 13 (5) | 4 (2) | 5 (3) |
| Smoking status, no. (%) | ||||
| Never | 106 (71) | 176 (67) | 108 (62) | 111 (64) |
| Former | 42 (28) | 73 (28) | 59 (34) | 54 (31) |
| Current | 1 (<1) | 12 (5) | 5 (3) | 9 (5) |
| Histology, no. (%) | ||||
| Adenocarcinoma | 144 (97) | 245 (94) | 164 (95) | 164 (94) |
| ECOG performance status, no. (%) | ||||
| 0 | 56 (38) | 68 (26) | 72 (42) | 65 (37) |
| 1 | 75 (50) | 148 (57) | 84 (49) | 95 (55) |
| ≥2e | 18 (12) | 45 (17) | 16 (9) | 14 (8) |
| No. of previous regimens for advanced or metastatic disease, no. (%) | ||||
| 0 | 24 (16) | 0 | 2 (1) | 5 (3) |
| 1 | 47 (32) | 32 (12) | 155 (90) | 150 (86) |
| 2 | 31 (21) | 91 (35) | 14 (8) | 19 (11) |
| ≥3 | 47 (32) | 138 (53) | 1 (<1) | 0 |
ALK, anaplastic lymphoma kinase; ECOG, Eastern Cooperative Oncology Group; NSCLC, non‐small cell lung cancer.
a
As of June 2011.
b
As of January 2012.
c
As of March 2012.
d
Smoking status, ECOG performance status, and previous regimen data missing for 1 patient each.
e
ECOG performance status 2 for PROFILE 1007.