Study ID | Diagnosis (no. of patients) |
Sub-groups | N | Tumor Response | ||||
---|---|---|---|---|---|---|---|---|
% CR | % PR | % SD | % DP | % NE | ||||
Phase III | ||||||||
Shepherd, et al., 200424,25 | NSCLC (~750) |
Placebo Erlotinib |
211 427 |
< 1 1 |
< 1 8 |
27 35 |
57 38 |
15 18 |
ISEL press release, 200426 | NSCLC (1692) |
Placebo Gefitinib |
NR NR |
- - | - - 8.2 |
Better in drug arm a |
Better in drug arm a |
- - |
Phase II | ||||||||
Kris, et al., 200329 | NSCLC (216) [Gefitinib] |
250-mg dose 500-mg dose |
102 114 |
0 0 |
12 9 |
- - | - - | - - |
Fukuoka, et al., 200330 | NSCLC (210) [Gefitinib] |
250-mg dose 500-mg dose |
104 106 |
0 1 |
18.5 18.1 |
35.9 32.4 |
40.8 41.9 |
4.9 6.7 |
Perez-Soler, et al., 200431 | NSCLC (57) [Erlotinib] |
- - | 57 | 3.5 | 8.8 | 35.1 | 49.1 | 3.5 |
Cappuzzo, et al., 200445 | NSCLC (40) [Gefitinib] |
- - | 40 | 2.5 | 2.5 | 45 | - - | - - |
Barlesi, et al., 200546 | NSCLC (51) [Gefitinib] |
- - | 51 | 0 | 11.7 | 58.9 | - - | - - |
Felip, et al., 200528 | NSCLC (59) [Erlotinib] |
- - | 52 | 0 | 10 | 36 | 48 | 3 |
a Quantitative data not reported in available data (AstraZeneca press release on ISEL study).
Abbreviations: CR = complete response; DP = disease progression; EGFR-TK = epidermal growth factor receptor tyrosine kinase; ISEL = Iressa Survival Evaluation in Lung cancer trial; NE = not evaluable; NSCLC = non-small cell lung cancer; no. = number; PR = partial response; SD = stable disease