|
| Author (yr) | Setting | Design | Pts | Gefitinib dose | Results | Toxicity |
|
| Fukuoka et al. (2003) [15] | Pretreated with 1-2 lines | Randomized phase 2 | 210 | 250 mg versus 500 mg | RR: 18.4% (250 mg) versus 19% (500 mg); PFS: 2.7 versus 2.8 months | Diarrhea, rash and other skin events |
| Kris et al. (2003) [16] | Pretreated with 2-3 lines | Randomized phase 2 | 221 | 250 mg versus 500 mg | RR: 12 versus 9%; OS: 7 versus 6 months | Diarrhea, rash and other skin events |
| D’Addario et al. (2008) [17] | Chemonaive | Phase 2, single arm | 63 | 250 mg | RR: 9.5 %; DSR at 12 weeks: 38% | Rash and other skin events, hepatotoxicity |
| Wan et al. (2006) [18] | Not fit for chemo or pretreated | Phase 2, single arm | 151 | 250 mg | RR: 29.8%; TTP: 12 months; 1 yr OS: 57% | Rash, diarrhea, nasal/oral mucosa bleeding |
| Lin et al. (2006) [19] | Chemonaive | Phase 2, single arm | 53 | 250 mg | RR: 32.1%; TTP: 12 months; OS: 15.3 months; 1 yr OS: 57% | Skin toxicity, diarrhea, nail change, ILD |
| Niho et al. (2006) [20] | Chemonaive | Phase 2, single arm | 42 | 250 mg | RR: 30%; OS: 13.9 months; 1 yr OS: 55% | Rash and other skin events, ILD |
| Reck et al. (2006) [21] | Chemonaive | Phase 2, single arm | 58 | 250 mg | RR: 5%; TTP: 1.8 months; OS: 7.3 months | Skin toxicity and diarrhea |
| Suzuki et al. (2006) [22] | Chemonaive | Phase 2, single arm | 34 | 250 mg | RR: 26.5%; OS: 14 months; 1 yr OS: 58.2% | Rash, fatigue, hepatotoxicity |
| Spigel et al. (2005) [23] | Chemonaive | Phase 2, single arm | 70 | 250 mg | RR: 4%; TTP: 3.7 months; OS: 6.3 months; 1 yr OS: 24% | Rash and diarrhea |
|
