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Table 8. Summary of Tumor Response in Studies of Second-line Treatment With EGFR-TK Inhibitors for Advanced NSCLC
| 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
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