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Table 3. Summary of Tumor Response in Studies of First-line Treatment With EGFR-TK Inhibitors Combined With Cytotoxic Agents for patients With Advanced NSCLC
| 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
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