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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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