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760
Interim analysis after 340 deaths: HR of
death 1.40 in experimental arm (P=0.002);
OS 10.8 mos (standard arm) vs. 7.7 mos
(experimental arm)
7
Unselected, stage
IIIB/IV
Erlotinib followed at progression
by Cisplatin-Gemcitabine
(experimental arm) vs. CisplatinGemcitabine followed at
progression by Erlotinib
(standard arm)
Cisplatin-Gemcitabine ±
Gefitinib
1,093
8
INTACT-2
Unselected, stage
IIIB/IV
Carboplatin-Paclitaxel ±
Gefitinib
1,037
IPASS
East Asian, nonor former light
smoker, stage
IIIB/IV, adenoca
Stage IIIB/IV,
EGFR mutant in
Japan
Korean, neversmoker, stage
IIIB/IV
Stage IIIB/IV,
EGFR mutant in
Japan
Gefitinib vs.
Carboplatin-Paclitaxel
1,217
OS 9.9 mos (gefitinib 500 mg/d) vs. 9.9 mos
(Gefitinib 250 mg/d) vs. 10.9 mos (placebo)
(P=0.46)
OS 8.7 mos (gefitinib 500 mg/d) vs. 9.8 mos
(gefitinib 250 mg/d) vs. 9.9 mos (placebo)
(P=0.64)
PFS: 12-mo PFS rate 24.9% (gefitinib) vs.
6.7% (chemo) (P<0.001)
Gefitinib vs. Cisplatin-Docetaxel
172
PFS 9.2 mos (Gefitinib) vs. 6.3 mos (chemo)
(P<0.001)
11
Gefitinib vs. CisplatinGemcitabine
313
OS 20.3 mos (Gefitinib) vs. 23.1 mos
(chemo) (P=0.43)
12
Gefitinib vs. CarboplatinPaclitaxel
200
13
EGFR+, stage
IIIB/IV
Unselected, stage
IIIB/IV
Cisplatin-Vinorelbine ±
Cetuximab
Carboplatin-Taxane ±
Cetuximab
1,125
Unselected, stage
IV or recurrent
disease after prior
surgery and/or
irradiation
Carboplatin-PaclitaxelBevacizumab ± Cetuximab
Enrolling
PFS 10.8 mos (gefitinib) vs. 5.4 mos (chemo
alone) (P<0.001)
[Secondary endpoints: RR 73.7% (Gefitinib)
vs. 30.7% (chemo) (P<0.001); OS 30.5 mos
(Gefitinib) vs. 23.6 mos (chemo) (P=0.31)
OS 11.3 mos (chemo + Cetuximab) vs. 10.1
mos (chemo alone) (P=0.04)
PFS 4.4 mos (chemo + Cetuximab) vs. 4.24
mos (chemo alone) (P=0.236) [Secondary
endpoint OS 9.69 mos (chemo + Cetuximab)
vs. 8.38 mos (chemo alone) (P=0.169)
OS and PFS
Unselected, stage
4 cycles platinum doublet
889
PFS 12.3 weeks (Erlotinib) vs. 11.1 weeks
16
TORCH
Unselected, stage
IIIB/IV
INTACT-1
WJTOG3405
First-SIGNAL
NEJ002
FLEX
BMS 099
SWOG
NCT00946712
Maintenance — Advanced
SATURN
EGFR
676
4
9
10
14
15
1
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