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Table 9. Summary of Survival in Studies of Second-line Treatment With EGFR Inhibitors for Advanced NSCLC

Study ID Diagnosis
(no. of patients)
Sub-groups Survival from Start of Treatment Progression-free Survival
Median (months) 1-year
(%)
HR (95% CI)
[p-value]
Median TTP
(months)
1-year
(%)
HR (95% CI)
[p-value]
Phase III
Shepherd, et al., 200424,25 NSCLC
(~750)
Placebo
Erlotinib
4.7
6.7
22
31
0.70 (0.58-
0.85)
[p = 0.001]
1.8
2.2
- -
- -
0.61 (0.51-
0.74)
[p < 0.001]
ISEL press release, 200426 NSCLC
(1692)
Placebo—all
Gefitinib—all

Placebo—adeno
Gefitinib—adeno
5.1
5.6

5.4
6.3
- -
- -

- -
- -
0.89
[p = 0.11]

0.83
[p = 0.07]
- -
- -

- -
- -
- -


- -
- -
- -


- -
Phase II
Kris, et al., 200329 NSCLC
(216)
[Gefitinib]
250-mg dose
500-mg dose
7
6
27
25
- - - -
- -
- -
- -
- -
Fukuoka, et al., 200330 NSCLC
(210)
[Gefitinib]
250-mg dose
500-mg dose
7.6
8
35
29
- - 2.7
2.8
- -
- -
- -
Perez-Soler, et al., 200431 NSCLC
(57)
[Erlotinib]
- - 8.4 40 - - 2.1 - - - -
Cappuzzo, et al., 200445 NSCLC
(40)
[Gefitinib]
- - 5 - - - - 3 - - - -
Barlesi, et al., 200546 NSCLC
(51)
[Gefitinib]
- - 4 - - - - - - - - - -

Abbreviations: adeno = adenocarcinoma; EGFR = epidermal growth factor receptor; HR = hazard ratio; ISEL = Iressa Survival Evaluation in Lung cancer trial; no. = number; NSCLC = non-small cell lung cancer; TTP = time to progression.

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