Table 1.
Baseline Patient Demographics and Characteristics
| EGFR FISH+ Patients | All Patients | |||
|---|---|---|---|---|
| % (n) | Control (n=201) |
+ Cetuximab (n=199) |
Control (n=657) |
+ Cetuximab (n=656) |
| Age (median, range) | 64 (34 – 84) | 62 (37 – 80) | 63 (30 – 86) | 63 (19 – 84) |
| >65 years | 94 (47) | 78 (39) | 278 (42) | 275 (42) |
| Sex | ||||
| Male | 57 (115) | 63 (125) | 55 (359) | 59 (385) |
| Female | 43 (86) | 37 (74) | 45 (298) | 41 (271) |
| M-stage | ||||
| M1a | 27 (54) | 22 (43) | 45 (297) | 45 (292) |
| M1b | 73 (147) | 78 (156) | 46 (303) | 46 (305) |
| Bevacizumab treatment | ||||
| Bevacizumab | 40 (80) | 44 (87) | 42 (277) | 43 (283) |
| No Bevacizumab | 60 (121) | 56 (112) | 58 (380) | 57 (373) |
| Smoking History | ||||
| Current | 44 (89) | 47 (94) | 45 (297) | 45 (292) |
| Former | 47 (94) | 44 (87) | 46 (303) | 46 (305) |
| Never | 9 (18) | 9 (18) | 9 (57) | 9 (59) |
| Histology | ||||
| SC | 28 (56) | 28 (55) | 25 (161) | 24 (160) |
| Adenocarcinoma | 60 (120) | 65 (130) | 62 (408) | 63 (411) |
| Other* | 12 (25) | 7 (14) | 13 (88) | 13 (85) |
| Performance Status** | ||||
| 0 | 32 (64) | 41 (81) | 35 (229) | 39 (256) |
| 1 | 68 (137) | 59 (118) | 65 (427) | 61 (400) |
| EGFR FISH Status† | ||||
| EGFR-FISH+ | 201 (100%) | 199 (100%) | 31 (201) | 30 (199) |
| EGFR FISH-negative | – | – | 45 (293) | 43 (283) |
| EGFR FISH-unknown | – | – | 25 (163) | 27 (174) |
*
Includes large cell, BAC, mixed, other, and not reported;
**
One patient on the Control arm was missing documentation.
†
In the control and cetuximab arms, EGFR FISH analysis failed in 4% and 5% of patients, there was inadequate specimen in 12% and 11% of cases, and there were no data in 9% and 10% of cases, respectively.