Table 2.
Patient and tumor characteristics by FISH status
EGFR FISH (+) | EGFR FISH (−) | |||
---|---|---|---|---|
Placebo (n = 57) | Erlotinib (n = 43) | Placebo (n = 67) | Erlotinib (n = 78) | |
Age (y) | ||||
Median | 65 | 67 | 65 | 62 |
Range | 40–82 | 24–81 | 36–80 | 35–79 |
Sex | ||||
Male | 33 (57.9) | 19 (44.2) | 41 (61.2) | 46 (59.0) |
Female | 24 (42.1) | 24 (55.8) | 26 (38.8) | 32 (41.0) |
Ethnicity | ||||
Caucasian | 53 (93) | 36 (83.7) | 64 (95.5) | 67 (85.9) |
Asian or Pacific Islander | 3 (5.3) | 1 (2.3) | 0 (0.0) | 3 (3.8) |
Other | 1 (1.8) | 6 (14.0) | 3 (4.5) | 8 (10.3) |
Smoking history | ||||
Never | 5 (8.8) | 4 (9.3) | 2 (3.0) | 8 (10.3) |
Current | 3 (5.3) | 7 (16.3) | 16 (23.9) | 12 (15.4) |
Previous | 49 (86.0) | 32 (74.4) | 49 (73.1) | 58 (74.4) |
Baseline ECOG | ||||
0 | 22 (38.6) | 13 (30.2) | 21 (31.3) | 34 (43.6) |
1 | 35 (61.4) | 30 (69.8) | 46 (68.7) | 44 (56.4) |
2 | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
Prior radiotherapy | ||||
Yes | 12 (21.1) | 15 (34.9) | 17 (25.4) | 17 (21.8) |
No | 45 (78.9) | 28 (65.1) | 50 (74.6) | 61 (78.2) |
Cancer type | ||||
Metastatic disease | 48 (84.2) | 41 (95.3) | 57 (85.1) | 70 (89.7) |
Local advanced disease | 9 (15.8) | 2 (4.7) | 10 (14.9) | 8 (10.3) |
Months since initial NSCLC diagnosis | ||||
<6 | 47 (82.5) | 39 (90.7) | 50 (74.6) | 67 (85.9) |
6–12 | 4 (7.0) | 1 (2.3) | 4 (6.0) | 2 (2.6) |
>12 | 6 (10.5) | 3 (7.0) | 13 (19.4) | 9 (11.5) |
Histology | ||||
Squamous cell | 7 (12.3) | 9 (20.9) | 14 (20.9) | 16 (20.5) |
Adenocarcinoma | 40 (70.2) | 25 (58.1) | 38 (56.7) | 43 (55.1) |
Large cell | 3 (5.3) | 3 (7.0) | 10 (14.9) | 9 (11.5) |
Other | 7 (12.3) | 6 (14.0) | 5 (7.5) | 10 (12.8) |
Weight loss* | ||||
Yes | 21 (36.8) | 13 (30.2) | 18 (26.9) | 25 (32.1) |
No | 36 (63.2) | 30 (69.8) | 49 (73.1) | 53 (67.9) |
Disease measurability | ||||
Measurable | 54 (94.7) | 30 (90.7) | 60 (89.6) | 74 (94.9) |
Nonmeasurable | 3 (5.3) | 4 (9.3) | 7 (10.4) | 4 (5.1) |
Cancer stage | ||||
IIIB | 10 (17.5) | 2 (4.7) | 10 (14.9) | 8 (10.3) |
IV | 47 (82.5) | 41 (95.3) | 57 (85.1) | 70 (89.7) |
EGFR mutation | ||||
N | 43 | 32 | 49 | 55 |
Yes | 13 (30.2) | 11 (34.4) | 3 (6.1) | 3 (5.5) |
No | 30 (69.8) | 21 (65.6) | 46 (93.9) | 52 (94.5) |
K-ras mutation | ||||
n | 46 | 34 | 55 | 57 |
Yes | 12 (26.1) | 3 (8.8) | 12 (21.8) | 15 (26.3) |
No | 34 (73.9) | 31 (91.2) | 43 (78.2) | 42 (73.7) |
Lost >5 lbs in last 6 mo.