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.