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. 2010 Dec 1;10(24):1–48.

Table 2: Characteristics of the studies included in the review: EGFR mutation testing as a predictor of response to gefitinib compared with chemotherapy in the first-line setting.


Author, year
Patient selection Design Tissue
available/
pts treated
Mutated/
assessable
pts (%)
Median PFS, ORR, OS
[p-value]
Subset analyses of the phase III trials for selected patients based on clinical characteristics
EGFR Mutated EGFR Wild-type
G C+P G C+P

Mok, 2009
IPASS
(n=1217)
Asian 99.7%
Female 79%
Non- or former light
smokers 99.8%
Adenocarcinoma 96.3%

Gefitinib vs. carboplatin/
paclitaxel
Phase III RCT


683/1217
(56%)


261/437
(60%)
PFS
HR, 0.48 (0.36-0.64)
ORR
71.2 vs. 47.3
OS
HR, 0.78 (0.50-1.20)
PFS
HR, 2.85 (2.05-3.98)
ORR
1.1 vs. 23.5
OS
HR, 1.39 (0.92-2.09)
G Cis+G G Cis+G

Lee, 2009
FIRST-SIGNAL
(n=309)


Asian
Female
Never-smokers
Adenocarcinoma



Gefitinib vs. cisplatin-
gemcitabine
Phase III RCT



92/309
(30%)



42/96
(44%)
PFS
8.5 vs. 6.7 months
HR, 0.61 (95%CI, 0.31-1.22)
ORR
84.6 vs. 37.5
[0.002]
OS
30.6 vs. 26.5 months
HR, 0.82 (95%CI, 0.35-1.92)





NR
Subset analyses of phase III trials pf patients selected according to EGFR mutation status
G C+P G C+P

Maemondo, 2010
NEJ002
(n=230)

Asian 100%
Female 64%
Never-smokers 62%
Adenocarcinoma 93%


Gefitinib vs. Carboplatin/
paclitaxel
Phase III RCT
PFS
10.8 vs. 5.4 months
HR, 0.30 (95%CI, 0.22-0.41)
ORR
73.7% vs. 30.7%
OS
30.5 vs. 23.6 months
[NS]




0
G Cis+D G Cis+D

Mitsudomi, 2010
WJTOG3405
(n=177)

Asian 100%
Female 69%
Never-smokers 69%
Adenocarcinoma 98%
Gefitinib vs. cisplatin-
docetaxel
Asian, female,
adendocarcinoma
Never-smoker
PFS
9.2 vs. 6.3 months
HR, 0.48 (95%CI, 0.33-0.71)
ORR
62.1% vs. 32.2%
[P<0.0001]



0

Abbreviations: PFS, Progression-free survival; ORR, Objective response rate; OS, overall survival; HR, Hazard ratio; G, gefitinib; C, Cisplatin; P, paclitaxel; Cis, Cisplatin; D, docetaxel; NR, Not reported.