Table 1.
Clinical characteristics for patients with tissue samples evaluable for EGFR gene copy number by FISH compared with the overall study population
| Patients with EGFR FISH results | All patients | |||
|---|---|---|---|---|
| Placebo (n = 124) | Erlotinib (n = 121) | Placebo (n = 540) | Erlotinib (n = 539) | |
| Age (y) | ||||
| Median | 65 | 64 | 63 | 63 |
| Range | 36–82 | 24–81 | 26–84 | 24–84 |
| Sex | ||||
| Male | 74 (59.7) | 65 (53.7) | 332 (61.6) | 322 (59.7) |
| Female | 50 (40.3) | 56 (46.3) | 207 (38.4) | 217 (40.3) |
| Ethnicity | ||||
| Caucasian | 117 (94.4) | 103 (81.1) | 482 (89.4) | 452 (83.9) |
| Asian or Pacific Islander | 3 (2.4) | 4 (3.3) | 13 (2.4) | 21 (3.9) |
| Other | 4 (3.2) | 14 (11.5) | 44 (8.1) | 66 (12.2) |
| Smoking history | ||||
| Never | 7 (5.6) | 12 (9.9) | 44 (8.2) | 72 (13.4) |
| Current | 19 (15.3) | 19 (15.7) | 106 (19.7) | 100 (18.6) |
| Previous | 98 (79.0) | 90 (74.4) | 389 (72.2) | 367 (68.1) |
| Baseline ECOG | ||||
| 0 | 43 (34.7) | 47 (38.8) | 195 (36.2) | 186 (34.5) |
| 1 | 81 (65.3) | 74 (61.2) | 342 (63.6) | 353 (65.5) |
| 2 | (0.0) | (0.0) | 1 (0.2) | (0.0) |
| Prior radiotherapy | ||||
| Yes | 29 (23.4) | 32 (26.4) | 119 (22.1) | 118 (21.9) |
| No | 95 (76.6) | 89 (73.6) | 419 (77.9) | 421 (78.1) |
| Cancer type | ||||
| Metastatic disease | 105 (84.7) | 111 (91.7) | 444 (82.4) | 456 (84.6) |
| Local advanced disease | 19 (15.3) | 10 (8.3) | 95 (17.6) | 83 (15.4) |
| Months since initial NSCLC diagnosis | ||||
| <6 | 97 (78.2) | 106 (87.6) | 476 (88.3) | 488 (90.5) |
| 6–12 | 8 (6.5) | 3 (2.5) | 19 (3.5) | 16 (3.0) |
| >12 | 19 (15.3) | 12 (9.9) | 44 (8.2) | 35 (6.5) |
| Histology | ||||
| Squamous cell | 21 (16.9) | 25 (20.7) | 87 (16.1) | 97 (18.0) |
| Adenocarcinoma | 78 (62.9) | 68 (56.2) | 331 (61.4) | 323 (59.9) |
| Large cell | 13 (10.5) | 12 (9.9) | 56 (10.4) | 43 (8.0) |
| Other | 12 (9.7) | 16 (13.2) | 65 (12.1) | 76 (14.1) |
| Weight loss* | ||||
| Yes | 39 (31.5) | 38 (31.4) | 169 (31.5) | 165 (30.6) |
| No | 85 (68.5) | 83 (68.6) | 368 (68.5) | 374 (69.4) |
| Cancer stage | ||||
| IIIB | 20 (16.1) | 10 (8.3) | 96 (17.8) | 84 (15.6) |
| IV | 104 (83.9) | 111 (91.7) | 443 (82.2) | 455 (84.4) |
| Disease measurability | ||||
| Measurable | 114 (91.9) | 113 (93.4) | 504 (93.3) | 506 (93.9) |
| Nonmeasurable | 10 (8.1) | 8 (6.6) | 36 (6.7) | 33 (6.1) |
NOTE: All data n (%), unless otherwise noted.
Abbreviations: EGOG, Eastern Cooperative Oncology Group.
*
Lost >5 lbs in last 6 mo.