Table 3: Phase II trials with Gefitinib as single agent in “selected” patients with NSCLC.

Author (yr)SettingPtsTreatmentResultsToxicity

Asahina et al. (2006) [44]Chemonaive, EGFR mutation16Gefitinib 250 mgRR: 75%; PFS: 8.9 months, 1 yr OS: 88%Rash, hepatotoxicity
Inoue et al. (2006) [45]Chemonaive, EGFR mutation16Gefitinib 250 mgRR: 75%; PFS: 9.7 months; 1 yr OS: 88%Skin toxicity, stomatitis, diarrhea
Yang et al. (2008) [46]Chemonaive, EGFR mutation55Gefitinib 250 mgRR: 84.2%; PFS: 8.9 months, OS: 24 monthsSkin toxicity, hepatotoxicity, diarrhea
Sequist et al. (2008) [47]Chemonaive, EGFR mutation31Gefitinib 250 mgRR: 55%; PFS: 9.2 months, OS: 17.5 monthsSkin toxicity, diarrhea, nausea, fatigue
Sutani et al. (2006) [48]1st-2nd line, EGFR mutation27Gefitinib 250 mgRR: 78%; PFS: 9.4 months, OS: 15.4 monthsDiarrhea, skin toxicity
Yoshida et al. (2007) [49]Chemonaive, EGFR mutation21Gefitinib 250 mgRR: 90%; TTP: 7.7 monthsSkin toxicity, diarrhea, hepatotoxicity
Sunaga et al. (2007) [50]Chemonaive, EGFR mutation19Gefitinib 250 mgRR: 76%; DSR: 90%; TTP: 12.9 monthsSkin toxicity
Tamura et al. (2008) [51]Chemonaive, EGFR mutation27Gefitinib 250 mgRR: 75%; DSR: 96%; PFS: 11.5 months,1 yr OS: 79%Skin toxicity, hepatotoxicity, stomatitis, diarrhea
Sugio et al. (2009) [52]Chemonaive, EGFR mutation19Gefitinib 250 mgRR: 63.2%; PFS 7.1 months, OS: 20 monthsSkin toxicity, nail change
Inoue et al. (2009) [53]Chemonaive, EGFR mutation and poor PS30Gefitinib 250 mgRR: 66%, DSR 90%, PFS 6.5 months, OS 17.8 months, PS improvement rate: 79%Hepatotoxicity, anemia, skin toxicity
Cappuzzo et al. (2007) [54]FISH positive or never smokers42Gefitinib 250 mgRR: 47.6%; PFS: 6.4 months; 1 y OS: 64%.Skin toxicity, diarrhea
West et al. (2006) [55]Brochoalveolar carcinoma, 1st-2nd line91Gefitinib 500 mgRR: 9% and OS 13 months in 2nd line; RR 17% and OS 13 months in 1st lineSkin toxicity, diarrhea
D. H. Lee et al. (2005) [56]Adenocarcinoma and never smokers37Gefitinib 250 mgRR: 69%; PFS: 33 weeks; 1 yr OS: 73%Skin toxicity, diarrhea

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