Table 4: Characteristics of the studies included in the review: EGFR mutation testing as a predictor of response with gefitinib compared with chemotherapy in the second- or third-line setting.
| Author, year |
Patient selection |
Design | Tissue available/ pts treated |
Mutated/ assessa ble pts (%) |
Median PFS, ORR, OS [p-value] |
|||
|---|---|---|---|---|---|---|---|---|
| Mutated | Wild-type | |||||||
| G | D | G | D | |||||
|
Douilard, 2010 (n=1466) |
Caucasian 88% Female 35% Non- smokers 20% Adenocarcinoma 54% |
Gefitinib vs. docetaxel Phase III trial |
297/1466 (20%) |
44/297 (15%) |
PFS 7.0 vs. 4.1 months HR, 0.16 (95%CI, 0.05-0.49) ORR 42.1% vs. 21.1 [0.04] |
PFS 1.7 vs. 2.6 months HR, 1.24 (95%CI, 0.94-1.64) ORR 6.6% vs. 9.8% [0.37] |
||
|
Hirsch, 2006 (n=1692) |
Caucasian 93% Female 36% Non-smokers14% Adenocarcinoma 50% |
Gefitinib+ BSC vs. placebo+ BSC Phase III trial |
215/1692 (12%) |
26/215 (12%) |
ORR 37.5% vs. 2.6% [0.04] |
NR |
||
Abbreviations: PFS, Progression-free survival; ORR, Objective response rate; OS, overall survival; HR, Hazard ratio; G, gefitinib; D, Docetaxel; NR, not reported.