| Study name |
Setting |
Treatment |
Pts
(n) |
RR (CR+PR)
(%) |
mPFS
(months) |
mOS
(months) |
IDEAL-1
(phase II) |
2nd and 3rd-line |
gefitinib (250 mg)
(500 mg) |
103
106 |
18.4
19.0 |
2.7
2.8 |
7.6
8.0 |
IDEAL-2
(phase II) |
3rd-line |
gefitinib (250 mg)
(500 mg) |
102
114 |
12
9 |
N.R.
N.R. |
7.0
6.0 |
ISEL
(phase III) |
2nd and 3rd-line |
gefitinib (250 mg)
placebo |
1129
563 |
8 (p<0.0001)
1 |
N.R
N.R. |
5.6
5.1 |
BR.21
(phase III) |
2nd and 3rd-line |
erlotinib (150 mg)
placebo |
448
243 |
9 (p<0.0001)
<1 |
2.2 (p<0.001)
1.8 |
6.7 (p=0.001)
4.7 |
IPASS
(phase III) |
1st-line
EGFR
Mutation positive patients |
gefitinib (250 mg)
chemotherapy |
609
608 |
43 (p<0.001)
32.2 |
5.7
5.8 |
18.6
17.3 |
gefitinib (250 mg)
chemotherapy |
132
129 |
71.2 (p<0.001)
47.3 |
9.5 (p<0.001)
6.3 |
N.R
N.R. |
RR: response rate, CR: complete response, PR: partial response, mPFS: median progression free survival, mOS: median overall survival, N.R.: not reported |
