Table 1: Phase II clinical trials with Gefitinib as single agent in “unselected” NSCLC.

Author (yr)SettingDesignPtsGefitinib doseResultsToxicity

Fukuoka et al. (2003) [15]Pretreated with 1-2 linesRandomized phase 2210250 mg versus 500 mgRR: 18.4% (250 mg) versus 19% (500 mg); PFS: 2.7 versus 2.8 monthsDiarrhea, rash and other skin events
Kris et al. (2003) [16]Pretreated with 2-3 linesRandomized phase 2221250 mg versus 500 mgRR: 12 versus 9%; OS: 7 versus 6 monthsDiarrhea, rash and other skin events
D’Addario et al. (2008) [17]ChemonaivePhase 2, single arm63250 mgRR: 9.5 %; DSR at 12 weeks: 38%Rash and other skin events, hepatotoxicity
Wan et al. (2006) [18]Not fit for chemo or pretreatedPhase 2, single arm151250 mgRR: 29.8%; TTP: 12 months; 1 yr OS: 57%Rash, diarrhea, nasal/oral mucosa bleeding
Lin et al. (2006) [19]ChemonaivePhase 2, single arm53250 mgRR: 32.1%; TTP: 12 months; OS: 15.3 months; 1 yr OS: 57%Skin toxicity, diarrhea, nail change, ILD
Niho et al. (2006) [20]ChemonaivePhase 2, single arm42250 mgRR: 30%; OS: 13.9 months; 1 yr OS: 55%Rash and other skin events, ILD
Reck et al. (2006) [21]ChemonaivePhase 2, single arm58250 mgRR: 5%; TTP: 1.8 months; OS: 7.3 monthsSkin toxicity and diarrhea
Suzuki et al. (2006) [22]ChemonaivePhase 2, single arm34250 mgRR: 26.5%; OS: 14 months; 1 yr OS: 58.2%Rash, fatigue, hepatotoxicity
Spigel et al. (2005) [23]ChemonaivePhase 2, single arm70250 mgRR: 4%; TTP: 3.7 months; OS: 6.3 months; 1 yr OS: 24%Rash and diarrhea

RR: response rate; PFS: progression-free survival; OS: overall survival; DSR: disease stabilization rate; TTP: time to progression; ILD: interstitial lung disease.