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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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