Table 2. Patient Response by intent to treat and EGFR mutation status.
| All patients | Erlotinib + celecoxib (n= 54) |
Erlotinib + placebo (n= 53) |
|---|---|---|
| CR/PR (%) | 12 (22.6) | 17 (32.7) |
| SD (%) | 22 (41.5) | 13 (25) |
| PD (%) | 19 (35.8) | 22 (42.3) |
| DCR (CR/PR/SD) (%) | 34 (64) | 30 (57.7) |
| EGFR wild type | Erlotinib + celecoxib (n= 30) |
Erlotinib + placebo (n= 27) |
| CR/PR (%) | 3 (10) | 0 (0) |
| SD (%) | 12 (40) | 10 (37) |
| PD (%) | 15 (50) | 17 (63) |
| DCR (CR/PR/SD) (%) | 15 (50) | 10 (37) |
| PFS (mo) | 3.2 (1.7-6.7) | 1.8 (1.7-3.5) |
| HR (95% CI) | 0.54 (0.30-0.97), p= 0.03 | |
| EGFR mutation positive | Erlotinib + celecoxib (n= 12) |
Erlotinib + placebo (n= 14) |
| CR/PR (%) | 5 (41.7) | 9 (64.3) |
| SD (%) | 6 (50) | 4 (29) |
| PD (%) | 1 (8) | 1 (7) |
| DCR (CR/PR/SD) (%) | 11 (91.7) | 13 (92.9) |
| PFS (mo) | 9.2 (5.4-16.5) | 9.2 (4.8-10.8) |
| HR (95% CI) | 0.98 (0.41-2.39), p= 0.97 | |
| EGFR not available | Erlotinib + celecoxib (n= 11) |
Erlotinib + placebo (n= 12) |
| CR/PR (%) | 1 (9) | 2 (16.7) |
| SD (%) | 5 (45.5) | 4 (33.3) |
| PD (%) | 5 (45.5) | 6 (50) |
| DCR (CR/PR/SD) (%) | 6 (54.6) | 6 (50) |
| PFS (mo) | 2.8 (1.0-8.0) | 2.9 (1.8-11.5) |
| HR (95% CI) | 1.48 (0.62-3.5), p= 0.36 | |
CR, complete response; PR, partial response; SD, stable disease; PD, progressive disease; DCR (disease control rate); PFS, progression free survival; HR, hazard ratio.