Table 2: Randomized clinical trials with Gefitinib in unselected NSCLC.

Author (yr)SettingDesignPtsTreatmentRR (%)PFS (mos)OS (mos)

Giaccone et al. (2004) [24]ChemonaivePhase 31093CIS/GEM + gefitinib 500 versus CIS/GEM + gefitinib 250 versus CIS/GEM + placebo50.3 versus 51.2 versus 47.2
ns
5.5 versus 5.8 versus 6.0 9.9 versus 9.9 versus 10.9
Herbst et al. (2004) [25]ChemonaivePhase 31037Carbo/taxol + gefitinib 500 versus Carbo/taxol + gefitinib 250 versus Carbo/taxol + placebo30 versus 30.4 versus 28.7
ns
4.6 versus 5.3 versus 5.0 8.7 versus 9.8 versus 9.9
Takeda et al. (2010) [29]ChemonaivePhase 3604CIS/GEM × 3 → gefitinib versus CIS/GEM × 634.2 versus 29.3 4.6 versus 4.3 HR: 0.68, 95% CI 0.57–0.80, 13.7 versus 12.9 HR 0.86, 95% CI 0.72–1.03,

Thatcher et al. (2005) [30]Pretreated with 1-2 linesPhase 31692Gefitinib 250 mg + BSC versus placebo + BSC8 versus 1.3 3 versus 2.6 HR: 0.82, 95% CI 0.73–0.92, 5.6 versus 5.1 HR: 0.89, 95% CI 0.77–1.02,
Cufer et al. (2006) [32]Second lineRandomized phase 2133Gefitinib 250 mg versus Docetaxel 75 mg/mq13.2 versus 13.7 HR 0.98, 95% CI 0.47–2.033 versus 3.4 HR: 0.94, 95% CI 0.64–1.397.5 versus 7.1 HR: 0.97, 95% CI 0.61–1.52
Kim et al. (2008) [33]Pretreated with 1-2 linesPhase 31466Gefitinib 250 mg versus Docetaxel 75 mg/mq9.1 versus 7.6 2.2 versus 2.7 HR: 1.04, 95% CI 0.93–1.18, 7.6 versus 8.0 HR: 1.020, 95% CI 0.905–1.150
Maryuama et al. (2008) [35]Pretreated with 1-2 linesPhase 3489Gefitinib 250 mg versus Docetaxel 60 mg/mq22.5 versus 12.8 2 versus 2 HR: 0.90, 95% CI 0.72–1.12, 11.5 versus 14 HR: 1.12, 95% CI 0.89–1.40,
D. H. Lee et al. (2010) [36]Second linePhase 3161Gefitinib 250 mg versus Docetaxel 60 mg/mq28.1 versus 7.6 3.3 versus 3.4 HR 0.729, 95% CI 0.533–0.998, HR: 0.870, 95% CI 0.613–1.236,

Crinò et al. (2008) [40]Chemonaive ≥70 yrsRandomized phase 2196Gefitinib 250 mg versus Vinorelbine 30 mg/mq 1–83.1 versus 5.12.7 versus 2.9 HR:1.19, 95% CI 0.85–1.655.9 versus 8 HR: 0.98, 95% CI 0.66–1.47
G. Goss et al. (2009) [41]Chemonaive PS 2-3Randomized phase 2201Gefitinib 250  mg + BSC versus Placebo + BSC6% versus 1% OR: 6.57, 95% CI 0.74–58.171,4 versus 1,3 HR: 0.82, 95% CI 0.60–1.123.7 versus 2.8 HR:0.84, 95% CI 0.62–1.15

Kelly et al. (2008) [39]Maintenance after chemo-radio Inoperable stage IIIPhase 3243Gefitinib 500/250 mg versus Placebo8.3 versus 11.7 HR: 0.80, 95% CI 0.58–1.10, 23 versus 35.0 HR: 0.633, 95% CI 0.44–0.91,
G. D. Goss et al. (2010) [38]AdjuvantPhase 3503Gefitinib 250 mg versus Placebo4.2 yrs*versus nr HR: 1.22, 95% CI 0.93–1.61, 5.1 yrs* versus nr HR: 1.24, 95% CI 0.94–1.64,

CIS: cisplatin; Gem: gemcitabine; RR: response rate; PFS: progression-free survival; OS: overall survival; ns: not significant; nr: not yet reached; *disease-free survival.