Study ID | Diagnosis (no. of patients) |
Chemotherapy (all patients) |
Sub-groups | Tumor response | ||||
---|---|---|---|---|---|---|---|---|
% CR | % PR | % SD | % DP | % NE | ||||
Phase III | ||||||||
Herbst, et al., 20066 | NSCLC (345) (345) (347) |
Carboplatin AUC 6 mg/ml x min and paclitaxel 225 mg/m2 x 6 cycles |
Placebo Gefitinib 250 mg/day Gefitinib 500 mg/day |
1.2 2.6 0.6 |
28.7 30.4 30.0 |
- - - - - - |
- - - - - - |
- - - - - - |
Giaccone, et al., 20047 | NSCLC (363) (365) (365) |
Cisplatin 80 mg/m2 and gemcitabine 1250 mg/m2 x 6 cycles |
Placebo Gefitinib 250 mg/day Gefitinib 500 mg/day |
0.9 3.3 2.1 |
46.3 47.9 48.2 |
- - - - - - |
- - - - - - |
- - - - - - |
Miller, et al., 20048 | NSCLC (533) (526) |
Carboplatin/ paclitaxel (6 cycles) |
Placebo Erlotinib 150 mg/day |
No differences between groups |
- - - - |
- - - - |
- - - - |
- - - - |
Gatzemeier, et al., 20049 | NSCLC (~575) (~575) |
Cisplatin 80 mg/m2 and gemcitabine 1250 mg/m2 x 6 cycles |
Placebo Erlotinib 150 mg/day |
NR |
NR |
NR |
NR |
NR |
Phase II | ||||||||
Williams, et al., 200410 | NSCLC (12) |
Docetaxel 75 mg/m2 every 3 weeks |
Gefitinib 250 mg/day | 0 | 0 | 30 | 20 | - - |
Abbreviations: CR = complete response; DP = disease progression; EGFR-TK = epidermal growth factor receptor tyrosine kinase; NE = not evaluable; NSCLC = non-small cell lung cancer; no. = number; PR = partial response; SD = stable disease